Gardasil

Dosage Form: injection, suspension
FULL PRESCRIBING INFORMATION

Indications and Usage for Gardasil

Girls and Women

Gardasil®1 is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

•  Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18


• Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

• Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS)


• Cervical intraepithelial neoplasia (CIN) grade 1


• Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3


• Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3


•  Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

Boys and Men

 Gardasil is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by HPV types included in the vaccine:

•  Anal cancer caused by HPV types 16 and 18


•  Genital warts (condyloma acuminata) caused by HPV types 6 and 11

 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

•  Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

Limitations of Gardasil Use and Effectiveness

  The health care provider should inform the patient, parent, or guardian that vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive Gardasil should continue to undergo cervical cancer screening per standard of care. [See Patient Counseling Information (17).]

 Recipients of Gardasil should not discontinue anal cancer screening if it has been recommended by a health care provider. [See Patient Counseling Information (17).]

  Gardasil has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity. [See Clinical Studies (14.4, 14.5).]

  Gardasil is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN.

  Gardasil has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. [See Clinical Studies (14.4, 14.5).]

  Not all vulvar, vaginal, and anal cancers are caused by HPV, and Gardasil protects only against those vulvar, vaginal, and anal cancers caused by HPV 16 and 18.

Gardasil does not protect against genital diseases not caused by HPV.

Vaccination with Gardasil may not result in protection in all vaccine recipients.

Gardasil Dosage and Administration

Dosage

Gardasil should be administered intramuscularly as a 0.5-mL dose at the following schedule: 0, 2 months, 6 months. [See Clinical Studies (14.8).]

Method of Administration

For intramuscular use only.

Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine. Gardasil should not be diluted or mixed with other vaccines. After thorough agitation, Gardasil is a white, cloudy liquid. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use the product if particulates are present or if it appears discolored.

Gardasil should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh.

Syncope has been reported following vaccination with Gardasil and may result in falling with injury; observation for 15 minutes after administration is recommended. [See Warnings and Precautions (5.1).]

Single-Dose Vial Use

Withdraw the 0.5-mL dose of vaccine from the single-dose vial using a sterile needle and syringe and use promptly.

Prefilled Syringe Use With and Without Needle Guard (Safety) Device

Prefilled Syringe With Needle Guard (Safety) Device

Instructions for using the prefilled single-dose syringes preassembled with needle guard (safety) device

NOTE: Please use the enclosed needle for administration. If a different needle is chosen, it should fit securely on the syringe and be no longer than 1 inch to ensure proper functioning of the needle guard device. Two detachable labels are provided which can be removed after the needle is guarded.

At any of the following steps, avoid contact with the Trigger Fingers to keep from activating the safety device prematurely.

Remove Syringe Tip Cap and Needle Cap. Attach Luer Needle by pressing both Anti-Rotation Tabs to secure syringe and by twisting the Luer Needle in a clockwise direction until secured to the syringe. Remove Needle Sheath. Administer injection per standard protocol as stated above under DOSAGE AND ADMINISTRATION. Depress the Plunger while grasping the Finger Flange until the entire dose has been given. The Needle Guard Device will NOT activate to cover and protect the needle unless the ENTIRE dose has been given. While the Plunger is still depressed, remove needle from the vaccine recipient. Slowly release the Plunger and allow syringe to move up until the entire needle is guarded. For documentation of vaccination, remove detachable labels by pulling slowly on them. Dispose in approved sharps container.

Prefilled Syringe Without Needle Guard (Safety) Device

This package does not contain a needle guard (safety device) or a needle. Shake well before use. Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Administer the entire dose as per standard protocol.

Dosage Forms and Strengths

Gardasil is a suspension for intramuscular administration available in 0.5-mL single dose vials and prefilled syringes. See Description (11) for the complete listing of ingredients.

Contraindications

Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of Gardasil. [See Description (11).]

Warnings and Precautions

Syncope

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with Gardasil. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.

Managing Allergic Reactions

Appropriate medical treatment and supervision must be readily available in case of anaphylactic reactions following the administration of Gardasil.

Adverse Reactions

Overall Summary of Adverse Reactions

Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with Gardasil.

Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with Gardasil and may result in falling with injury; observation for 15 minutes after administration is recommended. [See Warnings and Precautions (5.1).] 

Anaphylaxis has been reported following vaccination with Gardasil.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

Studies in Girls, Women, Boys, and Men 9 Through 26 Years of Age

In 6 clinical trials (4 Amorphous Aluminum Hydroxyphosphate Sulfate [AAHS]-controlled, 1 saline placebo-controlled, and 1 uncontrolled), 14,273 individuals were administered Gardasil or AAHS control or saline placebo on the day of enrollment, and approximately 2 and 6 months thereafter, and safety was evaluated using vaccination report cards (VRC)-aided surveillance for 14 days after each injection of Gardasil or AAHS control or saline placebo in these individuals. The individuals who were monitored using VRC-aided surveillance included 8180 individuals 9 through 26 years of age at enrollment who received Gardasil and 6093 individuals who received AAHS control or saline placebo. Few individuals (0.2%) discontinued due to adverse reactions. The race distribution of the girls and women in the safety population was as follows: 62.3% White; 17.6% Hispanic (Black and White); 6.8% Asian; 6.7% Other; 6.4% Black; and 0.3% American Indian. The race distribution of the boys and men in the safety population was as follows: 42.0% White; 19.7% Hispanic (Black and White); 11.0% Asian; 11.2% Other; 15.9% Black; and 0.1% American Indian.

Common Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age

The injection site adverse reactions that were observed among recipients of Gardasil at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 1.

Table 1: Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age*

Adverse Reaction (1 to 5 Days Postvaccination)	Gardasil (N = 5088) %	AAHS Control† (N = 3470) %	Saline Placebo (N = 320) %
* The injection-site adverse reactions that were observed among recipients of Gardasil were at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
Injection Site     Pain     Swelling     Erythema     Pruritus     Bruising	83.9 25.4 24.7 3.2 2.8	75.4 15.8 18.4 2.8 3.2	48.6 7.3 12.1 0.6 1.6

Common Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age

The injection site adverse reactions that were observed among recipients of Gardasil at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients are shown in Table 2.

Table 2: Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age*

Adverse Reaction (1 to 5 Days Postvaccination)	Gardasil (N = 3093) %	AAHS Control† (N = 2029) %	Saline Placebo (N = 274) %
* The injection-site adverse reactions that were observed among recipients of Gardasil were at a frequency of at least 1.0% and also at a greater frequency than that observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
Injection Site     Pain     Erythema     Swelling     Hematoma	61.4 16.7 13.9 1.0	50.8 14.1 9.6 0.3	41.6 14.5 8.2 3.3

Evaluation of Injection-Site Adverse Reactions by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of injection-site adverse reactions in girls and women by dose is shown in Table 3. Of those girls and women who reported an injection-site reaction, 94.3% judged their injection-site adverse reaction to be mild or moderate in intensity.

Table 3: Postdose Evaluation of Injection-Site Adverse Reactions in Girls and Women 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

	Gardasil (% occurrence)			AAHS Control* (% occurrence)			Saline Placebo (% occurrence)
* AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of individuals with follow-up ‡ Intensity of swelling and erythema was measured by size (inches): Mild = 0 to ≤1; Moderate = >1 to ≤2; Severe = >2.
Adverse Reaction	Post- dose 1 N† = 5011	Post- dose 2 N = 4924	Post- dose 3 N = 4818	Post- dose 1 N = 3410	Post- dose 2 N = 3351	Post- dose 3 N = 3295	Post- dose 1 N = 315	Post- dose 2 N = 301	Post- dose 3 N = 300
Pain Mild/Moderate Severe	63.4 62.5 0.9	60.7 59.7 1.0	62.7 61.2 1.5	57.0 56.6 0.4	47.8 47.3 0.5	49.6 48.9 0.6	33.7 33.3 0.3	20.3 20.3 0.0	27.3 27.0 0.3
Swelling‡ Mild/Moderate Severe	10.2 9.6 0.6	12.8 11.9 0.8	15.1 14.2 0.9	8.2 8.1 0.2	7.5 7.2 0.2	7.6 7.3 0.2	4.4 4.4 0.0	3.0 3.0 0.0	3.3 3.3 0.0
Erythema‡ Mild/Moderate Severe	9.2 9.0 0.2	12.1 11.7 0.3	14.7 14.3 0.4	9.8 9.5 0.3	8.4 8.4 0.1	8.9 8.8 0.1	7.3 7.3 0.0	5.3 5.3 0.0	5.7 5.7 0.0

Evaluation of Injection-Site Adverse Reactions by Dose in Boys and Men 9 Through 26 Years of Age

An analysis of injection-site adverse reactions in boys and men by dose is shown in Table 4. Of those boys and men who reported an injection-site reaction, 96.4% judged their injection-site adverse reaction to be mild or moderate in intensity.

Table 4: Postdose Evaluation of Injection-Site Adverse Reactions in Boys and Men 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

	Gardasil (% occurrence)			AAHS Control* (% occurrence)			Saline Placebo (% occurrence)
Adverse Reaction	Post- dose 1 N† = 3003	Post- dose 2 N = 2898	Post- dose 3 N = 2826	Post- dose 1 N = 1950	Post- dose 2 N = 1854	Post- dose 3 N = 1799	Post- dose 1 N = 269	Post- dose 2 N = 263	Post- dose 3 N = 259
* AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of individuals with follow-up ‡ Intensity of swelling and erythema was measured by size (inches): Mild = 0 to ≤1; Moderate = >1 to ≤2; Severe = >2.
Pain Mild/Moderate Severe	44.7 44.5 0.2	36.9 36.4 0.5	34.4 34.1 0.3	38.4 37.9 0.4	28.2 28.2 0.1	25.8 25.5 0.3	27.5 27.5 0.0	20.5 20.2 0.4	16.2 16.2 0.0
Swelling‡ Mild/Moderate Severe	5.6 5.3 0.2	6.6 6.2 0.3	7.7 7.1 0.5	5.6 5.4 0.2	4.5 4.5 0.0	4.1 4.0 0.1	4.8 4.8 0.0	1.5 1.5 0.0	3.5 3.1 0.4
Erythema‡ Mild/Moderate Severe	7.2 6.8 0.3	8.0 7.7 0.2	8.7 8.3 0.3	8.3 8.0 0.2	6.3 6.2 0.1	5.7 5.6 0.1	7.1 7.1 0.0	5.7 5.7 0.0	5.0 5.0 0.0

Common Systemic Adverse Reactions in Girls and Women 9 Through 26 Years of Age

Headache was the most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 28.2% and AAHS control or saline placebo = 28.4%). Fever was the next most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 13.0% and AAHS control or saline placebo = 11.2%).

Adverse reactions that were observed among recipients of Gardasil, at a frequency of greater than or equal to 1.0% where the incidence in the Gardasil group was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 5.

Table 5: Common Systemic Adverse Reactions in Girls and Women 9 Through 26 Years of Age (Gardasil ≥Control)*

Adverse Reactions (1 to 15 Days Postvaccination)	Gardasil (N = 5088) %	AAHS Control† or Saline Placebo (N = 3790) %
* The adverse reactions in this table are those that were observed among recipients of Gardasil at a frequency of at least 1.0% and greater than or equal to those observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
Pyrexia	13.0	11.2
Nausea	6.7	6.5
Dizziness	4.0	3.7
Diarrhea	3.6	3.5
Vomiting	2.4	1.9
Cough	2.0	1.5
Toothache	1.5	1.4
Upper respiratory tract infection	1.5	1.5
Malaise	1.4	1.2
Arthralgia	1.2	0.9
Insomnia	1.2	0.9
Nasal congestion	1.1	0.9

Common Systemic Adverse Reactions in Boys and Men 9 Through 26 Years of Age

Headache was the most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 12.3% and AAHS control or saline placebo = 11.2%). Fever was the next most commonly reported systemic adverse reaction in both treatment groups (Gardasil = 8.3% and AAHS control or saline placebo = 6.5%).

Adverse reactions that were observed among recipients of Gardasil, at a frequency of greater than or equal to 1.0% where the incidence in the group that received Gardasil was greater than or equal to the incidence in the AAHS control or saline placebo group, are shown in Table 6.

Table 6: Common Systemic Adverse Reactions in Boys and Men 9 Through 26 Years of Age (Gardasil ≥Control)*

Adverse Reactions (1 to 15 Days Postvaccination)	Gardasil (N = 3093) %	AAHS Control† or Saline Placebo (N = 2303) %
* The adverse reactions in this table are those that were observed among recipients of Gardasil at a frequency of at least 1.0% and greater than or equal to those observed among AAHS control or saline placebo recipients. † AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate
Headache	12.3	11.2
Pyrexia	8.3	6.5
Oropharyngeal pain	2.8	2.1
Diarrhea	2.7	2.2
Nasopharyngitis	2.6	2.6
Nausea	2.0	1.0
Upper respiratory tract infection	1.5	1.0
Abdominal pain upper	1.4	1.4
Myalgia	1.3	0.7
Dizziness	1.2	0.9
Vomiting	1.0	0.8

Evaluation of Fever by Dose in Girls and Women 9 Through 26 Years of Age

An analysis of fever in girls and women by dose is shown in Table 7.

Table 7: Postdose Evaluation of Fever in Girls and Women 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

	Gardasil (% occurrence)			AAHS Control* or Saline Placebo (% occurrence)
* AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of subjects with follow-up
Temperature (°F)	Postdose 1 N† = 4945	Postdose 2 N = 4804	Postdose 3 N = 4671	Postdose 1 N = 3681	Postdose 2 N = 3564	Postdose 3 N = 3467
≥100 to <102	3.7	4.1	4.4	3.1	3.8	3.6
≥102	0.3	0.5	0.5	0.2	0.4	0.5

Evaluation of Fever by Dose in Boys and Men 9 Through 26 Years of Age

An analysis of fever in boys and men by dose is shown in Table 8.

Table 8: Postdose Evaluation of Fever in Boys and Men 9 Through 26 Years of Age (1 to 5 Days Postvaccination)

	Gardasil (% occurrence)			AAHS Control* or Saline Placebo (% occurrence)
Temperature (°F)	Postdose 1 N† = 2972	Postdose 2 N = 2849	Postdose 3 N = 2792	Postdose 1 N = 2194	Postdose 2 N = 2079	Postdose 3 N = 2046
* AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † N = Number of individuals with follow-up
≥100 to <102	2.4	2.5	2.3	2.1	2.2	1.6
≥102	0.6	0.5	0.5	0.5	0.3	0.3

Serious Adverse Reactions in the Entire Study Population

Across the clinical studies, 258 individuals (Gardasil N = 128 or 0.8%; placebo N = 130 or 1.0%) out of 29,323 (Gardasil N = 15,706; AAHS control N = 13,023; or saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men) reported a serious systemic adverse reaction.

Of the entire study population (29,323 individuals), 0.04% of the reported serious systemic adverse reactions were judged to be vaccine related by the study investigator. The most frequently (frequency of 4 cases or greater with either Gardasil, AAHS control, saline placebo, or the total of all three) reported serious systemic adverse reactions, regardless of causality, were:

Headache [0.02% Gardasil (3 cases) vs. 0.02% AAHS control (2 cases)],

Gastroenteritis [0.02% Gardasil (3 cases) vs. 0.02% AAHS control (2 cases)],

Appendicitis [0.03% Gardasil (5 cases) vs. 0.01% AAHS control (1 case)],

Pelvic inflammatory disease [0.02% Gardasil (3 cases) vs. 0.03% AAHS control (4 cases)],

Urinary tract infection [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (2 cases)],

Pneumonia [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (2 cases)],

Pyelonephritis [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (3 cases)],

Pulmonary embolism [0.01% Gardasil (2 cases) vs. 0.02% AAHS control (2 cases)].

One case (0.006% Gardasil; 0.0% AAHS control or saline placebo) of bronchospasm; and 2 cases (0.01% Gardasil; 0.0% AAHS control or saline placebo) of asthma were reported as serious systemic adverse reactions that occurred following any vaccination visit.

In addition, there was 1 individual in the clinical trials, in the group that received Gardasil, who reported two injection-site serious adverse reactions (injection-site pain and injection-site joint movement impairment).

Deaths in the Entire Study Population

Across the clinical studies, 40 deaths (Gardasil N = 21 or 0.1%; placebo N = 19 or 0.1%) were reported in 29,323 (Gardasil N = 15,706; AAHS control N = 13,023, saline placebo N = 594) individuals (9- through 45-year-old girls and women; and 9- through 26-year-old boys and men). The events reported were consistent with events expected in healthy adolescent and adult populations. The most common cause of death was motor vehicle accident (5 individuals who received Gardasil and 4 individuals who received AAHS control), followed by drug overdose/suicide (2 individuals who received Gardasil and 6 individuals who received AAHS control), gun shot wound (1 individual who received Gardasil and 3 individuals who received AAHS control), and pulmonary embolus/deep vein thrombosis (1 individual who received Gardasil and 1 individual who received AAHS control). In addition, there were 2 cases of sepsis, 1 case of pancreatic cancer, 1 case of arrhythmia, 1 case of pulmonary tuberculosis, 1 case of hyperthyroidism, 1 case of post-operative pulmonary embolism and acute renal failure, 1 case of traumatic brain injury/cardiac arrest, 1 case of systemic lupus erythematosus, 1 case of cerebrovascular accident, 1 case of breast cancer, and 1 case of nasopharyngeal cancer in the group that received Gardasil; 1 case of asphyxia, 1 case of acute lymphocytic leukemia, 1 case of chemical poisoning, and 1 case of myocardial ischemia in the AAHS control group; and 1 case of medulloblastoma in the saline placebo group.

Systemic Autoimmune Disorders in Girls and Women 9 Through 26 Years of Age

In the clinical studies, 9- through 26-year-old girls and women were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received Gardasil or AAHS control or saline placebo are shown in Table 9. This population includes all girls and women who received at least one dose of Gardasil or AAHS control or saline placebo, and had safety data available.

Table 9: Summary of Girls and Women 9 Through 26 Years of Age Who Reported an Incident Condition Potentially Indicative of a Systemic Autoimmune Disorder After Enrollment in Clinical Trials of Gardasil, Regardless of Causality

Conditions	Gardasil (N = 10,706)	AAHS Control* or Saline Placebo (N = 9412)
	n (%)	n (%)
N = Number of individuals enrolled n = Number of individuals with specific new Medical Conditions NOTE: Although an individual may have had two or more new Medical Conditions, the individual is counted only once within a category. The same individual may appear in different categories.
* AAHS Control = Amorphous Aluminum Hydroxyphosphate Sulfate † Arthralgia/Arthritis/Arthropathy includes the following terms: Arthralgia, Arthritis, Arthritis reactive, and Arthropathy ‡ Hyperthyroidism includes the following terms: Basedow's disease, Goiter, Toxic nodular goiter, and Hyperthyroidism § Hypothyroidism includes the following terms: Hypothyroidism and thyroiditis ¶ Inflammatory bowel disease includes the following terms: Colitis ulcerative, Crohn's disease, and Inflammatory bowel disease # Nephritis includes the following terms: Nephritis, Glomerulonephritis minimal lesion, Glomerulonephritis proliferative Þ Pigmentation disorder includes the following terms: Pigmentation disorder, Skin depigmentation, and Vitiligo ß Psoriasis includes the following terms: Psoriasis, Pustular psoriasis, and Psoriatic arthropathy à Rheumatoid arthritis includes juvenile rheumatoid arthritis. One woman counted in the rheumatoid arthritis group reported rheumatoid arthritis as an adverse experience at Day 130.
Arthralgia/Arthritis/Arthropathy†	120 (1.1)	98 (1.0)
Autoimmune Thyroiditis	4 (0.0)	1 (0.0)
Celiac Disease	10 (0.1)	6 (0.1)
Diabetes Mellitus Insulin-dependent	2 (0.0)	2 (0.0)
Erythema Nodosum	2 (0.0)	4 (0.0)
Hyperthyroidism‡

V-Cof Suspension

Pronunciation: BROME-fen-IR-a-meen/KAR-bay-ta-PEN-tane/FEN-il-EF-rin
Generic Name: Brompheniramine/Carbetapentane/Phenylephrine
Brand Name: Examples include V-Cof and Vazotan

V-Cof Suspension is used for:

Relieving symptoms of sinus congestion, pressure, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

V-Cof Suspension is an antihistamine, decongestant, and cough suppressant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure. The cough suppressant works in the brain to help decrease the cough reflex.

Do NOT use V-Cof Suspension if:

• you are allergic to any ingredient in V-Cof Suspension


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using V-Cof Suspension:

Some medical conditions may interact with V-Cof Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat


• if you have a history of asthma; lung problems (eg, emphysema); adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; blood vessel problems; stroke; glaucoma; a blockage of your bladder, stomach, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; phenylketonuria; or an overactive thyroid


• if you are very drowsy, sedated, or are confined to a bed or chair

Some MEDICINES MAY INTERACT with V-Cof Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of V-Cof Suspension's side effects


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by V-Cof Suspension


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by V-Cof Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if V-Cof Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use V-Cof Suspension:

Use V-Cof Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take V-Cof Suspension by mouth with or without food.


• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of V-Cof Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use V-Cof Suspension.

Important safety information:

• V-Cof Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use V-Cof Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol while you are using V-Cof Suspension.


• Do not take diet or appetite control medicines while you use V-Cof Suspension unless your doctor tells you to.


• V-Cof Suspension has brompheniramine and phenylephrine in it. Before you start any new medicine, check the label to see if it has brompheniramine and phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose or take V-Cof Suspension for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 7 days or if they get worse, check with your doctor.


• V-Cof Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to V-Cof Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.


• V-Cof Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking V-Cof Suspension for a few days before the tests.


• Tell your doctor or dentist that you take V-Cof Suspension before you receive any medical or dental care, emergency care, or surgery.


• Use V-Cof Suspension with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using V-Cof Suspension in CHILDREN; they may be more sensitive to its effects.


• V-Cof Suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using V-Cof Suspension while you are pregnant. It is not known if V-Cof Suspension is found in breast milk. Do not breast-feed while taking V-Cof Suspension.

Possible side effects of V-Cof Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: V-Cof side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of V-Cof Suspension:

Store V-Cof Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep V-Cof Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about V-Cof Suspension, please talk with your doctor, pharmacist, or other health care provider.


• V-Cof Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about V-Cof Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More V-Cof resources

• V-Cof Side Effects (in more detail)
• V-Cof Use in Pregnancy & Breastfeeding
• V-Cof Drug Interactions
• V-Cof Support Group
• 0 Reviews for V-Cof - Add your own review/rating

Compare V-Cof with other medications

• Cold Symptoms
• Cough and Nasal Congestion
• Hay Fever

Terbinafine Spray

Pronunciation: TER-bin-a-feen
Generic Name: Terbinafine
Brand Name: Lamisil AT

Terbinafine Spray is used for:

Relieving, itching, burning, cracking, and scaling associated with jock itch, athlete's foot, ringworm, and other fungal infections of the skin.

Terbinafine Spray is topical antifungal agent. It works by killing sensitive fungi.

Do NOT use Terbinafine Spray if:

• you are allergic to any ingredient in Terbinafine Spray

Contact your doctor or health care provider right away if any of these apply to you.

Before using Terbinafine Spray:

Some medical conditions may interact with Terbinafine Spray. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have kidney problems

Some MEDICINES MAY INTERACT with Terbinafine Spray. Because little, if any, of Terbinafine Spray is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Terbinafine Spray may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Terbinafine Spray:

Use Terbinafine Spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash the affected area with soap and water. Be sure the area is completely dry before applying Terbinafine Spray.


• Spray a think layer of medicine onto the affected area as directed by your doctor or the package labeling.


• If you are using Terbinafine Spray for the athlete's foot, make sure you spray the spaces between the toes. Wear well-fitting, ventilated shoes. Change shoes and socks at least once a day.


• Wash your hands immediately after using Terbinafine Spray unless your hands are part of the treated area.


• To clear up your infection completely, use Terbinafine Spray for the full course of treatment. Keep using it even if you notice improvement in a few days.


• If you miss a dose of Terbinafine Spray, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Terbinafine Spray.

Important safety information:

• Terbinafine Spray is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.


• Do not use Terbinafine Spray on the nails or scalp. Do not use it for vaginal yeast infections.


• Do not use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Do not get Terbinafine Spray in your eyes, nose, or mouth. In case of contact with the eyes, rinse eyes thoroughly with water.


• Terbinafine Spray should not be used in CHILDREN younger than 12 years old without first checking with the child's doctor; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Terbinafine Spray while you are pregnant. It is not known if Terbinafine Spray is found in breast milk after topical use. If you are or will be breast-feeding while you use Terbinafine Spray, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Terbinafine Spray:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); new or worsening skin irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.

Proper storage of Terbinafine Spray:

Store Terbinafine Spray between 46 and 77 degrees F (8 and 25 degrees C). Store away from heat, moisture, and light. Keep Terbinafine Spray out of the reach of children and away from pets.

General information:

• If you have any questions about Terbinafine Spray, please talk with your doctor, pharmacist, or other health care provider.


• Terbinafine Spray is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Terbinafine Spray. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Terbinafine resources

• Terbinafine Use in Pregnancy & Breastfeeding
• Terbinafine Support Group
• 5 Reviews for Terbinafine - Add your own review/rating

Compare Terbinafine with other medications

• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Cuprimine

Generic Name: penicillamine (pen ih SILL ah meen)

Brand Names: Cuprimine, Depen

What is Cuprimine (penicillamine)?

Penicillamine is a chelating agent. It attaches to other chemicals in the body, which aids in their removal.

Penicillamine is used to remove excess copper associated with Wilson's disease. It is also used to reduce cystine in the urine and to treat severe rheumatoid arthritis.

Penicillamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Cuprimine (penicillamine)?

Notify your doctor immediately if you develop fever; chills; a sore throat; unusual bruising or bleeding; blood in your urine, unexplained shortness of breath, coughing, or wheezing; muscle weakness; or double vision. These symptoms could be early signs of dangerous side effects.

What should I discuss with my healthcare provider before taking Cuprimine (penicillamine)?

You cannot take penicillamine if you have taken it in the past and it has damaged your blood cells.

Before taking penicillamine, tell your doctor if you have kidney disease or any other serious illness. You may not be able to take penicillamine, or you may require a lower dose or special monitoring during therapy.

Penicillamine may cause birth defects in an unborn baby. However, it has also been used during pregnancy with no evidence of defects. Penicillamine should not be used during pregnancy except to treat Wilson's disease and some cases of cystine in the urine. Do not take this medication without first talking to your doctor if you are pregnant. It is not known whether penicillamine passes into breast milk. Since penicillamine may harm a nursing infant, breast-feeding is not recommended during treatment with this medication.

How should I take Cuprimine (penicillamine)?

Take penicillamine exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Penicillamine must be taken on an empty stomach, at least 1 hour before or 2 hours after a full meal, and at least 1 hour before or after any other drug, food, or milk. Taking penicillamine with anything else in the stomach greatly decreases its effectiveness. Do not stop taking penicillamine without first talking to your doctor. Stopping therapy may cause your body to react abnormally when therapy is restarted. If you do stop taking the medication, do not restart without first talking to your doctor. You may need special monitoring.

Your doctor may want you to take a vitamin and mineral supplement during treatment with penicillamine. Penicillamine may reduce vitamin B6 and iron in the body. Follow your doctor's instructions.

Store penicillamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose on an empty stomach as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and take only your next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor. If you have missed several doses in a row, do not take any more doses without first talking to your doctor.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of a penicillamine overdose are not known.

What should I avoid while taking Cuprimine (penicillamine)?

Follow any special diet restrictions recommended by your doctor.

Cuprimine (penicillamine) side effects

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

• 
  

  an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);

  
  


• 
  

  fever or chills;

  
  


• 
  

  a sore throat;

  
  


• 
  

  unusual bleeding or bruising;

  
  


• 
  

  blood in the urine;

  
  


• 
  

  unexplained shortness of breath, coughing, or wheezing;

  
  


• 
  

  abdominal pain;

  
  


• 
  

  yellow skin or eyes;

  
  


• 
  

  muscle weakness; or

  
  


• 
  

  double vision.

  
  

Other, less serious side effects may be more likely to occur. Continue to take penicillamine and notify your doctor if you experience

• 
  

  itching or a rash;

  
  


• 
  

  nausea, vomiting, diarrhea, or decreased appetite;

  
  


• 
  

  ringing in the ears;

  
  


• 
  

  decreased taste;

  
  


• 
  

  sores in the mouth;

  
  


• 
  

  poor wound healing; or

  
  


• 
  

  increased wrinkling of the skin.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cuprimine (penicillamine)?

Do not take penicillamine if you are taking any of the following medicines:

• 
  

  a gold-therapy product such as auranofin (Ridaura), aurothioglucose (Solganal), or gold sodium thiomalate (Myochrysine, Aurolate);

  
  


• 
  

  an antimalarial medicine such as quinine (Quinamm), mefloquine (Lariam), chloroquine (Aralen), hydroxychloroquine (Plaquenil), primaquine, or pyrimethamine (Daraprim);

  
  


• 
  

  a cancer chemotherapy medicine; or

  
  


• 
  

  phenylbutazone.

  
  

Like penicillamine, the medications listed above can affect the blood and the kidneys. Combined with penicillamine, any of these medicines can be very dangerous.

Before taking penicillamine, tell your doctor if you are taking digoxin (Lanoxin, Lanoxicaps). Penicillamine may decrease the effects of digoxin, and your doctor may want to adjust your dosage or monitor your therapy.

Many other drugs, especially antacids and vitamin and mineral supplements, can decrease the effects of penicillamine. Do not take any medicines or over-the-counter drugs or supplements within 1 hour of a penicillamine dose.

Drugs other than those listed here may also interact with penicillamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More Cuprimine resources

• Cuprimine Side Effects (in more detail)
• Cuprimine Use in Pregnancy & Breastfeeding
• Drug Images
• Cuprimine Drug Interactions
• Cuprimine Support Group
• 0 Reviews for Cuprimine - Add your own review/rating

• Cuprimine MedFacts Consumer Leaflet (Wolters Kluwer)


• Cuprimine Advanced Consumer (Micromedex) - Includes Dosage Information


• Cuprimine Prescribing Information (FDA)


• Penicillamine Monograph (AHFS DI)


• Penicillamine Professional Patient Advice (Wolters Kluwer)


• Depen Prescribing Information (FDA)

Compare Cuprimine with other medications

• Cystinuria
• Rheumatoid Arthritis
• Wilson's Disease

Where can I get more information?

• Your pharmacist has additional information about penicillamine written for health professionals that you may read.

See also: Cuprimine side effects (in more detail)

Hizentra

Generic Name: immune globulin (Intramuscular route, Intravenous route, Subcutaneous route)

i-MUNE GLOB-ue-lin

Intravenous route(Powder for Solution;Solution)

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose . Flebogamma(R) 5%, Flebogamma(R) 5% DIF, Flebogamma(R) 10% DIF, Gammagard (R), Gamunex(R)-C, and Previgen(R) do not contain sucrose . Glycine is used as a stabilizer in Gamunex(R)-C .

Subcutaneous route(Solution)

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose. Gammagard(R) does not contain sucrose .

Commonly used brand name(s)

In the U.S.

• Baygam


• Carimune


• Gamimune N


• Gammagard


• Gammar-P


• Hizentra


• Iveegam EN


• Octagam


• Panglobulin NF


• Polygam S/D


• Sandoglobulin


• Vivaglobin

Available Dosage Forms:

• Solution


• Powder for Solution

Therapeutic Class: Immune Serum

Uses For Hizentra

Immune globulin injection belongs to a group of medicines known as immunizing agents. It is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

This medicine is to be administered only by or under the supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, immune globulin is used in certain patients with the following medical conditions:

• Chronic parvovirus B19 infection (treatment).


• Dermatomyositis (treatment).


• Guillain-Barré syndrome (treatment).


• Hyperimmunoglobulinemia E syndrome (treatment).


• Infections in low-birth-weight preterm high-risk neonates (prophylaxis and treatment adjunct).


• Lambert-Eaton myasthenic syndrome (treatment).


• Multifocal motor neuropathy (treatment).


• Relapsing-remitting multiple sclerosis (treatment).

Before Using Hizentra

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of immune globulin injection in children. However, safety and efficacy have not been established in children with CIDP, safety and efficacy have not been established for Flebogamma® and subcutaneous injection of Gamunex®-C in children with PI, and safety and efficacy have not been established for Gammagard Liquid and Vivaglobin® in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of immune globulin injection in the elderly. However, elderly patients are more likely to have age-related blood clotting problems, kidney disease, or heart disease, which may require caution for patients receiving immune globulin injection.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia, history of or


• Bleeding problems, history of or


• Hyponatremia (low sodium in the blood) or


• Kidney problems—Use with caution. May make these conditions worse.

• Atherosclerosis (hardening of the arteries), history of or


• Blood clotting problems, history of or


• Diabetes or


• Heart attack or stroke, recent or


• Heart or blood vessel disease or


• Hyperproteinemia (high protein in the blood) or


• Hyperviscosity (thick blood), known or suspected or


• Hypovolemia (low blood volume or major loss of body fluids) or


• IgA (immunoglobulin A) deficiency with antibodies against IgA or


• Paraproteinemia (paraproteins in the blood) or


• Sepsis (serious infection in the body)—Use with caution. May cause side effects to become worse.

Proper Use of immune globulin

This section provides information on the proper use of a number of products that contain immune globulin. It may not be specific to Hizentra. Please read with care.

A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins, as a shot into one of your muscles, or as a shot under your skin.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

While you or your child are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.

The Gammagard Liquid, Gamunex®-C, Hizentra®, and Vivaglobin® products may sometimes be given at home to patients who do not need to be in the hospital or clinic. They are given as an infusion under your skin once every week. If you or your child are using this medicine at home, your doctor will teach you how to prepare and infuse the medicine. Be sure you understand how to use the medicine.

Do not change the brand or type of your immune globulin unless your doctor tells you to. If you or your child must change the brand or type of medicine, talk to your doctor before giving yourself an injection.

If you or your child are using Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin® at home, you will be shown the body areas where the medicine can be given. Use a different body area each time you give yourself an infusion. Keep track of where you give each infusion to make sure you rotate body areas. This will help prevent skin problems.

Allow the Gammagard Liquid, Gamunex®-C, or Vivaglobin® brand to reach room temperature before using it.

To use Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin®:

• First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.


• Wash your hands with soap and water before and after using this medicine.


• If you have been told to wear gloves when preparing your infusion, put the gloves on.


• Check the liquid in the vial (glass container). It should be clear and slightly yellow to light brown in color. If it is cloudy, discolored, or contains large flecks (particles), do not use the vial. Select another vial.


• If the liquid is clear, place it on the clean, flat surface. Do not heat up or shake the medicine.


• Follow your doctor's instructions on how to prepare the correct amount of medicine.


• Choose an injection site on your body (e.g., abdomen or stomach area, thigh, upper arm, upper leg, or hip). Clean the injection site with a fresh alcohol wipe, and let it dry.


• With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.


• Put sterile gauze and tape over the injection site to keep the needle from coming out.


• Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.


• Follow your doctor's instructions on how to use the infusion pump.


• Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.


• It usually takes about 60 minutes for each infusion.


• When all of the medicine has been infused, turn off the pump.


• Take the gauze off and remove the needle and tube from your skin.


• Clean and store the infusion pump.


• Throw away used needles and tubes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Hizentra® product at room temperature, away from heat and moisture. Keep from freezing.

Protect the Hizentra® product from direct light. Keep the medicine in the original package until you are ready to use it.

Store the Gamunex®-C and Vivaglobin® products in the refrigerator, but do not freeze the medicine. Store it in the original container.

You may store the Gammagard Liquid product in the refrigerator for 36 months, or at room temperature for up to 12 months (if within the first 24 months of the date of manufacture). Check the box for the date of manufacture. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.

Precautions While Using Hizentra

It is very important that your doctor check the progress of you or your child at regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Patients with idiopathic thrombocytopenic purpura (ITP) should not be treated with Gamunex®-C that is injected under the skin (subcutaneously). Doing so may increase the risk of having a hematoma (buildup of blood under the skin).

This medicine may cause fever, chills, flushing, headaches, nausea, and vomiting, especially if you are receiving it for the first time or if you have not received it for more than 8 weeks. Check with your doctor or nurse right away if you have any of these symptoms.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made from human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing of the medicine when it is made. Although the risk is low, talk with your doctor if you have concerns.

This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin products should not use this medicine.

Check with your doctor right away if you or your child start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

This medicine may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you or your child have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.

Check with your doctor right away if you or your child start having chest pain; difficult, fast, or noisy breathing, sometimes with wheezing; blue lips and fingernails; fever; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; shortness of breath; or swelling of the legs and ankles, after receiving this medicine. These may be symptoms of a serious lung problem.

This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking. .

Check with your doctor right away if you or your child start having red or dark brown urine; lower back or side pain; a sudden weight gain; a swollen face, arms, or legs; decreased urine output; or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Hizentra Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Chills


• cough


• difficulty with breathing


• fast, pounding, or irregular heartbeat or pulse


• fever


• noisy breathing


• shortness of breath


• tightness in the chest


• troubled breathing


• unusual tiredness or weakness

Less common

• Bluish coloring of the lips or nailbeds


• burning sensation in the head


• faintness or lightheadedness

Rare

• Difficulty with swallowing


• hives or welts


• itching, especially of the feet or hands


• reddening of the skin, especially around the ears


• swelling of the eyes, face, or inside of the nose

Incidence not known

• Back, leg, or stomach pains


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloody, black, or tarry stools


• blurred vision


• change in consciousness


• chest pain or discomfort


• cold, clammy, or pale skin


• confusion


• convulsions


• coughing that sometimes produces a pink frothy sputum


• dark urine


• decrease in urine amount


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• fever with or without chills


• headache that is severe and occurs suddenly


• increased sweating


• light-colored stools


• loss of appetite


• loss of bladder control


• loss of consciousness


• low blood pressure or pulse


• muscle spasm or jerking of all extremities


• nausea or vomiting


• nosebleeds


• painful or difficult urination


• pains in the chest, groin, or legs, especially calves of the legs


• red skin lesions, often with a purple center


• red, irritated eyes


• shakiness in the legs, arms, hands, or feet


• shivering


• skin blisters


• slurred speech that occurs suddenly


• slow breathing


• sores, ulcers, or white spots in the mouth or on the lips


• sudden loss of consciousness


• sudden loss of coordination


• sudden vision changes


• sudden, severe weakness or numbness in the arm or leg


• sweating


• swelling in the legs and ankles


• tightness in the chest


• trembling or shaking of the hands or feet


• unusual bleeding or bruising


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea


• dizziness


• headache


• joint pain


• muscle pain


• redness, swelling, itching, or pain at the injection site


• skin rash

Less common

• Hip pain


• leg cramps

Incidence not known

• Feeling of warmth


• redness of the face, neck, arms, and occasionally, upper chest


• stomach pain


• swollen glands


• tiredness


• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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