Hyperhep B

HyperHEP B S/D is supplied in a 0.5 mL neonatal single dose syringe with attached needle, a 1 mL single dose syringe with attached needle and a 1 mL and a 5 mL single dose vial. HyperHEP B S/D is preservative-free and latex-free.

Storage

Store at 2–8°C (36–46°F). Do not freeze. Do not use after expiration date.

Caution

U.S. federal law prohibits dispensing without prescription.

REFERENCES

5. Jhaveri R, Rosenfeld W, Salazar JD, et al: High titer multiple dose therapy with HBIG in newborn infants of
HBsAg positive mothers. J Pediatr 97(2):305–8, 1980.

6. Hoofnagle JH, Seeff LB, Bales ZB, et al: Passive-active immunity from hepatitis B immune globulin. Ann Intern
Med 91(6):813-8, 1979.

7. Scheiermann N, Kuwert EK: Uptake and elimination of hepatitis B immunoglobulins after intramuscular
application in man. Dev Biol Stand 54:347-55, 1983.

8. Recommendations of the Immunization Practices Advisory Committee (ACIP): Hepatitis B Virus: A
Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood
Vaccination. Appendix A: Postexposure Prophylaxis for Hepatitis B. MMWR 40(RR-13):21-25, 1991.

9. Stevens CE, Beasley RP, Tsui J, et al: Vertical transmission of hepatitis B antigen in Taiwan. N Engl J Med
292(15):771-4, 1975.

10. Shiraki K, Yoshihara N, Kawana T, et al: Hepatitis B surface antigen and chronic hepatitis in infants born to
asymptomatic carrier mothers. Am J Dis Child 131(6):644-7, 1977.

11. Recommendation of the Immunization Practices Advisory Committee (ACIP): Immune globulins for protection
against viral hepatitis. MMWR 30(34):423-8; 433-5, 1981.

12. Okada K, Kamiyama I, Inomata M, et al: e antigen and anti-e in the serum of asymptomatic carrier mothers as
indicators of positive and negative transmission of hepatitis B virus to their infants. N Engl J Med 294(14):746-9, 1976.

13. Beasley RP, Trepo C, Stevens CE, et al: The e antigen and vertical transmission of hepatitis B surface antigen.
Am J Epidemiol 105(2):94-8, 1977.

14. Beasley RP, Hwang LY, Lee GCY, et al: Prevention of perinatally transmitted hepatitis B virus infections with
hepatitis B immune globulin and hepatitis B vaccine. Lancet 2(8359): 1099-102, 1983.

15. Recommendation of the Immunization Practices Advisory Committee (ACIP): Recommendations for protection
against viral hepatitis. MMWR 34(22):313–35, 1985.

16. Szmuness W, Stevens CE, Olesko WR, et al: Passive-active immunisation against hepatitis B: immunogenicity
studies in adult Americans. Lancet 1:575–77, 1981.

Grifols Therapeutics Inc., Research Triangle Park, NC 27709 USA 08941117. Revised: Sep 2012

Hepatitis B Immune Globulin (Human) provides passive immunization for individuals exposed to the hepatitis B virus (HBV) as evidenced by a reduction in the attack rate of hepatitis B following its use.1-6 The administration of the usual recommended dose of this immune globulin generally results in a detectable level of circulating anti-HBs which persists for approximately 2 months or longer. The highest antibody (IgG) serum levels were seen in the following distribution of subjects studied: 7

Mean values for half-life were between 17.5 and 25 days, with the shortest being 5.9 days and the longest 35 days. 7 Cases of type B hepatitis are rarely seen following exposure to HBV in persons with preexisting anti-HBs. No confirmed instance of transmission of hepatitis B has been associated with this product. In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), HyperRAB® S/D, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period. These results suggest that passive immunization with immune globulin products is not affected by the solvent/detergent treatment.

REFERENCES

1. Grady GF, Lee VA: Hepatitis B immune globulin — prevention of hepatitis from accidental exposure among medical personnel. N Engl J Med 293(21):1067–70, 1975.

2. Seeff LB, Zimmerman HJ, Wright EC, et al: Efficacy of hepatitis B immune serum globulin after accidental exposure. Lancet 2(7942):939-41, 1975.

3. Krugman S, Giles JP: Viral hepatitis, type B (MS-2-strain). Further observations on natural history and prevention. N Engl J Med 288(15):755-60, 1973.

4. Current trends: Health status of Indochinese refugees: malaria and hepatitis B. MMWR 28(39):463-4; 469-70, 1979.

5. Jhaveri R, Rosenfeld W, Salazar JD, et al: High titer multiple dose therapy with HBIG in newborn infants of HBsAg positive mothers. J Pediatr 97(2):305–8, 1980.

6. Hoofnagle JH, Seeff LB, Bales ZB, et al: Passive-active immunity from hepatitis B immune globulin. Ann Intern Med 91(6):813-8, 1979.

7. Scheiermann N, Kuwert EK: Uptake and elimination of hepatitis B immunoglobulins after intramuscular application in man. Dev Biol Stand 54:347-55, 1983.

Hyperhep B is part of the drug class:

• Specific immunoglobulins

Hepatitis B immune globulin is made from human plasma containing proteins that protect against the type B form of hepatitis (inflammation of the liver).

Hepatitis B immune globulin is used to prevent hepatitis B in people receiving a liver transplant, and in babies born to mothers infected with hepatitis B. It is also used to prevent hepatitis B in people who have been exposed to hepatitis B through contaminated blood products, sexual contact with an infected person, or living in a home with an infected person.

Hepatitis B immune globulin is not a vaccine. Therefore it will not provide long-term protection from hepatitis B. For long-term protection you must receive a hepatitis B vaccine such as Engerix-B, Recombivax HB, or Twinrix.

Hepatitis B immune globulin may also be used for purposes not listed in this medication guide.

You should not receive hepatitis B immune globulin if you are allergic to it.

Hepatitis B immune globulin may increase your risk of blood clots, especially if you have:

• heart disease, coronary artery disease (hardened arteries), history of blood clots;

• risk factors for coronary artery disease (such as menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being an older adult);

• if you need to use a blood thinner;

• if you take birth control pills or hormone replacement;

• if you use certain types of catheters; or

• if you are bedridden or otherwise debilitated.

To make sure hepatitis B immune globulin is safe for you, tell your doctor if you have:

• an allergy to human immune globulins;

• bleeding or blood clotting disorder such as hemophilia; or

• diabetes.

Hepatitis B immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether hepatitis B immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether hepatitis B immune globulin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever, mouth sores, red or swollen gums;

• a light-headed feeling, like you might pass out;

• liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• symptoms of fluid buildup around your lungs--chest pain, pain when you breathe, rapid heart rate, feeling light-headed or short of breath (especially when lying down); or

• symptoms of a blood clot or stroke--sudden numbness or weakness (especially on one side of the body); chest pain, trouble breathing, rapid heart rate, coughing up blood; or pain, swelling, warmth, or redness in your arms or legs.

Common side effects may include:

• nausea, vomiting, diarrhea, upset stomach;

• back pain, tired feeling;

• tremors, memory problems, agitation, vision problems;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• mild rash; or

• pain, redness, bruising, or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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:

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating
• unusual tiredness or weakness

• Chills
• cough
• difficult or labored breathing
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in the chest
• wheezing

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:

• Back pain
• general feeling of discomfort
• headache
• muscle aches or pain
• nausea
• pain at the injection site

• Abdominal or stomach cramping
• burning, heat, and redness at the injection site
• diarrhea
• feeling as if you are going to vomit
• joint pain

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• cold sweats
• feeling cold
• flu-like symptoms
• upper abdominal or stomach pain

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.

Applies to hepatitis b immune globulin: injectable solution, intramuscular solution

General

Most side effects have been classified as mild.[Ref]

Local

Local side effects have included erythema, pain, ecchymosis, and tenderness at the injection site.[Ref]

Hypersensitivity

Hypersensitivity side effects including allergic reactions have been commonly reported. Urticaria, angioedema, and anaphylactic reactions have been reported rarely.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting have been commonly reported. Aphthous stomatitis, diarrhea, dyspepsia, and gingival hyperplasia have been reported in greater than 10% of patients.[Ref]

Other

Other side effects have included fatigue (greater than 10%), peripheral edema (greater than 10%), pyrexia (greater than 10%), cold or flu symptoms (10%), lightheadedness (3%), fainting (3%), malaise, chills, and fever.[Ref]

Musculoskeletal

Musculoskeletal side effects have been commonly reported. These have included back pain (greater than 10%), moderate low back pain, and arthralgia. Myalgia and joint stiffness have been reported.[Ref]

Hematologic

Hematologic side effects have included splenomegaly (greater than 10%) and decreased white blood cells.[Ref]

Hepatic

Hepatic side effects have included hepatobiliary disease (greater than 10%), increased AST, and alkaline phosphatase.[Ref]

Renal

Renal side effects have included nocturia (greater than 10%) and increased creatinine.[Ref]

Respiratory

Respiratory side effects including pleural effusion have been reported in greater than 10% of patients.

Dermatologic

Dermatologic side effects including pruritus and rash have been reported in greater than 10% of patients.

Psychiatric

Psychiatric side effects including agitation have been reported in greater than 10% of patients.

Immunologic

Immunologic side effects including liver transplant rejection, diarrhea infections, pneumonia, and sepsis have been reported in greater than 10% of patients.

Cardiovascular

Cardiovascular side effects including hypertension and hypotension have been reported in greater than 10% of patients.

Metabolic

Metabolic side effects have included hyperglycemia.

Nervous system

Nervous system side effects have included amnesia (greater than 10%), essential tremor (greater than 10%), and headache (6% to greater than 10%). At least two cases of tremor have been reported.

Ocular

Ocular side effects including presbyopia have been reported in greater than 10% of patients.

Some side effects of Hyperhep B may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.