Bayhep B

Name: Bayhep B

Overdose

Although no data are available, clinical experience with other immunoglobulin preparations suggests that the only manifestations would be pain and tenderness at the injection site.

Uses For Bayhep B

Hepatitis B immune globulin (Human) injection is used to prevent hepatitis B from occurring again in HBsAg-positive liver transplant patients who have had liver transplants. This medicine also helps keep you from getting sick if you have been exposed to hepatitis B virus.

Hepatitis B immune globulin (Human) injection may be used for the following patients:

  • Sexual partners of persons with hepatitis B.
  • Persons who may be exposed to the virus by means of blood, blood products, or human bites, such as health care workers, employees in medical facilities, patients and staff of live-in facilities and day-care programs for the developmentally disabled, morticians and embalmers, police and fire department personnel, and military personnel.
  • Those who have household exposure to persons with acute hepatitis B and babies less than 12 months old whose caregiver tests positive for hepatitis B.
  • Babies born to mothers who test positive for hepatitis B.

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of hepatitis B immune globulin injection in the pediatric population. However, safety and efficacy have been established in children who are receiving similar medicines for prevention of hepatitis B infection after exposure to hepatitis B virus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Side effects

Local pain and tenderness at the injection site, urticaria and angioedema may occur; anaphylactic reactions, although rare, have been reported following the injection of human immune globulin preparations.19

Read the entire FDA prescribing information for BayHep B (Hepatitis B Immune Globulin (Human))

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For the Consumer

Applies to hepatitis b immune globulin: solution

Along with its needed effects, hepatitis b immune globulin (the active ingredient contained in BayHep B) 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 while taking hepatitis b immune globulin:

Rare
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • sweating
  • unusual tiredness or weakness
Incidence not known
  • 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 of hepatitis b immune globulin 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
  • Back pain
  • general feeling of discomfort
  • headache
  • muscle aches or pain
  • nausea
  • pain at the injection site
Less common
  • Abdominal or stomach cramping
  • burning, heat, and redness at the injection site
  • diarrhea
  • feeling as if you are going to vomit
  • joint pain
Incidence not known
  • 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

For Healthcare Professionals

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

Usual Adult Dose for Exposure to Hepatitis B Virus

Prevention of recurrence following liver transplantation:
HBIG 20,000 intl units IV once with the grafting of the transplanted liver (the anhepatic phase)
Week 1 postoperative: 20,000 intl units IV daily from day 1 to 7
Week 2 to 12 postoperative: 20,000 intl units IV every two weeks from day 14
Month 4 onwards: 20,000 intl units IV monthly

If patients fail to reach anti-HBs levels of 500 intl units/L within the first week post-liver transplantation, dosage adjustments may be required.

Dosage regimen should be increased to 10,000 intl units IV every 6 hours until the target anti-HBs are reached in patients who are especially susceptible to extensive loss of circulated anti-HBs, such as those who have surgical bleeding or abdominal fluid drainage (greater than 500 mL) or patients who undergo plasmapheresis.

Percutaneous or permucosal blood exposure:
Source is HBsAg-positive and exposed person has been vaccinated:
If exposed person's anti-HBs level is less than 10 sample ratio units (10 million intl units) by RIA or negative by EIA:
Hepatitis B immune globulin (HBIG) 0.06 mL/kg IM once plus
hepatitis B vaccine booster dose or second dose of hepatitis B immune globulin 1 month later.

Source is HBsAg-positive and exposed person is unvaccinated:
HBIG 0.06 mL/kg IM once plus start hepatitis B vaccine series.

Source is high risk for HBsAg-positive and exposed person has been vaccinated:
Previously vaccinated exposed person:
If vaccine nonresponder and source is HBsAg-positive, give HBIG 0.06 mL/kg IM once plus hepatitis B vaccine booster dose or second dose of hepatitis B immune globulin 1 month later.
If exposed person does not respond to at least 4 doses of vaccine, give 2 doses of HBIG.

Source is high risk for HBsAg-positive and exposed person is unvaccinated:
Start hepatitis B vaccine series within 7 days of exposure
plus HBIG 0.06 mL/kg IM once if source tests positive for HBsAg.

Source unknown or low risk for HBsAg-positive and exposed person is vaccinated:
No treatment required.

Source unknown or low risk for HBsAg-positive and exposed person is unvaccinated:
Start hepatitis B vaccine series within 7 days of exposure.

Sexual exposure to HBsAg-positive source:
HBIG 0.06 mL/kg IM once
plus start hepatitis B vaccine series within 14 days of last contact or if contact will continue.

Hepatitis b immune globulin Pregnancy Warnings

Hepatitis B immune globulin has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. Hepatitis B immune globulin should only be given during pregnancy if clearly needed. Its use is recommended for postexposure prophylaxis during pregnancy by the American College of Obstetricians and Gynecologists.

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