Nabi-HB

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Fifty male and female volunteers received Nabi-HB, Hepatitis B Immune Globulin (Human), intramuscularly in pharmacokinetics trials20. The number of patients with reactions related to the administration of Nabi-HB (hepatitis b vaccine recombinant) included local reactions such as erythema 6 (12%) and ache 2 (4%) at the injection site, as well as systemic reactions such as headache 7 (14%), myal-gia 5 (10%), malaise 3 (6%), nausea 2 (4%), and vomiting 1 (2%). The majority (92%) of reactions were reported as mild. The following adverse events were reported in the phar-macokinetics trials and were considered probably related to Nabi-HB (hepatitis b vaccine recombinant) : elevated alkaline phos-phatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%), elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine 1 (2%). All adverse events were mild in intensity. There were no serious adverse events.

No anaphylactic reactions with Nabi-HB (hepatitis b vaccine recombinant) have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins23.

Read the entire FDA prescribing information for Nabi HB (Hepatitis B Vaccine Recombinant)

Nabi-HB is part of the drug class:

• Specific immunoglobulins

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

In the U.S.

• Bayhep B
• HepaGam B
• HyperHEP B
• Nabi-HB
• Nabi-HB NovaPlus

Available Dosage Forms:

• Solution

Therapeutic Class: Immune Serum

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

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into a muscle or a vein.

If you are using this medicine for prevention of hepatitis B from occurring again in patients who have had liver transplants, this medicine is given through a needle placed in one of your veins.

If you are using this medicine for prevention of hepatitis B infection after being exposed to hepatitis B virus, it should be given as a shot into one of your muscles.

This medicine works best if you receive it soon after being exposed to hepatitis B. If you had sexual contact with a person who has hepatitis B, you should receive this medicine within 14 days. If you were exposed some other way, you should receive this medicine within 24 hours of being exposed to hepatitis B.

You may need to have a second dose of medicine 1 month after the first dose. Make sure you understand the schedule if you need to have a second dose.

This medicine may be given to a baby if the baby's mother has hepatitis B. The baby is often given the medicine within 12 hours after birth. Ask your doctor about the schedule if your baby needs this medicine.

Hepatitis B vaccine is often used in addition to hepatitis B immune globulin. Make sure you understand if you also need the vaccine.

Use Nabi-HB as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Fever or chills.
• Headache.
• Upset stomach or throwing up.
• Joint pain.
• Back pain.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Nabi-HB or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Nabi-HB (hepatitis B immune globulin (human)). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

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