Nabi-HB Side Effects

Generic name: hepatitis b immune globulin

Note: This document contains side effect information about hepatitis b immune globulin. Some of the dosage forms listed on this page may not apply to the brand name Nabi-HB.

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.

For the Consumer

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

Get emergency medical help if you have any of these signs of an allergic reaction while taking hepatitis b immune globulin (the active ingredient contained in Nabi-HB) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

• left-sided stomach pain; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of hepatitis b immune globulin may include:

• upset stomach, diarrhea;

• tremors or shaking;

• joint or back pain;

• fever, chills;

• headache; or

• tired feeling.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

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

General

Most side effects have been classified as mild.

Local

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

Hypersensitivity

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

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.

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.

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.

Hematologic

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

Hepatic

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

Renal

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

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.

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