Nabi-HB NovaPlus

Name: Nabi-HB NovaPlus

Commonly used brand name(s)

In the U.S.

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

Available Dosage Forms:

  • Solution

Therapeutic Class: Immune Serum

Before Using Nabi-HB NovaPlus

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 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.

Geriatric

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

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.

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:

  • Allergy (severe) to human globulin, history of or
  • Immunoglobulin (IgA) deficiency—Should not be given to patients with these conditions.
  • Atherosclerosis (hardening of the arteries), history of or
  • Blood clotting problems, history of or
  • Diabetes or
  • Heart or blood vessel disease or
  • Hyperviscosity (thick blood), known or suspected or
  • Prolonged periods of immobilization—Use with caution. May cause side effects to become worse.
  • Blood clotting problems or
  • Thrombocytopenia (low number of platelets), severe—Should not be given to patients who are receiving this medicine for postexposure prophylaxis unless the benefits outweigh the risks.

Nabi-HB NovaPlus 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:

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 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

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.

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

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