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Arzerra Side Effects

Generic name: ofatumumab

Medically reviewed by Drugs.com. Last updated on Apr 12, 2023.

Note: This document contains side effect information about ofatumumab. Some dosage forms listed on this page may not apply to the brand name Arzerra.

Applies to ofatumumab: solution.

Warning

Intravenous route (Solution)

Hepatitis B Virus (HBV) reactivation can occur in patients receiving CD20-directed cytolytic antibodies, including ofatumumab, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Progressive Multifocal Leukoencephalopathy (PML) resulting in death can occur in patients receiving CD20-directed cytolytic antibodies, including ofatumumab.

Serious side effects of Arzerra

Along with its needed effects, ofatumumab (the active ingredient contained in Arzerra) 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 ofatumumab:

More common

Less common

Incidence not known

Check with your doctor immediately if any of the following side effects occur while taking ofatumumab:

More common

Other side effects of Arzerra

Some side effects of ofatumumab 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

Less common

For Healthcare Professionals

Applies to ofatumumab: intravenous solution, subcutaneous solution.

Hematologic

Very common (10% or more): Neutropenia (up to 27%), anemia (up to 18%)

Common (1% to 10%): Leukopenia, febrile neutropenia, thrombocytopenia

Uncommon (0.1% to 1%): Agranulocytosis, coagulopathy, red cell aplasia, lymphopenia[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 19%), pneumonia (up to 23%), cough (up to 19%), dyspnea (up to 14%), bronchitis (up to 11%), lower respiratory tract infection

Common (1% to 10%): Sinusitis, nasopharyngitis, bronchospasm, hypoxia, dyspnea, chest discomfort, pharyngolaryngeal pain, nasal congestion

Uncommon (0.1% to 1%): Pulmonary edema[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 18%), nausea (up to 11%)

Common (1% to 10%): Upper abdominal pain

Uncommon (0.1% to 1%): Small bowel obstruction[Ref]

Dermatologic

Very common (10% or more): Rash (e.g., rash, rash macular, rash vesicular) (up to 14%)

Common (1% to 10%): Urticaria, hyperhidrosis, erythema, pruritus

Uncommon (0.1% to 1%): Coagulopathy, red cell aplasia

Postmarketing reports: Stevens-Johnson syndrome, porphyria cutanea tarda[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, chills, muscle spasms, rigors[Ref]

Psychiatric

Common (1% to 10%): Insomnia[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, hypotension, tachycardia

Uncommon (0.1% to 1%): Bradycardia

Postmarketing reports: Cardiac arrest (infusion related)[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis B infection and reactivation[Ref]

Hypersensitivity

Common (1% to 10%): Anaphylactoid reactions, hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic shock, cytokine release syndrome[Ref]

Immunologic

Common (1% to 10%): Herpes simplex (e.g., oral herpes, herpes, herpes virus infection, genital herpes), influenza, herpes zoster, hypogammaglobulinemia, bacterial infections, viral infections, fungal infections, sepsis (e.g., sepsis, neutropenic sepsis, bacteremia, septic shock)

Uncommon (0.1% to 1%): Immunogenicity[Ref]

Metabolic

Very common (10% or more):

Common (1% to 10%): Peripheral edema

Uncommon (0.1% to 1%): Tumor lysis syndrome[Ref]

Other

Very common (10% or more): Pyrexia (up to 20%), fatigue (up to 15%)[Ref]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Pharmaceutical Society of Australia. APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp 2006.

3. Product Information. Arzerra (ofatumumab). GlaxoSmithKline. 2009.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.