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 What is Arzerra? how to use?

Arzerra (ofatumumab) injection is a monoclonal antibody used to treat chronic lymphocytic leukemia. Arzerra is usually given after other drugs have been tried but the symptoms have not been successfully treated.

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What are the side effects of Arzerra?

Common side effects of Arzerra include:

  • nausea,
  • Vomiting
  • diarrhea,
  • tired
  • Swelling of hands/ankles/feet,
  • Difficulty sleeping,
  • Skin rash, or
  • Cold symptoms such as stuffy nose, sneezing and sore throat.

Arzerra reduces bone marrow function, which may result in a decrease in the number of blood cells, such as red blood cells, white blood cells and platelets. This side effect of Arzerra can cause anemia, reduce the body's ability to fight infection or cause easy bruising or bleeding. Tell the doctor if you have the following symptoms:

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Easy bruising/bleeding,

Pale skin,

Unusual tiredness, or

Signs of infection (eg fever, chills, cough, persistent sore throat).

caveat

Activation of hepatitis B virus and progressive multifocal leukoplakia

Patients receiving CD20-directed cytolytic antibodies (including ARZERRA®) may develop hepatitis B virus (HBV) activation, which in some cases can lead to fulminant hepatitis, liver failure and death [see Warnings and Precautions].

Patients receiving CD20-directed cytolytic antibodies (including ARZERRA) may develop progressive multifocal leukoencephalopathy (PML) that leads to death [see Warnings and Precautions].

Description

ARZERRA (ofatumumab) is an IgG1κ human monoclonal antibody with a molecular weight of approximately 149 kDa. The antibody is produced through transgenic mouse and hybridoma technology, and is produced in a recombinant mouse cell line (NS0) using standard mammalian cell culture and purification techniques.

ARZERRA is a sterile, clear to milky white, colorless, preservative-free liquid concentrate for intravenous administration. The concentration of ARZERRA in the disposable vial is 20 mg/mL. Each disposable vial contains 100 mg ofatumumab in 5 mL of solution or 1,000 mg ofatumumab in 50 mL of solution.

Inactive ingredients include: 10 mg/mL arginine, dilute hydrochloric acid, 0.019 mg/mL disodium edetate, 0.2 mg/mL polysorbate 80, 6.8 mg/mL sodium acetate, 2.98 mg/mL sodium chloride and water for injection, USP. The pH is 5.5.

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