ofatumumab

Contraindicated in:

Hypersensitivity;
Acute hepatitis B virus (HBV) infection.

Use Cautiously in:

History of HBV infection (may reactivate);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: peripheral edema

Derm: sweating

GI: HBV INFECTION OR REACTIVATION, INTESTINAL OBSTRUCTION

Hemat: anemia, neutropenia, thrombocytopenia

Local: injection site reactions

MS: back pain, muscle spasm

Neuro: headache, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML), weakness

Misc: Infection, chills, fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), tumor lysis syndrome

Interactions ⬆ ⬇

Drug-drug:

May ↓ antibody response to and ↑ risk of adverse reactions from live-virus vaccines; may also interfere with effectiveness of inactivated vaccines.
Immunosuppressants may ↑ risk of immunosuppression.

Availability ⬆ ⬇

Solution for SUBQ injection (prefilled pens and syringes): 20 mg/0.4 mL

Route/Dosage ⬆ ⬇

Relapsing Multiple Sclerosis

SC (Adults ): 20 mg once weekly for 3 wk (Wk 0, 1, and 2), then 20 mg once monthly starting on Wk 4.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

A monoclonal antibody that specifically binds to CD20 molecule found on the surface of B lymphocytes, resulting in B-cell lysis.

Therapeutic effects:

Decreased incidence of relapses in MS.

Classifications ⬆ ⬇

Therapeutic Classification: anti-multiple sclerosis agents

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following SUBQ administration unknown.

Distribution: Unknown.

Metabolism/Excretion: Undergoes enzymatic degradation to smaller peptides.

Half-Life: 16 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy. Instruct patient about correct preparation, injection technique, and equipment disposal. Administer missed doses as soon as remembered; then administer subsequent doses at recommended intervals.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
Advise patient to avoid live-virus vaccines during therapy.
Inform patients about the signs and symptoms of injection-related reactions and hypersensitivity reactions. Inform patients that injection-related reactions generally occur within 24 hr and mainly after the first injection but may occur with any injection. Advise patients to contact their health care provider or seek immediate medical attention if reactions occur.
Rep: Advise females of reproductive potential to use effective contraception during and for 6 mo after last dose and to notify health care professional if breastfeeding. May cause fetal B-cell depletion. Avoid administering live vaccines to neonates and infants exposed to ofatumumab in utero until B-cell recovery occurs.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0078- Novartis Pharmaceuticals Corporation
- 0078-0669- ARZERRA
  - 0078-0669-13- 3 VIAL, SINGLE-USE in 1 CARTON (0078-0669-13) > 5 mL in 1 VIAL, SINGLE-USE (0078-0669-61)

0078- Novartis Pharmaceuticals Corporation
- 0078-0690- ARZERRA
  - 0078-0690-61- 50 mL in 1 VIAL, SINGLE-USE (0078-0690-61)

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Indications ⬇

Contraind./Precautions ⬆ ⬇