• Chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab.
• Previously untreated patients with CLL when fludarabine is considered inappropriate (in combination with chlorambucil).
• Extended treatment of patients who are in complete or partial response after 2 lines of therapy for recurrent or progressive CLL.
• Relapsed CLL (in combination with fludarabine and cyclophosphamide).
• Relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Contraindicated in:

• Acute hepatitis B infection (subcut only).

Use Cautiously in:

• History of hepatitis B infection (may reactivate)
• OB: Safety not established in pregnancy (may cause fetal B-cell depletion)
• Lactation: Safety not established in breastfeeding
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children.

CNS: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML), headache, weakness.

CV: peripheral edema.

Derm: sweating.

GI: HEPATITIS B INFECTION OR REACTIVATION, INTESTINAL OBSTRUCTION.

Hemat: anemia, neutropenia, thrombocytopenia.

Local: injection reactions (subcut only).

MS: back pain, muscle spasm.

Misc: Infection, infusion reactions, chills, fever, tumor lysis syndrome.

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.

• Solution for IV injection: 20 mg/mL;
• Solution for subcutaneous injection (prefilled pens and syringes): 20 mg/0.4 mL;

Refractory CLL

• IV (Adults): 300 mg initially, followed 1 wk later by 2000 mg weekly for 7 doses, followed 4 wk later by 2000 mg every 4 wk for 4 doses (total regimen is 12 doses).

Previously Untreated CLL

• IV (Adults): 300 mg initially, followed 1 wk later by 1000 mg (on Day 8; Cycle 1), followed by 1000 mg on Day 1 of subsequent 28–day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles.

Extended Treatment of CLL

• IV (Adults): 300 mg initially, followed 1 wk later by 1000 mg (on Day 8), followed by 1000 mg 7 wk later and then every 8 wk thereafter for up to a maximum of 2 years.

Relapsed CLL

• IV (Adults): 300 mg initially, followed 1 wk later by 1000 mg (on Day 8; Cycle 1), followed by 1000 mg on Day 1 of subsequent 28–day cycles for a maximum of 6 cycles.

Relapsing MS

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

Arzerra, Kesimpta

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

• ↓numbers of leukemic cells in CLL.
• Decreased incidence of relapses in MS.

Therapeutic Classification: anti-multiple sclerosis agents, antineoplastics

Pharmacologic Classification: monoclonal antibodies

Absorption: IV administration results in complete bioavailability. Extent of absorption following subcutaneous administration unknown.

Distribution: Unknown.

Metabolism/Excretion: Undergoes enzymatic degradation to smaller peptides.

Half-life: IV — 14 days (range: 2.3–61.5 days); Subcut — 16 days.

(plasma concentrations)

• Explain the purpose of ofatumumab to patient and caregiver. Instruct patient taking Kesimpta in correct preparation, injection technique, and equipment disposal. Administer missed doses as soon as remembered, then administer subsequent doses at recommended intervals.
• Advise patient to avoid live viral vaccines during therapy.
• Advise patient to notify health care professional immediately if signs and symptoms of infusion reactions (fever, chills, rash, breathing problems) occur within 24 hr of infusion or if bleeding, PML (progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; changes in thinking, memory, and orientation leading to confusion and personality changes). bruising, petechiae, pallor, worsening weakness, fatigue, cough, infection, confusion, dizziness, loss of balance, difficulty talking or walking, vision problems, yellow discoloration of skin or eyes, new or worsening abdominal pain or nausea 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.
• Emphasize the need for periodic blood count monitoring.

oh-fa-TOO-moo-mab

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)