Multiple sclerosis:

Indications for KESIMPTA:

Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Adult:

Perform first inj under the guidance of a healthcare provider. Give by SC inj into abdomen, thigh, or outer upper arm. Initially 20mg at Weeks 0, 1, and 2, followed by 20mg once monthly starting at Week 4.

Children:

Not established.

Contraindications:

Active HBV infection.

Warnings/Precautions:

Increased risk of infections; delay treatment in those with active infection until resolved. Risk of HBV reactivation. Perform HBV screening in all patients prior to initiation. Withhold at first sign/symptom of progressive multifocal leukoencephalopathy (PML) and evaluate; discontinue if confirmed. Monitor and treat if inj-related reactions occur. Monitor levels of quantitative serum immunoglobulins before initiating, during and after discontinuation until B-cell repletion; consider discontinuing if low immunoglobulins with a serious opportunistic infection or recurrent infections occur, or if prolonged hypogammaglobulinemia requires IV immunoglobulins. Prior to initiation, complete all immunizations according to guidelines ≥4 weeks for live or live-attenuated vaccines, and if possible, ≥2 weeks for non-live vaccines. Infants born to mothers treated during pregnancy: do not administer live or live-attenuated vaccines before confirming B-cell recovery; non-live vaccines may be given prior to recovery, but should consider assessment of vaccine immune response. Advise females or reproductive potential to use effective contraception during and ≥6 months after the last dose. Pregnancy. Nursing mothers.

Pharmacologic Class:

CD20-directed cytolytic monoclonal antibody.

Interactions:

Concomitant live or live-attenuated vaccines: not recommended during treatment and after discontinuation until B-cell repletion. May interfere with the effectiveness of non-live vaccines. Potential additive immunosuppressive effects with other immunosuppressants including systemic corticosteroids.

Adverse Reactions:

Upper respiratory tract infection, headache, inj-related reactions, local inj-site reactions; infections, reduction in immunoglobulins.

Generic Availability:

NO

How Supplied:

Single-dose prefilled Sensoready pen—1; Single-dose prefilled syringe—1