Kesimpta Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Kesimpta Indications
Indications
Kesimpta Dosage and Administration
Adult
Children
Kesimpta Contraindications
Contraindications
Kesimpta Boxed Warnings
Not Applicable
Kesimpta Warnings/Precautions
Warnings/Precautions
Increased risk of infections. Delay Kesimpta 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. Complete all immunizations according to guidelines ≥4 weeks for live or live-attenuated vaccines, and if possible, ≥2 weeks for non-live vaccines prior to initiation. 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.
Kesimpta Pharmacokinetics
Absorption
After subcutaneous administration, ofatumumab is believed to be predominantly absorbed via the lymphatic system.
Elimination
Ofatumumab is eliminated by both linear catabolic pathways and a non-linear B-cell mediated pathway. The half-life at steady state was estimated to be approximately 16 days following subcutaneous administration of repeated Kesimpta 20mg dosage.
Kesimpta Interactions
Interactions
Kesimpta Adverse Reactions
Adverse Reactions
Kesimpta Clinical Trials
Kesimpta Note
Not Applicable
Kesimpta Patient Counseling
Cost Savings Program
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