Miscellaneous neurodegenerative disorders:

Indications for UPLIZNA:

Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.

Adult:

Premedicate with a corticosteroid (IV), an antihistamine (oral), and an antipyretic (oral) prior to each infusion. Give by IV infusion via an infusion pump at an increasing rate to completion (approx. 90mins); see full labeling. Initial dose: 300mg, followed by a second 300mg infusion 2 weeks later. Subsequent doses (starting 6 months from 1st infusion): single 300mg every 6 months.

Children:

Not established.

Contraindications:

Active hepatitis B infection. Active or untreated latent tuberculosis. History of life-threatening infusion reaction to Uplizna.

Warnings/Precautions:

Monitor for infusion reactions during and ≥1hr after therapy completion; permanently discontinue if life-threatening infusion reactions occur; treat appropriately. Increased risk of infections. Assess for infections prior to every infusion; if active, delay Uplizna treatment until resolved. Risk of HBV reactivation. Perform HBV screening in all patients prior to initiation. Evaluate for TB risks and test/treat latent TB prior to initiation. Monitor levels of quantitative serum immunoglobulins before initiating, during and until B-cell repletion after discontinuation; consider discontinuing if low immunoglobulin G or M with a serious opportunistic infection or recurrent infections occur, or if prolonged hypogammaglobulinemia requires IV immunoglobulins. Withhold at first sign/symptom of progressive multifocal leukoencephalopathy (PML) and evaluate. Complete all immunizations according to guidelines ≥4 weeks prior to treatment. 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 of reproductive potential to use effective contraception during and for ≥6 months after the last dose. Pregnancy. Nursing mothers.

Pharmacologic Class:

CD19-directed cytolytic monoclonal antibody.

Interactions:

Concomitant live or live-attenuated vaccines: not recommended during treatment and after discontinuation until B-cell repletion. Additive immunosuppressive effects with other immunosuppressants including systemic corticosteroids.

Adverse Reactions:

Urinary tract infection, nasopharyngitis, infusion reaction, arthralgia, headache; lab abnormalities (decreased immunoglobulins, lymphocytes, and neutrophils).

Generic Availability:

NO

How Supplied:

Single-dose vials (10mL)—3

Pricing for UPLIZNA

3 vials of 100mg/ml carton (Qty: 1)
Appx. price $13372
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