inebilizumab

Contraindicated in:

History of life-threatening infusion reaction to inebilizumab;
Active hepatitis B virus (HBV) infection;
Active or untreated latent tuberculosis;
Active infection
OB: Pregnancy.

Use Cautiously in:

Rep: Women of reproductive potential;
Lactation: Use while breastfeeding only if potential maternal benefits justify potential risks to infant;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

GI: HBV reactivation

Hemat: hypogammaglobulinemia, lymphocytopenia, neutropenia

MS: arthralgia

Neuro: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML), headache

Misc: INFECTION, infusion reactions

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with other immunosuppressants may ↑ risk of infection.
Live vaccines or live-attenuated vaccinesshould not be given concurrently; administer ≥4 wk prior to initiation of inebilizumab therapy. Do not administer live or live-attenuated vaccines to infants exposed to inebilizumab therapy in utero until recovery of B-cell counts confirmed.

Availability ⬆ ⬇

Solution for injection: 10 mg/mL

Route/Dosage ⬆ ⬇

IV (Adults ): 300 mg initially; then 300 mg 2 wk later; then 300 mg every 6 mo (beginning 6 mo after the first 300 mg dose).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to CD19, a cell-surface antigen present on pre-B and mature B lymphocytes, which results in antibody-dependent cellular cytolysis.

Therapeutic effects:

Prolonged time to relapse.

Classifications ⬆ ⬇

Therapeutic Classification: none assigned

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Minimal distribution to extravascular tissues.

Metabolism/Excretion: Degraded by proteolytic enzymes; excretion pathway unknown.

Half-Life: 18 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	unknown

Patient/Family Teaching ⬆ ⬇

Inform patient of the purpose for inebilizumab. Instruct patient to read the Medication Guide before starting therapy and every 6 mo in case of changes.
Advise patient to notify health care professional immediately if signs and symptoms of infection, infusion reaction, or PML occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and avoid breastfeeding during and for 6 mo after the last dose of therapy. In infants of mothers exposed to inebilizumab during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant.

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Indications ⬇

Contraind./Precautions ⬆ ⬇