ublituximab

Contraindicated in:

Active hepatitis B virus infection (may reactivate infection during and for several mo after treatment);
History of life-threatening infusion reaction to ublituximab;
Active infection;
OB: Pregnancy (may cause fetal B-cell depletion).

Use Cautiously in:

Patients who are immunocompromised or receiving other immunosuppressants;
Lactation: Safety not established in breastfeeding;
Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Hemat: neutropenia

MS: fatigue, insomnia, pain

Neuro: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Misc: infection, infusion reactions (including anaphylaxis)

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with immunosuppressive therapies may ↑ risk of immunosuppression.
May ↓ antibody response to or ↑ risk of adverse reactions to non-live vaccines and live vaccines.

Availability ⬆ ⬇

Solution for injection: 25 mg/mL

Route/Dosage ⬆ ⬇

IV (Adults ): 150 mg as single dose on Day 1; then 450 mg as single dose 2 wk later; then 450 mg as single dose 24 wk after initial 150-mg dose; then 450 mg every 24 wk thereafter.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to the CD20 antigen on pre-B and mature B lymphocytes, which results in antibody-dependent and complement-mediated cell lysis.

Therapeutic effects:

Reduction in relapse rate and decreased progression toward disability.

Classifications ⬆ ⬇

Therapeutic Classification: anti-multiple sclerosis agents

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Not widely distributed to tissues.

Metabolism/Excretion: Degraded to small peptides and amino acids by proteolytic enzymes.

Half-Life: 22 days

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of ublituximab. Do not stop receiving drug without consulting health care professional. If an appointment is missed, contact health care professional as soon as possible to reschedule. Advise patient to read Patient Information before starting therapy.
Advise patient to notify health care professional if signs and symptoms of infusion reactions (fever, chills or shivering, nausea, vomiting, diarrhea, tiredness, dizziness, sweating, hives, itching, shortness of breath, wheezing) occur.
Advise patient to immediately report any signs or symptoms of infection (fever, chills, cough, headache, malaise, flu-like symptoms, painful urination, blood in urine, flank pain, abdominal pain, rashes).
Tell patient to avoid live-attenuated or live vaccines during treatment and until B-cell recovery.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: May cause fetal harm. Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise patient to use effective contraception during treatment and for 6 mo after the last dose. Do not administer live or live-attenuated vaccines to neonates or infants who were exposed in utero until B-cell recovery occurs. Encourage women who become pregnant while taking ublituximab to enroll in the pregnancy registry by calling 1-877-411-4546 or visiting www.briumvipregnancyregistry.com.

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Indications ⬇

Contraind./Precautions ⬆ ⬇