ublituximab

UE-bli-TUX-i-mab

Therapeutic Classification: anti-multiple sclerosis agents

Pharmacologic Classification: monoclonal antibodies

REMS

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

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.

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

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	unknown

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.

Hemat: neutropenia

MS: fatigue, insomnia, pain

Neuro: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML)

Misc: infection, infusion reactions (including anaphylaxis)

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.

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.

Solution for injection: 25 mg/mL

Monitor for signs and symptoms of infection (especially in patients with neutropenia) (fever, chills, cough, headache, malaise, flu-like symptoms, dysuria, hematuria, cellulitis, erythematous nonhealing wound). Evaluate for active infection prior to each infusion and delay treatment in patients with an active infection until the infection is resolved.
Monitor for signs and symptoms of infusion-related reactions (fever, chills, sweating, myalgia, headache, dizziness, nausea, vomiting, urticaria, pruritus, shortness of breath, wheezing), including anaphylaxis (angioedema), during and within 24 hr of infusion. Premedication recommended (see implementation section). Observe patient for infusion-related reactions during the infusion, for ≥1 hr after the infusion for the 1st two infusions, and then as clinically indicated with subsequent infusions. If mild to moderate infusion-related reactions occur,↓ infusion rate by 50% of rate at onset of infusion reaction and maintain ↓ rate for ≥30 min; if tolerated, continue to ↑ infusion rate in usual manner for remainder of infusion; infusion duration may take longer if the infusion is interrupted or slowed. If severe infusion-related reactions occur, immediately interrupt infusion and administer any appropriate supportive treatment; may restart after all symptoms have resolved, at 50% of the infusion rate at the time of onset of infusion reaction; if tolerated, continue to ↑ infusion rate in usual manner for remainder of infusion; infusion duration may take longer if the infusion is interrupted or slowed. If life-threatening infusion-related reactions occur, immediately stop infusion and permanently discontinue use; provide appropriate supportive treatment.
Monitor for signs and symptoms of PML (confusion, weakness, headaches, aphasia, gait disturbance, ataxia, hemiparesis, seizures, visual deficits). MRI findings may be apparent before clinical signs or symptoms; withholding treatment or discontinuation may be necessary.

Lab Test Considerations:

Verify negative pregnancy test before starting therapy and prior to each infusion.
Perform hepatitis B virus screening prior to treatment.
Assess quantitative serum immunoglobulins before treatment and monitor during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation until B-cell repletion.
Obtain CBC at baseline and monitor periodically during treatment; may cause neutropenia.

Premedication: Methylprednisolone 100 mg IV (or equivalent ) approximately 30 min prior to each infusion and an antihistamine (diphenhydramine) PO/IV approximately 30–60 min prior to each infusion; consider addition of an antipyretic (acetaminophen).
Assess immunization history and administer any needed immunizations including live or live-attenuated vaccines ≥4 wk prior and non-live vaccines ≥2 wk prior.

IV Administration:

Administer missed dose as soon as possible; do not wait until the next planned infusion. Reset the infusion schedule for the next sequential infusion to 24 wk after the missed infusion is administered; separate infusions by ≥5 mo.
Y-Site Incompatibility:
- Do not administer other drugs through same IV line.

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.

Reduction in relapse rate and decreased progression toward disability.

Briumvi

NDC Code

71124- Samsung BioLogics Co. LTD
- 71124-0026-
  - 71124-0026-1- 6 mL in 1 VIAL, SINGLE-DOSE (71124-0026-1)

73150- TG Therapeutics, Inc.
- 73150-150- BRIUMVI
  - 73150-150-06- 1 VIAL, SINGLE-DOSE in 1 CARTON (73150-150-06) / 6 mL in 1 VIAL, SINGLE-DOSE

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