Leukemias, lymphomas, and other hematologic cancers:

Indications for PEPAXTO:

In combination with dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy and whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 CD38-directed monoclonal antibody.

Limitations of Use:

Not for use as a conditioning regimen for transplant outside of controlled clinical trials.

Adult Dosage:

Give by IV infusion over 30mins. 40mg on Day 1 of each 28-day cycle until disease progression or unacceptable toxicity. Administer dexamethasone 40mg (orally or IV) on Days 1, 8, 15 and 22 of each cycle; for patients ≥75yrs: reduce dexamethasone to 20mg. Consider providing a 5-HT3 receptor antagonist or other antiemetics prior to and during Pepaxto treatment. Dosage modifications for adverse reactions: see full labeling.

Children Dosage:

Not established.

PEPAXTO Contraindications:

History of serious hypersensitivity reaction to melphalan flufenamide or melphalan.

PEPAXTO Warnings/Precautions:

Monitor platelets, neutrophils, red blood cells at baseline, more frequently during 1st 2 months, and as clinically indicated. Withhold if platelet count <50×109/L or absolute neutrophil count <1×109/L. Increased risk of mortality at dosages higher than recommended. Monitor long-term for secondary malignancies. Renal impairment (CrCl 15–44mL/min): not studied. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).

PEPAXTO Classification:

Alkylating agent.

Adverse Reactions:

Fatigue, nausea, diarrhea, pyrexia, respiratory tract infection, lab abnormalities (decreased leukocytes, decreased platelets, decreased lymphocytes, decreased neutrophils, decreased hemoglobin, increased creatinine); thrombocytopenia, neutropenia, anemia, infections (may be fatal), secondary malignancies (eg, myelodysplastic syndromes, acute leukemia).

Generic Drug Availability:

NO

How Supplied:

Single-dose vial (50mL)—1