Respiratory and thoracic cancers:

Indications for: ZEPZELCA

Metastatic small cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy.

Adult Dosage:

Consider premedication with corticosteroids, serontonin antagonists. Initiate only if ANC is ≥1500cells/mm3 and platelet count is ≥100000/mm3. Give by IV infusion over 60mins. 3.2mg/m2 every 21 days until disease progression or unacceptable toxicity. Concomitant strong CYP3A inhibitors, if unavoidable: reduce Zepzelca dose by 50%. Dose modifications for adverse reactions: see full labeling.

Children Dosage:

Not established.

ZEPZELCA Warnings/Precautions:

Risk of myelosuppression, hepatotoxicity, rhabdomyolysis. Monitor blood counts with neutrophils, platelets prior to initiation. If neutrophils <500cells/mm3 or any value less than LLN: give G-CSF. Monitor LFTs, creatinine phosphokinase prior to and during therapy as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity. Extravasation resulting in tissue necrosis; monitor during infusion. Discontinue immediately if extravasation occurs. Moderate or severe hepatic impairment. Elderly. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or 4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).

ZEPZELCA Classification:

Alkylating agent.

ZEPZELCA Interactions:

Potentiated by strong or moderate CYP3A inhibitors (eg, grapefruit, Seville oranges); avoid concomitant use. If concomitant strong CYP3A inhibitors unavoidable; reduce Zepzelca dose (see Adult dose). If concomitant moderate CYP3A inhibitors unavoidable; consider Zepzelca dose reduction, if needed. Antagonized by strong CYP3A inducers; avoid concomitant use.

Adverse Reactions:

Leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase, increased glucose, thrombocytopenia, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium, diarrhea.

Metabolism:

CYP3A4. 

Drug Elimination:

Fecal (89%), renal (6%). Half-life: 51 hours.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1