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

Contraindicated in:

• Baseline neutrophil count <1,500 cells/mm³
• Baseline platelet count <100,000 cells/mm³
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Moderate or severe hepatic impairment
• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Safety and effectiveness not established in children
• Geri: ↑risk of myelosuppression.

Endo: hyperglycemia.

F and E: hypomagnesemia, hyponatremia.

GI: abdominal pain, constipation, diarrhea, hypoalbuminemia, ↑liver enzymes, nausea, vomiting.

GU: ↑serum creatinine.

Hemat: neutropenia, anemia, leukopenia, lymphopenia, thrombocytopenia.

Metab: ↓appetite.

MS: pain.

Neuro: peripheral neuropathy , headache, dysgeusia.

Resp: cough, dyspnea, respiratory tract infection.

Misc: fatigue, fever.

Drug-Drug:

• Strong CYP3A4 inhibitors and moderate CYP3A4 inhibitors may ↑ levels and risk of toxicity; avoid concurrent use. If concurrent use with moderate CYP3A4 inhibitor unavoidable, consider ↓ lurbinectedin dose.
• Strong CYP3A4 inducers and moderate CYP3A4 inducers may ↓ levels and effectiveness; avoid concurrent use.

Drug-Food:

• Grapefruit juice may ↑ levels and risk of toxicity; avoid concurrent use.

• Lyophilized powder for injection: 4 mg/vial;

• IV (Adults): 3.2 mg/m² every 21 days until disease progression or unacceptable toxicity. Concurrent use of moderate CYP3A4 inhibitors — 2.6 mg/m² every 21 days until disease progression or unacceptable toxicity.

Zepzelca

• Acts as an alkylating agent and a selective inhibitor of oncogenic transcription which results in DNA double-strand breaks and tumor cell apoptosis.

• Decreased progression of metastatic SCLC.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: alkylating agents

Absorption: IV administration results in complete bioavailability.

Distribution: Extensively distributed to extravascular tissues.

Metabolism/Excretion: Primarily metabolized by the liver by the CYP3A4 isoenzyme. Primarily excreted in feces (89%, <0.2% as unchanged drug), with 6% excreted in urine (<1% as unchanged drug).

Half-life: 51 hr.

(plasma concentrations)

• Explain purpose of lurbinectedin to patient. Advise patient to read Patient Information before starting and periodically during therapy in case of changes.
• Instruct patient to avoid eating grapefruit or drinking grapefruit juice during therapy.
• Advise patient to notify health care professional if signs and symptoms of low blood cell counts (fever, any other signs of infection, tiredness, unusual bruising or bleeding, pale colored skin) or liver problems (loss of appetite, nausea or vomiting, pain on the right side of abdomen) 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 during and for at least 6 mo after last dose and to avoid breastfeeding during and for at least 2 wk after last dose. Advise males with female partners of reproductive potential to use effective contraception during and for 4 mo after last dose. Advise patient to notify health care professional immediately if pregnancy is suspected.

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