ZEPZELCA

LURBINECTEDIN

Manufacturer: Jazz Pharmaceuticals, Inc.

Score: 141.0

Quick Summary

ZEPZELCA is an alkylating drug used for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. The recommended dosage is 3.2 mg/m^2 every 21 days. ZEPZELCA can cause fetal harm when administered to a pregnant woman, and its safety and effectiveness in pediatric patients have not been established. The most common adverse reactions include leukopenia, lymphopenia, fatigue, anemia, neutropenia, and thrombocytopenia.

Key Clinical Findings and Indications

Treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy
Alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove

Important Safety Information

Warning

ZEPZELCA can cause fetal harm when administered to a pregnant woman

Contraindications

Adverse Reactions

Leukopenia
Lymphopenia
Fatigue
Anemia
Neutropenia
Thrombocytopenia
Nausea
Decreased appetite
Musculoskeletal pain
Decreased albumin
Constipation
Dyspnea
Decreased sodium
Increased aspartate aminotransferase
Vomiting
Cough
Decreased magnesium
Diarrhea

Dosing Recommendations

General Guidance

Reduce dose by 50% when coadministered with strong CYP3A inhibitors

Metastatic small cell lung cancer (SCLC)

Adult Dose

3.2 mg/m^2 every 21 days

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

ZEPZELCA can cause fetal harm when administered to a pregnant woman
Advise pregnant women of the potential risk to a fetus

Nursing Mothers

Pediatric Use

The safety and effectiveness of ZEPZELCA in pediatric patients have not been established

Geriatric Use

Of the 105 patients with SCLC administered ZEPZELCA in clinical studies, 37 (35%) patients were 65 years of age and older, while 9 (9%) patients were 75 years of age and older
No overall difference in effectiveness was observed between patients aged 65 and older and younger patients
There was a higher incidence of serious adverse reactions in patients ≥ 65 years of age than in patients < 65 years of age

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