Lurbinectedin Dosage

Medically reviewed by Drugs.com. Last updated on Aug 15, 2023.

Usual Adult Dose for Small Cell Lung Cancer

3.2 mg/m2 intravenously over 60 minutes every 21 days
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:

• Initiate this drug only if absolute neutrophil count (ANC) is at least 1500 cells/mm(3) and platelet count is at least 100,000/mm(3).
• Consider administering pre-infusion medications for antiemetic prophylaxis:
• Corticosteroids (dexamethasone 8 mg IV or equivalent)
• Serotonin antagonists (ondansetron 8 mg IV or equivalent)

Use: For the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

• Mild Liver Dysfunction (total bilirubin [TB] less than or equal to upper limit of normal [ULN] and AST greater than ULN or TB between 1 to 1.5 times ULN and any AST): No dose adjustment recommended
• Moderate to Severe Liver Dysfunction (TB greater than 1.5 times ULN and any AST): Data not available

Dose Modification for Patients who experience Hepatoxicity while in therapy:

• Grade 2: Withhold therapy until resolved to Grade 1 or less; resume therapy at the same dose.
• Grade 3 or greater: Withhold therapy until resolved to Grade 1 or less; resume at a reduced dose or permanently discontinue.

Dose Adjustments

Permanently discontinue this drug in patients who are unable to tolerate 2 mg/m2 or require a dose delay greater than 2 weeks.

Recommended Dose Reduction for Adverse Reactions:

• First dose reduction: 2.6 mg/m2 IV over 60 minutes every 21 days
• Second dose reduction: 2 mg/m2 IV over 60 minutes every 21 days

Dose Modification for Adverse Reactions:
NEUTROPENIA:

• Grade 4 or any grade febrile neutropenia: Withhold therapy until resolved to Grade 1 or less; resume therapy at a reduced dose.
• Patients with isolated Grade 4 neutropenia (neutrophil count less than 500 cells/mm(3) may receive G-CSF prophylaxis rather than undergo dose reduction.

THROMBOCYTOPENIA:

• Grade 3 with bleeding or Grade 4: Withhold therapy until platelet count is 100,000/mm(3) or greater; resume therapy at a reduced dose.

RHABDOMYOLYSIS:

• Grade 2: Withhold therapy until resolved to Grade 1 or less; resume therapy at the same dose.
• Grade 3 or greater: Permanently discontinue therapy

OTHER ADVERSE REACTIONS:

• Grade 2: Withhold therapy until resolved to Grade 1 or less; resume therapy at the same dose.
• Grade 3 or greater: Withhold therapy until resolved to Grade 1 or less; resume at a reduced dose or permanently discontinue.

Dose Modification for Concomitant Use with Strong CYP450 3A Inhibitors

• Avoid coadministration with strong CYP450 3A inhibitors.
• If coadministration cannot be avoided, reduce the dose of this drug by 50%.
• After discontinuation of strong CYP450 3A inhibitor for 5 half-lives, increase the dose of this drug to the dose used before starting.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For IV use only
• Inspect for particulate matter and discoloration before administration, and do not administer if observed.
• This drug can be administered with or without an in-line filter. Polyethersulfone in-line filters with pore size of 0.22 micron are recommended if in-line filters are used.
• Consider the use of a central venous catheter, especially in patients with limited venous access to reduce the risk of extravasation.

Storage requirements:

• This drug is a hazardous drug. Follow applicable special handling and disposal procedures.
• If not used immediately after reconstitution or dilution, this solution can be stored in the refrigerator at 2C to 8C (36F to 46F) or at room temperature/ambient light, prior to administration for up to 24 hours.
• Store vials in the refrigerator at 2C to 8C (36F to 46F).

Reconstitution/preparation techniques:

• The manufacturer's product information should be consulted.

IV compatibility:

• The manufacturer's product information should be consulted.
• This drug should not be co-administered with other IV drugs concurrently within the same IV line.

Monitoring:

• Hepatic: Liver function (prior to and during therapy)
• Hematologic: Blood counts (prior to and during therapy as indicated)
• Musculoskeletal: Creatine phosphokinase (prior to and periodically during therapy)
• Reproductive (for females of reproductive potential): Pregnancy test (prior to therapy)

Patient advice:

• Read the FDA-approved patient labeling (Patient Information )
• Inform your healthcare provider of all medications, herbal and dietary supplements.
• Avoid grapefruit products and Seville oranges during treatment with this drug.
• Contact your healthcare provider immediately if you have:
• signs of infection (such as fever), unusual bruising, bleeding, tiredness or pallor
• nausea, vomiting, or severe abdominal pain
• redness and/or swelling at the infusion site, severe muscle weakness or pain
• Women of reproductive potential should contact their healthcare provider if they become pregnant or suspect a pregnancy.
• Women of reproductive potential should use effective contraception during treatment and for at least 6 months after the last dose.
• Males with female partners of reproductive potential should use effective contraception during treatment and for at least 4 months after the last dose.
• Breastfeeding is not recommended during treatment and for at least 2 weeks after the last dose.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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