Detailed instructions for Lurbinectedin: indications, usage and dosage, side effects and precautions

In June 2020, the U.S. Food and Drug Administration (FDA) approved the marketing of lurbinectedin, bringing a new treatment option to patients with small cell lung cancer around the world.

Indications for rubitidine

Small cell lung cancer

It is indicated for the treatment of metastatic small cell lung cancer (SCLC) that has progressed during or after platinum-based chemotherapy. Designated as an orphan drug by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer.

Rubitidine administration method

1. Pre-treatment screening

(1) Evaluate blood routine at baseline

Treatment can only be started when the baseline absolute neutrophil count (ANC) is ≥1500 cells/mm³ and the platelet count is ≥100,000 cells/mm³.

(2) Detect pregnancy status

Before starting treatment, confirm the pregnancy status of women with childbearing potential.

(3) Liver function test

Carry out liver function test before starting treatment.

2. Pretreatment and prevention

Consider using corticosteroids (such as dexamethasone phosphate 8 mg intravenously or equivalent drugs) combined with serotonin 5-HT₃ receptor antagonists (such as ondansetron 8 mg intravenous injection or equivalent drugs) for antiemetic prevention to reduce the risk of nausea and/or vomiting.

Recommended dose of rubitidine

1. Recommended dose for small cell lung cancer

(1) Intravenous infusion of 3.2 mg per square meter of body surface area, once every 21 days.

(2) The infusion time needs to last 60 minutes.

(3) Continue treatment until disease progression or intolerable toxicity occurs.

2. Dose adjustment of adverse reactions

First dose reduction: once every 21 days, each infusion of 2.6 mg/m²;

Second dose reduction: once every 21 days, each infusion of 2 mg/m²;

Inability to tolerate 2 mg/m² or delay >2 weeks: permanent discontinuation.

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Common adverse reactions of Lurbinectedin

Leukopenia, lymphopenia, fatigue, anemia, Neutropenia, increased creatinine, increased alanine aminotransferase/aspartate aminotransferase, increased blood sugar, thrombocytopenia, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, vomiting, cough, decreased magnesium concentration, and diarrhea.

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Precautions of Lurbinectedin

1. ‌Hematological toxicity‌

‌Severe bone marrow suppression‌ (including neutropenia, thrombocytopenia and anemia) may occur.

2. ‌Hepatotoxicity‌

It may cause liver damage. Liver function needs to be monitored before treatment, regularly during treatment and when clinically necessary. Adjust the dose (suspend, reduce or discontinue) according to the degree of liver function abnormality.

3. ‌Fetal/neonatal risk‌

Based on the mechanism of action and animal experimental data, it may cause harm to the fetus.

Rubitidine medication for special populations

1. Pregnancy period

Inform pregnant women of potential fetal risks and confirm pregnancy status before treatment.

2. ‌Lactation period‌

It is not clear whether the drug is secreted with milk and its impact on the baby. It is recommended to stop breastfeeding during treatment and within 2 weeks after the last dose.

3. ‌Patients of childbearing age‌

‌Female‌: Confirm that you are not pregnant before treatment, and effective contraception is required during treatment and within 6 months after the last dose.

‌Male‌: During treatment and within 4 months after the last dose, your partner must ensure effective contraception.

4. ‌Children and elderly patients‌

‌Children‌: Safety and effectiveness have not been established.

‌Elderly patients‌: The efficacy is not significantly different from that of younger patients, but the incidence of serious adverse events is higher.

5. ‌Liver and renal insufficiency‌

‌Mild liver damage‌: total bilirubin ≤ ULN with AST > ULN, or bilirubin 1-1.5×ULN, no dose adjustment is required.

‌Moderate to severe liver damage‌: Bilirubin>1.5×ULN, not studied, use with caution.

‌Mild to moderate renal impairment‌: Clcr 30-89 mL/min, no dose adjustment required.

‌Severe renal impairment‌: Clcr <30 mL/min. Although not formally studied, renal excretion is very small and adjustment may not be needed.

Rubitidine drug interactions

1. Liver-drug enzyme-related interactions‌

(1) CYP3A4 inhibitors‌

‌ Moderately potent inhibitors (such as clarithromycin, itraconazole): may increase the blood concentration and toxicity of rubitidine, so combined use needs to be avoided; if combined use is necessary, it is recommended to reduce the dose after clinical evaluation.

(2) CYP3A4 inducers‌

Medium-potent inducers (such as rifampicin, carbamazepine): may reduce the plasma concentration and efficacy of rubitidine, so combined use should be avoided.

2. Specific drugs or foods‌

‌Grapefruit/grapefruit juice: may significantly increase the exposure and toxicity of rubitidine, and should be avoided during treatment.

Note: If you want to know more details, please check the original package insert of the drug. Please follow your doctor's instructions for specific medication.