What diseases does Lurbinectedin treat

Lurbinectedin is an alkylating anti-tumor drug that needs to be used under the guidance of a professional physician.

What disease does Lurbinectedin treat?

Small cell lung cancer

is used to treat metastatic small cell lung cancer (SCLC) that has progressed during or after platinum-based chemotherapy.

Orphan drug designation: Rupitidine has been designated by the FDA as an orphan drug for the treatment of SCLC.

Usage and dosage of Lurbinectedin

1. Pre-medication screening

Assess baseline blood cell count. Initiate treatment only if baseline absolute neutrophil count (ANC) ≥1500/mm³ and platelet count ≥100,000/mm³.

Verify pregnancy status in women of childbearing potential before initiating treatment.

Have liver function tests before starting treatment.

2. Patient monitoring

Monitor blood cell counts, including neutrophil counts and platelet counts, before each infusion. Initiate treatment only if ANC ≥1500/mm³ and platelet count ≥100,000/mm³. For patients with neutrophil counts <500/mm³ or below the lower limit of normal, granulocyte colony-stimulating factor (G-CSF) is recommended.

Monitor liver function tests regularly and as clinically indicated.

3. Premedication and prophylaxis

Consider antiemetic prophylaxis with corticosteroids (eg, dexamethasone phosphate 8 mg IV or equivalent) and serotonin 5-HT3 receptor antagonists (eg, ondansetron 8 mg IV or equivalent) to minimize the risk of nausea and/or vomiting.

4. Precautions for dispensing and administration

Follow the procedures for the correct handling and disposal of anti-tumor drugs.

The pictures are from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

5. Administration

Intravenous administration

Intravenous infusion and administration through central or peripheral intravenous lines. Commercially available lyophilized powders must be reconstituted and further diluted before administration.

6. Reconstitution

Add 8 mL of sterile water for injection into the vial containing 4 mg lurbinectedin for reconstitution to obtain a solution with a concentration of 0.5 mg/mL. Shake the vial until the powder is completely dissolved.

The reconstituted solution should be clear, colorless or slightly yellow, with no visible particles.

7. Dilution

For administration through peripheral intravenous lines: Draw an appropriate volume of the reconstituted solution and add it to an infusion container of at least 250 mL of 0.9% sodium chloride injection or 5% glucose injection.

For administration via central venous line: Withdraw an appropriate volume of reconstitution solution and add it to an infusion container of at least 100 mL of 0.9% Sodium Chloride Injection or 5% Dextrose Injection.

Visually inspect the diluted solution; do not use if particulate matter is present.

If not used immediately after reconstitution or dilution, the solution can be stored for up to 24 hours after reconstitution (including the time of infusion) at room temperature/ambient light or refrigerated at 2–8ºC.

8. Administration rate

Administer via intravenous infusion, with the infusion time exceeding 60 minutes.

9. Dosage

Once every 21 days, 3.2 mg/m² each time.

Continue treatment until disease progression or unacceptable toxicity.

10. Dose adjustment for toxicity

Adverse reactions may require temporary interruption of dosing, dose reduction, and/or permanent discontinuation.

When an adverse reaction of a specific severity occurs, administration should be suspended until recovery to ≤Grade 1 or baseline levels, and then treatment should be restarted at a reduced dose level.

The first dose is reduced to 2.6 mg/m² and the second dose is reduced to 2.0 mg/m².

Rubitidine should be permanently discontinued in patients who require further dose reduction.

For patients who cannot tolerate the 2 mg/m² dose or who need to delay dosing for more than 2 weeks, permanently discontinue lrubididine.

Lurbinectedin medication for special populations

1. Pregnancy

It may cause fetal damage. Pregnant women are advised to be aware of potential risks to the fetus.

2. Lactation

It is not known whether rupitidine will be excreted into breast milk or whether it will affect breast milk secretion or nursing infants.

Women should not breastfeed during treatment and for 2 weeks after the last dose.

3. Women and men of childbearing potential

Verify the pregnancy status of women of childbearing potential before initiating treatment, and advise such women to use effective contraception during treatment with rupitidine and for 6 months after the last dose.

Men who have a female partner of childbearing potential should use an effective method of contraception during treatment with rupitidine and for 4 months after the last dose.

4. Pediatric use

Safety and effectiveness have not been established.

5. Geriatric Use

Although no difference in efficacy was observed between elderly patients and young adult patients in the primary efficacy study, serious adverse events occurred more frequently in elderly patients.

6. Hepatic insufficiency

Mild hepatic insufficiency (total bilirubin ≤ ULN and AST concentration > ULN, or total bilirubin 1–1.5 times ULN and AST at any concentration) will not significantly change pharmacokinetics; no dose adjustment is required.

It has not been studied in patients with moderate or severe hepatic impairment (total bilirubin >1.5 times ULN and AST at any concentration).

7. Renal insufficiency

Mild or moderate renal insufficiency (creatinine clearance Clcr30–89mL/min) will not significantly affect pharmacokinetics.

Formal studies have not been conducted in patients with severe renal insufficiency (Clcr <30 mL/minute); however, renal clearance of lurbinectedin is minimal.