Lurbinectedin

Lurbinectedin is a prescription medicine indicated:

• for the treatment of metastatic small-cell lung cancer (SCLC) in adult patients with disease progression on or after platinum-based chemotherapy
• in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for the maintenance treatment of adult patients with extensive-stage SCLC (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin, and etoposide.

Lurbinectedin is available under the following different brand names: Zepzelca.

Common side effects of Lurbinectedin include:

• fatigue
• nausea
• vomiting
• diarrhea
• cough
• constipation
• dyspnea
• decreased appetite
• musculoskeletal pain
• anemia
• leukopenia 
• lymphopenia 
• neutropenia 
• thrombocytopenia
• increased creatinine 
• increased liver enzymes (alanine aminotransferase and aspartate aminotransferase)
• increased glucose
• decreased albumin 
• decreased sodium
• decreased magnesium

Serious side effects of Lurbinectedin include:

• myelosuppression
• hepatoxicity
• extravasation resulting in tissue necrosis
• rhabdomyolysis

Rare side effects of Lurbinectedin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 4 mg/single-dose vial

Small cell lung cancer

Adult dosage

• As a single agent or in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs 

  3.2 mg/m2 intravenous by intravenous infusion over 60 minutes every 21 days until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

Drug interaction overview

• Substrate of CYP3A
• Strong or moderate CYP3A inhibitors
  • Avoid coadministration; reduce dosage if concomitant use cannot be avoided
  • Strong or moderate CYP3A inhibitors may increase systemic exposure and risk of adverse reactions with lurbinectedin
• Strong CYP3A4 inducers
  • Avoid coadministration
  • Strong CYP3A inducers may decrease systemic exposure and efficacy of lurbinectedin

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• none

Effects of drug abuse

• none

Short-Term Effects

• See “What Are Side Effects Associated with Using Lurbinectedin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Lurbinectedin?”

Cautions

• May cause myelosuppression; monitor blood cell counts, including neutrophil count and platelet count, before each administration
• Hepatotoxicity reported; monitor liver function tests before initiating therapy, periodically during treatment, and as clinically indicated
• Based on animal data and mechanism of action, fetal harm may occur when administered to pregnant women
• Rhabdomyolysis reported; monitor creatine phosphokinase (CPK) before initiating and periodically during treatment as clinically indicated; withhold or reduce dose based on the severity
• Extravasation
  • Extravasation resulting in skin and soft tissue injury, including necrosis requiring debridement, can occur
  • Consider using a central venous catheter to reduce extravasation risk, particularly in patients with limited venous access; monitor for signs and symptoms of extravasation during infusion
  • If extravasation occurs, immediately discontinue the infusion, remove the infusion catheter, and monitor for signs and symptoms of tissue necrosis; the time to onset of necrosis after extravasation may vary
  • Administer supportive care and consult with appropriate medical specialists as needed for signs and symptoms of extravasation; administer subsequent infusions at a site that was not affected by extravasation
• Drug interaction overview
• Substrate of CYP3A4
• Strong or moderate CYP3A4 inhibitors
  • Avoid coadministration
  • Strong or moderate CYP3A inhibitor increases systemic exposure and risk of adverse reactions to Lurbinectedin
• Strong or moderate CYP3A4 inducers
  • Avoid coadministration
  • Strong or moderate CYP3A4 inducer decreases systemic exposure to and efficacy of Lurbinectedin

Pregnancy and Lactation

• Based on animal data and mechanism of action, fetal harm may occur when administered to pregnant women
• No data are available regarding risk in pregnant women
• Advise pregnant women of the potential risk to a fetus
• Verify the pregnancy status of women of reproductive potential before initiating treatment.
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment and for 6 months after the final dose
  • Men with a women sexual partner of reproductive potential: Use effective contraception during treatment and for 4 months after the final dose
• Lactation
  • There are no data on the presence of human milk, its effects on breastfed children, or milk production
  • Advise lactating women not to breastfeed during treatment and for 2 weeks after the final dose