Lurbinectedin is used to treat small cell lung cancer that has spread to other parts of the body (metastatic).

Lurbinectedin is given after a platinum cancer medicine did not work or has stopped working.

Lurbinectedin may also be used for purposes not listed in this medication guide.

Lurbinectedin can increase your risk of bleeding or infection. You will need frequent medical tests.

Before you receive a dose of lurbinectedin, you may need a blood test to check your liver function.

Lurbinectedin is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 1 hour to complete.

You may be given infusions of other medications to help prevent nausea and vomiting.

Lurbinectedin is usually given once every 21 days.

Lurbinectedin can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

Your doctor will determine how long to treat with you with this medicine.

Usual Adult Dose for Small Cell Lung Cancer:

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

Comments:
-Initiate this drug only if absolute neutrophil count (ANC) is at least 1500 cells/mm3 and platelet count is at least 100,000/mm3.
-Consider administering pre-infusion medications for antiemetic prophylaxis: Corticosteroids (e.g., dexamethasone 8 mg IV or equivalent) and serotonin antagonists (e.g., ondansetron 8 mg IV or equivalent).

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

Tell your doctor if you have ever had:

• liver or kidney disease;

You may need to have a negative pregnancy test before starting this treatment.

Lurbinectedin can harm an unborn baby if the mother or the father is using lurbinectedin.

• If you are a woman, do not use lurbinectedin if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using lurbinectedin.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Call your doctor for instructions if you miss an appointment for your lurbinectedin injection.

Since lurbinectedin is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Grapefruit may interact with lurbinectedin and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Lurbinectedin may cause serious side effects. Call your doctor at once if you have:

• easy bruising, unusual bleeding, purple or red spots under your skin;

• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

• signs of sepsis--confusion, fever or chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill; or

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of lurbinectedin may include:

• low blood cell counts;

• cough, trouble breathing;

• nausea, vomiting, loss of appetite;

• increased thirst or urination;

• diarrhea, constipation;

• muscle or joint pain;

• feeling tired; or

• abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect lurbinectedin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.