Lurbinectedin (loor-bin-EK-te-din)

Treats small cell lung cancer (SCLC).

Brand Name(s):

Zepzelca

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the needle will have to remain in place for at least 60 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• You may also receive other medicines (including dexamethasone, ondansetron) to help prevent nausea and vomiting.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how lurbinectedin works. Tell your doctor if you are using bosentan or itraconazole.
• Do not eat or drink grapefruit, Seville oranges, or products that contain grapefruit juice or Seville oranges during treatment.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start receiving this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 4 months after the last dose.
• Do not breastfeed during treatment and for at least 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, or any type of infection.
• This medicine may cause the following problems:
  • Liver problems
  • Injection site reaction
  • Rhabdomyolysis (serious muscle problem)
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or black, tarry stools
• Bone or joint pain
• Chest pain ,trouble breathing
• Dark urine, stomach pain, pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches
• Muscle pain, tenderness, or weakness
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Headache
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088