• Zepzelca is used to treat adults with a kind of lung cancer called small cell lung cancer (SCLC).
  Zepzelca may be used when your lung cancer:
  
  • has spread to other parts of the body (metastatic), and
  • you have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working.

It is not known if this medicine is safe and effective in children.

• Zepzelca is given by an intravenous (IV) infusion into a vein over 60 minutes.
• Zepzelca is usually given every 21 days.
• Before each treatment, you may receive medicines to help prevent nausea and vomiting or make it less severe.
• Your healthcare provider will decide how long you will continue treatment.
• Your healthcare provider may do certain tests during your treatment to check you for side effects, and to see how well you respond to the treatment.

Before receiving Zepzelca, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems.
• are pregnant or plan to become pregnant. Zepzelca can harm your unborn baby.
  Females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment.
  • You should use effective birth control (contraception) during treatment with and for 6 months after your final dose.
  • Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment.

Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your final dose.

• are breastfeeding or plan to breastfeed. It is not known if Zepzelca passes into your breastmilk.
  Do not breastfeed during treatment, and for 2 weeks after your final dose. Talk to your healthcare provider about the best way to feed your baby during treatment.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how Zepzelca works. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

• Avoid eating or drinking grapefruit, or products that contain grapefruit juice during treatment.

• Zepzelca can cause serious side effects, including:
• Low blood cell counts. Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with Zepzelca, and can also be severe. Some people with low white blood cell counts may get fever, or an infection throughout the body (sepsis), that can cause death. Your healthcare provider should do blood tests before you receive each treatment to check your blood cell counts.
  Tell your healthcare provider right away if you develop:
  • fever or any other signs of infection
  • unusual bruising or bleeding
  • tiredness
  • pale colored skin
• Liver problems. Increased liver function tests are common with Zepzelca, and can also be severe. Your healthcare provider should do blood tests to check your liver function before you start and during treatment.
  Tell your healthcare provider right away if you develop symptoms of liver problems including:
  • loss of appetite
  • nausea or vomiting
  • pain on the right side of your stomach-area (abdomen)
  Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop Zepzelca if you develop low blood cell counts or liver problems during treatment.

The most common side effects include:

• tiredness
• low white and red blood cell counts
• increased kidney function blood test (creatinine)
• increased liver function blood tests
• increased blood sugar (glucose)
• nausea
• decreased appetite
• muscle and joint (musculoskeletal) pain
• low level of albumin in the blood
• constipation
• trouble breathing
• low levels of sodium and magnesium in the blood
• vomiting
• cough
• diarrhea

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800 FDA-1088.