Zepzelca - Lurbinectedin Injection

What is this medication?

LURBINECTEDIN (LOOR bin EK te din) treats lung cancer. It works by slowing down the growth of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ZEPZELCA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Liver disease
• Low blood cell levels, such as low white cells, platelets, red blood cells
• An unusual or allergic reaction to lurbinectedin, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

• Grapefruit juice or Seville oranges

Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

This medication may make you feel generally unwell. This is not uncommon as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Avoid taking medications that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your care team. These medications may hide a fever.

Be careful brushing or flossing your teeth or using a toothpick because you may get an infection or bleed more easily. If you have any dental work done, tell your dentist you are receiving this medication.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 6 months after the last dose. You will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 6 months after the last dose.

If your partner can get pregnant, use a condom during sex while taking this medication and for 4 months after the last dose.

Do not breastfeed while taking this medication and for 2 weeks after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Muscle injury—unusual weakness or fatigue, muscle pain, dark yellow or brown urine, decrease in amount of urine
• Painful swelling, warmth, or redness of the skin, blisters or sores at the infusion site
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Constipation
• Cough
• Diarrhea
• Fatigue
• Loss of appetite
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.