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 counts—white cells, platelets, red blood cells
• An unusual or allergic reaction to lurbinectedin, other medicines, foods, dyes or preservatives
• Pregnant or trying to get pregnant
• Beast-feeding

How should I use this medication?

This medication is injected into a vein. It is given in a hospital or clinic setting.

Talk to your care team about the use of this medicine 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?

• Certain antibiotics like erythromycin or clarithromycin
• Certain antivirals for HIV or hepatitis
• Certain medicines for fungal infections like ketoconazole, itraconazole, posaconazole
• Certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• Grapefruit or grapefruit juice
• St. John's Wort

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?

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.

Do not become pregnant while taking this medication or for 6 months after stopping it. Women should inform their care team if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medication and for 4 months after stopping it. There is potential for serious side effects to an unborn child. Talk to your care team for more information. Do not breast-feed a child while taking this medication or for 2 weeks after stopping it.

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, or sore throat
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Leakage of medicine out of your vein during the infusion
• 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 count—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
• Unusual bruising or bleeding
• Vomiting

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

• Constipation
• Cough
• Diarrhea
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Loss of appetite
• Low magnesium level—muscle pain or cramps, unusual weakness or fatigue, fast or irregular heartbeat, tremors
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Nausea
• Trouble breathing

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 medicine is given in a hospital or clinic and 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.