lurbinectedin

What is the most important information I should know about lurbinectedin?

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

What is lurbinectedin?

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.

What should I discuss with my healthcare provider before taking lurbinectedin?

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.

• 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.

How should I take lurbinectedin?

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.

What happens if I miss a dose?

What happens if I overdose?

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

What should I avoid while taking lurbinectedin?

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

What are the possible side effects of lurbinectedin?

• 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 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.

What other drugs will affect lurbinectedin?

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.

Where can I get more information?

Your pharmacist can provide more information about lurbinectedin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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