Lurbinectedin Injection

WHY is this medicine prescribed?

Lurbinectedin injection is used to treat small cell lung cancer (SCLC) that has spread to other parts of the body and did not improve during or after treatment with platinum chemotherapy. Lurbinectedin injection is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Lurbinectedin injection comes as powder to be mixed with liquid to be injected intravenously (into a vein) over 60 minutes by a doctor or nurse in a hospital or medical facility. It is usually given once every 21 days. The length of your treatment depends on how well your body responds to the medication and any side effects that you experience.

Lurbinectedin injection should be administered only intravenously (into a vein). However, it may leak into surrounding tissue causing severe irritation or damage. Your doctor or nurse will monitor your administration site for this reaction. If you experience any of the following symptoms, call your doctor immediately: pain, itching, redness, swelling, or discomfort in the place where the medication was injected.

Your doctor may need to temporarily or permanently stop your treatment or decrease your dose if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with lurbinectedin injection.

Your doctor may give you medications to prevent nausea and vomiting before you receive each dose of lurbinectedin.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving lurbinectedin injection,

• tell your doctor and pharmacist if you are allergic to lurbinectedin, any other medications, or any of the ingredients in lurbinectedin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, or nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal products may interact with lurbinectedin: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start receiving lurbinectedin injection. Do not start this medication while receiving lurbinectedin injection without discussing with your healthcare provider.

• tell your doctor if you have or have ever had liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are receiving lurbinectedin injection. Your doctor may perform a pregnancy test to be sure that you are not pregnant before you receive lurbinectedin injection. If you are female, you should use birth control during your treatment and for 6 months after your final dose. If you are male, you and your female partner should use birth control during your treatment and for 4 months after your final dose. If you or your partner become pregnant while receiving lurbinectedin injection, call your doctor. Lurbinectedin injection may harm the fetus.

• tell your doctor if you are breast-feeding. You should not breast-feed while you are receiving lurbinectedin injection and for at least 2 weeks after your final dose.

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or Seville oranges (sometimes used in marmalades) or drink grapefruit juice while receiving this medication.

What should I do IF I FORGET to take a dose?

Call your doctor right away if you are unable to keep an appointment to receive a dose of lurbinectedin.

What SIDE EFFECTS can this medicine cause?

Lurbinectedin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• fatigue
• nausea
• vomiting
• constipation
• diarrhea
• loss of appetite
• joint or bone pain
• headache
• tingling, numbness, and pain in the hands and feet

Some side effects can be serious. If you experience any of these symptoms or those in the HOW section, call your doctor immediately or get emergency medical treatment:

• chest pain
• shortness of breath
• light-colored bowel movements, yellowing of the skin or eyes, loss of appetite, dark yellow or brown urine, or pain in the upper right part of stomach
• unusual bleeding or bruising
• fever, cough, chills, or other signs of infection
• tiredness or pale skin
• severe muscle pain or weakness

Lurbinectedin may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to lurbinectedin injection.

Ask your pharmacist any questions you have about lurbinectedin injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.