Lurbinectedin Injection

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.

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. Your doctor will decide how often you are to receive lurbinectedin based on your body's response to this medication.

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 will give you medication 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.

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

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. Be sure to mention any of the following: antifungal medications such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); clarithromycin (Biaxin, Prevpac); diltiazem (Cardizem, Dilacor, Tiazac, others); erythromycin (E-mycin, Ery-Tab, others); certain HIV medications such as efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); nefazodone; pioglitazone (Actos, in Oseni); rifabutin (Mycobutin); prednisone; rifampin (Rifadin, Rimactane, in Rifamate, in Rifater); certain medications for seizures such as carbamazepine (Carbatrol, Epitol, Tegretol, others), phenobarbital, and phenytoin (Dilantin, Phenytek); and verapamil (Calan, Verelan). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may interact with lurbinectedin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you more carefully for side effects.

• tell your doctor what herbal products you are taking, especially St. John's wort.

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

Do not eat grapefruit or drink grapefruit juice while receiving this medication.

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

• 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

  • muscle pain

  • headache

  • tingling, numbness, and pain in the hands and feet

• Some side effects can be serious. If you experience any of these symptoms, 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, unusual bleeding or bruising, dark yellow or brown urine, or pain in the upper right part of stomach

  • fever, cough, chills, or other signs of infection

  • tiredness or pale skin

• 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).

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.

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.

Ask your pharmacist any questions you have about lurbinectedin.

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.