Pronunciation:

loor-bin-EK-te-din

Brand Names:

• Zepzelca

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Lurbinectedin injection is used to treat metastatic (cancer that has already spread) small cell lung cancer (SCLC) in patients who have received other cancer medicines (eg, platinum-based chemotherapy) that did not work well.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lurbinectedin injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lurbinectedin injection in the elderly. However, elderly patients are more likely to have serious unwanted effects (eg, blood or bone marrow problems), which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Amprenavir
• Apalutamide
• Aprepitant
• Atazanavir
• Boceprevir
• Carbamazepine
• Ceritinib
• Cimetidine
• Ciprofloxacin
• Clarithromycin
• Clofazimine
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Darunavir
• Diltiazem
• Dronedarone
• Duvelisib
• Enzalutamide
• Erythromycin
• Fedratinib
• Fexinidazole
• Fluconazole
• Fluvoxamine
• Fosamprenavir
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ivosidenib
• Josamycin
• Ketoconazole
• Letermovir
• Lonafarnib
• Lopinavir
• Lumacaftor
• Mavacamten
• Mibefradil
• Mifepristone
• Mitotane
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Omaveloxolone
• Phenytoin
• Posaconazole
• Ribociclib
• Rifampin
• Rifapentine
• Ritonavir
• Saquinavir
• Schisandra sphenanthera
• St John's Wort
• Telaprevir
• Telithromycin
• Treosulfan
• Troleandomycin
• Tucatinib
• Verapamil
• Voriconazole
• Voxelotor

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Bitter Orange
• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Infection—Use with caution. This medicine may decrease your body’s ability to fight infection.

• Liver disease, moderate or severe—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins.

This medicine must be given slowly, so the needle will have to remain in place for at least 60 minutes. It is usually given every 21 days.

You may also receive other medicines (eg, dexamethasone, ondansetron) to help prevent nausea and vomiting.

Do not eat or drink grapefruit, Seville oranges, or products that contain grapefruit juice or Seville oranges during treatment with this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start receiving this medicine to make sure you are not pregnant. This medicine may also cause birth defects if the father is receiving it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 4 months after the last dose. If you think you have become pregnant or your partner has become pregnant while receiving this medicine, tell your doctor right away.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever, chills, cough, hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause leakage out of your vein during infusion (extravasation), which can cause tissue damage. Check with your doctor right away if you have pain, discomfort, itching, redness, or swelling at the injection site.

Check with your doctor right away if you or your child have dark-colored urine, fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

bloody urine

bone, joint, or muscle pain

chest pain or tightness

chills

dark urine

difficult or labored breathing

fever

general feeling of discomfort or illness

hoarseness

loss of appetite

lower back or side pain

nausea

painful or difficult urination

pale skin

pale stools

pinpoint red spots on the skin

sneezing

sore throat

stomach pain or tenderness

thickening of bronchial secretions

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

yellow eyes or skin

Less common

Swelling of the feet or lower legs

Incidence not known

Muscle cramps, spasms, or stiffness

pain, discomfort, itching, redness, or swelling at the injection site

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning, numbness, tingling, or painful sensations

change in or loss of taste

constipation

diarrhea

headache

unsteadiness or awkwardness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.