Tremelimumab-actl (tre-mel-IM-ue-mab - actl)

Treats liver cancer and non-small cell lung cancer (NSCLC).

Brand Name(s):

Imjudo

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. It must be given slowly, so the needle will have to remain in place for at least 60 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests before receiving this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 3 months after your last dose.
• Do not breastfeed while you are being treated with this medicine and for at least 3 months after the last dose.
• Tell your doctor if you have kidney disease, adrenal gland problems, diabetes, immune system problems (including Crohn disease, ulcerative colitis, lupus), or nervous system problems (including Guillain-Barré syndrome, myasthenia gravis), or thyroid problems.
• This medicine may cause the following problems:
  • Lung or breathing problem (including pneumonitis)
  • Hepatitis (inflammation of the liver)
  • Colitis (inflammation of the colon), which might damage your digestive system
  • Kidney problem (including nephritis)
  • Adrenal, pituitary, or thyroid gland problems
  • Other problems caused by the immune system, including swelling in the heart, skin, muscle, brain, nerve, eyes, kidney, or blood vessels
  • Serious skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), or toxic epidermal necrolysis)
  • Pancreatitis (swelling of the pancreas)
  • Infusion reaction, which can be life-threatening
• 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.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody or black, tarry stools, diarrhea, severe stomach pain
• Blurred vision, changes in vision, eye pain
• Bone or muscle pain
• Confusion, seizures, stiff neck, sleepiness, numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fast heartbeat, chest tightness or pain, trouble breathing
• Fever, chills, cough, sore throat, body aches
• Increased hunger or thirst, dry mouth, sweating, change in how much or how often you urinate, cloudy urine
• Lightheadedness, dizziness, fainting
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

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