Asciminib (as-KIM-i-nib)

Treats leukemia.

Brand Name(s):

Scemblix

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Do not change your dose or stop using this medicine without checking first with your doctor.
• It is best to take this medicine on an empty stomach. Do not eat for at least 2 hours before or 1 hour after you take this medicine.
• Swallow the tablet whole. Do not break, cut, crush, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  • Once a day regimen: If you miss a dose and it is more than 12 hours of your scheduled dose, skip the missed dose and go back to your regular dosing schedule.
  • Twice a day regimen: If you miss a dose and it is more than 6 hours of your scheduled dose, skip the missed dose and go back to your regular dosing schedule.
  • Do not use extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Some medicines can affect how asciminib works. Tell your doctor if you are using atorvastatin, clarithromycin, imatinib, itraconazole, midazolam, repaglinide, rosiglitazone, rosuvastatin, or a blood thinner (including warfarin).

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 to make sure you are not pregnant before starting this medicine. Use an effective birth control to keep from getting pregnant during treatment with this medicine and for at least 1 week after your last dose.
• Do not breastfeed during treatment with this medicine and for at least 1 week after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart rhythm problems, high blood pressure, or a history of heart disease or pancreas problems.
• This medicine may cause the following problems:
  • Pancreatitis (swelling of pancreas)
  • High blood pressure
  • Serious heart or blood vessel problems (including blood clots, heart attack, heart failure, stroke)
• Some women who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
• 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.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Chest pain, trouble breathing, coughing up blood, tiredness
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden and severe stomach pain, nausea, vomiting
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, or weakness

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

• Diarrhea
• Muscle or bone pain

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