Asciminib Tablets

What is this medication?

ASCIMINIB (as SIM i nib) treats leukemia. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): SCEMBLIX

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood clots
• Heart disease
• History of pancreatitis
• An unusual or allergic reaction to asciminib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush, or chew this medication. Swallow the tablets whole. Take it on an empty stomach, at least 2 hours before and 1 hour after food. Your care team may change your dose or tell you to stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Do not take this medication with grapefruit juice.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you take your medication once a day, take it as soon as you can unless it is more than 12 hours late. If it is more than 12 hours late, skip the missed dose. Take the next dose at the normal time.

If you take your medication twice a day, take it as soon as you can unless it is more than 6 hours late. If it is more than 6 hours late, skip the missed dose. Take the next dose at the normal time.

What may interact with this medication?

• Certain antibiotics, such as clarithromycin or telithromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections, such as itraconazole, ketoconazole, posaconazole, voriconazole
• Grapefruit juice
• Midazolam
• Repaglinide
• Rosiglitazone
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

You may need bloodwork while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may increase your risk to bruise or bleed. Call your care team if you notice any unusual bleeding.

Talk to your care team if you or your partner wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Contraception is recommended while taking this medication and for 1 week after stopping it. Talk to your care team about effective forms of contraception.

Do not breast-feed while taking this medication or for 1 week after stopping it.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Unusual bruising or bleeding

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Bone, joint, or muscle pain
• Diarrhea
• Headache
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.