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Pronunciation: as KIM i nib

Brand: Scemblix

What is the most important information I should know about asciminib?

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

What is asciminib?

Asciminib is used in adults to treat a type of blood cancer called Philadelphia chromosome-positive chronic myeloid leukemia (CML).

Asciminib is usually given after other treatments have failed.

Asciminib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking asciminib?

Tell your doctor if you have ever had:

  • inflammation of your pancreas (pancreatitis); or
  • heart problems or blood clots.

You may need to have a negative pregnancy test before starting this treatment.

It may be harder for you to get pregnant while you are using this medicine.

Asciminib may harm an unborn baby. Use effective birth control while you are using this medicine, and for at least 1 week after your last dose. Tell your doctor right away if you become pregnant.

You should not breastfeed while using this medicine, and for at least 1 week after your last dose.

How should I take asciminib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take without food.

Swallow the tablet whole and do not crush, chew, or break it.

Your blood will need to be tested often.

You should not stop using asciminib without your doctor's advice.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

If you take asciminib once a day: Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not use two doses at one time.

If you take asciminib twice a day: Take the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking asciminib?

Avoid eating for at least 2 hours before and 1 hour after taking asciminib.

What are the possible side effects of asciminib?

Get emergency medical help if you have signs of an allergic reaction: hives, rash; feeling dizzy or faint; fever; fast heartbeat; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • heart problems --pain in your arms, legs, back, neck or jaw, numbness or weakness on one side of your body, problems with speech or vision, dizziness, headache, swelling in your ankles or feet, chest pain, irregular heartbeat, rapid weight gain, feeling short of breath, severe stomach pain;
  • high blood pressure --severe headache, blurred vision, pounding in your neck or ears;
  • low blood cell counts --fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet; or
  • pancreas problems --sudden stomach pain or discomfort, nausea, or vomiting.

Common side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • muscle, bone, or joint pain;
  • tiredness;
  • nausea, diarrhea;
  • rash; or
  • abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect asciminib?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Many drugs can affect asciminib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.

Where can I get more information?

Your doctor or pharmacist can provide more information about asciminib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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