Pronunciation:

as-KIM-i-nib

Brand Names:

• Scemblix

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Tyrosine Kinase Inhibitor

Uses of This Medicine:

Asciminib is used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) who have taken 2 or more medicines, including tyrosine-kinase inhibitors (TKIs). It is also used to treat Ph+ CML in CP with the T315I mutation. Leukemia is a type of cancer where the body makes too many abnormal white blood cells.

Asciminib belongs to the general group of medicines known as antineoplastics or cancer medicines. It interferes with the growth of cancer cells, which are eventually destroyed by the body.

This medicine is available only with your doctor's prescription.

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 asciminib 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 asciminib in the elderly.

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 taking 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.

• Alfentanil
• Celecoxib
• Cyclosporine
• Dihydroergotamine
• Dofetilide
• Ergotamine
• Fentanyl
• Flibanserin
• Fosphenytoin
• Itraconazole
• Oxycodone
• Phenytoin
• Pimavanserin
• Pimozide
• Quinidine
• Sirolimus
• Tacrolimus
• Temsirolimus
• Warfarin

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Heart or blood vessel disease, history of or
• Heart rhythm problems (eg, arrhythmia, QT prolongation) or
• Hypertension (high blood pressure) or
• Pancreatitis (swelling of the pancreas), history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not change the dose or stop using this medicine without checking first with your doctor.

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

This medicine should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

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.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For the treatment of Ph+ CML in CP in patients who have taken 2 or more TKIs:
    • Adults—80 milligrams (mg) once a day or 40 mg 2 times a day at least 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.
  • For the treatment of Ph+ CML in CP with the T315I mutation:
    • Adults—200 milligrams (mg) 2 times a day at least 12 hours apart. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. 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 form of birth control during treatment with this medicine and for at least 1 week after the last dose to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

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.

Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have bloating, chills, constipation, dark urine, fast heartbeat, fever, loss of appetite, nausea, pains in the stomach, side, or abdomen, possibly radiating to the back, upset stomach, vomiting, or yellow eyes or skin.

Check with your doctor right away if you have chest discomfort or pain, dizziness, decreased urine output, fast, irregular, or pounding heartbeat, numbness or weakness on one side of the body, pain in the arms, legs, back, neck, or jaw, problems with vision, speech, or walking, rapid weight gain, swelling of the feet or lower legs, sudden or severe headache, trouble breathing, or unusual tiredness or weakness. These could be symptoms of a serious heart or blood vessel problem (eg, blood clots, heart attack, heart failure, stroke).

This medicine may cause hypertension (high blood pressure). Check with your doctor right away if you have blurred vision, dizziness, headache, nervousness, pounding in the ears, or slow or fast heartbeat.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious allergic reactions. Check with your doctor right away if you have chest tightness, cough, dizziness, fainting, fast heartbeat, fever, skin rash or redness, swelling of the face, lips, or tongue, or trouble breathing or swallowing.

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 immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

body aches or pain

chest pain or tightness

chills

cough

decreased urine output

dilated neck veins

dizziness

ear congestion

difficulty in breathing

fainting

fever

headache

hives, itching, skin rash

hoarseness

irregular heartbeat

irritation

joint pain, stiffness, or swelling

loss of voice

lower back or side pain

nervousness

painful or difficult urination

pale skin

pinpoint red spots on the skin

pounding in the ears

redness of the skin

slow or fast heartbeat

sneezing

sore throat

stuffy or runny nose

swelling of the eyelids, face, lips, hands, or feet

trouble swallowing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

weight gain

Less common

Bladder pain

bloating

bloody or cloudy urine

burning urination

coughing up blood

frequent urge to urinate

increased menstrual flow or vaginal bleeding

indigestion

nosebleeds

pains in the chest, groin, or legs, especially calves of the legs

pains in the stomach, side, or abdomen, possibly radiating to the back

paralysis

prolonged bleeding from cuts

severe headaches of sudden onset

sudden loss of coordination

sudden onset of slurred speech

sudden vision changes

vomiting

yellow eyes or skin

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

Diarrhea

difficulty in moving

muscle or bone pain

muscle stiffness

pain in the joints

stomach pain

Less common

Constipation

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.