Uses
What is Scemblix used for?
Scemblix (asciminib) is commonly used for treating certain kinds of Philadelphia chromosome-positive chronic myeloid leukemia (PH+ CML) in adults. Chronic myeloid leukemia (CML) is a type of blood cancer. The Philadelphia chromosome occurs when pieces of 2 chromosomes, chromosomes 9 and 22, break off and swap places. The new abnormal chromosome that is created is known as Philadelphia chromosome-positive (PH+). The PH+ affects your bone marrow and changes your white blood cells, causing leukemia. Scemblix may be used to treat certain PH+ CML.
Scemblix may also be used for other conditions as determined by your healthcare provider.
How does Scemblix work (mechanism of action)?
Scemblix is a type of medicine known as a tyrosine kinase inhibitor (TKI). When the Philadelphia chromosome is created, it creates a fusion between two genes, known as the BCR-ABL1 fusion. Scemblix works by blocking the ABL1 part of the fusion and helps to prevent or limit changes in the bone marrow that lead to abnormal white blood cells.
How is Scemblix supplied (dosage forms)?
Scemblix is available in the following dosage forms that are taken by mouth.
- 20 mg oral tablets
- 40 mg oral tablets
- 100 mg oral tablets
How should I store Scemblix?
Scemblix should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Keep Scemblix in its original container to protect it from moisture and store in a cool, dry place.
Side Effects
What are the most common side effects of Scemblix?
The most common side effects of Scemblix are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Infection in the nose or throat, sore throat, or common cold symptoms
- Muscle or bone pain
- Headache
- Tiredness
- Nausea
- Rash
- Diarrhea
- Blood disorders (see below)
- Changes in liver function tests
- Changes in uric acid levels
There may be other side effects of Scemblix that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Scemblix?
While less common, the most serious side effects of Scemblix are described below, along with what to do if they happen.
Severe Allergic Reactions. Scemblix may cause allergic reactions, which can be serious. Stop taking Scemblix and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Blood Disorders. Scemblix can cause blood disorders, such as anemia, low platelet levels (thrombocytopenia), and low neutrophil levels (neutropenia). Tell your healthcare provider and get help right away if you have any of the following symptoms of blood disorders.
- Fever
- Shortness of breath
- Pale or yellowish skin
- Easy bruising or bleeding
- Frequent infection
- Unusual weakness or tiredness
- Dizziness, lightheadedness, or feeling like you are about to pass out
- Headache
- Fast or abnormal heartbeat
Inflammation of the Pancreas (Pancreatitis). Scemblix may cause inflammation of the pancreas, which is called pancreatitis. Stop taking Scemblix and call your healthcare provider right away if you have symptoms of pancreatitis, including vomiting or severe pain in the upper part of your belly that travels to your back.
Increased Blood Pressure (Hypertension). Scemblix may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your healthcare provider if your blood pressure increases while taking this medicine.
If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable but look out for any of the following symptoms of severely high blood pressure.
- Sudden severe headache
- Chest pain
- Dizziness or confusion
- Trouble breathing
- Nausea/vomiting
- Blurry or other changes to vision
- Anxiety
- Buzzing in the ears
- Nosebleed
- Feeling of skipped heartbeats
Heart Attack and Stroke. Scemblix can increase your risk of a heart attack or stroke that can lead to death. It can also increase your risk of blood clots, heart failure, and having an abnormal heartbeat. This risk is increased in people with existing heart disease or if you’ve taken certain medicines in the past. This can be dangerous and even life-threatening. Do not take Scemblix if you have had a recent heart attack without talking to your healthcare provider. This could increase your risk of having another heart attack. Get emergency help if you have any of the following symptoms of a heart attack or stroke.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
Warnings & Precautions
Who should not use Scemblix?
Allergies to Ingredients. People who are allergic to any of the following should not take Scemblix.
- Asciminib
- Scemblix
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Scemblix.
What should I know about Scemblix before using it?
Do not take Scemblix unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Scemblix with other people, even if they have the same condition as you. It may harm them.
Keep Scemblix out of the reach of children.
Do not chew, cut, or crush Scemblix.
What should I tell my healthcare provider before using Scemblix?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Scemblix is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.
- Pancreas problems
- Heart problems or blood clots
Other Medicines and Supplements. Scemblix may interact with other medicines and supplements. Before taking Scemblix, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. Scemblix may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. You must not be pregnant before starting Scemblix. If you can become pregnant, use effective birth control during treatment with Scemblix and for 1 week after your last dose.
Breastfeeding. It is not known if Scemblix passes into breast milk. Do not undergo treatment with Scemblix while you are breastfeeding and for 1 week after your last dose. Tell your healthcare provider if you are breastfeeding or plan to breastfeed.
Infertility. Scemblix may cause fertility problems in people who were assigned female at birth. Talk with your healthcare provider if this is a concern for you.
How can I get more information about Scemblix?
For more information about Scemblix, you can visit the manufacturer’s website at www.scemblix.com or call them at 866-433-8000.
Interactions
Does Scemblix interact with foods or drinks?
Scemblix should be taken without food. This is because food can cause decreased absorption of the medicine in your body. Avoid eating at least 2 hours before taking your dose and for 1 hour after taking your dose.
It is unknown if drinking alcohol will affect Scemblix.
Does Scemblix interact with other medicines (drug interactions)?
Some other medicines may alter the blood levels of Scemblix, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Scemblix. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Scemblix?
If you or someone else has used too much Scemblix, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Scemblix?
If you miss a dose, take it as soon as you remember. If you are taking Scemblix once a day and it is less than 12 hours until your next dose, skip the missed dose and only take the next dose. If you are taking Scemblix twice a day and it is less than 6 hours until your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.
Are you currently using Scemblix (asciminib)?
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