Scemblix

Asciminib belongs to the class of medications called anti-neoplastics. Specifically, it is a tyrosine kinase inhibitor. It is used to treat adults with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (long-term illness), after treatment with 2 or more tyrosine kinase inhibitors has failed.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor.Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended dose of asciminib is40 mg taken by mouth twice daily, approximately 12 hours apart. Alternatively, you may take 80 mg by mouth once a day, at the same time each day. This medication should be taken on an empty stomach, either 1 hour before eating or 2 hours after eating. Swallow the tablets whole. Do not crush, break, or chew them.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications.If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you are taking this medication twice a day and you miss a dose, and it is less than 6 hours since your missed dose, take it as soon as possible, then continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. If you are taking this medication once a day and you have missed a dose by less than 12 hours, take it as soon as possible and continue with your regular schedule.Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

20 mg
Each pale-yellow, round, biconvex, film-coated tablet with bevelled edges, approximately 6.2 mm in diameter, unscored and debossed with the Novartis logo on one side and "20" on the other side, contains 21.62 mg of asciminib hydrochloride, which is equivalent to 20 mg of asciminib. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropylcellulose, iron oxide yellow, iron oxide red, lactose monohydrate, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.

40 mg
Each violet-white, round, biconvex, film-coated tablet with bevelled edges, approximately 8.2 mm diameter, unscored and debossed with the Novartis logo on one side and "40" on the other side, contains 43.24 mg of asciminib hydrochloride, which is equivalent to 40 mg of asciminib. Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropylcellulose, iron oxide black, iron oxide red, lactose monohydrate, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.

Do not take this medication if you are allergic to asciminib or any ingredients of the medication.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication.If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• blurred vision
• cough
• diarrhea
• dizziness
• dry eyes
• headache
• itching
• loss of appetite
• nausea
• nose and throat infections
• tiredness
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain
• fast, pounding heartbeat
• fever
• fluid retention, edema
• flu-like symptoms (e.g., muscle aches, fever or chills, sore throat, sudden lack of energy)
• muscle, joint, bone or chest pain
• shortness of breath or difficulty breathing
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools
• signs of a systematic hypersensitivity/allergic reaction (e.g., fever, swollen lymph glands, severe rash, flu-like feeling, signs of liver or kidney problems)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• symptoms of heart failure (e.g., shortness of breath, fatigue, swelling in legs, ankles, or feet)
• symptoms of high blood pressure (e.g., shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, bluish colour to lips and skin, fast or pounding heartbeat, swelling in ankles, feet, or lower legs)
• symptoms of a lung infection (e.g., fever, cough, difficulty breathing, wheezing)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• fever combined with low levels of white blood cells
• irregular heartbeat
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, swelling of the face and throat)
• symptoms of fluid around the lungs (e.g., chest pain, difficult or painful breathing, cough)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Anemia: Asciminibmay cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Blood clotting: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Tell your doctor of any signs that your blood is not clotting as quickly as usual. Such symptoms may include black and tarry stools, blood in the urine, easy bruising, or cuts that won't stop bleeding.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including platelets, in your blood.

High blood pressure: Asciminib may increase your blood pressure. Your doctor will monitor your blood pressure while you are taking this medication. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Heart problems and heart failure:  Heart problems including heart failure, have been reported with the use of asciminib. If you are at risk for heart problems such as heart failure (e.g., people with high blood pressure, diabetes, and coronary artery disease), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Contact your doctor immediately if you have symptoms of heart failure such as leg swelling, chest pain, or shortness of breath.

Heart rhythm: Asciminib can cause changes to the normal rhythm of the heart, including an irregular heartbeat called QT prolongation. QT prolongation is a serious life-threatening condition that can cause fainting, seizures, and sudden death. If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Your doctor will monitor your heart rhythm regularly while you are taking this medication with a test called an electrocardiogram (ECG). You should not take this medication if your ECG already shows that you have QT prolongation or if you are taking a medication that can cause QT prolongation.

Infection: As well as killing cancer cells, asciminib can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. 

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Hepatitis B reactivation: People who have hepatitis B infection that is dormant may experience the infection returning, causing further liver dysfunction or liver failure. If you have a history of hepatitis B infection, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this mediation, and whether any special monitoring is needed.

If you experience symptoms of worsening liver function, such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Liver function: Decreased liver function or liver disease may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pancreatitis: Asciminib can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

If you have a history of pancreatitis, gallstones, alcoholism, or high triglycerides, you may be more at risk of experiencing this.

Pregnancy: Asciminib may cause harm to the developing baby if it is taken during pregnancy. It should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Anyone who may become pregnant or whose partner may become pregnant should use 2 forms of effective birth control, one of which should be a barrier method, while taking this medication and for at least 7 days after the last dose.

Breast-feeding: It is not known if asciminib passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

For a full list of interactions, use the Drug Interaction Checkeravailable on the Drugs.com website.

If you are taking other medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Scemblix