Asciminib (Scemblix®)

Asciminib is a kinase inhibitor. A kinase is an enzyme that promotes cell growth. There are many types of kinases, which control different phases of cell growth. By blocking a particular enzyme from working, this medication can slow the growth of cancer cells.

How to Take Asciminib

This medication comes in a tablet form to be taken by mouth on an empty stomach. You should not eat 2 hours before and 2 hours after taking the medication. They should be swallowed whole. Do not break, crush, or chew the tablets. This medication may be taken once or twice a day, depending on your situation. If you take it once a day and your dose is missed by more than about 12 hours, skip the dose and take your next dose as scheduled. If you take it twice a day and your dose is missed by more than about 6 hours, skip the dose and take your next dose as scheduled.

It is important to make sure you are taking the correct amount of medication every time. Before every dose, check that what you are taking matches what you have been prescribed.

The blood levels of this medication can be affected by certain foods and medications, so they should be avoided. These include (but are not limited to): St. John’s wort, grapefruit, grapefruit juice, itraconazole, diltiazem, fluconazole, verapamil, rifampin, bosentan, efavirenz, repaglinide, midazolam, rosuvastatin, atorvastatin, cyclosporine, digoxin, tacrolimus, and itraconazole. Make sure to tell your provider about all medications and supplements you are taking.

Storage and Handling

Store your medication in the original, labeled container at room temperature and in a dry location (unless otherwise directed by your healthcare provider or pharmacist). This medication should not be stored in a pillbox. Keep containers out of reach of children and pets.

If a caregiver prepares your dose for you, they should consider wearing gloves or pouring the pills directly from their container into the cap, a small cup, or directly into your hand. They should avoid touching the pills. They should always wash their hands before and after giving you the medication. Pregnant or nursing women should not prepare the dose for you. Ask your oncology team where to return any unused medication for disposal. Do not flush down the toilet or throw it in the trash.

Where do I get this medication?

Asciminib is available through select specialty pharmacies. Your oncology team will work with your prescription drug plan to identify an in-network specialty pharmacy for the distribution of this medication and shipment directly to your home.

Insurance Information

This medication may be covered under your prescription drug plan. Patient assistance may be available to qualifying individuals depending upon prescription drug coverage. Co-pay cards, which reduce the patient co-pay responsibility for eligible commercially (non-government sponsored) insured patients, may also be available. Your care team can help you find these resources if they are available.

Possible Side Effects of Asciminib

There are a number of things you can do to manage the side effects of asciminib. Talk to your care team about these recommendations. They can help you decide what will work best for you. These are some of the most common or important side effects:

Increased Blood Cholesterol

Asciminib can cause an increase in your cholesterol levels. Your healthcare team will monitor your cholesterol levels throughout your treatment.

Infection and Low White Blood Cell Count (Leukopenia or Neutropenia)

White blood cells (WBC) are important for fighting infection. While receiving treatment, your WBC count can drop, putting you at a higher risk of getting an infection. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4°F or 38°C), sore throat or cold, shortness of breath, cough, burning with urination, or a sore that doesn't heal.

Tips to preventing infection:

• Washing hands, both yours and your visitors, is the best way to prevent the spread of infection.
• Avoid large crowds and people who are sick (i.e.: those who have a cold, fever, or cough or live with someone with these symptoms).
• When working in your yard, wear protective clothing including long pants and gloves.
• Do not handle pet waste.
• Keep all cuts or scratches clean.
• Shower or bath daily and perform frequent mouth care.
• Do not cut cuticles or ingrown nails. You may wear nail polish, but not fake nails.
• Ask your oncology care team before scheduling dental appointments or procedures.
• Ask your oncology care team before you, or someone you live with has any vaccinations.

Low Platelet Count (Thrombocytopenia)

Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. Let your oncology care team know if you have any excess bruising or bleeding, including nose bleeds, bleeding gums, or blood in your urine or stool. If the platelet count becomes too low, you may receive a transfusion of platelets.

• Do not use a razor (an electric razor is fine).
• Avoid contact sports and activities that can result in injury or bleeding.
• Do not take aspirin (salicylic acid), non-steroidal, anti-inflammatory medications (NSAIDs) such as Motrin/Advil (ibuprofen), Aleve (naproxen), Celebrex (celecoxib), etc. as these can all increase the risk of bleeding. Please consult with your healthcare team regarding the use of these agents and all over-the-counter medications/supplements while on therapy.
• Do not floss or use toothpicks and use a soft-bristle toothbrush to brush your teeth.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your oncology care team know if you experience any shortness of breath, difficulty breathing, or pain in your chest. If the count gets too low, you may receive a blood transfusion.

Muscle Pain

Your healthcare provider can recommend medications and other strategies to help relieve pain.

Allergic Reactions

In some cases, patients can have an allergic reaction to this medication. Signs of a reaction can include: swelling, rash, trouble swallowing, fever, fast heartbeat, and trouble breathing. Call your provider right away if you have any of these symptoms.

Fatigue

Fatigue is very common during cancer treatment and is an overwhelming feeling of exhaustion that is not usually relieved by rest. While on cancer treatment, and for a period after, you may need to adjust your schedule to manage fatigue. Plan times to rest during the day and conserve energy for more important activities. Exercise can help combat fatigue; a simple daily walk with a friend can help. Talk to your healthcare team for helpful tips on dealing with this side effect.

Nausea and/or Vomiting

Talk to your oncology care team so they can prescribe medications to help you manage nausea and vomiting. In addition, dietary changes may help. Avoid things that may worsen the symptoms, such as heavy or greasy/fatty, spicy or acidic foods (lemons, tomatoes, oranges). Try saltines, or ginger ale to lessen symptoms.

Call your oncology care team if you are unable to keep fluids down for more than 12 hours or if you feel lightheaded or dizzy at any time.

Diarrhea

Diarrhea can be a serious side effect of this medication. Notify your care provider if you start to have diarrhea to determine which medications you should be taking. Diarrhea can lead to dehydration so it is important to manage this side effect.

Your oncology care team can recommend medications to relieve diarrhea. Also, try eating low-fiber, bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole-grain bread, cereals, and seeds. Soluble fiber is found in some foods and absorbs fluid, which can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange sections, boiled potatoes, white rice, products made with white flour, oatmeal, cream of rice, cream of wheat, and farina. Drink 8-10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Liver Toxicity

This medication can cause liver toxicity, which your oncology care team may monitor for using blood tests called liver function tests. Notify your healthcare provider if you notice yellowing of the skin or eyes, your urine appears dark or brown, or you have pain in your abdomen, as these can be signs of liver toxicity.

Important but Less Common Side Effects

• High Blood Pressure: This medication can cause high blood pressure (hypertension). Patients should have their blood pressure checked regularly during therapy. Any hypertension should be treated appropriately. If hypertension cannot be controlled, the medication may be stopped. Report any headaches, vision changes, or dizziness to your oncology care team.
• Heart Problems: This medication can heart and blood vessel problems such as heart attack, stroke, blood clots, blockage of the arteries, heart failure, and abnormal heartbeats. Call your provider or 911 right away if you have shortness of breath, chest pain or pressure, feel like your heart is racing, new swelling, dizziness, sudden weight gain, numbness or weakness on one side of your body, loss of vision, trouble talking, pain in your arms, legs, back, neck or jaw, headache, or severe stomach pain.
• Pancreas Problems: This medication can increase the enzymes amylase and lipase which may be signs of issues with your pancreas. You will have these levels checked while you take this medication. If you have sudden stomach pain or discomfort, nausea, or vomiting you should call your provider right away as these are signs of pancreatitis.

Reproductive Concerns

Exposure of an unborn child to this medication could cause birth defects, so you should not become pregnant or father a child while on this medication. Effective birth control is necessary during treatment and for at least 1 week after treatment. Even if your menstrual cycle stops or you believe you are not producing sperm, you could still be fertile and conceive. Do not breastfeed while taking this medication and for 1 week after treatment has ended.