Asciminib (Scemblix®)

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. The tablet 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 dose. If you take it once a day and your dose is missed by more than about 12 hours, skip that 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 that 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 told otherwise by your 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 provider 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 provider will work with your prescription drug plan to find 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 on 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 provider 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 provider 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 provider 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 provider 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 provider before scheduling dental appointments or procedures.
• Ask your provider 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 provider 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 talk with your provider about all over-the-counter medications/supplements while on this medication.
• 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 provider 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.

Rash

Some patients may develop a rash, scaly skin, or red itchy bumps. Use an alcohol-free moisturizer on your skin and lips; avoid moisturizers with perfumes or scents. Your oncology care team can recommend a topical medication if itching is bothersome. If your skin does crack or bleed, be sure to keep the area clean to avoid infection. Be sure to notify your provider of any rash that develops, as this can be a reaction. They can give you more tips on caring for your skin.

Muscle Pain

Your 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 provider for helpful tips on dealing with this side effect.

Nausea and/or Vomiting

Talk to your provider 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 provider 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 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 provider 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 to 10 glasses of non-alcoholic, un-caffeinated fluid a day to prevent dehydration.

Liver Toxicity

This medication can cause liver toxicity, which your provider may monitor for using blood tests called liver function tests. Notify your provider if you notice yellowing of the skin or eyes, if your urine appears dark or brown, or if you have pain in your abdomen (belly), 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. Hypertension should be treated. If hypertension cannot be controlled, the medication may be stopped. Report any headaches, vision changes, or dizziness to your provider.
• 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.

Sexual and Reproductive Concerns

This medication may affect a female's reproductive system, resulting in the menstrual cycle becoming irregular or stopping permanently. Females may experience menopausal effects including hot flashes and vaginal dryness. In addition, the desire for sex may decrease during treatment. You may want to consider egg harvesting if you may wish to have a child in the future. Discuss these options with your provider.

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 for females during treatment and for at least 1 week after treatment. Males should talk with their provider about necessary birth control. 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.