Scemblix

Scemblix (asciminib) is an oral kinase inhibitor that may be used to treat adults with a type of cancer called chronic myelogenous leukemia (CML; also called chronic myeloid leukemia). It is approved to treat:

• Adults with Philadelphia chromosome-positive (Ph+) CML in chronic phase (CP), previously treated
• Ph+ CML in CP with the T315I mutation. This mutation can cause resistance to some medications.
• Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). This indication is and accelerated approval and continued approval is dependent of confirmation of clinical benefit from clinical studies.

Scemblix is a targeted treatment that works by specifically targeting the ABL myristoyl pocket (STAMP), which is a different site of action than other kinase inhibitors. This different way of working is important for people with Ph+ CML who have experienced an inadequate response to other treatments or troublesome side effects. It may also be given to Ph+ CML patients in CP with the T315I mutation – this mutation prevents certain tyrosine kinase inhibitors from working.

Scemblix was approved on October 29, 2021. Scemblix FDA approval for newly diagnosed adults with Philadelphia chromosome-positive (Ph+) CML in chronic phase (CP) is an accelerated approval, and continued approval is dependent on confirmation of clinical benefit from clinical studies.

Take Scemblix exactly as your healthcare provider tells you. Do not change your dose or schedule or stop treatment unless your healthcare provider tells you to.

Take Scemblix tablets without food. You should avoid eating for at least 2 hours before and 1 hour after taking a dose.

Swallow the tablets whole. Do not break, crush, or chew.

Scemblix may cause low blood cell counts, including low platelet counts (thrombocytopenia), low white blood cell counts (neutropenia), and low red blood cell counts (anemia). Your healthcare provider will do regular blood tests. Tell your healthcare provider right away if you have unexpected bleeding or easy bruising, blood in your urine or stools, fever, or any signs of an infection.

May cause pancreas problems including toxicity. Your healthcare provider will monitor your pancreatic enzymes, amylase, and lipase, throughout treatment. Tell your healthcare provider right away if you have sudden stomach-area pain or discomfort, nausea, or vomiting.

Scemblix may cause high blood pressure. Your healthcare provider may check your blood pressure and treat any high blood pressure during treatment as needed. Tell your healthcare provider if you develop elevated blood pressure or symptoms of high blood pressure including confusion, headaches, dizziness, chest pain, or shortness of breath.

May cause hypersensitivity reactions. Stop taking Scemblix and get medical help right away if you get any signs or symptoms of an allergic reaction, including trouble breathing or swallowing, swelling of the face, lips, or tongue, skin rash or flushing of your skin, feeling dizzy or faint, fever, or a fast heartbeat.

Scemblix may cause heart and blood vessel problems, including a heart attack, stroke, blood clots, artery blockages, heart failure, or an abnormal heartbeat, some of which may be life-threatening. Tell your healthcare provider or get medical help right away if you develop shortness of breath, chest pain or pressure, feel like your heart is beating too fast, feel abnormal heartbeats, swelling in your ankles or feet, dizziness, weight gain, numbness or weakness on one side of your body, decreased vision or loss of vision, trouble talking, pain in your arms, legs, back, neck or jaw, headache, or severe stomach area pain

Can cause harm to an unborn baby and should not be used during pregnancy. Your doctor should conduct a pregnancy test if you are a woman of childbearing age before prescribing Scemblix and you should use adequate contraception during treatment. Do not breastfeed.

It is not known if this medicine is safe and effective in children.

Before you start treatment, tell your healthcare provider about all your medical conditions, including if you:

• have a history of inflammation of your pancreas (pancreatitis)
• have a history of heart problems or blood clots in your arteries and veins (types of blood vessels)
• are pregnant, plan to become pregnant, or are breastfeeding.

Pregnancy and breastfeeding

Scemblix can harm an unborn baby. Your healthcare provider will do a pregnancy test before you start treatment. Females who can become pregnant should use effective birth control during treatment and for 1 week after their last dose. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you inadvertently become pregnant or think you may be pregnant during treatment.

It is not known if Scemblix passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose.

Scemblix may cause fertility problems in females. This may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.

Get emergency medical help if you have signs of an allergic reaction to Scemblix, such as hives, itching; dizziness; back pain, joint pain; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of high blood pressure including confusion, headaches, dizziness, chest pain, or shortness of breath
• signs of a low blood cell count such as fever, chills, tiredness, flu-like symptoms, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet
• signs of pancreatic problems, such as sudden stomach-area pain or discomfort, nausea, or vomiting
• signs of cardiovascular disease, including shortness of breath, chest pain or pressure, feeling like your heart is beating too fast or you feel abnormal heartbeats, swelling in your ankles or feet, dizziness, weight gain, numbness or weakness on one side of your body, decreased vision or loss of vision, trouble talking, pain in your arms, legs, back, neck or jaw, headache, or severe stomach area pain

The most common side effects occurring in 20% or more people include:

• Nose, throat, or sinus (upper respiratory tract) infections
• Muscle, bone, or joint pain
• Headache
• Fatigue
• Nausea
• Rash
• Diarrhea
• Laboratory test abnormalities.

Your healthcare provider may change your dose or temporarily or permanently stop treatment if you have certain side effects.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800 FDA-1088.

Recommended dosages for:

• Ph+ CML in CP: 80 mg orally once daily or 40 mg twice daily
• Ph+ CML in CP with the T315I Mutation: 200 mg orally twice daily.

If you take Scemblix once a day and you miss a dose by more than 12 hours, skip the missed dose and take your next dose at your regular time.

If you take Scemblix twice a day and miss a dose by more than 6 hours, skip the missed dose and take your next dose at your regular time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective. Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Interactions include:

• antibiotics - clarithromycin
• antifungal medicines - itraconazole, ketoconazole, posaconazole, voriconazole
• HIV medicines containing atazanavir, darunavir, indinavir, nelfinavir, ritonavir, saquinavir, cobicistat
• itraconazole in combination with hydroxypropyl-β-cyclodextrin
• mifepristone
• nefazodone
• other strong CYP3A inhibitors or substrates, such as diltiazem and verapamil, especially with higher dosages
• substrates of CYP2C9, such as fluoxetine, losartan, phenytoin, tolbutamide, torsemide, S-warfarin, and numerous NSAIDs (best to avoid combination)
• certain P-gp substrates, such as colchicine, loperamide, dabigatran, or digoxin.

Many other drugs can interact with Scemblix. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Store at room temperature 20°C to 25°C (68°F to 77°F) away from moisture and heat.

Keep all medicines out of the reach of children and pets.

Active ingredient: asciminib

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hydroxypropyl cellulose, lactose monohydrate, lecithin, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, titanium dioxide, and xanthan gum.

The 20 mg tablets contain ferric oxide, yellow, and ferric oxide, red.

The 40 mg tablets contain ferrosoferric oxide and ferric oxide, red.

Novartis.