Asciminib

What is Asciminib?

• Asciminib (Scemblix) is a kinase inhibitor used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

Asciminib

What are the uses of this medicine?

Asciminib (Scemblix) is used to treat adults with:

• Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with 2 or more tyrosine kinase inhibitor (TKI) medicines.
• Ph+ CML in chronic phase (CP) with the T315I mutation.

How does this medicine work?

Asciminib is an ABL/BCR-ABL1 tyrosine kinase inhibitor. Asciminib binds to the Abl portion of the Bcr-Abl fusion protein at a location that is distinct from the ATP-binding domain. This binding results in the inhibition of Bcr-Abl-mediated proliferation and enhanced apoptosis of Philadelphia chromosome-positive (Ph+) hematological malignancies. The Bcr-Abl fusion protein tyrosine kinase is an abnormal enzyme produced by leukemia cells that contain the Philadelphia chromosome.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Closely monitor for adverse reactions in patients treated with Scemblix at 200 mg twice daily with concomitant use of strong CYP3A4 inhibitors.
• Avoid coadministration of Scemblix at all recommended doses with itraconazole oral solution containing hydroxypropyl-β-cyclodextrin.
• Avoid coadministration of Scemblix at 200 mg twice daily with certain CYP3A4 substrates, where minimal concentration changes may lead to serious adverse reactions.
• Avoid coadministration of Scemblix at 80 mg total daily dose with certain CYP2C9 substrates, where minimal concentration changes may lead to serious adverse reactions. If coadministration is unavoidable, reduce the CYP2C9 substrate dosage as recommended in its prescribing information.
• Closely monitor for adverse reactions in patients treated with Scemblix at all recommended doses with concomitant use of P-gp substrates, where minimal concentration changes may lead to serious toxicities.

Is this medicine FDA approved?

• Asciminib was approved for medical use in the United States in October 2021.

How should this medicine be used?

Recommended dosage: Recommended Dosage in Patients with Ph+ CML-CP, Previously Treated with Two or More TKIs:

• The recommended dose of Scemblix is 80 mg taken orally once daily at approximately the same time each day or 40 mg twice daily at approximately 12-hour intervals.

Recommended Dosage in Patients with Ph+ CML-CP with the T315I Mutation:

• The recommended dose of Scemblix is 200 mg taken orally twice daily at approximately 12-hour intervals.

Administration:

• Take Scemblix without food. You should avoid eating for at least 2 hours before and 1 hour after taking Scemblix.
• Swallow Scemblix tablets whole. Do not break, crush, or chew Scemblix tablets.
• If you take Scemblix 1 time a day and 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 2 times a day and miss a dose by more than 6 hours, skip the missed dose and take your next dose at your regular time.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Film-coated tablets: 20 mg and 40 mg

This medicine is available in fallowing brand namesː

• Scemblix

What side effects can this medication cause?

The most common side effects of this medicine include:

• nose, throat, or sinus (upper respiratory tract) infections
• muscle, bone, or joint pain
• tiredness
• nausea
• rash
• diarrhea
• decreased blood platelet counts, white blood cell counts, and red blood cell counts
• increased blood fat (triglycerides) levels
• increased blood creatine kinase levels
• increased blood liver enzyme levels
• increased blood pancreas enzyme (amylase and lipase) levels

Scemblix may cause serious side effects, including:

• Low blood cell counts
• Pancreas problems
• High blood pressure
• Allergic reaction
• Heart and blood vessel (cardiovascular) problems

What special precautions should I follow?

• Severe thrombocytopenia and neutropenia events may occur. Monitor complete blood counts regularly during therapy and manage by treatment interruption or dose reduction.
• Pancreatitis occurred in patients receiving Scemblix. Monitor serum lipase and amylase. Interrupt, then resume at reduced dose or discontinue Scemblix based on severity. Evaluate for pancreatitis when lipase elevation is accompanied by abdominal symptoms.
• Hypertension occurred in patients receiving Scemblix. Monitor blood pressure and manage hypertension as clinically indicated. Interrupt, dose reduce, or stop Scemblix if hypertension is not medically controlled.
• Hypersensitivity occurred in patients receiving Scemblix. Monitor patients for signs and symptoms and initiate appropriate treatment as clinically indicated.
• Cardiovascular toxicity (including ischemic cardiac and CNS conditions, arterial thrombotic and embolic conditions) and cardiac failure occurred in patients receiving Scemblix. Monitor patients with history of cardiovascular risk factors for cardiovascular signs and symptoms. Initiate appropriate treatment as clinically indicated.
• Based on findings from animal studies and its mechanism of action, Scemblix can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Scemblix can harm your unborn baby.
• Your healthcare provider will do a pregnancy test before you start treatment with Scemblix.
• Females who are able to become pregnant should use effective birth control during treatment and for 1 week after your last dose of Scemblix.

Can this medicine be used in children?

• The safety and efficacy of Scemblix in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• 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.

Who manufactures and distributes this medicine?

• Distributed by: Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey

What should I know about storage and disposal of this medication?

• Store Scemblix at room temperature between 68°F to 77°F (20°C to 25°C).
• Dispense and store Scemblix in the original container to protect it from moisture.

• Dailymed label info on Asciminib
• FDA Asciminib

Asciminib Resources
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Asciminib Resources
Latest articles Most recent articles Ongoing trials	Wikipedia