Scemblix
Generic Name
Asciminib
Manufacturer
Novartis Pharmaceuticals Corporation
Country
Switzerland
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ascimib 40 mg tablet | ৳ 1,200.00 | N/A |
Description
Overview of the medicine
Asciminib is an oral, potent, and selective BCR-ABL1 tyrosine kinase inhibitor (TKI) that specifically targets the ABL myristoyl pocket (STAMP inhibitor). It is approved for the treatment of chronic myeloid leukemia (CML) in adult patients.
Uses & Indications
Dosage
Adults
For patients previously treated with two or more TKIs: 80 mg once daily or 40 mg twice daily. For patients with T315I mutation: 80 mg once daily or 40 mg twice daily. Taken orally, swallowed whole with water. Avoid food for at least 2 hours before and 1 hour after dose.
Elderly
No specific dose adjustment is recommended based on age alone.
Renal_impairment
No dose adjustment needed for mild or moderate renal impairment. For severe renal impairment, monitor closely, and consider dose reduction.
How to Take
Oral administration. Take tablets whole with water. Avoid food for at least 2 hours before and 1 hour after the dose.
Mechanism of Action
Asciminib acts as a STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor. Unlike other TKIs that bind to the ATP-binding site, asciminib binds to the myristoyl pocket of the ABL1 kinase, thereby inhibiting the activity of BCR-ABL1, including some mutations resistant to other TKIs.
Pharmacokinetics
Onset
Not precisely defined, but clinical response seen within weeks to months.
Excretion
Mainly excreted in feces (80%), with a smaller portion in urine (5%).
Half life
Approximately 6-12 hours.
Absorption
Rapidly absorbed, peak plasma concentrations typically achieved within 2-4 hours. Absolute bioavailability is approximately 42%.
Metabolism
Primarily metabolized by CYP3A4 and UGT2B7. The main metabolite is asciminib glucuronide.
Side Effects
Contraindications
- Hypersensitivity to asciminib or any excipients in the formulation.
Drug Interactions
Strong CYP3A4 inducers
May decrease asciminib concentrations. Avoid co-administration if possible, or consider increasing asciminib dose.
UGT inhibitors/inducers
Potential for altered asciminib metabolism, monitor closely.
Strong CYP3A4 inhibitors
May increase asciminib concentrations. Reduce asciminib dose.
Sensitive CYP2C9 substrates
Asciminib may increase concentrations of CYP2C9 substrates (e.g., warfarin). Monitor closely.
Storage
Store at room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Keep in the original container to protect from moisture.
Overdose
There is limited clinical experience with overdose. In case of an overdose, discontinue asciminib and initiate supportive medical care. Monitor for adverse reactions.
Pregnancy & Lactation
Asciminib can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Use effective contraception during treatment and for 1 week after the last dose. It is unknown if asciminib is excreted in human milk; due to potential for serious adverse reactions in breastfed infants, advise against breastfeeding during treatment and for 1 week after the last dose.
Side Effects
Contraindications
- Hypersensitivity to asciminib or any excipients in the formulation.
Drug Interactions
Strong CYP3A4 inducers
May decrease asciminib concentrations. Avoid co-administration if possible, or consider increasing asciminib dose.
UGT inhibitors/inducers
Potential for altered asciminib metabolism, monitor closely.
Strong CYP3A4 inhibitors
May increase asciminib concentrations. Reduce asciminib dose.
Sensitive CYP2C9 substrates
Asciminib may increase concentrations of CYP2C9 substrates (e.g., warfarin). Monitor closely.
Storage
Store at room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Keep in the original container to protect from moisture.
Overdose
There is limited clinical experience with overdose. In case of an overdose, discontinue asciminib and initiate supportive medical care. Monitor for adverse reactions.
Pregnancy & Lactation
Asciminib can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Use effective contraception during treatment and for 1 week after the last dose. It is unknown if asciminib is excreted in human milk; due to potential for serious adverse reactions in breastfed infants, advise against breastfeeding during treatment and for 1 week after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from the date of manufacture.
Availability
Globally in countries where approved (e.g., USA, EU, Japan)
Approval Status
FDA Approved
Patent Status
Patented
Clinical Trials
Asciminib was approved based on results from the ASCEMBL study (NCT03106779), a Phase 3 trial comparing asciminib to bosutinib in patients with chronic-phase CML previously treated with two or more TKIs. Other trials are ongoing to explore its use in earlier lines of therapy or in other CML phases.
Lab Monitoring
- Complete Blood Count (CBC) with differential, weekly for the first month, then monthly or as clinically indicated.
- Liver function tests (ALT, AST, bilirubin) prior to initiation and as clinically indicated.
- Pancreatic enzymes (amylase, lipase) prior to initiation and as clinically indicated.
- Lipids (fasting serum lipids) prior to initiation and periodically during treatment.
- Glucose (fasting serum glucose) prior to initiation and periodically during treatment.
- Electrolytes (especially potassium, magnesium, calcium) as clinically indicated.
Doctor Notes
- Emphasize strict adherence to empty stomach administration to optimize absorption.
- Close monitoring of CBC, LFTs, pancreatic enzymes, and cardiovascular risk factors is crucial.
- Consider dose modification for significant drug interactions or adverse reactions.
Patient Guidelines
- Take asciminib exactly as prescribed by your doctor.
- Take on an empty stomach, at least 2 hours after food and 1 hour before food.
- Do not crush, chew, or split the tablets.
- Report any unusual side effects or symptoms to your doctor immediately.
Missed Dose Advice
If a dose is missed by more than 6 hours, skip the missed dose and take the next dose at the regularly scheduled time. Do not take two doses to make up for a missed dose.
Driving Precautions
Asciminib may cause side effects like fatigue, dizziness, or visual disturbances that could affect your ability to drive or operate machinery. Exercise caution until you know how asciminib affects you.
Lifestyle Advice
- Maintain adequate hydration throughout treatment.
- Follow a balanced diet and regular exercise regimen as advised by your healthcare provider.
- Avoid grapefruit products, as they may interact with asciminib.
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