Asciminib
Asciminib is a targeted kinase inhibitor used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults, including newly diagnosed cases, previously treated cases, and cases involving the T315I mutation.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Asciminib: Patient Information Guide
A plain-language walkthrough of Asciminib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Asciminib (brand name Scemblix) is a targeted treatment for a specific type of blood cancer called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). It is approved for use in adult patients in the following situations:
- Newly diagnosed Ph+ CML in chronic phase (CP): Scemblix is approved for adults who have just been diagnosed — this approval is based on early response data (accelerated approval) and may depend on results from ongoing confirmatory trials
- Previously treated Ph+ CML in chronic phase: Scemblix is used in adults whose CML has already been treated with other therapies
- Ph+ CML in chronic phase with the T315I mutation: Scemblix is specifically approved for adults whose CML carries this mutation, which makes many standard CML drugs less effective
⚙️How it works▾
Asciminib targets an abnormal protein called BCR-ABL1 — the engine that drives CML cells to grow out of control. Unlike most other CML drugs, which block the protein's active site, asciminib binds to a different location called the ABL myristoyl pocket. Think of it as locking a back door instead of the front — shutting the protein down from a unique angle. This distinct approach allows it to remain active even against mutations, including the T315I mutation, that have evolved to dodge other treatments.
💊How it's taken▾
Scemblix tablets are taken by mouth on an empty stomach — food can significantly reduce how much of the drug your body absorbs. Avoid eating for at least 2 hours before and 1 hour after each dose. Tablets must be swallowed whole; do not break, crush, or chew them.
- For newly diagnosed or previously treated Ph+ CML-CP: taken once daily or twice daily at roughly 12-hour intervals, depending on what your prescriber decides
- For Ph+ CML-CP with the T315I mutation: taken twice daily, approximately 12 hours apart
- Missed dose: if you miss a once-daily dose by more than about 12 hours, skip it and take your next scheduled dose; if you miss a twice-daily dose by more than about 6 hours, skip it and resume your normal schedule
🤒Side effects — in detail▾
The most common side effects reported in clinical trials of Scemblix include:
- Musculoskeletal pain — muscle aches, joint pain, back pain, or pain in the limbs
- Skin rash (various types, including red, bumpy, or pustular rash)
- Fatigue or general weakness
- Upper respiratory tract infections, such as colds or congestion
- Headache
- Abdominal (stomach) pain
- Diarrhea
- High blood pressure (hypertension)
- Dyslipidemia (abnormal cholesterol or triglyceride levels)
Serious reactions that require prompt medical attention include severe drops in blood counts (which can cause bleeding or dangerous infections), pancreatitis (pancreas inflammation signaled by severe stomach pain), cardiovascular events (chest pain, sudden weakness, or shortness of breath), and severe allergic reactions (swelling, trouble breathing, or worsening rash).
⚠️Warnings & precautions▾
- Low blood counts (myelosuppression): Scemblix can significantly reduce platelets, white blood cells, and red blood cells — raising risks of serious bleeding and infection. Blood counts are monitored every two weeks for the first 3 months, then monthly.
- Pancreatic toxicity: Scemblix can raise pancreatic enzyme levels (lipase and amylase) and in some cases cause pancreatitis. Enzymes are checked monthly. Severe or persistent stomach pain warrants immediate evaluation.
- High blood pressure: Hypertension occurred in about 18% of patients and can be severe. Blood pressure should be monitored and managed throughout treatment.
- Cardiovascular toxicity: Heart attack, stroke, blood clots, arrhythmia (irregular heartbeat), and heart failure have occurred — most often in patients with pre-existing heart disease or risk factors. Report any chest pain, sudden weakness, or palpitations right away.
- Hypersensitivity (allergic reactions): Reactions including rash, swelling, and bronchospasm (airway tightening) have been reported. Severe reactions may require stopping the drug.
- Embryo-fetal harm: Animal studies showed that asciminib causes birth defects and fetal death. Pregnancy must be ruled out before starting, and effective contraception is required during treatment and for 1 week after the last dose.
🔀What it interacts with▾
Asciminib is processed by and can also affect liver enzymes and drug transporters, creating several clinically important interactions:
- Strong CYP3A4 inhibitors (e.g., clarithromycin): can raise asciminib levels and increase the risk of side effects — monitor closely
- Itraconazole oral solution (containing hydroxypropyl-β-cyclodextrin): avoid at all Scemblix doses — this specific formulation lowers asciminib absorption and may make treatment less effective
- Strong CYP3A4 inducers (e.g., phenytoin, rifampin): can lower asciminib levels and reduce how well it works
- Imatinib: substantially increases asciminib exposure when used together — use with caution
- CYP2C9 substrates (e.g., warfarin): Scemblix inhibits this enzyme pathway, raising levels of these drugs and their side effect risk — avoid or reduce their dose as directed
- CYP3A4 substrates where small level changes matter: avoid combination at the higher Scemblix dose; monitor closely at lower doses
- P-gp substrates: Scemblix can raise plasma levels of these drugs — monitor for increased side effects at all Scemblix doses
- Rosuvastatin (a BCRP substrate): avoid combining with Scemblix at any dose; monitor other BCRP substrates closely
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Scemblix can cause serious harm to an unborn baby, including birth defects and pregnancy loss. A pregnancy test is required before starting. Do not use Scemblix during pregnancy.
- Breastfeeding: Do not breastfeed during treatment or for 1 week after the last dose — the potential risk to the infant is unknown but considered serious.
- Contraception: Women who can become pregnant must use effective contraception throughout treatment and for 1 week after stopping.
- Fertility: Animal studies suggest Scemblix may impair female fertility; whether this is reversible in humans is unknown.
- Children: Safety and effectiveness in patients under 18 have not been established.
- Older adults (65+): Clinical trial data showed no meaningful difference in safety or effectiveness compared to younger patients — no special dose adjustment needed based on age alone.
- Kidney impairment: No dose adjustment is needed for mild to severe kidney impairment in patients not on dialysis.
- Liver impairment: No dose adjustment is needed for mild to severe liver impairment.
- History of pancreatitis or cardiovascular disease: Tell your doctor — more frequent monitoring is recommended.
📡Pharmacodynamics — effects in the body▾
Asciminib lowers the level of BCR-ABL1 activity in the blood — the key measure of CML disease control. At higher blood concentrations, the drug tends to produce greater reductions in BCR-ABL1 levels and higher rates of major molecular response (a deep, measurable reduction in leukemia), but very high concentrations are also linked to a slightly greater risk of certain side effects, including elevated liver enzymes, elevated pancreatic enzymes, and low blood counts. Asciminib does not cause a clinically large change in the heart's electrical rhythm (QTc interval) at the highest recommended dose, though a small effect cannot be fully ruled out.
🔬Pharmacokinetics — how your body processes it▾
After an oral dose, asciminib reaches peak blood levels in about 2.5 hours, and steady-state levels are achieved within 3 days of starting treatment. Food significantly reduces absorption — a high-fat meal can lower drug exposure by up to 62%, which is why it must be taken on an empty stomach. The drug is mostly cleared through the feces (about 80%), with a smaller amount exiting through urine. It is broken down primarily by liver enzymes (CYP3A4) and cleared in part via biliary secretion. The half-life (the time for blood levels to drop by half) is approximately 5.5 to 9 hours depending on the dosing regimen. Body weight, age, sex, race, and mild to severe kidney or liver impairment do not meaningfully change how the body handles asciminib.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) . store in the original container in order to protect from moisture.
📄 Written from Asciminib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Asciminib
31 supplements and herbal products have documented interactions with Asciminib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 20
- Minor · 10
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Asciminib — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Scemblix treating, and why do I need it? ▾
Why do I have to take it on an empty stomach? What if I accidentally eat first? ▾
What side effects are most likely, and which ones should make me call my doctor right away? ▾
I take other medications. Is that going to be a problem with Scemblix? ▾
Can I take Scemblix if I'm pregnant or trying to get pregnant? ▾
Will I need regular blood tests while I'm on this medication? ▾
Is Asciminib available over the counter? ▾
When was Asciminib first available? ▾
Who makes Asciminib? ▾
💬 Answers drafted from Asciminib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Asciminib comes
Asciminib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Scemblix tablets are used to treat newly diagnosed Ph+ CML in chronic phase in adults (approved under accelerated approval based on early response data)
- Scemblix tablets are used to treat previously treated Ph+ CML in chronic phase in adults
- Scemblix tablets are used to treat Ph+ CML in chronic phase with the T315I mutation in adults
- Scemblix tablets must be swallowed whole — do not break, crush, or chew them
- Scemblix tablets are taken on an empty stomach: avoid food for at least 2 hours before and 1 hour after each dose
- Scemblix tablets are taken at the same time each day; the T315I mutation regimen requires twice-daily dosing approximately 12 hours apart
- If a dose is missed, follow the missed-dose timing guidance on your Scemblix label and skip the missed dose rather than doubling up
📊 Asciminib across the U.S. market
How Asciminib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Asciminib is used
A general measure of how commonly Asciminib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Asciminib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Asciminib prescribed? Of the 1,596 medications we measure, Asciminib ranks #1,113 by Medicaid prescriptions — more than 30% of them.
Utilization by Asciminib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
asciminib 40 MG Oral Tablet Most dispensed
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2584328
asciminib 100 MG Oral Tablet
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2680278
asciminib 20 MG Oral Tablet
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2584320
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Asciminib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 10 listed Asciminib NDCs with Medicaid activity.
🔍 Compare Asciminib products
A representative set of FDA-listed product records for Asciminib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 20 mg | Oral | Novartis Pharmaceuticals Corporation × 3 listings | NDA | View NDC → |
| 40 mg | Oral | Novartis Pharmaceuticals Corporation × 3 listings | NDA | View NDC → |
| 100 mg | Oral | Novartis Pharmaceuticals Corporation | NDA | View NDC → |
| 20 mg | — | Novartis Pharma Stein AG | DRUG FOR FURTHER PROCESSING | View NDC → |
| 40 mg | — | Novartis Pharma Stein AG | DRUG FOR FURTHER PROCESSING | View NDC → |
| 100 mg | — | Novartis Pharma Stein AG | DRUG FOR FURTHER PROCESSING | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Hetero Labs Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Laboratories Private Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Novartis Pharma Schweizerhalle AG | BULK INGREDIENT | View NDC → |
Showing 13 of 13 products — FDA National Drug Code Directory. See every product, package size and price: browse all 13 Asciminib NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Asciminib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Asciminib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Asciminib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2584304 1 dose form · 3 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 2584319In current FDA listings
Look up RxCUI 2584304 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Asciminib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Asciminib belongs to the BCR-ABL tyrosine kinase inhibitors class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.