Is Asciminib approved by the FDA?

Asciminib (Brand name: Scemblix) is an oral tablet classified under the drug class BCR-ABL tyrosine kinase inhibitors. Asciminib was approved by the U.S. Food and Drug Administration (FDA) on October 29, 2021. The approval was granted under accelerated approval based on the major molecular response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Usage and Dosage

Asciminib is available in oral tablet forms of 20 mg and 40 mg. The typical dosages are:

• For Ph+ CML-CP Previously Treated with 2 or More TKIs (Tyrosine Kinase Inhibitors):
  • 80 mg orally once a day, or
  • 40 mg orally every 12 hours
• For Ph+ CML-CP with the T315I Mutation:
  • 200 mg orally every 12 hours

How to Take Asciminib

• Take asciminib without food.
• Swallow the tablet whole; do not crush, chew, or break it.
• Follow your doctor's dosage instructions carefully.
• Regular blood tests are required to monitor your condition.
• Do not stop using asciminib without your doctor's advice.
• Store the medication at room temperature away from moisture and heat.

Side Effects

Common side effects of asciminib include:

• Cold symptoms such as stuffy nose, sneezing, and sore throat
• Muscle, bone, or joint pain
• Tiredness
• Nausea, diarrhea
• Rash
• Abnormal blood tests

Serious side effects may include:

• Heart problems (e.g., chest pain, irregular heartbeat)
• High blood pressure
• Low blood cell counts
• Pancreas problems (e.g., sudden stomach pain, nausea, vomiting)

If you experience any severe side effects, seek medical attention immediately.

Warnings

• Asciminib may cause severe side effects such as heart problems, high blood pressure, and low blood cell counts.
• It may also cause pancreas problems.
• Inform your doctor if you have a history of pancreatitis, heart problems, or blood clots.
• Asciminib can harm an unborn baby, so use effective birth control while on this medication and for at least one week after the last dose.
• Do not breastfeed while using asciminib and for at least one week after the last dose.

Interactions

• Asciminib can interact with many other drugs, including prescription and over-the-counter medicines, vitamins, and herbal products.
• Inform your doctor about all your current medications to avoid adverse interactions.

Conclusion

Asciminib (Scemblix) is a targeted treatment option for Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase, particularly for patients who have not responded to other treatments. Approved by the FDA on October 29, 2021, asciminib offers a new hope for managing this condition, although it comes with potential side effects and necessary precautions. Always follow your doctor's instructions and report any adverse effects immediately.

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