Asciminib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Tejasvi Aryaputra
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Asciminib FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Asciminib in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Asciminib in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Asciminib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Asciminib in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Asciminib in pediatric patients.
Contraindications
There are no contraindications associated with Asciminib.
Warnings
-Myelosuppression
-Studies conducted show evidence of Thrombocytopenia, Netropenia, and Amenia.
-Pancreatic Toxicity -Hypertension -Hypersensitivity -Cardiovascular Toxicity -Embryo-Fetal Toxicity
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Asciminib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Asciminib Postmarketing Experience in the drug label.
Drug Interactions
Strong CYP3A4 Inhibitors
-Concomitant use of these drugs potentially increases the likelihood of adverse effects in patients because of the inhibitory effect that Asciminib plays of CYP3A4.
Intraconazole Oral Use containing Hydroxypropyl-β-cyclodextrin
-Concomitant use of these drugs may decrease Asciminib efficacy in patients.
Certain CYP3A4
-Concomitant use of these drugs potentially increases the likelihood of adverse effects in patients.
CYP2C9 Substrates
-Concomitant use of these drugs potentially increases the likelihood of adverse effects in patients because of the inhibitory effect that Asciminib plays of CYP2C9.
Certain P-gp Substrates
-Concomitant use of these drugs potentially increases the likelihood of adverse effects in patients because of the increase in plasma membrane concentration of these substrates.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Reproduction studies done on rats and rabbits at doses up to 600 mg/kg/day and 300 mg/kg/day, respectively, revealed both maternal toxicity at the highest doses and malformations in different areas of the body. These studies display the potential harms and risks in the embryo of pregnant woman.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Asciminib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Asciminib during labor and delivery.
Nursing Mothers
No data has been conducted on nursing in human when taking Asciminib. Based on studies done on rats and rabbits, it is recommended not to lactate when talking Asciminib.
Pediatric Use
Safety and effectiveness in pediatric populations have not been established.
Geriatic Use
Of the total number of subjects in the ASCEMBL clinical studies, around 19% of the patients were 65 years or older in age, and 2.6% were 75 years or older in age. In X2101 that tested patients with T315I mutation, around 33% of the patients were 65 years or older in age, and 8% were 75 years or older in age. No differences among young patients compared to patients 65 years or older in age were found when looking at safety and efficacy of Asciminib. More data is required to assess safety and efficacy between young patients and patients 75 year or older in age.
Gender
There is no FDA guidance on the use of Asciminib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Asciminib with respect to specific racial populations.
Renal Impairment
Patients with mild and severe renal impairment require no change to dosage usage.
Hepatic Impairment
Patients with mild and severe hepatic impairment require no change to dosage usage.
Females of Reproductive Potential and Males
Infertility can be impaired in females based on studies done on rats and rabbits. Asciminib has shown signs of harm in the embryo of pregnant women. There has been no effects recorded in males on their reproductive potential.
Immunocompromised Patients
There is no FDA guidance on the use of Asciminib with respect to immunocompromised populations.
Administration and Monitoring
Administration
There is limited information regarding Asciminib Administration in the drug label.
Monitoring
There is limited information regarding Asciminib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Asciminib and IV administrations.
Overdosage
There is limited information regarding Asciminib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Asciminib Pharmacology in the drug label.
Mechanism of Action
Asciminib is a tyrosine kinase inhibitor that has an inhibitory effect on the ABL1 kinase protein.
Structure
There is limited information regarding Asciminib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Asciminib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Asciminib Pharmacokinetics in the drug label.
Nonclinical Toxicology
No research has been conducted on the carcinogenicity when dealing with Asciminib. When looking at fertility, studies conducted on male rats have shown evidence of a decrease in sperm count and motility when dosed with 200 mg/kg/day of Asciminib. Studies on female mice showed evidence of decreased living embryos when dosed with 200 mg/kg/day of Asciminib. Mutagenicity studies have shown that Asciminib is not genotoxic.
Clinical Studies
There is limited information regarding Asciminib Clinical Studies in the drug label.
How Supplied
Asciminib is supplied either as a 20 mg or 40 mg coated tablet. The 20 mg are "pale yellow, unscored, round, biconvex, with beveled edges, film-coated tablet". The 40 mg are "violet white, unscored, round, biconvex, with beveled edges, film-coated tablet".
Storage
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. To protect from moisture, store in original container.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Asciminib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Asciminib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Scemblix
Look-Alike Drug Names
There is limited information regarding Asciminib Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.