Scemblix

About Asciminib

• Asciminib, marketed under the brand name Scemblix, is a pharmaceutical indicated for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). 
• Scemblix Novartis received FDA approval on October 29, 202. 
• Asciminib is a unique protein kinase inhibitor that works by specifically inhibiting BCR-ABL1 through a novel allosteric mechanism.
• Its unique mechanism involves selective binding to a myristoyl pocket, inducing conformational changes by interacting with the N-terminus of ABL1 under normal conditions. 
• In the context of chronic myeloid leukemia, characterized by the presence of the Philadelphia chromosome, Asciminib addresses the abnormality in blood cells. 
• This form of leukemia progresses slowly, necessitating vigilant medical attention to prevent its advancement into acute leukemia.

Strength: 

The medication is available in film-coated tablets of 20 mg and 40 mg. 

Recommended Dosage:

• The suggested dosage for patients with Ph+ CML-chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs), is 80 mg of Scemblix taken orally once daily at approximately the same time each day or 40 mg twice daily at approximately 12-hour intervals.
• It is recommended to take Scemblix orally without food, and individuals should refrain from consuming food for at least 2 hours before and 1 hour after taking the medication. 
• Treatment with Scemblix should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs. 
• For patients with Ph+ CML-CP with the T315I mutation, the recommended dosage is 200 mg of Scemblix taken orally twice daily at approximately 12-hour intervals, following the same guidelines regarding food consumption.

Important:

Before starting the Scemblix 40 mg treatment, it is essential to promptly notify your doctor of any adverse reactions you may encounter. If you observe any unusual symptoms throughout the treatment, seek immediate consultation with your doctor. Additionally, disclose any pre-existing health conditions before initiating the treatment. Your doctor needs comprehensive information about your overall health status to ensure the safe and effective administration of Scemblix. Maintaining open communication about your health is crucial for personalized care and addressing any potential concerns that may arise during the treatment process.

Warnings & Precautions

• The use of Scemblix may give rise to severe myelosuppression events, including thrombocytopenia and neutropenia, necessitating regular monitoring of complete blood counts throughout the therapy. 
• Management of these events involves treatment interruption or dose reduction. Pancreatic toxicity is a concern, requiring monitoring of serum lipase and amylase levels. If toxicity occurs, Scemblix should be interrupted, then resumed at a reduced dose, or discontinued based on severity, with evaluation for pancreatitis in the presence of accompanying abdominal symptoms. 
• Regular blood pressure monitoring is crucial, and hypertension should be addressed clinically, with considerations for interrupting, dose reduction, or discontinuation if not medically controlled. 
• Hypersensitivity reactions are possible, demanding vigilant monitoring for signs and symptoms and prompt initiation of appropriate treatment. 
• Cardiovascular toxicity is also a potential issue, requiring monitoring of patients with a history of cardiovascular risk factors for signs and symptoms, with appropriate treatment initiated as clinically indicated.

Common Scemblix Side Effects:

• Upper respiratory tract infections (Including nasal congestion, runny nose, sore throat, and sinus infections)
• Musculoskeletal pain (Muscle, bone, or joint pain)
• Headache
• Fatigue
• Nausea
• Rash
• Diarrhea
• Decreased blood cell counts (Can include platelets, white blood cells, and red blood cells)
• Increased blood fat (triglycerides) levels
• Increased blood creatine kinase levels
• Increased blood liver enzyme levels
• Increased blood pancreas enzyme (amylase and lipase) levels
• Increased blood uric acid levels

Use in Specific Population

Pregnancy and Breastfeeding: Scemblix poses a risk of embryo-fetal harm when administered to pregnant women, based on animal studies and its mechanism of action. No data on the presence of Asciminib or its metabolites in human milk are available. Due to potentially serious adverse reactions in breastfed infants, women are advised not to breastfeed during Scemblix treatment and for 1 week after the last dose.

Females and Males of Reproductive Potential: Animal studies indicate the potential for embryo-fetal harm with Scemblix use during pregnancy. Before starting Scemblix, verify the pregnancy status of females of reproductive potential. Effective contraception is recommended for females during Scemblix treatment and for 1 week after the last dose.

Infertility: Scemblix may impair fertility in females based on animal findings. The reversibility of this effect is unknown.

Pediatric Use: The safety and efficacy of Scemblix in pediatric patients have not been established. No significant differences in safety or efficacy were observed between patients 65 years of age or older and younger patients. Limited data are available for patients 75 years of age or older.

Kidney Impairment: No dose adjustment is necessary for patients with mild to severe kidney impairment not requiring dialysis and receiving Scemblix.

Liver Impairment: No dose adjustment is required for patients with mild to severe liver impairment.

Storage and Handling

• Store Scemblix at room temperature between 20°C to 25°C (68°F to 77°F) in the original container to protect it from moisture. 
• Do not freeze.
• Keep the medicine away from pets and children.