Alyftrek | Cystic Fibrosis | HongKong DengYue Medicine

Alyftrek Application Scope

Alyftrek is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene.

It is a triple combination CFTR modulator that helps improve the function of the defective CFTR protein, thereby enhancing lung function and reducing symptoms associated with CF.

Characteristics

• Ingredients:

  • Vanzacaftor

  • Tezacaftor

  • Deutivacaftor

 

• Properties: Alyftrek is a once-daily, triple-combination CFTR modulator designed to enhance the function of the defective CFTR protein in patients with cystic fibrosis (CF). It is indicated for individuals aged 6 years and older who possess at least one F508del mutation or another responsive mutation in the CFTR gene.​

• Packaging Specification: 10 mg / 50 mg / 125 mg

• Storage:

  • Store at room temperature between 68°F to 77°F (20°C to 25°C)

  • Short-term excursions permitted between 59°F to 86°F (15°C to 30°C)​

• Expiry Date: ​Refer to the expiration date printed on the product packaging

• Executive Standard: ​Approved under FDA New Drug Application (NDA) 205718.

• Approval Number: FDA approval granted on December 20, 2024

• Date of Revision: ​December 2024

• Manufacturer:Vertex Pharmaceuticals Incorporated

Guidelines for the Use of Ensartinib

• Dosage and Administration:

  • Patients aged 6 to less than 12 years:

    • Weight <40 kg: Three tablets of 4 mg/20 mg/50 mg

    • Weight ≥40 kg: Two tablets of 10 mg/50 mg/125 mg

  • Patients aged 12 years and older:

    • Two tablets of 10 mg/50 mg/125 mg

• Adverse Reactions:

  • Cough

  • Headache

  • Nasopharyngitis

  • Upper respiratory tract infection

  • Oropharyngeal pain

  • Fatigue

  • Elevated liver enzymes (ALT/AST)

  • Rash

  • Sinus congestion

  • Non-congenital lens opacities/cataracts

  • Hepatic injury/failure

  • Hypersensitivity reactions

• Contraindications:

  • Should not be used in patients with severe hepatic impairment (Child-Pugh Class C).

  • It is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B) unless the benefit outweighs the risk.

• Precautions:

  • Liver Function Monitoring: Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) before initiating treatment, every month during the first 6 months, every 3 months during the next 12 months, and at least annually thereafter.

  • Hypersensitivity Reactions: Monitor for signs of serious hypersensitivity reactions, including anaphylaxis. Discontinue Alyftrek if such reactions occur.

  • Cataracts: Non-congenital lens opacities/cataracts have been reported in pediatric patients. Baseline and follow-up ophthalmological examinations are recommended.

Interactions

• Drug Interactions:

  • CYP3A Inhibitors: Strong (e.g., itraconazole) or moderate (e.g., fluconazole) CYP3A inhibitors may increase exposure to Alyftrek components; dosage adjustment may be necessary.

  • CYP3A Inducers: Strong or moderate CYP3A inducers (e.g., rifampin, carbamazepine) may decrease the effectiveness of Alyftrek; concurrent use is not recommended.

  • Other Interactions: Caution is advised when co-administering with CYP2C9 substrates (e.g., warfarin), BCRP substrates, or P-gp substrates with a narrow therapeutic index. Monitor for potential interactions

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.