4680036910298

The barcode 4680036910298 is associated with a product named "JUQILI" (generic name: elexacaftor/tezacaftor/ivacaftor), a triple-combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator. Below are key details based on available data:

Product Overview

• Brand Name: JUQILI (manufactured by Vertex Pharmaceuticals)
• Generic Name: Elexacaftor/tezacaftor/ivacaftor (a fixed-dose combination)
• Therapeutic Class: CFTR potentiator/corrector/amplifier (used to treat cystic fibrosis).
• Mechanism of Action: Targets multiple defects in the CFTR protein, improving chloride transport and reducing symptoms in eligible patients (e.g., those with F508del mutations or other specific genetic variants).

Warnings & Concerns

1. Hepatotoxicity (Liver Toxicity):

   • Rare but serious cases of elevated liver enzymes (ALT/AST) have been reported, sometimes requiring discontinuation.
   • Monitoring: Regular liver function tests (LFTs) are recommended during treatment.

2. Drug Interactions:

   • Strong CYP3A inhibitors (e.g., ketoconazole, ritonavir) or inducers (e.g., rifampin, St. John’s wort) can significantly alter drug levels.
   • P-glycoprotein (P-gp) substrates: Concurrent use with P-gp inhibitors (e.g., cyclosporine) may increase exposure.

3. Pregnancy & Lactation:

   • Category C (risk cannot be ruled out in humans). Use only if potential benefit outweighs risk.
   • Breastfeeding: Not recommended due to unknown risks to infants.

4. Adverse Effects:

   • Common: Headache, diarrhea, elevated liver enzymes, rash.
   • Rare: Severe allergic reactions, vision changes (e.g., cataracts, uveitis—monitored in clinical trials).

5. Resistance/Effectiveness:

   • Efficacy varies by genetic mutation. Not effective for all CF patients (e.g., those with G551D or R117H mutations may respond differently).

Price Range (Approximate, U.S. Market)

• Wholesale/Retail Cost: ~$300–$500 per month (varies by insurance coverage, pharmacy, and country).
  • Vertex’s Patient Assistance Program: May offer discounts or copay cards for eligible patients.
  • Generic Availability: Not yet available (patent protected until 2030+).

Regulatory Status

• FDA-Approved: 2019 (for patients ≥12 years with F508del mutations or double homozygous for F508del).
• EMA/Other Regions: Approved in the EU, Canada, and Australia under similar indications.

Important Notes

• Prescription-Only: Requires a doctor’s prescription and genetic testing to confirm eligibility.
• Not a Cure: Manages symptoms but does not treat the underlying cause of CF.
• Clinical Trials: Ongoing research explores use in younger children (<12 years) and broader mutation profiles.

Disclaimer

If this barcode does not match the product name "JUQILI" (e.g., mislabeled or counterfeit), do not use it. Counterfeit medications pose serious health risks (ineffective treatment, incorrect dosing, or adulteration). Always verify with a healthcare provider or official sources like the FDA’s Drug Enforcement Administration (DEA) or Vertex Pharmaceuticals.

For health-related disclaimers, this is a prescription-only medication with risks/benefits that should be discussed with a healthcare professional. Self-medication or misuse can lead to severe complications.