Kalydeco

Ivacaftor, the active ingredient in Kalydeco, is a CFTR potentiator presented as a 150 mg tablet for oral use. It treats cystic fibrosis in patients aged six years and older who have at least one gating mutation in the CFTR gene, improving chloride transport across cell membranes.

GNH USA supplies Kalydeco as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing, quality assurance and regulatory compliance for this specialized cystic fibrosis therapy.

Kalydeco (ivacaftor) is used in cystic fibrosis therapy targeting the CFTR protein. - Cystic fibrosis (patients ≥ 6 years with at least one gating mutation): Improves lung function by enhancing chloride transport. - Cystic fibrosis (patients ≥ 6 years with at least one gating mutation): Reduces frequency of pulmonary exacerbations. - Cystic fibrosis (patients ≥ 6 years with at least one gating mutation): Improves nutritional status and weight gain.

Ivacaftor may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects: - Headache: mild to moderate intensity. - Diarrhea: usually transient. - Upper respiratory tract infection: symptoms of congestion or sore throat. - Nausea: occasional. - Abdominal pain: mild discomfort. - Elevated liver enzymes: mild increase in ALT/AST.

Serious or Rare Side Effects: - Liver injury: signs of hepatitis or jaundice. - Cataracts: visual disturbances. - Severe rash or hypersensitivity: including Stevens‑Johnson syndrome. - Pulmonary hemorrhage: rare bleeding in the lungs.

When prescribing ivacaftor, clinicians should consider several safety precautions. - Liver function monitoring: check ALT/AST before starting and periodically during therapy. - Drug interactions: review concomitant medications that affect CYP3A4 metabolism. - Pregnancy and lactation: use only if potential benefit justifies potential risk, as safety data are limited. - Respiratory status: monitor for pulmonary exacerbations despite therapy. - Vision assessment: periodic eye examinations to detect cataract formation. - Store at ambient temperature: keep tablets below 25 °C in the original container, protect from moisture and light.

Ivacaftor interacts with several medicines, primarily through CYP3A4 metabolism.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce ivacaftor exposure. - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase ivacaftor levels and risk of toxicity.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may require dose adjustment. - Antacids containing aluminum or magnesium: may affect absorption; separate dosing by at least 2 hours. - Oral contraceptives: monitor efficacy as ivacaftor may alter hormone levels. - Statins metabolized by CYP3A4 (e.g., simvastatin): monitor for increased statin exposure.