Kalydeco

Ivacaftor, the active ingredient in Kalydeco, is a CFTR potentiator presented as a 150 mg tablet for oral use. It is indicated for the treatment of cystic fibrosis in patients who carry at least one CFTR gating mutation, such as G551D, and is approved for individuals aged six years and older.

GNH USA supplies Kalydeco as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution.

Kalydeco (ivacaftor) is used to treat cystic fibrosis by targeting the CFTR protein.

Cystic fibrosis with G551D mutation: Improves lung function and reduces pulmonary exacerbations. Cystic fibrosis with other CFTR gating mutations: Enhances chloride transport and respiratory outcomes. Cystic fibrosis in patients ≥6 years with eligible mutations: Improves nutritional status and overall disease progression.

Ivacaftor may be associated with several adverse reactions, ranging from mild to serious.

Common Side Effects: - Headache: mild to moderate intensity. - Diarrhea: watery stools, may be transient. - Nausea: occasional feeling of sickness. - Upper respiratory tract infection: nasopharyngitis.

Serious or Rare Side Effects: - Liver enzyme elevation: increased ALT/AST requiring monitoring. - Cataracts: lens opacity observed in some patients. - Rash or severe skin reactions: including Stevens‑Johnson syndrome.

When prescribing ivacaftor, several safety considerations should be observed.

Liver function monitoring: baseline and periodic ALT/AST tests are recommended. Drug interactions: review concomitant medications, especially CYP3A inducers or inhibitors. Pregnancy and lactation: safety not established; use only if benefits outweigh risks. Respiratory status: monitor for worsening symptoms, especially in severe disease. Cardiac considerations: assess QT interval if patient has risk factors. Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture.

Ivacaftor can interact with other medicines; some combinations should be avoided while others require careful monitoring.

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

Moderate Interactions (Monitor Closely): - Azole antifungals (e.g., fluconazole): may increase ivacaftor concentrations modestly. - Macrolide antibiotics (e.g., erythromycin): may elevate ivacaftor exposure. - Oral contraceptives: ivacaftor may reduce efficacy, consider alternative contraception.