GNH USA

Europe — EMA

Kaftrio

GNH USA supplies Kaftrio (elexacaftor/tezacaftor/ivacaftor), a CFTR modulator for cystic fibrosis in patients 12 years and older with an F508del mutation.

Tezacaftor, Elexacaftor, Ivacaftor

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What is Tezacaftor, Elexacaftor, Ivacaftor?

elexacaftor/tezacaftor/ivacaftor, the active ingredient in Kaftrio, is a CFTR modulator presented as a 100 mg elexacaftor / 50 mg tezacaftor / 75 mg ivacaftor tablet for oral use. It is indicated for the treatment of cystic fibrosis in patients aged 12 years and older who carry at least one F508del mutation in the CFTR gene.

GNH USA supplies Kaftrio as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, clinics and research institutions worldwide, with a focus on quality assurance and regulatory compliance.

What is Tezacaftor, Elexacaftor, Ivacaftor used for?

Kaftrio is a CFTR modulator used in the management of cystic fibrosis, a genetic disorder affecting chloride transport. - Cystic fibrosis (≥12 years) with at least one F508del mutation: improves lung function and reduces pulmonary exacerbations. - Cystic fibrosis (≥12 years) homozygous F508del: enhances CFTR protein processing and chloride transport. - Cystic fibrosis (≥12 years) heterozygous F508del plus a second mutation: provides clinical benefit by increasing CFTR activity.

What are the side effects of Tezacaftor, Elexacaftor, Ivacaftor?

Kaftrio may cause a range of adverse reactions. Patients should be aware of both common and less frequent events.

Common Side Effects: - Headache: mild to moderate intensity. - Diarrhea: may be watery or loose. - Nausea: often transient. - Abdominal pain: cramp-like discomfort. - Rash: skin erythema or pruritus. - Elevated liver enzymes: mild transaminase increase.

Serious or Rare Side Effects: - Hepatic injury: significant transaminase elevation or jaundice. - Cataracts: lens opacity reported in some patients. - Respiratory distress: worsening of pulmonary symptoms. - Severe rash or hypersensitivity: including Stevens‑Johnson syndrome.

What precautions apply to Tezacaftor, Elexacaftor, Ivacaftor?

Before initiating Kaftrio, clinicians should consider several safety measures. - Monitor liver function: obtain baseline tests and repeat periodically. - Assess drug interactions: review concomitant CYP3A4 modulators and other CFTR modulators. - Pregnancy and lactation: use only if potential benefit justifies potential risk. - Take with fat-containing food: enhances absorption of ivacaftor. - Contraindication in severe hepatic impairment: avoid in patients with Child‑Pugh class C disease. - Store at ambient temperature: keep below 25 °C, retain original packaging, protect from moisture.

What does Tezacaftor, Elexacaftor, Ivacaftor interact with?

Kaftrio interacts with several medicines through CYP3A4 and transport pathways.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce exposure. - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): can increase drug levels and toxicity. - BCRP inhibitors (e.g., elacridar): may raise ivacaftor concentrations.

Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may require dose adjustment. - Oral contraceptives: reduced efficacy, consider alternative contraception. - Statins metabolized by CYP3A4 (e.g., simvastatin): monitor for myopathy. - Antacids containing aluminum or magnesium: may affect absorption if taken simultaneously.

Frequently asked questions

What is Kaftrio used for?+
Kaftrio is prescribed for the treatment of cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene. It helps improve lung function, reduce pulmonary exacerbations, and enhance overall quality of life by restoring chloride transport.
How does elexacaftor/tezacaftor/ivacaftor work?+
The combination includes two CFTR correctors (elexacaftor and tezacaftor) that aid the folding and trafficking of the defective F508del CFTR protein to the cell surface, and a CFTR potentiator (ivacaftor) that increases the opening probability of the channel. Together they improve chloride ion flow across epithelial cells.
What is the usual dose of Kaftrio?+
The prescribed dose of Kaftrio is determined by the treating physician based on the patient’s age, weight, and clinical status. The medication is supplied as a fixed‑dose tablet containing 100 mg elexacaftor, 50 mg tezacaftor, and 75 mg ivacaftor, and the prescriber sets the dosing schedule.
Is Kaftrio safe during pregnancy or breastfeeding?+
Safety data for Kaftrio in pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss risks and alternatives with their healthcare provider.
How do I order Kaftrio from GNH USA?+
To request Kaftrio, submit an enquiry on the product page at gnh-usa.com with the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams across international markets. After submission, the team will verify trade or institutional credentials and respond with pricing, availability, shipping details, and any necessary import documentation.
How does Kaftrio compare with other cystic fibrosis treatments?+
Kaftrio is a triple‑combination CFTR modulator that targets the F508del mutation, offering broader coverage than earlier dual‑combination therapies such as lumacaftor/ivacaftor. It provides greater improvements in lung function and reduction in exacerbations for patients with at least one F508del allele, while maintaining a comparable safety profile.
What are the storage and handling requirements for Kaftrio?+
Kaftrio tablets should be stored at ambient temperature, below 25 °C (77 °F). Keep the tablets in the original blister pack, protect them from moisture and direct sunlight, and store them out of reach of children.
How is Kaftrio administered?+
Kaftrio is taken orally as a whole tablet, usually twice daily, with a fat‑containing meal to enhance absorption of ivacaftor. The tablets should be swallowed whole with water and not crushed, chewed, or split.
What are the most serious risks associated with Kaftrio?+
Serious risks include significant liver injury, marked elevations in liver enzymes, and rare ocular events such as cataract formation. Patients should have baseline liver function tests and periodic monitoring, and any signs of visual changes should prompt immediate medical evaluation.
Who should not use Kaftrio?+
Kaftrio is contraindicated in patients with severe hepatic impairment (Child‑Pugh class C) and in individuals who are known to be hypersensitive to any of its components. It should also be avoided in patients taking strong CYP3A4 inducers or inhibitors without appropriate medical supervision.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Tezacaftor, Elexacaftor, Ivacaftor
Route
Oral Use
Manufacturer
Vertex Pharmaceuticals (Ireland) Limited
Origin
EU

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