GNH USA

Europe — EMA

Kaftrio

GNH USA supplies Kaftrio (Tezacaftor/Elexacaftor/Ivacaftor), a CFTR modulator for cystic fibrosis patients with at least one F508del mutation.

Tezacaftor, Elexacaftor, Ivacaftor

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What is Tezacaftor, Elexacaftor, Ivacaftor?

Tezacaftor/Elexacaftor/Ivacaftor, the active ingredient in Kaftrio, is a CFTR modulator presented as a tablet for oral use. It is indicated for the treatment of cystic fibrosis in patients who carry at least one F508del mutation of the CFTR gene. The combination therapy targets the underlying protein defect, improving lung function and reducing disease complications.

GNH USA supplies Kaftrio as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to global quality standards and provides regulatory support for cross‑border distribution.

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 (≥1 F508del allele): improves lung function and reduces pulmonary exacerbations. Cystic fibrosis (≥2 F508del alleles): enhances sweat chloride levels and supports nutritional status. Cystic fibrosis (any eligible mutation): contributes to overall disease management and quality of life.

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

Kaftrio may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects: - Headache: mild to moderate pain in the head region. - Diarrhea: loose, watery stools occurring intermittently. - Nausea: sensation of unease and urge to vomit. - Rash: skin redness or irritation.

Serious or Rare Side Effects: - Hepatitis: significant liver inflammation requiring medical attention. - Cataracts: clouding of the eye lens that may affect vision. - Severe allergic reaction: anaphylaxis or angioedema.

What precautions apply to Tezacaftor, Elexacaftor, Ivacaftor?

Before prescribing Kaftrio, clinicians should consider several precautionary measures to ensure patient safety. - Liver function monitoring: assess baseline transaminases and repeat periodically. - Visual assessment: perform regular eye examinations to detect cataract development. - Drug interaction review: evaluate concomitant medications that affect CYP3A metabolism. - Pregnancy and lactation counseling: discuss limited data and potential risks with women of childbearing potential. - Hypersensitivity: avoid use in patients with known allergy to any component. - Store at room temperature: keep in the original pack, protect from moisture and heat.

What does Tezacaftor, Elexacaftor, Ivacaftor interact with?

Kaftrio can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid): - Strong CYP3A inducers (e.g., rifampin, carbamazepine): may reduce plasma concentrations of Kaftrio components. - Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole): may increase exposure and risk of toxicity.

Moderate Interactions (Monitor Closely): - Hormonal contraceptives: efficacy may be decreased, consider alternative methods. - Warfarin: potential alteration of anticoagulant effect, monitor INR. - Macrolide antibiotics (e.g., clarithromycin): may increase ivacaftor levels, monitor for side effects.

Frequently asked questions

What is Kaftrio used for?+
Kaftrio is prescribed for the treatment of cystic fibrosis in patients who have at least one copy of the F508del mutation in the CFTR gene. By targeting the underlying protein defect, it helps improve lung function, reduce pulmonary exacerbations, and support overall disease management.
How does Tezacaftor/Elexacaftor/Ivacaftor work?+
The combination contains two correctors (tezacaftor and elexacaftor) that assist the misfolded CFTR protein to reach the cell surface, and a potentiator (ivacaftor) that enhances the channel’s opening. Together they restore chloride transport across epithelial cells, addressing the root cause of cystic fibrosis.
What is the usual dose of Kaftrio?+
The specific dose and dosing schedule of Kaftrio are determined by the prescribing healthcare professional based on the patient’s age, weight, genotype and clinical condition. Patients should follow the exact regimen provided by their prescriber and not adjust the dose on their own.
Is Kaftrio safe during pregnancy or breastfeeding?+
Safety data for Kaftrio in pregnancy and lactation are limited. Healthcare providers should weigh the potential benefits against possible risks and discuss them with women of childbearing potential. Breastfeeding decisions should also be made in consultation with a medical professional.
How do I order Kaftrio from GNH USA?+
To request Kaftrio, submit an enquiry on the product page at gnh-usa.com indicating the required quantity. GNH USA supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.
How does Kaftrio compare with other CFTR modulators?+
Kaftrio combines two correctors with a potentiator, offering a broader mutation coverage than some earlier modulators that contain only a single corrector. Clinical studies suggest comparable or improved efficacy in lung function and reduction of exacerbations for patients with at least one F508del allele, while safety profiles remain similar.
How should Kaftrio be stored and handled?+
Kaftrio tablets should be stored at room temperature, below 25 °C, in their original packaging to protect them from moisture and excessive heat. Keep the container tightly closed and out of reach of children. No special refrigeration is required.
How is Kaftrio administered?+
Kaftrio is taken orally as a tablet, usually with a glass of water. The medication may be taken with or without food, but patients should follow the instructions given by their prescriber to maintain consistent absorption and therapeutic effect.
What are the most serious risks to watch for with Kaftrio?+
Serious adverse events include hepatitis, cataract formation, and severe allergic reactions such as anaphylaxis. Patients should be monitored regularly for liver enzyme elevations, undergo periodic eye examinations, and report any signs of rash, swelling, or breathing difficulty immediately.
Who should not use Kaftrio?+
Kaftrio is contraindicated in individuals with known hypersensitivity to any of its components. Caution is also advised for patients with severe liver disease, active cataracts, or those taking strong CYP3A 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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