Europe — EMA
Kaftrio
GNH USA supplies Kaftrio (Tezacaftor/Elexacaftor/Ivacaftor), a CFTR modulator for cystic fibrosis patients with at least one F508del mutation.
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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?+
How does Tezacaftor/Elexacaftor/Ivacaftor work?+
What is the usual dose of Kaftrio?+
Is Kaftrio safe during pregnancy or breastfeeding?+
How do I order Kaftrio from GNH USA?+
How does Kaftrio compare with other CFTR modulators?+
How should Kaftrio be stored and handled?+
How is Kaftrio administered?+
What are the most serious risks to watch for with Kaftrio?+
Who should not use Kaftrio?+
Product details
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