GNH USA

Europe — EMA

Kaftrio

GNH USA supplies Kaftrio (Tezacaftor/Elexacaftor/Ivacaftor), a CFTR modulator for cystic fibrosis in patients aged 12 years and older with at least one

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 treats cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation.

GNH USA supplies Kaftrio as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Tezacaftor, Elexacaftor, Ivacaftor used for?

Kaftrio is a CFTR modulator indicated for cystic fibrosis, a genetic disease affecting the respiratory and digestive systems. - Cystic fibrosis with one F508del allele: Improves lung function and reduces pulmonary exacerbations. - Cystic fibrosis with two F508del alleles: Further enhances sweat‑chloride levels and respiratory outcomes. - Cystic fibrosis patients aged 12 years and older: Decreases the frequency of severe respiratory infections and improves overall health status.

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

Common Side Effects: - Headache: mild to moderate intensity. - Diarrhea: occasional loose stools. - Abdominal pain: mild discomfort. - Rash: skin redness or itching. - Nasopharyngitis: cold‑like symptoms. - Elevated liver enzymes: mild increase in ALT/AST.

Serious or Rare Side Effects: - Significant liver injury: jaundice or marked enzyme rise. - Cataracts or retinal pigment changes: visual disturbances. - Severe allergic reactions: swelling, hives, or anaphylaxis. - Pulmonary hemorrhage: coughing up blood. - Acute pancreatitis: severe abdominal pain with nausea. - Myopathy: muscle weakness or pain.

What precautions apply to Tezacaftor, Elexacaftor, Ivacaftor?

Kaftrio requires careful monitoring and patient education before and during therapy. - Liver function monitoring: check ALT/AST regularly. - Drug interaction awareness: review concomitant medications. - Pregnancy and breastfeeding: discuss risks with a healthcare professional. - Age considerations: not recommended for children under 12 years. - Adherence importance: take tablets exactly as prescribed. - Store at ambient temperature: keep in the original pack, protect from moisture.

What does Tezacaftor, Elexacaftor, Ivacaftor interact with?

Kaftrio may interact with several drug classes, requiring dose adjustments or avoidance. Major Interactions (Avoid): - Strong CYP3A inducers (e.g., rifampin): may reduce efficacy. - Strong CYP3A inhibitors (e.g., ketoconazole): may increase toxicity. - Certain macrolide antibiotics (e.g., clarithromycin): risk of elevated drug levels. Moderate Interactions (Monitor Closely): - Warfarin: monitor INR for anticoagulation changes. - Oral contraceptives: assess hormonal efficacy. - Statins (e.g., simvastatin): watch for increased muscle toxicity. - Antifungal azoles (e.g., itraconazole): adjust dosing as needed. - Proton pump inhibitors: may affect absorption of ivacaftor.

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 carry at least one F508del mutation in the CFTR gene. It works by improving the function of the defective protein, helping to restore normal chloride transport in the lungs and other affected organs.
How does Tezacaftor/Elexacaftor/Ivacaftor work?+
The combination includes two CFTR correctors (tezacaftor and elexacaftor) that assist the misfolded CFTR protein to reach the cell surface, and a CFTR potentiator (ivacaftor) that enhances the opening of the channel. Together they increase chloride flow, improving hydration of airway surfaces and reducing disease symptoms.
What is the usual dose of Kaftrio?+
The specific dosage and dosing schedule for Kaftrio are determined by the prescribing clinician based on the patient’s age, weight, and genetic profile. Patients should follow the prescriber’s instructions and not adjust the dose without medical guidance.
Is Kaftrio safe during pregnancy or breastfeeding?+
Safety of Kaftrio in pregnancy and lactation has not been fully established. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss potential risks and benefits with their healthcare provider before starting or continuing therapy.
How do I order Kaftrio from GNH USA?+
To request Kaftrio, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with 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 broader coverage for patients with at least one F508del mutation compared with earlier two‑component regimens. It may provide greater improvements in lung function and sweat‑chloride levels, though individual response varies and treatment choice should be guided by a specialist.
What are the storage and handling requirements for Kaftrio?+
Kaftrio tablets should be stored at ambient temperature, below 25 °C, in the original packaging to protect them from moisture. Keep the product out of direct sunlight and away from heat sources to maintain stability.
How is Kaftrio administered?+
Kaftrio is taken orally as a tablet, usually with a glass of water. The tablets are swallowed whole and should be taken exactly as prescribed, typically once daily, unless the prescriber advises a different schedule.
What are the most serious risks associated with Kaftrio?+
Serious risks include significant liver injury, cataracts or retinal pigment changes, severe allergic reactions, pulmonary hemorrhage, and acute pancreatitis. Patients should be monitored regularly for liver function, eye health, and any signs of severe adverse events.
Who should not use Kaftrio?+
Kaftrio is not recommended for children under 12 years of age, for patients without the F508del mutation, or for individuals taking strong CYP3A inducers or inhibitors without medical supervision. Patients with severe liver disease should also avoid use unless closely monitored by a physician.
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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