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 an F508del

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 100 mg elexacaftor / 50 mg tezacaftor / 75 mg ivacaftor oral tablet for oral use. It treats cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene.

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 disorder that impairs chloride transport.

- Cystic fibrosis (patients ≥ 12 years with at least one F508del mutation): improves lung function, reduces pulmonary exacerbations, and supports better nutritional status.

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 but serious events.

Common Side Effects: - Headache: mild to moderate intensity. - Diarrhea: watery stools, may be transient. - Nausea: occasional, often resolves with continued therapy. - Abdominal pain: cramping or discomfort. - Rash: skin redness or itching. - Elevated liver enzymes: mild increases in ALT/AST.

Serious or Rare Side Effects: - Hepatic injury: significant elevation of liver enzymes or bilirubin. - Cataracts: lens opacity requiring ophthalmologic monitoring. - Severe allergic reaction: anaphylaxis, angioedema, or urticaria. - Pulmonary hemorrhage: rare bleeding in the lungs. - Elevated serum creatinine: possible renal function impact. - Myopathy: muscle weakness or pain, rarely reported.

What precautions apply to Tezacaftor, Elexacaftor, Ivacaftor?

Before initiating Kaftrio, clinicians should evaluate several safety considerations.

- Monitor liver function: obtain baseline ALT/AST and repeat periodically. - Assess for cataracts: schedule annual ophthalmologic examinations. - Avoid in severe hepatic impairment: contraindicated in patients with advanced liver disease. - Pregnancy and lactation: discuss potential risks with the patient; safety data are limited. - Review concomitant medications: evaluate for interactions that may affect drug exposure. - Store at ambient temperature: keep below 25 °C, protect from moisture, and retain in the original packaging.

What does Tezacaftor, Elexacaftor, Ivacaftor interact with?

Kaftrio interacts with several medicines that can alter its effectiveness or safety.

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

Moderate Interactions (Monitor Closely): - Warfarin: may increase INR; monitor coagulation parameters. - Digoxin: potential increase in serum levels; observe for signs of toxicity. - Oral contraceptives: reduced efficacy reported; consider alternative contraception.

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 aims to improve lung function, reduce the frequency of pulmonary exacerbations, and support better nutritional status.
How does Tezacaftor/Elexacaftor/Ivacaftor work?+
The combination contains two CFTR correctors—tezacaftor and elexacaftor—that help the defective CFTR protein fold correctly and reach the cell surface. Ivacaftor, a CFTR potentiator, then enhances the opening of the channel, together restoring chloride transport across epithelial cells.
What is the usual dose of Kaftrio?+
The dosing regimen for Kaftrio is individualized by the prescribing healthcare professional based on the patient’s age, weight, and clinical condition. The prescriber determines the number of tablets and timing, and patients should follow the exact instructions provided on the prescription label.
Is Kaftrio safe in pregnancy or breastfeeding?+
Safety data for Kaftrio during pregnancy and lactation are limited. Healthcare providers should weigh the potential benefits against possible risks and discuss these considerations with the patient. Women who are pregnant, planning to become pregnant, or breastfeeding should consult their physician before using the medication.
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 supplies hospitals, pharmacies, and procurement teams worldwide. After submission, the sales team will verify trade or institutional credentials, then respond with pricing, availability, shipping details, and any necessary import documentation.
How does Kaftrio compare with the main alternative drug or class?+
The primary alternative is the lumacaftor/ivacaftor combination (Orkambi) or the tezacaftor/ivacaftor combination (Symdeko). Kaftrio adds a second corrector, elexacaftor, which provides broader coverage of CFTR mutations and generally yields greater improvements in lung function and reduced exacerbations for patients with at least one F508del allele.
What are the storage and handling requirements for Kaftrio?+
Kaftrio tablets should be stored at ambient temperature, preferably below 25 °C. Keep the product in its original blister pack, protect it from moisture and direct sunlight, and store out of reach of children.
How is Kaftrio administered?+
Kaftrio is taken orally as a tablet. Patients should swallow the tablet whole with water, with or without food, following the dosing schedule prescribed by their healthcare provider.
What are the most serious risks to watch for while taking Kaftrio?+
Serious risks include significant liver injury (marked elevation of liver enzymes or bilirubin), development of cataracts, severe allergic reactions such as anaphylaxis, and rare pulmonary hemorrhage. Patients should report any signs of jaundice, visual changes, difficulty breathing, or unusual bleeding to their clinician promptly.
Who should not use Kaftrio?+
Kaftrio is contraindicated in individuals with a known hypersensitivity to any of its components, and in patients with severe hepatic impairment. Caution is also advised for those with a history of cataracts or liver disease, and it should be used only under 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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