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 an oral tablet for oral use. It treats cystic fibrosis in patients aged 12 years and older who have at least one F508del mutation. The combination corrects processing and trafficking of the defective CFTR protein and potentiates channel gating, improving chloride transport in the lungs.

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 used in the management of cystic fibrosis, a genetic disorder affecting chloride transport.

- Cystic fibrosis (homozygous F508del): Improves lung function, reduces pulmonary exacerbations, and supports nutritional status. - Cystic fibrosis (heterozygous F508del with a minimal‑function mutation): Provides similar respiratory and nutritional benefits. - Cystic fibrosis (≥12 years, at least one F508del allele): Enhances overall disease control and quality of life.

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

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

Common Side Effects: - Headache: mild to moderate intensity. - Diarrhea: usually transient. - Nausea: may occur after dosing. - Abdominal pain: occasional. - Rash: skin irritation or erythema. - Elevated liver enzymes: mild increases in ALT/AST.

Serious or Rare Side Effects: - Significant liver injury: marked elevation of hepatic enzymes or bilirubin. - Pulmonary exacerbation worsening: rare cases of rapid lung function decline. - Cataracts: infrequent ocular changes reported. - Severe allergic reaction (anaphylaxis): rare but potentially life‑threatening.

What precautions apply to Tezacaftor, Elexacaftor, Ivacaftor?

When prescribing Kaftrio, clinicians should consider several safety measures.

- Monitor liver function: obtain baseline tests and repeat periodically. - Assess drug interactions: review concomitant CYP3A4 modulators and adjust therapy as needed. - Pregnancy and breastfeeding: discuss potential risks with the patient and consider alternative treatments if appropriate. - Adherence: advise taking tablets with a fat‑containing meal to maximize absorption. - Avoid use in severe hepatic impairment: contraindicated in patients with advanced liver disease. - Store at ambient temperature below 25°C: keep in the original pack, protect from moisture.

What does Tezacaftor, Elexacaftor, Ivacaftor interact with?

Kaftrio interacts with several medicines that affect its metabolism or efficacy.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin): may markedly reduce Kaftrio exposure. - Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase drug levels and risk of toxicity.

Moderate Interactions (Monitor Closely): - Azole antifungals (e.g., itraconazole): may require dose adjustment of Kaftrio. - HMG‑CoA reductase inhibitors (e.g., simvastatin): increased risk of myopathy; monitor muscle symptoms. - Oral contraceptives: possible reduction in hormonal efficacy; consider additional contraceptive methods.

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 CFTR protein, which helps to enhance lung function, reduce exacerbations, and support nutritional status.
How does Tezacaftor/Elexacaftor/Ivacaftor work?+
The three components act together on the CFTR protein. Tezacaftor and elexacaftor act as correctors, helping the misfolded F508del CFTR protein to reach the cell surface. Ivacaftor is a potentiator that increases the opening of the CFTR channel once it is at the membrane, thereby improving chloride transport across epithelial cells.
What is the usual dose of Kaftrio?+
The dosing regimen for Kaftrio is individualized and must be determined by a qualified prescriber based on the patient’s age, weight, mutation profile, and clinical condition. Healthcare professionals will provide specific instructions on tablet strength, frequency, and any required food considerations.
Is Kaftrio safe during pregnancy or breastfeeding?+
Safety data for Kaftrio in pregnancy and lactation are limited. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss potential risks and benefits with their healthcare provider, who can decide whether the medication should be continued, adjusted, or discontinued.
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 and respond with pricing, availability, shipping details, and any necessary import documentation.
How does Kaftrio compare with other cystic fibrosis therapies?+
Kaftrio is a triple‑combination CFTR modulator that targets the F508del mutation, offering broader coverage than dual‑combination products such as lumacaftor/ivacaftor. Clinical studies have shown greater improvements in lung function and reduced exacerbations with Kaftrio for eligible patients, though individual response may vary.
What are the storage and handling requirements for Kaftrio?+
Kaftrio tablets should be stored at ambient temperature below 25 °C. Keep them in the original packaging to protect from moisture and light. Do not store in a refrigerator or freezer, and keep out of reach of children.
How is Kaftrio administered?+
Kaftrio is taken orally as a tablet, usually in combination with a fat‑containing meal to enhance absorption. The tablets are swallowed whole with water and should be taken exactly as prescribed by the treating physician.
What are the most serious risks associated with Kaftrio?+
Serious risks include significant liver injury, marked elevations in liver enzymes, and rare cases of cataract formation. Patients should be monitored regularly for hepatic function and any visual changes, and they should report symptoms such as jaundice, dark urine, or eye discomfort promptly.
Who should not use Kaftrio?+
Kaftrio is contraindicated in patients with severe hepatic impairment and in those who are known to be hypersensitive to any of its components. It should also be used with caution in individuals taking strong CYP3A4 inducers or inhibitors, and it is not indicated for patients without the F508del mutation.
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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