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
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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?+
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 cystic fibrosis therapies?+
What are the storage and handling requirements for Kaftrio?+
How is Kaftrio administered?+
What are the most serious risks associated with Kaftrio?+
Who should not use Kaftrio?+
Product details
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