Europe — EMA
Kaftrio
GNH USA supplies Kaftrio (Elexacaftor/tezacaftor/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?
Elexacaftor/tezacaftor/ivacaftor, the active ingredient in Kaftrio, is a CFTR modulator presented as a 200 mg/100 mg/150 mg oral 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 used to address the underlying protein defect in cystic fibrosis.
Cystic fibrosis (patients ≥ 12 years with at least one F508del mutation): improves lung function, reduces pulmonary exacerbations, and enhances overall respiratory health.
What are the side effects of Tezacaftor, Elexacaftor, Ivacaftor?
Kaftrio may cause a range of adverse reactions. Monitoring and reporting are essential.
Common Side Effects: - Headache: mild to moderate intensity. - Diarrhea: watery stools, may be transient. - Nausea: occasional, often resolves with continued therapy. - Abdominal pain: cramp-like discomfort. - Rash: skin erythema or itching. - Elevated liver enzymes: mild transaminase increase.
Serious or Rare Side Effects: - Significant liver injury: jaundice, hepatitis. - Cataracts: visual disturbances, lens opacity. - Severe respiratory events: bronchospasm, dyspnea. - Allergic reactions: anaphylaxis, angioedema. - Elevated serum bilirubin: potential hepatic dysfunction. - Pancreatitis: abdominal pain with elevated enzymes.
What precautions apply to Tezacaftor, Elexacaftor, Ivacaftor?
Before initiating Kaftrio, several safety considerations should be observed.
Liver monitoring: assess baseline liver function and repeat periodically. Pregnancy assessment: discuss potential risks and benefits with a healthcare provider. Drug interaction review: evaluate concomitant medications for CYP3A interactions. Visual examination: perform baseline eye exam and monitor for cataract development. Severe hepatic disease: avoid use in patients with advanced liver impairment. Store at room temperature: keep below 25 °C, retain in original packaging, protect from moisture.
What does Tezacaftor, Elexacaftor, Ivacaftor interact with?
Kaftrio interacts with several medicines that affect its metabolism and efficacy.
Major Interactions (Avoid): - Strong CYP3A inducers (e.g., rifampin, carbamazepine): may markedly reduce exposure. - Strong CYP3A inhibitors (e.g., ketoconazole, itraconazole): may increase exposure and toxicity. - Certain antiretrovirals (e.g., ritonavir): can lead to unsafe drug levels.
Moderate Interactions (Monitor Closely): - Moderate CYP3A inducers (e.g., phenytoin): may require dose adjustment. - Hormonal contraceptives: efficacy may be reduced, consider alternative methods. - Antibiotics such as clarithromycin: may increase plasma concentrations. - Antifungal agents (e.g., fluconazole): may modestly raise exposure.
Frequently asked questions
What is Kaftrio used for?+
How does elexacaftor/tezacaftor/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?+
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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