GNH USA

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

Tezacaftor, Elexacaftor, Ivacaftor

Request sourcing

1
Pack/s

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?+
Kaftrio is indicated for the treatment of cystic fibrosis in patients aged 12 years and older who carry at least one F508del mutation in the CFTR gene. By targeting the defective protein, it helps improve lung function, reduces the frequency of pulmonary exacerbations, and supports overall respiratory health.
How does elexacaftor/tezacaftor/ivacaftor work?+
The combination contains two CFTR correctors—elexacaftor and tezacaftor—that enhance the folding and trafficking of the misfolded CFTR protein to the cell surface. Ivacaftor, a CFTR potentiator, then increases the opening probability of the channel, together restoring chloride transport and improving mucociliary clearance.
What is the usual dose of Kaftrio?+
The prescribed dose of Kaftrio is individualized by the treating physician based on the patient’s age, weight, and clinical status. Typically, the regimen involves taking one tablet twice daily with a fat‑containing meal, but the exact schedule must be set by a qualified healthcare professional.
Is Kaftrio safe during pregnancy or breastfeeding?+
Safety data for Kaftrio in pregnancy and lactation are limited. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss treatment options with their physician.
How do I order Kaftrio from GNH USA?+
To place an order, submit an enquiry on the Kaftrio product page at gnh-usa.com, specifying the required quantity. GNH USA supplies hospitals, pharmacies, and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details, and any necessary import documentation.
How does Kaftrio compare with other CFTR modulators?+
Kaftrio (elexacaftor/tezacaftor/ivacaftor) offers broader coverage of CFTR mutations than earlier combinations such as Orkambi (lumacaftor/ivacaftor) and provides greater improvements in lung function for patients with at least one F508del allele. Its triple‑combination design targets both protein processing and channel gating, resulting in higher efficacy for eligible patients.
What are the storage and handling requirements for Kaftrio?+
Kaftrio tablets should be stored at room temperature, below 25 °C, in the original blister pack. Protect them from excess moisture and direct sunlight. Do not refrigerate or freeze the tablets, and keep them out of reach of children.
How is Kaftrio administered?+
Kaftrio is taken orally as a whole tablet. Patients should swallow the tablet with water and a meal that contains fat to maximize absorption. The usual schedule is twice daily, but the exact timing and any dose adjustments are determined by the prescribing clinician.
What are the most serious risks associated with Kaftrio?+
The most serious adverse events include significant liver injury (elevated transaminases or hepatitis), development of cataracts, severe respiratory reactions such as bronchospasm, and rare cases of pancreatitis. Patients should undergo regular liver function tests and eye examinations, and report any new or worsening symptoms promptly.
Who should not use Kaftrio?+
Kaftrio is contraindicated in patients with known hypersensitivity to any of its components, in those with severe hepatic impairment, and in individuals younger than 12 years. It should also be avoided in patients who cannot safely take a high‑fat meal or who have conditions that preclude the use of CFTR modulators.
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

Related products