Medical Use
Trikafta is a combination therapy consisting of ivacaftor (a CFTR potentiator), tezacaftor, and elexacaftor. It is used to treat cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the CFTR gene or another responsive CFTR mutation.
Recommended Dosage
General Instructions:
- -Take the morning and evening doses approximately 12 hours apart.
- -Swallow the tablets whole.
- -Consume Trikafta with fat-containing food. Examples include meals or snacks prepared with oils, butter, cheese, eggs, nuts, whole milk, or meats.
Dosage for Patients Aged 6 to Less Than 12 Years Weighing Less Than 30 kg:
- -Morning Dose: Two tablets, each containing elexacaftor 50 mg, tezacaftor 25 mg, and ivacaftor 37.5 mg.
- -Evening Dose: One tablet of ivacaftor 75 mg.
Dosage for Patients Aged 6 to Less Than 12 Years Weighing 30 kg or More:
- -Morning Dose: Two tablets, each containing elexacaftor 100 mg, tezacaftor 50 mg, and ivacaftor 75 mg.
- -Evening Dose: One tablet of ivacaftor 150 mg.
Dosage for Patients Aged 12 Years and Older:
- -Morning Dose: Two tablets, each containing elexacaftor 100 mg, tezacaftor 50 mg, and ivacaftor 75 mg.
- -Evening Dose: One tablet of ivacaftor 150 mg.
Missed Dose Instructions
- -If less than 6 hours have passed since the missed morning or evening dose, take the missed dose as soon as possible and continue with the regular schedule.
- -If more than 6 hours have passed since the missed morning dose, take the missed dose as soon as possible but skip the evening dose. Resume the regular schedule the next morning.
- -If more than 6 hours have passed since the missed evening dose, skip the missed dose and continue with the regular schedule the next morning.
- -Morning and evening doses must not be taken at the same time.
Warning & Precautions
Elevated transaminases have been noted in patients taking Trikafta for cystic fibrosis, along with bilirubin elevations. It is recommended to assess ALT, AST, and bilirubin levels for all patients before starting Trikafta, every three months during the first year of treatment, and annually thereafter.
Drug Interactions:
- -Strong CYP3A Inducers: The use of strong CYP3A inducers significantly decreases the exposure to ivacaftor and is expected to reduce the exposure to elexacaftor and tezacaftor, potentially diminishing Trikafta’s therapeutic effectiveness. Therefore, concurrent use with strong CYP3A inducers is not recommended.
- -Strong/Moderate CYP3A Inhibitors: When used with strong or moderate CYP3A inhibitors, the exposure to elexacaftor, tezacaftor, and ivacaftor increases. Consequently, the dosage of Trikafta should be reduced when taken with these inhibitors.
Pediatric Considerations:
- -Lens Opacities: Non-congenital lens opacities have been reported in pediatric patients treated with ivacaftor-containing regimens. Although other risk factors such as corticosteroid use and radiation exposure were present in some cases, a potential risk from ivacaftor therapy cannot be ruled out. Therefore, follow-up ophthalmological examinations are advised for pediatric patients starting Trikafta therapy.
Documentation Availability
Documents required to import TRIKAFTA to India?
TRIKAFTA (elexacaftor, tezacaftor, and ivacaftor) tablets can be imported by patients or treating physicians on behalf of patients. The following documentation is required to import the product:
- (i)2 ID proofs along with PAN card details along with attested scanned copies
- (ii)Valid doctor prescription scanned copy
- (iii)Doctor’s MCI number
- (iv)Doctor’s mobile number
- (v)Patients diagnostic reports
How is the order confirmed?
The order will be confirmed only after the receipt of:
- (i)The above-mentioned documents and drug availability.
- (ii)Import permit if applicable.
Sourcing & Delivery
The Rx4U team has extensive experience in sourcing TRIKAFTA (Cancer Treatment Medicines) from around the world, ensuring global access to the best available treatments for our customers. We are dedicated to promptly dispensing any valid prescription. All prescriptions are verified and dispatched directly to the patient’s address. Our patients are our top priority, and we strive to improve their lives through our services.
FAQ
What is the Generic Name for the trade name drug Trikafta®?
The generic name for Trikafta® is Elexacaftor/Ivacaftor/Tezacaftor.
Who manufactures Trikafta®?
Trikafta® is manufactured by Vertex Pharmaceuticals Incorporated.
Is Trikafta® approved by the FDA?
Yes, Trikafta® received its first FDA approval on October 21, 2019.
In which countries is Trikafta® approved?
Trikafta® has been approved in 32 countries, including 27 within the EMA centralized regulatory approval, as well as the United States, United Kingdom, Liechtenstein, Norway, and Iceland.
What is the dosage and form of Trikafta®?
Trikafta® is available as a fixed-dose combination drug containing elexacaftor, tezacaftor, and ivacaftor, co-packaged with ivacaftor for oral administration.
What are the most common side effects of Trikafta®?
Common side effects of Trikafta® include influenza, headache, upper respiratory tract infection, abdominal pain, diarrhea, increased alanine aminotransferase, nasal congestion, rhinorrhea, rhinitis, sinusitis, rash, and increased blood bilirubin.
How much does Trikafta® cost in India?
The cost of Trikafta® in India is considered reasonable and may vary. For authentic procurement, you can reach out to Rx4u team.
What are the storage conditions for Trikafta®?
Store Trikafta® at 68 to 77°F (20 to 25°C), with excursions permitted to 59 to 86°F (15 to 30°C). Do not use the medication after the expiration date on the package.
Is it safe to buy Trikafta® online in India?
Yes, you can safely purchase Trikafta® tablets online in India from https://rx4u.in/
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