Medical Use
Symdeko is a fixed-dose combination (FDC) of tezacaftor and ivacaftor, prescribed for treating cystic fibrosis (CF) in patients aged 12 years and older. It is suitable for those with two copies of the F508del mutation or at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that responds to Symdeko (tezacaftor/ivacaftor).
If the patient’s genotype is unknown, a CF mutation test should be considered to identify the presence of a CFTR mutation, followed by verification with bi-directional sequencing as required by the test instructions.
Recommended Dosage: For adults, adolescents, and children aged 12 years and older, the recommended dosage is one tablet (tezacaftor 100 mg/ivacaftor 150 mg) in the morning and one tablet (ivacaftor 150 mg) in the evening, approximately 12 hours apart. Symdeko is for oral use, and patients should swallow the tablets whole. It should be taken with fat-containing food, such as meals or snacks that include oils, butter, cheese, nuts, eggs, whole milk, or meats.
Missed Dose Instructions:
- -If a dose is missed and it has been 6 hours or less, take the missed dose as soon as possible and continue with the regular schedule.
- -If more than 6 hours have passed, skip the missed dose and take the next scheduled dose at the usual time. Do not take more than one dose at a time.
Warning & Precautions
Elevated transaminases can occur in patients with cystic fibrosis (CF) treated with Symdeko tablets or ivacaftor monotherapy. It is essential to assess ALT and AST levels for all patients before starting treatment, every 90 days during the first year, and annually thereafter. Patients with a history of transaminase elevations require more frequent monitoring.
The effectiveness of Symdeko may be reduced when taken with CYP3A inducers, as these can significantly lower ivacaftor levels and potentially decrease tezacaftor levels. Therefore, avoid co-administering Symdeko with strong CYP3A inducers.
Non-congenital lens opacities have been reported in pediatric patients treated with Symdeko and ivacaftor monotherapy. The risk associated with Tezacaftor/Ivacaftor and Ivacaftor therapy cannot be ruled out. Pediatric patients starting this therapy should undergo baseline and follow-up eye examinations.
Do not take Symdeko (tezacaftor 100 mg/ivacaftor 150 mg) if you are using certain medications or herbal supplements, such as antibiotics like rifabutin (Mycobutin) and rifampin (Rifater, Rifamate), seizure medications like carbamazepine, phenobarbital (Carbatrol, Tegretol, Equetro), or phenytoin (Phenytek, Dilantin), and St. John’s wort.
Symdeko may cause dizziness in some individuals. Avoid driving, operating machinery, or engaging in activities that require full alertness until you know how this medication affects you. Additionally, avoid consuming grapefruit or Seville oranges while on Symdeko treatment.
Symdeko should always be taken with a fat-containing meal or snack to aid absorption. Avoid foods and drinks containing grapefruit while taking Symdeko, as they may be responsible for affecting the existence of Symdeko in the body.
Documentation Availability
Documents required to import SYMDEKO to India?
SYMDEKO (tezacaftor/ivacaftor; 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 SYMDEKO (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 Symdeko®?
The generic name for Symdeko® is Tezacaftor/Ivacaftor and Ivacaftor.
Who Manufactures Symdeko®?
Symdeko® is manufactured by Vertex Pharmaceuticals Incorporated.
Is Symdeko® FDA Approved?
Yes, Symdeko® was approved by the FDA on February 12, 2018.
Where Can I Find the Best Price for Symdeko® in India?
For the best price on Symdeko® in India, contact Rx4u team.
What is the Dosage and Form of Symdeko®?
Symdeko® is available as a co-packaged product containing tezacaftor 100 mg/ivacaftor 150 mg fixed-dose combination tablets and ivacaftor 150 mg tablets for oral use.
How is Symdeko® Packaged?
Each box of Symdeko® contains 4 weekly wallets, with each wallet typically holding 14 tablets.
What are the Common Side Effects of Symdeko®?
Common side effects include sinus congestion, headache, nausea, and dizziness.
How Much Does Symdeko® Cost in India?
The cost of Symdeko® in India varies. For authentic procurement, you can order from www.rx4u.in.
What are the Storage Conditions for Symdeko®?
Store Symdeko® at 20°C to 25°C (68°F to 77°F), with permissible excursions to 15°C to 30°C (59°F to 86°F).
Is it Safe to Buy Symdeko® Online from India?
Yes, you can safely buy Symdeko® online in India from https://rx4u.in/
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