Symdeko (Tezacaftor/Ivacaftor)
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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
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Prescription Required
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Product Details
Description
Symdeko (tezacaftor/ivacaftor) is prescribed to treat cystic fibrosis in patients who are at least 6 years of age.
Symdeko is available in oral tablets of the following strengths:
- tezacaftor 50 mg/ivacaftor 75 mg fixed-dose combination tablets co-packaged with ivacaftor 75 mg tablets
- tezacaftor 100 mg/ivacaftor 150 mg fixed-dose combination tablets co-packaged with ivacaftor 150 mg tablets
Fact Table
Formula
C26H27N3O2•C24H28N2O5
License
US FDA
Bioavailability
Tezacaftor: 79% (with fat-containing meal), Ivacaftor: 100% (with fat-containing meal)
Legal status
Prescription only
Chemical Name
Tezacaftor: (3R,6S)-1-(2,2-Difluorobenzo[d][1,3]dioxol-5-yl)-7-(2-hydroxy-1,1-dimethylethyl)-4-oxo-6-((1-(2,2,2-trifluoroethyl)piperidin-4-yl)carbamoyl)-1,4-dihydroquinoline-3-carboxylate, Ivacaftor: N-(2,4-Di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxo-1-(2,2,2-trifluoro-1-hydroxyethyl)quinoline-3-carboxamide
Elimination half-life
Tezacaftor: 19 hours, Ivacaftor: 12 hours
Dosage (Strength)
100 mg Tezacaftor/150 mg Ivacaftor
Pregnancy
Consult a doctor
Brands
Symdeko
Protein binding
Tezacaftor: ~99%, Ivacaftor: 99%
PubChem CID
Tezacaftor: 71587662, Ivacaftor: 16220172
MedlinePlus
a618070
ChEBI
Tezacaftor: CHEBI:133015, Ivacaftor: CHEBI:68549
ATC code
R07AX31
DrugBank
Tezacaftor: DB12029, Ivacaftor: DB08820
KEGG
D10852
Routes of administration
Oral
Directions
You or your child should take Symdeko exactly as prescribed by the treating physician, who will determine an appropriate dose based on age, weight, and liver function.
Store Symdeko tablets between 20oC and 25oC (68oF and 77oF).
For additional instructions for use, refer to the medication guide that accompanies your prescription.
If you have any questions or concerns, talk to your doctor or pharmacist.
Ingredients
The active ingredients in Symdeko are tezacaftor and ivacaftor.
Inactive ingredients in tezacaftor 50 mg/ivacaftor 75 mg fixed-dose combination tablets and ivacaftor 75 mg tablets include croscarmellose sodium, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coat of the tablet includes HPMC/hypromellose 2910, hydroxypropyl cellulose, talc, and titanium dioxide.
The ivacaftor 75 mg tablet includes colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coat of the tablet includes carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc, and titanium dioxide. The printing ink includes ammonium hydroxide, iron oxide black, propylene glycol, and shellac.
Inactive ingredients in tezacaftor 100 mg/ivacaftor 150 mg fixed-dose combination tablets and ivacaftor 150 mg tablets include croscarmellose sodium, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coating of the tablet includes HPMC/hypromellose 2910, hydroxypropyl cellulose, iron oxide yellow, talc, and titanium dioxide.
The ivacaftor 150 mg includes colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The film coat of the tablet includes carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc, and titanium dioxide. The printing ink includes ammonium hydroxide, iron oxide black, propylene glycol, and shellac.
Contraindications
According to the most recent Prescribing Information, there are no contraindications to taking Symdeko.
Cautions
- Before you or your child begins treatment with Symdeko, talk to the doctor about:
- All the prescription and over-the-counter medications you or your child takes
- Your or your child’s allergies
- Your or your child’s current health problems and past medical history
- Your or your child’s pregnancy or breastfeeding status
- Symdeko contains the following warnings and precautions:
- Elevated liver enzymes
- Allergic reactions, including anaphylaxis
- Decreased effects of Symdeko if taken with strong CYP3A inducers like rifampin or St. John’s wort
- Cataracts
Side Effects
Headache, nausea, sinus congestion, and dizziness are common side effects of Symdeko. However, other side effects may also occur. Immediately tell the doctor about any side effects that bother you or your child or side effects that won’t go away.
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Reference
Symdeko. Boston, MA: Vertex Pharmaceuticals Incorporated; 2023.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14910
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