Comprehensive medication guide to Symdeko including estimated pricing, availability information, side effects, and how to find it in stock at your local pharmacy.
Estimated Insurance Pricing
$0–$500 copay per fill for commercially insured patients enrolled in Vertex GPS co-pay assistance (max $20,000/year savings); Tier 4–5 specialty drug on most plans requiring prior authorization; Medicare Part D patients subject to the $2,000 annual out-of-pocket cap starting 2025.
Estimated Cash Pricing
$25,000–$27,000 per month at list price for a 28-day supply (100-150mg strength); no generic is available. Commercially insured patients enrolled in the Vertex GPS Co-Pay Assistance Program may pay as little as $0 per fill.
Medfinder Findability Score
65/100
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Symdeko is a prescription CFTR (cystic fibrosis transmembrane conductance regulator) modulator manufactured by Vertex Pharmaceuticals. It combines two active ingredients — tezacaftor (a CFTR corrector) and ivacaftor (a CFTR potentiator) — into a co-packaged daily treatment for cystic fibrosis (CF). Symdeko is also known internationally as Symkevi.
Symdeko was first FDA-approved in February 2018 for patients ages 12 and older, and expanded in 2020 to cover patients ages 6 and older. It is indicated for CF patients who are homozygous for the F508del mutation or who have at least one of 154 specified responsive CFTR mutations.
As a second-generation CFTR modulator, Symdeko demonstrated improvements over its predecessor Orkambi (lumacaftor/ivacaftor) in efficacy and tolerability. However, the newer triple-combination therapies Trikafta (elexacaftor/tezacaftor/ivacaftor) and Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) have since surpassed Symdeko in clinical outcomes and are now preferred for most eligible CF patients.
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Cystic fibrosis is caused by mutations in the CFTR gene that result in a defective or misfolded CFTR protein. The most common mutation, F508del, causes the CFTR protein to misfold so it cannot reach the surface of airway cells — and even when it does reach the surface, it fails to open properly as a chloride channel. This leads to thick, sticky mucus buildup throughout the body.
Symdeko addresses this with a two-pronged approach: Tezacaftor is a CFTR corrector that acts as a molecular chaperone — it binds to the misfolded CFTR protein and helps it fold into the correct three-dimensional shape, allowing it to travel to and remain at the cell surface. Ivacaftor is a CFTR potentiator that keeps the chloride channel gate open once the protein is at the cell surface, allowing chloride and water to flow more normally through airway membranes.
Together, tezacaftor and ivacaftor restore partial CFTR function, reducing the thickness of mucus in the lungs, improving airflow (measured as ppFEV1), and reducing pulmonary exacerbations. In the pivotal EVOLVE trial, Symdeko improved ppFEV1 by approximately 4 percentage points compared to placebo and reduced acute pulmonary exacerbations by 35%.
100 mg/150 mg + 150 mg — tablet (weekly wallet)
For patients ages 12 and older: tezacaftor 100 mg/ivacaftor 150 mg tablet (morning) + ivacaftor 150 mg tablet (evening)
50 mg/75 mg + 75 mg — tablet (weekly wallet)
For patients ages 6–11: tezacaftor 50 mg/ivacaftor 75 mg tablet (morning) + ivacaftor 75 mg tablet (evening)
Symdeko is not in an active FDA shortage as of 2026, and Vertex Pharmaceuticals maintains a stable supply through its specialty pharmacy distribution network. However, Symdeko is a limited distribution drug — it is not available at any retail pharmacy. It is dispensed exclusively through authorized specialty pharmacies such as Accredo and CVS Specialty, always by mail delivery.
The primary barriers to access are insurance-related: virtually all commercial and government insurance plans require prior authorization (PA) before covering Symdeko, and the PA process can take days to weeks. Some payers have also updated their formularies to prefer newer modulators like Trikafta or Alyftrek, adding an additional documentation burden for Symdeko prescriptions.
If you are having difficulty confirming which specialty pharmacy can fill your Symdeko prescription, medfinder can call pharmacies on your behalf and text you the results — saving hours of phone navigation and helping you stay on treatment.
Symdeko is not a controlled substance and does not require a DEA number or special DEA certification. Any licensed prescriber can technically write a Symdeko prescription. However, because insurance prior authorization for Symdeko typically requires documentation from a CF specialist, most patients obtain their Symdeko prescriptions from CF-specialized providers or with CF specialist oversight.
The most common prescribers of Symdeko include:
Pulmonologists — especially those at accredited CFF care centers
Pediatric pulmonologists — for CF patients ages 6–17
CF center physicians — specialists at CFF-accredited care centers nationwide
Nurse practitioners and physician assistants — at CF centers, in collaboration with supervising physicians
Primary care physicians — in rural areas, often co-managing with CF specialists via telehealth
Telehealth options are available for established CF patients at many CF centers. Initial evaluations — including genetic testing confirmation and baseline spirometry — typically require in-person visits. Use the CFF Care Center Locator at cff.org to find an accredited CF center near you.
No. Symdeko (tezacaftor/ivacaftor) is not a controlled substance and has no DEA schedule designation. It has no recognized abuse, addiction, or misuse potential. Symdeko does not require a DEA number on prescriptions and can be refilled without the restrictions that apply to Schedule II–V substances.
While Symdeko is not a controlled substance, it is still a prescription medication that requires a prescription from a licensed healthcare provider. Because it is a specialty drug, prescriptions are typically routed through specialty pharmacies and require prior authorization from the patient's insurance plan before dispensing.
The most common adverse reactions occurring in ≥3% of patients in clinical trials were:
Headache — most commonly reported side effect
Nausea — often reduced by taking Symdeko with fat-containing food
Sinus congestion (nasopharyngitis) — stuffy nose and sinus pressure
Dizziness — avoid driving until you know how Symdeko affects you
Elevated liver enzymes (hepatotoxicity) — LFT monitoring required before and during treatment
Cataracts / lens opacities — reported in children and adolescents; periodic eye exams required for pediatric patients
Intracranial hypertension — headache, blurred vision, diplopia (post-marketing reports)
Serious allergic reactions including anaphylaxis — seek emergency care immediately
Mental health problems — anxiety, depression, suicidal thoughts; contact doctor or 988 immediately if experiencing these symptoms
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Trikafta (elexacaftor/tezacaftor/ivacaftor)
Triple-combination CFTR modulator; more effective than Symdeko with 10+ point greater ppFEV1 improvement in head-to-head trials; approved ages 2+; now preferred first-line therapy for most eligible CF patients
Alyftrek (vanzacaftor/tezacaftor/deutivacaftor)
Newest once-daily triple CFTR modulator approved December 2024; approved ages 6+; Trikafta-equivalent efficacy with convenient once-daily dosing; expanded to cover 564 CFTR variants as of April 2026
Orkambi (lumacaftor/ivacaftor)
Second-generation CFTR modulator for F508del homozygous patients ages 1+; less effective than Symdeko; higher rate of respiratory side effects (chest tightness); twice-daily dosing
Kalydeco (ivacaftor)
First-generation CFTR potentiator monotherapy; approved for specific gating/residual function mutations ages 4 months+; may serve as bridge if tezacaftor-containing therapy is not accessible for specific mutation types
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Rifampin/Rifabutin
majorStrong CYP3A4 inducers — contraindicated with Symdeko; significantly reduce Symdeko blood levels, making it ineffective
Phenobarbital, Carbamazepine (Tegretol), Phenytoin (Dilantin)
majorStrong CYP3A4 inducers — contraindicated with Symdeko; seizure medications that reduce Symdeko levels to subtherapeutic concentrations
St. John's Wort
majorStrong CYP3A4 inducer — contraindicated with Symdeko; herbal supplement that significantly reduces Symdeko efficacy
Ketoconazole, Itraconazole, Posaconazole, Voriconazole (Azole antifungals)
moderateStrong CYP3A4 inhibitors — dose adjustment required (Symdeko reduced to 1 tezacaftor/ivacaftor tablet twice weekly); increase Symdeko blood levels
Clarithromycin, Telithromycin
moderateStrong CYP3A4 inhibitors — dose adjustment required; increase Symdeko blood levels
Fluconazole (Diflucan), Erythromycin
moderateModerate CYP3A4 inhibitors — alternate-day dosing schedule required; increase Symdeko blood levels to a lesser degree
Grapefruit / Seville Oranges
moderateFood interactions — inhibit gut CYP3A4, increasing Symdeko blood levels uncontrollably; avoid all forms of grapefruit and Seville oranges (including marmalade) during treatment
Symdeko (tezacaftor/ivacaftor) represents a meaningful advance in cystic fibrosis care — a second-generation CFTR modulator that improved on Orkambi's efficacy and tolerability. For patients with two F508del mutations or one of 154 responsive mutations, Symdeko has demonstrated clinically significant improvements in lung function and quality of life.
In 2026, most patients who are eligible for Symdeko are also eligible for the more effective Trikafta or Alyftrek. However, Symdeko remains an important option for patients who cannot tolerate newer triple-combination therapies, or when specific clinical situations make it the best choice. It is a specialty drug with no generic equivalent until approximately 2031, requiring specialty pharmacy access and insurance prior authorization.
If you or a loved one has been prescribed Symdeko, don't let pharmacy navigation slow you down. medfinder calls pharmacies on your behalf to find which ones can fill your prescription — so you spend less time on hold and more time focused on your health.
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