Symdeko
Symdeko is a combination medication containing tezacaftor and ivacaftor used to treat cystic fibrosis (CF) in people aged 6 years and older. It's for people who have two copies of the F508del mutation (change in DNA) in the CFTR (cystic fibrosis transmembrane conductance regulator) gene or at least one mutation in the CFTR gene that responds to treatment with Symdeko. This medication is typically only available at certain pharmacies.
What is Symdeko?
What is Symdeko used for?
- Cystic fibrosis
How Symdeko works
Symdeko is a combination of two medications.
- Ivacaftor is a CFTR potentiator. It works by keeping chloride "gates" on the CFTR protein open so that salt and water can move freely in the lungs. This helps prevent mucus buildup in the lungs.
- Tezacaftor is a CFTR corrector. It works by correcting the shape of the CFTR protein, which is often misshaped in people with CF. Once the CFTR protein forms the correct 3-D shape, it's able to move to the surface of cells in the body and work properly.
Drug facts
Side effects of Symdeko
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (15%)
- Nausea (9%)
- Sinus congestion (4%)
- Dizziness (4%)
Symdeko serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Liver damage: upper right stomach pain or discomfort, dark-colored urine, pale-colored stools, yellowing of the skin or eyes
The following Symdeko side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Change in vision
- Increased pressure around the brain—severe headache, blurry vision, change in vision, nausea, vomiting
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
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Pros and cons of Symdeko
Pros
- Combination medication that works well to target the underlying cause of CF
- Packaged as weekly "wallets" that make it clear which tablet you're supposed to take and when you're supposed to take them
Cons
- Only available as brand medication and is very expensive
- Only available at specialty pharmacies
- Cannot be used in children younger than 6 years of age
Pharmacist tips for Symdeko
- Keep in mind that taking your Symdeko doses about 12 hours apart is not the same as taking it twice a day. Set alarms, sticky notes, or other reminders for yourself to help remember to take it on time every 12 hours.
- Always take Symdeko with foods high in fat to help your body absorb the medication better.
- Avoid foods or drinks with grapefruit, because these might raise the amount of Symdeko in your body.
- Talk to your provider before starting, changing, or stopping any medications while taking Symdeko, including prescription and non-prescription medications, vitamins, and supplements. Symdeko can interact with certain medications, so it's important that your provider knows about all the medications you take or plan to take to make sure they're safe for you.
- You can follow these tips and tricks to help encourage your child to take this medication safely and on time every day.
Common questions about Symdeko
Symdeko works in people who have two copies of the F508del mutation (change in DNA) in the CFTR (cystic fibrosis transmembrane conductance regulator) gene. The CFTR gene gives the body instructions to make the CFTR protein. This mutation causes faulty CFTR proteins. They aren't able to travel to the cell surface and open correctly to keep a healthy balance of salt and water in your cells. This causes mucus to get trapped in the lungs, leading to airway infections or other CF complications. Symdeko helps the CFTR protein work better so that salt and water can move more freely in the lungs and not get trapped or cause mucus buildup.
Butter on toast or bagels, peanut butter, eggs, avocados, and whole-milk dairy products (e.g., whole-milk, yogurt, cheese) are good examples of foods that are high in fat. These high-fat foods will help your body absorb Symdeko. You won't get as much medication in your system if you take it on an empty stomach or with a low-fat meal.
If less than 6 hours have passed since your missed dose, go ahead and take your Symdeko dose with food (something fatty) as soon as possible. If more than 6 hours have passed, don't take your missed dose. In that case, just take your next dose at the regular time with a high-fat meal. Don't take 2 doses at the same time.
If you don’t know your or your child's CF gene mutations, make sure to work with your healthcare provider to find out. Knowing your mutations can help your provider decide if this medication will even work for you or your child. If you're not eligible for Symdeko, you might need to use a different treatment for your CF.
Not quite. Symdeko and Orkambi are both combination medications used to treat people with CF with two copies of the F508del mutation. Both medications should be taken with a high-fat meal in order for your body to absorb the medication. The two medications both contain the CFTR potentiator ivacaftor, but they have different CFTR correctors: Symdeko contains tezacaftor, whereas Orkambi contains lumacaftor. In addition, Symdeko is different than Orkambi in that it can also help treat people with a single copy of one of 26 mutations, no matter what their other mutation is.
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Risks and warnings for Symdeko
Symdeko can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
High liver test results
- Risk factors: History of liver problems
Symdeko can sometimes cause abnormally high liver test results. Your provider will check your liver before you start Symdeko, then every 3 months for the next year, and then every year after that. If you have a history of liver problems, your provider might check your liver labs more often. While taking this medication, if you experience stomach pain, dark-colored urine, pale-colored stools, or yellowing of the skin or eyes, get medical help right away.
Interactions with other medications
Taking Symdeko along with certain medications can affect the amount of Symdeko in your body, how well it works, and the risk of side effects.
Some medications, like the antibiotic, rifampin, and a common supplement, St. John's wort, can lower the amount of Symdeko in your body. This can make Symdeko not work as well.
Other medications can raise the levels of Symdeko in your body. You'll also want to avoid grapefruit and grapefruit juice while taking this medication, because grapefruit might cause you to have too much medication in your body as well. This can lead to a higher risk of side effects.
Symdeko can also affect how other medications work, so tell your provider and pharmacist about all the medications and supplements you're taking before starting Symdeko. They will make sure all your medications are safe for you to take.
Cataracts
- Risk factors: Taking steroid medications | Exposure to radiation
Symdeko can cause cataracts in children. Your child's provider will likely give your child an eye exam before starting the medication and throughout treatment.
Symdeko dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 56 tablets of 50mg/75mg/75mg | 1 carton | $23,894.87 | $23,894.87 |
Typical dosage for Symdeko
The typical dose is 1 tezacaftor/ivacaftor combination tablet by mouth in the morning with a high-fat meal and 1 ivacaftor tablet in the evening with a high-fat meal or snack. Take the morning and evening dose about 12 hours apart.
Symdeko is packaged with two different tablets: a fixed-dose tezacaftor/ivacaftor combination tablet and an ivacaftor-only tablet.
- Adults and children 6 years or older weighing at least 66 lbs (30 kg): The combination tablets contain 100 mg/150 mg (tezacaftor/ivacaftor) and the ivacaftor-only tablets contain 150 mg of ivacaftor.
- Children 6 to 12 years old weighing less than 66 lbs (30 kg): The combination tablets contain 50 mg/75 mg (tezacaftor/ivacaftor) and the ivacaftor-only tablets contain 75 mg of ivacaftor.
The dose might differ if you or your child has liver problems or if you're taking certain medications.
How much does Symdeko cost?
$23,894.87
What are alternatives to Symdeko?
Symdeko images
