Alyftrek
Alyftrek (vanzacaftor / tezacaftor / deutivacaftor) is a CFTR modulator used to treat cystic fibrosis (CF). It’s FDA‑approved for people 6 years and older who have at least one F508del mutation or another CFTR mutation that responds to this medication. You usually take it by mouth once a day with a meal or snack that contains fat, and your dose depends on your age and weight. Common side effects include cough, stuffy/runny nose, and headache. Alyftrek has a boxed warning for liver injury and liver failure, so regular blood tests are required.
What is Alyftrek?
What is Alyftrek used for?
- Cystic fibrosis (CF) in people 6 years and older with certain mutations
How Alyftrek works
Alyftrek is a CFTR modulator. It combines three medications to help the CFTR protein work better so salt and water can move more normally in your body
- Vanzacaftor and tezacaftor are CFTR correctors. They help fix the shape of the CFTR protein so it can reach the surface of your cells and work properly.
- Deutivacaftor is a CFTR potentiator. It helps keep channels open so salt and water can move more easily in your lungs, which helps prevent thick mucus buildup and improves your breathing..
Drug facts
| Common Brands | Alyftrek |
|---|---|
| Drug Class | CFTR modulator |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Alyftrek
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
Adults and children 12 years and older
- Cough (25%)
- Stuffy/runny nose (21%)
- Upper respiratory tract infection (21%)
- Headache (16%)
- Mouth or throat pain (14%)
- Flu infection (11%)
- Tiredness (11%)
- Rash (8%)
- Higher liver enzymes (up to 8%)
- Sinus congestion (7%)
Less Common Side Effects
- Rise in blood pressure
- Depression
- Fainting
- Fever
- Diarrhea
- Stomach pain
- Back pain
- Joint pain
- Nausea
- Vomiting
- Constipation
Alyftrek serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Liver injury or liver failure: yellow skin or whites of the eyes, dark urine, right‑upper stomach pain, nausea or vomiting, confusion, swelling of the stomach, loss of appetite
- Severe allergic reaction (anaphylaxis): rash or hives, swelling, tight chest or throat, trouble breathing, feeling faint
- High pressure around the brain: severe or unusual headache, blurry or double vision, vision loss, seeing halos, nausea
- Eye changes (cataracts): blurry vision, glare/halos, trouble seeing at night
The following Alyftrek 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
- Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Cough
- Fatigue
- Headache
- Runny or stuffy nose
- Sore throat
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Pros and cons of Alyftrek
Pros
- Once‑daily dosing
- Works for many people with at least one F508del or another responsive CFTR mutation
- Approved for certain children as young as 6 years old
Cons
- Frequent blood tests required to check liver health
- Many interactions with other medications and grapefruit
- Not recommended for people with moderate to severe liver problems
Pharmacist tips for Alyftrek
- Take Alyftrek with a meal or snack that contains fat. Fat helps your body absorb the medication so it works better. Good options include eggs, peanut butter, whole‑milk yogurt, cheese, nuts, or foods cooked with oil.
- Take Alyftrek at the same time each day. Keeping a routine helps you stay on track and keeps the level of medication steady so you feel the most benefit.
- Swallow Alyftrek tablets whole. Don’t crush, chew, or split them.
- If you miss a dose of Alyftrek and it's been 6 hours or less, take it with food as soon as you remember. If more than 6 hours have passed, skip it and take your next dose at the usual time. Don’t take two doses at once.
- Keep all scheduled liver blood tests while taking Alyftrek. These tests help catch liver problems early. Your care team will check your labs regularly.
- Watch for signs of liver problems while taking Alyftrek. Call your care team right away if you notice yellowing of your skin or eyes, dark urine, stomach pain, severe nausea or vomiting, confusion, or swelling in your stomach.
- Alyftrek can cause serious allergic reactions. Stop taking it and get medical help right away if you have a rash, hives, itching, swelling of your face, chest tightness, or trouble breathing.
- Avoid grapefruit and grapefruit juice while taking Alyftrek. Grapefruit can raise the amount of medication in your body and increase side effects.
- Tell your pharmacist and prescriber about all medications and supplements before starting Alyftrek. Some medications make it work less well, while others can increase side effects. Your dose might need to be adjusted.
- Stop Alyftrek and get medical care right away if you or your child have a severe headache or changes in vision. This could be a rare but serious side effect related to pressure in the brain.
- If your child is taking Alyftrek, schedule regular eye exams. This checks for cataracts, which have been reported with similar medications. Early exams help protect vision.
Risks and warnings for Alyftrek
Alyftrek 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.
Liver damage
- Risk factors: History of liver problems
Alyftrek can sometimes affect your liver. Liver damage can happen as early as the first month or many months after starting treatment. Before you start the medication, your care team will check your liver with blood tests. You’ll need these tests every month for the first 6 months, then every 3 months for the next year, and at least once a year after that. You might need tests more often if you’ve had liver problems before.
Call your care team right away if you notice yellowing of your skin or eyes, dark urine, pain in the upper right side of your stomach, severe nausea or vomiting, confusion, or a swollen stomach. Your prescriber might pause Alyftrek and have you see a liver specialist, and could restart it only if the benefits outweigh the risks.
Allergic reactions
Serious allergic reactions, including anaphylaxis, have been reported with medications similar to Alyftrek. Symptoms can include rash or hives, tightness in your chest or throat, trouble breathing, feeling lightheaded, or fainting. If this happens, stop Alyftrek and get medical help right away. Your care team will treat your symptoms and decide if it’s safe to start the medication again.
People who stopped similar CF medications due to side effects
There isn't enough information to know if it's safe to switch to Alyftrek if you've had side effects from medications containing elexacaftor, tezacaftor, or ivacaftor in the past. If you do switch, your care team will weigh the risks and benefits. They will also monitor you closely for side effects after you start.
High pressure around the brain
- Risk factors: High vitamin A levels
Rare cases of high pressure around the brain have been reported with medications similar to Alyftrek. Symptoms can include a severe or unusual headache, blurry or double vision, or vision loss. If you notice these symptoms, stop Alyftrek and get medical care right away.
Your care team will monitor you until your symptoms go away and to make sure they don’t come back. Your risk may be higher if you have high vitamin A levels.
Interactions with other medications
Taking Alyftrek along with certain medications can affect the amount of Alyftrek in your body, how well it works, and the risk of side effects.
Some medications can affect how well Alyftrek works. Certain medications, like rifampin or carbamazepine, can lower the amount of Alyftrek in your body, which might make it less effective, so they shouldn’t be used together.
Other medications, like ketoconazole or clarithromycin, can raise the amount of Alyftrek in your body, which can increase your risk of side effects. If you need to take these, your prescriber might lower your dose. Always tell your care team about all medications and supplements you take.
Cataracts
- Risk factors: Children | Taking steroid medications | Exposure to radiation
Alyftrek can cause cataracts in children. Your child's prescriber will likely check their eyes before starting the medication and during treatment.
Alyftrek dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 4mg/20mg/50mg of | 84 tablets | $27,274.33 | $324.69 |
| 10mg/50mg/125mg of | 56 tablets | $27,274.31 | $487.04 |
Typical dosage for Alyftrek
The dose depends on your age and body weight.
- Children 6 to less than 12 years old
- Weight less than 40 kg (under 88 lb): The typical dose is 12 mg/60 mg/150 mg (vanzacaftor/tezacaftor/deutivacaftor) by mouth once daily.
- Weight 40 kg (88 lb) or more: The typical dose is 20 mg/100 mg/250 mg (vanzacaftor/tezacaftor/deutivacaftor) by mouth once daily.
- People 12 years and older: The typical dose is 20 mg/100 mg/250 mg (vanzacaftor/tezacaftor/deutivacaftor) by mouth once daily.
Your dose might differ if you're taking certain medications that interact with Alyftrek.
How much does Alyftrek cost?
$27,274.31
