Hyftor
Hyftor (sirolimus) is applied to the face to treat reddish bumps (angiofibroma) in people with tuberous sclerosis, a condition where there's tumor growth in different parts of the body. You'll need to apply Hyftor (sirolimus) twice a day, and it can take several months to see the full benefit. This medication is brand-name only, so it might be expensive.
What is Hyftor (sirolimus)?
What is Hyftor (sirolimus) used for?
- Facial angiofibroma from tuberous sclerosis (adults and children age 6 years and older)
How Hyftor (sirolimus) works
Hyftor (sirolimus) is a mTOR inhibitor. This means that it blocks mTOR, a protein that helps control how our cells grow and survive. People who have tuberous sclerosis have broken copies of the genes that turns on mTOR, so mTOR becomes overly active. This leads to the growth of angiofibroma. While the exact way Hyftor (sirolimus) works in tuberous sclerosis isn't known, it's thought to ease the appearance angiofibroma by preventing mTOR from becoming too active.
Drug facts
Side effects of Hyftor (sirolimus)
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
- Dry skin (40%)
- Irritation where you apply the medication (37%)
- Itchy skin (17%)
- Acne (7%)
Less Common Side Effects
- Red eyes
- Skin bleeding
- Skin irritation
Hyftor (sirolimus) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reaction: rash, peeling skin, chest pain or tightness, swelling of the face or mouth, difficulty breathing
The following Hyftor (sirolimus) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
- Dry cough, shortness of breath or trouble breathing
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
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Pros and cons of Hyftor (sirolimus)
Pros
- First and only FDA-approved topical medication to treat facial angiofibroma associated with tuberous sclerosis
- Can be used in children 6 years and older
- Easy to use
Cons
- Might take months to see the full benefit
- Can cause irritation around the area where it's applied
- Not recommended while pregnant or breastfeeding
Pharmacist tips for Hyftor (sirolimus)
- Wash your hands before and after applying Hyftor (sirolimus). This will prevent it from getting onto places besides your face.
- Hyftor (sirolimus) is only meant for skin of the face affected with angiofibroma. Don't swallow the medication or put it in your eyes or vagina, since this can lead to side effects.
- Avoid sun exposure, tanning beds, and ultraviolet light therapy while using this medication to lower your risk of skin damage. If you go outside, wear protective clothing like a hat or long-sleeves.
- Don't cover the area of your face where you apply Hyftor (sirolimus) with bandages, wraps, or bandages. This might lead to a higher risk of side effects.
- Always store Hyftor (sirolimus) in the refrigerator when you're not using it.
Common questions about Hyftor (sirolimus)
No. You might be thinking of oral (by mouth) sirolimus (Rapamune), which is used to prevent kidney transplant rejection. Although Hyftor (sirolimus) contains the same active ingredient, it's topical (meaning it's only applied on the skin) and doesn't prevent transplant rejection.
No. Don't cover your face with any kind of bandage or dressing after applying Hyftor (sirolimus). This could affect the way the medication works for you.
While everyone responds differently, it can take months of using Hyftor (sirolimus) twice daily to see the full benefit. In a clinical study, nearly a quarter of participants had an improvement in redness and at least 50% reduction in size of their angiofibroma(s) after 3 months. If it's been 3 months and you haven't seen any improvement in your face, talk with your provider.
No. Hyftor (sirolimus) is only available with a prescription from your healthcare provider.
Limit your time in the sun and UV light (e.g., tanning beds) while using Hyftor (sirolimus). Some people developed skin cancer after taking the oral form of this medication, so be sure to take care of your skin in the sun while using Hyftor (sirolimus). Also, females using Hyftor (sirolimus) should avoid getting pregnant because it can cause harm to their unborn baby (see Risks and Warnings). In fact, your provider will counsel you to use an effective form of birth control during treatment and for 3 months after your final dose of Hyftor (sirolimus). Similarly, breastfeeding is also not recommended while using Hyftor (sirolimus). Speak to your provider if you have questions.
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Risks and warnings for Hyftor (sirolimus)
Hyftor (sirolimus) 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.
Serious allergic reactions
Allergic reactions, including life-threatening reactions, have been associated with the oral form of this medication. These reactions are possible with Hyftor (sirolimus). Tell your provider all of the medications you're taking before starting Hyftor (sirolimus) because some medications, like ACE inhibitors, might raise your risk of swelling. Get medical help right away if you experience signs of an allergic reaction, including swelling in your face, rash, peeling skin, or trouble breathing.
Cancer
Skin cancer, lymphoma (a cancer of the immune system), and other cancers have been observed in some people who took the oral form of this medication. Though it's unclear whether Hyftor (sirolimus) puts you at the same risk, limit your exposure to sunlight and ultraviolet light, wear protective clothing, and use sunblock to protect your skin. If you have concerns, speak with your provider.
Serious infections
- Risk factors: Taking other medications that lower your immune system
Some people have reported serious infections after taking the oral form of this medication. It's possible that Hyftor (sirolimus) can raise your risk of serious or life-threatening bacterial, fungal, and viral infections. Be sure to stay away from people who are sick and wash your hands often to prevent infection. If you develop symptoms of fever, chills, muscle aches, change in appetite or weight loss, vomiting, or skin rash, tell your provider right away. They might have you stop Hyftor (sirolimus) if you develop an infection.
Harm to unborn babies
Based on studies in pregnant animals, Hyftor (sirolimus) can harm unborn babies and shouldn't be used during pregnancy. Females should avoid pregnancy during treatment with Hyftor (sirolimus) and for 12 weeks after stopping it. Discuss options to prevent pregnancy with your provider.
Difficulty getting pregnant
It's possible that Hyftor (sirolimus) can affect the ability to have children in both males and females. Males taking the oral form of this medication have experienced lower sperm counts or a complete absence of sperm in their semen. In addition, females taking the oral form have experienced ovarian cysts and menstrual problems. Family planning is an important conversation to have with your provider to discuss your options.
High lipids (cholesterol and triglycerides)
Based on side effects from the oral form of this medication, Hyftor (sirolimus) might raise your cholesterol and triglyceride levels. Your provider will monitor your labs and might recommend exercise and dietary changes that can help lower your levels.
Vaccines might be less effective
Immunosuppressants, like Hyftor (sirolimus), can change the way your immune system responds to vaccines. This means vaccines might work less well for you while you're using Hyftor (sirolimus). Your provider will make sure you're up-to-date with your vaccines before you start this medication. Avoid live vaccines while taking this medication because they can make you sick. Always tell your provider or pharmacist that you're taking an immunosuppressant like Hyftor (sirolimus) before getting vaccinated and they can let you know which vaccines are safe for you.
Hyftor (sirolimus) dosage
Tube of gel| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 10g of 0.2% | 1 tube | $2,079.85 | $2,079.85 |
Typical dosage for Hyftor (sirolimus)
- Adults and children 12 years and older: Apply to the affected area(s) of the face twice daily in the morning and at bedtime. The maximum recommended daily dose is 2.5 centimeters (equal to 800 mg).
- Children 6 to 11 years old: Apply to the affected area(s) of the face twice daily in the morning and at bedtime. The maximum recommended daily dose is 2 centimeters (equal to 600 mg).
Ask your provider or pharmacist to show you how to measure out your dose correctly.
How much does Hyftor (sirolimus) cost?
$2,079.85
Hyftor (sirolimus) images
