Hyftor Generic Name & Formulations
Sirolimus 0.2%; topical gel.
mTOR inhibitor suppressant.
Facial angiofibroma associated with tuberous sclerosis.
Hyftor Dosage and Administration
Adults and Children
<6yrs: not established. Apply on the face to skin affected with angiofibroma twice daily (in the AM and at bedtime). 6–11yrs: max 600mg (2cm) daily; ≥12yrs: max 800mg (2.5cm) daily. Do not occlude.
Hyftor Boxed Warnings
Not for oral, ophthalmic, or intravaginal use. Discontinue immediately if symptoms of hypersensitivity, infection, or interstitial lung disease occur. Avoid sun, UV light. Monitor for hyperlipidemia during therapy. Reevaluate if no improvement after 12 weeks. Complete all age-appropriate vaccinations according to current guidelines prior to initiation. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception prior to, during, and for 12 weeks after the last dose. Pregnancy, nursing mothers: not recommended.
Increased risk of developing angioedema with other drugs known to cause angioedema (eg, ACE inhibitors). Avoid live vaccines during treatment. Potentiated by CYP3A4 inhibitors; monitor. May potentiate drugs that are both substrates and inhibitors of CYP3A; monitor.
Hyftor Adverse Reactions
Dry skin, application site irritation, pruritus, acne, acneiform dermatitis, ocular hyperemia, skin hemorrhage, skin irritation; hypersensitivity reactions, serious infections (eg, PML), malignancy (eg, skin, lymphoma), interstitial lung disease (eg, pneumonitis, bronchiolitis obliterans organizing pneumonia, pulmonary fibrosis), male infertility.
Hyftor Clinical Trials
Hyftor Patient Counseling