• Miscellaneous dermatological conditions

Hyftor Generic Name & Formulations

General Description

Sirolimus 0.2%; topical gel.

Pharmacological Class

mTOR inhibitor suppressant.

How Supplied


Generic Availability


Hyftor Indications


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 Contraindications

Not Applicable

Hyftor Boxed Warnings

Not Applicable

Hyftor Warnings/Precautions


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.

Hyftor Pharmacokinetics

See Literature

Hyftor Interactions


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

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

See Literature

Hyftor Note

Not Applicable

Hyftor Patient Counseling

See Literature