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Hyftor Generic Name & Formulations
Legal Class
Rx
General Description
Sirolimus 0.2%; topical gel.
Pharmacological Class
mTOR inhibitor suppressant.
How Supplied
Gel—10g
Manufacturer
Generic Availability
NO
Hyftor Indications
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
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
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
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