sirolimus
Hyftor, Rapamune · ATC code 4498
- Key facts
- Active substance
- sirolimus
- ATC code
- 4498
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Hyftor 2 mg/g gel · Rapamune 1 mg/mL oral solution · Rapamune 0.5 mg coated tablets / Rapamune 1 mg coated tablets / Rapamune 2 mg coated tablets
- Marketing authorisation holder
- Plusultra pharma GmbH, Pfizer Europe MA EEIG
- Information as of
- 2026-10-27
Key facts
Sirolimus is an mTOR inhibitor with immunosuppressive activity. Orally (Rapamune) it is used to prevent rejection after kidney transplantation and in lymphangioleiomyomatosis; as a gel (Hyftor) for facial angiofibroma in tuberous sclerosis complex.
What it is used for
- Rapamune: prophylaxis of organ rejection in adult renal transplant patients at low to moderate immunological risk
- Rapamune: sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function
- Hyftor gel: facial angiofibroma associated with tuberous sclerosis complex from 6 years
Dosing
- Rapamune, renal transplant: 6 mg loading dose, then 2 mg once daily; adjust to trough levels (initially 4 to 12 ng/mL, maintenance 12 to 20 ng/mL)
- Rapamune: initially with ciclosporin and corticosteroids, taken 4 hours after ciclosporin; ciclosporin later withdrawn over 4 to 8 weeks
- Rapamune, S-LAM: initial dose 2 mg/day, trough 5 to 15 ng/mL
- Hyftor: apply twice daily to angiofibromas; maximum 600 mg gel per day (6-11 years) or 800 mg gel per day (12 years and older)
- Rapamune: avoid grapefruit juice; take consistently with or without food
Contraindications
- Hypersensitivity to the active substance or any of the excipients
- Rapamune oral solution: peanut or soya allergy (contains soya oil)
Important warnings
- Rapamune: not recommended at high immunological risk; may delay recovery of graft function
- Rapamune: hypersensitivity reactions; infections, lymphoma and other malignancies, particularly of the skin, from immunosuppression
- Rapamune: monitor renal function when combined with ciclosporin
- Hyftor: not for immunocompromised patients, wounds, irritated or infected skin; avoid eyes and mucous membranes
- Hyftor: photosensitivity; avoid sunlight exposure
Side effects
- Rapamune, very common: thrombocytopaenia, anaemia, pyrexia, hypertension, hypokalaemia, urinary tract infection, hyperlipidaemia, hyperglycaemia, peripheral oedema, lymphocoele, acne, diarrhoea
- Rapamune: adverse reactions may increase with higher trough levels
- Hyftor: application site irritation (34.7%), dry skin (33.7%), acne (19.4%), pruritus (11.2%)
Interactions
- Strong CYP3A4 inhibitors (e.g. ketoconazole, voriconazole, clarithromycin) raise and inducers (e.g. rifampicin) lower levels; combination not recommended
- Vaccinations may be less effective; avoid live vaccines
Pregnancy and breastfeeding
- Rapamune: only if clearly necessary; effective contraception during and for 12 weeks after therapy
- Hyftor: not during pregnancy unless the woman's condition requires sirolimus
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
Source: European Medicines Agency (EMA), product information
Germany
- Sirolimus Panacea BiotecPanacea Biotec Germany Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Brand names in 3 more European countries
- Iceland
- Hyftor, Rapamune
- Liechtenstein
- Hyftor, Rapamune
- Norway
- Hyftor, Rapamune
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Hyftor – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/hyftor-epar-product-information_en.pdf
- European Medicines Agency. Rapamune – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/rapamune-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.