RAPAMUNE
As listed in the register: RAPAMUNE 1 mg/ml, solution buvable
1 mg · solution buvable
- Prescription only
- Active substance
- Sirolimus
- Made by
- PFIZER EUROPE MA EEIG (BELGIQUE)
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Sirolimus). It describes the substance, not this exact product.
Sirolimus inhibits T-lymphocyte activation and proliferation that occurs in response to antigenic and cytokine (Interleukin [IL]-2, IL-4, and IL-15) stimulation by a mechanism that is distinct from that of other immunosuppressants.
Sirolimus also inhibits antibody production.
Sirolimus is extensively metabolized in the intestinal wall and liver and undergoes counter-transport from enterocytes of the small intestine into the gut lumen.
After a single dose of [ 14 C] sirolimus oral solution in healthy volunteers, the majority (91%) of radioactivity was recovered from the feces, and only a minor amount (2.2%) was excreted in urine.
Food Effects To minimize variability in sirolimus concentrations, both Rapamune Oral Solution and sirolimus tablets should be taken consistently with or without food [see Dosage and Administration (2) ].
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-20
Safety of the active substance
From the US prescribing label for the same active substance (Sirolimus). It describes the substance, not this exact product.
WARNING: IMMUNOSUPPRESSION, USE IS NOT RECOMMENDED IN LIVER OR LUNG TRANSPLANT PATIENTS Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression.
- Sirolimus tablets are contraindicated in patients with a hypersensitivity to sirolimus [see Warnings and Precautions ( 5.4 ) ].
- Hypersensitivity to sirolimus (4).
The most common (≥20%) adverse reactions observed with sirolimus in the clinical study for the treatment of LAM are: stomatitis, diarrhea, abdominal pain, nausea, nasopharyngitis, acne, chest pain, peripheral edema, upper respiratory tract infection, headache, dizziness, myalgia, and hypercholesterolemia.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
European UnionNo exact match for this strength and form
Canada2 matching products
Details
| Made by | PFIZER EUROPE MA EEIG (BELGIQUE) |
|---|---|
| Active substance | Sirolimus |
| Strength | 1 mg |
| Form | solution buvable |
| Route | orale |
| Dispensing (as stated by the register) | prescription initiale hospitalière semestrielle · liste I |
| Marketed | Yes, according to the register |
| Authorisation procedure | Procédure centralisée |
| EU number | EU/1/01/171 |
| Name in the register | RAPAMUNE 1 mg/ml, solution buvable |
| Packs | 1 flacon(s) en verre jaune(brun) de 60 ml avec adaptateur avec 30 seringue(s) doseuse(s) polypropylène |
| CIS | 61752409 |
| CIP13 | 3400935688477 |
Source: Base de données publique des médicaments · 2026-09-30 · not reviewed by a clinician
Source : Base de données publique des médicaments (ANSM / Ministère de la Santé), sous Licence Ouverte. Reuse terms: Licence Ouverte / Open Licence (Etalab).
Other strengths and forms
4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.