What is sirolimus used for?

1 INDICATIONS AND USAGE Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 months to 4 months after transplantation ( 1.1 ). Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (

How does sirolimus work?

11 DESCRIPTION Sirolimus is an mTOR inhibitor immunosuppressive agent.

What pharmaceutical form is sirolimus available in?

sirolimus: Tabletki drażowane 1 mg (doustna)

Is sirolimus OTC or prescription only?

sirolimus requires a doctor's prescription.

What are the side effects of sirolimus?

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label. Increased susceptibility to infection, lymphoma, and malignancy [ see Boxed Warning, Warnings and Precautions ( 5.1 ) ] Excess mortality, graft loss, and hepatic artery thrombosis in liver transplant patients [ see Boxed Warning, Warnings and Precautions ( 5.2 ) ] Bronchial anastomotic dehiscence in lung transplant patients [ see Boxed Warning, Warnings and Precautions ( 5.3 ) ] Hy

Who should NOT take sirolimus?

4 CONTRAINDICATIONS Sirolimus is contraindicated in patients with a hypersensitivity to sirolimus [ see Warnings and Precautions ( 5.4 ) ]. Hypersensitivity to sirolimus ( 4 ).

Does sirolimus interact with other medications?

7 DRUG INTERACTIONS Sirolimus is known to be a substrate for both cytochrome P-450 3A4 (CYP3A4) and p-glycoprotein (P-gp). Inducers of CYP3A4 and P-gp may decrease sirolimus concentrations whereas inhibitors of CYP3A4 and P-gp may increase sirolimus concentrations. Avoid concomitant use with strong CYP3A4/P-gp inducers or strong CYP3A4/P-gp inhibitors that decrease or increase sirolimus concentrations ( 7.4 , 12.3 ). Therapeutic drug monitoring and dose reduction for sirolimus should be consider

Can sirolimus be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data can cause fetal harm ( 5.15 , 8.1 ). Lactation: Potential for serious adverse effects in breastfed infants based on mechanism of action ( 8.2 ). Females and Males of Reproductive Potential: May impair fertility ( 8.1 , 8.3 , 13.1 ). 8.1 Pregnancy Risk Summary Based on animal studies and the mechanism of action, sirolimus can cause fetal harm when administered to a pregnant woman [see Data, Clinical Pharmacology ( 12.1 )] . There are l

What precautions should be taken with sirolimus?

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Who manufactures sirolimus?

Pfizer Europe MA EEIG (Irlandia)

What ATC class does sirolimus belong to?

sirolimus: ATC L04AH01. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

sirolimus

1 mg, Tabletki drażowane

INN: Sirolimusum

Data updated: 2026-04-13

Available in:

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Form

Tabletki drażowane

Dosage

1 mg

Route

doustna

Storage

Sirolimus oral solution bottles should be stored protected from light and refrigerated at 2°C to 8°C (36°F to 46°F). Once the bottle is opened, the contents should be used within one month. If necessary, the patient may store the bottles at room temperatures up to 25°C (77°F) for a short period of time (e.g., not more than 15 days for the bottles). A syringe (amber color) and cap are provided for dosing, and the product may be kept in the syringe for a maximum of 24 hours at room temperatures up to 25°C (77°F) or refrigerated at 2°C to 8°C (36°F to 46°F). The syringe should be discarded after one use. After dilution, the preparation should be used immediately. Sirolimus oral solution provided in bottles may develop a slight haze when refrigerated. If such a haze occurs, allow the product to stand at room temperature and shake gently until the haze disappears. The presence of this haze does not affect the quality of the product.

User Reviews

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