Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Información selecta para pacientes y cuidadores que se encuentra disponible en Español.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
Not a healthcare professional? Go to the patient or caregiver website.

SIROLIMUS Tablets (GREENSTONE LLC)

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

SIROLIMUS Tablets (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
Did you find an answer to your question? Yes No

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...
Did you find an answer to your question? Yes No

1 INDICATIONS AND USAGE

1.1 Prophylaxis of Organ Rejection in Renal Transplantation

Sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13...

Did you find an answer to your question? Yes No

2 DOSAGE AND ADMINISTRATION

Sirolimus is to be administered orally once daily, consistently with or without food [see

2.1 General Dosing Guidance for Renal Transplant Patients

...

Did you find an answer to your question? Yes No

3 DOSAGE FORMS AND STRENGTHS

3.1 Sirolimus Tablets

  • 0.5 mg, tan, triangular-shaped tablets marked "RAPAMUNE 0.5 mg" on one side.
  • 1 mg, white, triangular-...
Did you find an answer to your question? Yes No

5 WARNINGS AND PRECAUTIONS

5.1 Increased Susceptibility to Infection and the Possible Development of Lymphoma

Increased susceptibility to infection and the possible...

Did you find an answer to your question? Yes No

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 [...
Did you find an answer to your question? Yes No

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-...

Did you find an answer to your question? Yes No

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on animal studies...

Did you find an answer to your question? Yes No

10 OVERDOSAGE

Reports of overdose with sirolimus have been received; however, experience has been limited. In general, the adverse effects of overdose are consistent with those listed in the adverse reactions section [...

Did you find an answer to your question? Yes No

11 DESCRIPTION

Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as...

Did you find an answer to your question? Yes No

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Sirolimus inhibits T-lymphocyte activation and proliferation that occurs in response to antigenic and cytokine (...

Did you find an answer to your question? Yes No

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies were conducted in mice and rats. In an 86-week female...

Did you find an answer to your question? Yes No

14 CLINICAL STUDIES

14.1 Prophylaxis of Organ Rejection in Renal Transplant Patients

...

Did you find an answer to your question? Yes No

16 HOW SUPPLIED/STORAGE AND HANDLING

Since sirolimus is not absorbed through the skin, there are no special precautions.

Do not use sirolimus after the expiration date. The expiration date refers to the last day of...

Did you find an answer to your question? Yes No
This Medication Guide has been...
Did you find an answer to your question? Yes No

This product's label may have been updated. For current Full Prescribing Information, please visit www.greenstonellc.com.

...

Did you find an answer to your question? Yes No
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event