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RAPAMUNE®(sirolimus)
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RAPAMUNE® Quick Finder
Highlights
Boxed Warning
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...
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Indications and Usage
1 INDICATIONS AND USAGE
1.1 Prophylaxis of Organ Rejection in Renal Transplantation
Rapamune (sirolimus) is indicated for the prophylaxis of organ rejection in...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
Rapamune is to be administered orally once daily, consistently with or without food [see Dosage and Administration (2.5), Clinical...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
3.1 Rapamune Oral Solution
- 60 mg per 60 mL in amber glass bottle.
3.2...
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Contraindications
4 CONTRAINDICATIONS
Rapamune is contraindicated in patients with a hypersensitivity to Rapamune [see Warnings and Precautions (5.4)].
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Increased Susceptibility to Infection and the Possible Development of Lymphoma
Increased susceptibility to infection and the possible...
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Adverse Reactions
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...
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Drug Interactions
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-...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on animal studies...
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Overdosage
10 OVERDOSAGE
Reports of overdose with Rapamune 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 [...
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Description
11 DESCRIPTION
Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Sirolimus inhibits T-lymphocyte activation and proliferation that occurs in response to antigenic and cytokine (...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies were conducted in mice and rats. In an 86-week female...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Prophylaxis of Organ Rejection in Renal Transplant Patients
...
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References
15 REFERENCES
Clinical Therapeutics, Volume 22, Supplement B, April 2000 [see Dosage and Administration (2.5)].
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Since Rapamune is not absorbed through the skin, there are no special precautions. However, if direct contact of the oral solution occurs with the skin or eyes, wash skin thoroughly with...
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Medication Guide
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised Aug 2022 | ||
| MEDICATION GUIDE ... | |||
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Instructions For Use
INSTRUCTIONS FOR USE
RAPAMUNE /RAAP-a-mune/
(sirolimus)
Oral Solution
Be sure that you read and understand the following...
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