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RAPAMUNE®(sirolimus)

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RAPAMUNE® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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2 DOSAGE AND ADMINISTRATION

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

2.1 General Dosing Guidance for Renal Transplant Patients

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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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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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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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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on animal studies...

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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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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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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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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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14 CLINICAL STUDIES

14.1 Prophylaxis of Organ Rejection in Renal Transplant Patients

...

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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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This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised XXX 2021
MEDICATION GUIDE
...
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INSTRUCTIONS FOR USE

RAPAMUNE /RAAP-a-mune/
(sirolimus)
Oral Solution

Be sure that you read and understand the following...

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

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