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Sirolimus (Rapamune)

Trade Name : Rapamune

Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

SOLUTION

Strength 1 mg/mL

SIROLIMUS Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sirolimus (Rapamune) which is also known as Rapamune and Manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.. It is available in strength of 1 mg/mL per ml. Read more

Sirolimus (Rapamune) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use Rapamunen- for prophylaxis of organ rejection in patients receiving renal transplants. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient []
  • The use of Rapamune in combination with tacrolimus was associated with excess mortality and graft loss in a study in liver transplant patients. Many of these patients had evidence of infection at or near the time of death.
  • In this and another study in liver transplant patients, the use of Rapamune in combination with cyclosporine or tacrolimus was associated with an increase in HAT; most cases of HAT occurred within 30 days post-transplantation and most led to graft loss or death [].
  • Cases of bronchial anastomotic dehiscence, most fatal, have been reported in de novo lung transplant patients when Rapamune has been used as part of an immunosuppressive regimen [].
  • WARNING: IMMUNOSUPPRESSION, USE IS NOT RECOMMENDED IN LIVER OR LUNG TRANSPLANT PATIENTS
  • See full prescribing information for complete boxed warning.
  • Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression (). Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use Rapamune for prophylaxis of organ rejection in patients receiving renal transplants.
  • The safety and efficacy of Rapamune as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore, such use is not recommended (n n ).
  • No data
  • No data
  • Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged u226513 years receiving renal transplants:n
  • Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis ().
  • Rapamune is to be administered orally once daily, consistently with or without food [].
  • Tablets should not be crushed, chewed or split. Patients unable to take the tablets should be prescribed the solution and instructed in its use.
  • Renal Transplant Patients:
  • In renal transplant patients at low-to moderate-immunologic risk
  • In renal transplant patients at high-immunologic risk:
  • Lymphangioleiomyomatosis Patients:
  • Therapeutic drug monitoring is recommended for all patients (, ).
  • No data
  • Oral Solution: 60 mg per 60 mL in amber glass bottle ().
  • Tablets: 0.5 mg, 1 mg, 2 mg ().
  • Rapamune is contraindicated in patients with a hypersensitivity to Rapamune [].
  • Hypersensitivity to Rapamune ().
  • No data
  • Hypersensitivity Reactions ()
  • Angioedema ()
  • Fluid Accumulation and Impairment of Wound Healing ()
  • Hyperlipidemia ()
  • Decline in Renal Function ()
  • Proteinuria ()
  • Latent Viral Infections ()
  • Interstitial Lung Disease/Non-Infectious Pneumonitis ()
  • De Novo
  • Increased Risk of Calcineurin Inhibitor-Induced Hemolytic Uremic Syndrome/ Thrombotic Thrombocytopenic Purpura/ Thrombotic Microangiopathy ()
  • Embryo-Fetal Toxicity: Can cause fetal harm. Use of highly effective contraception is recommended for females of reproductive potential during treatment and for 12 weeks after final dose of Rapamune (, )
  • Male Infertility: Azoospermia or oligospermia may occur (, )
  • Immunizations: Avoid live vaccines ()
  • The following adverse reactions are discussed in greater detail in other sections of the label.
  • The most common (u226530%) adverse reactions observed with Rapamune in clinical studies for organ rejection prophylaxis in recipients of renal transplantation are: peripheral edema, hypertriglyceridemia, hypertension, hypercholesterolemia, creatinine increased, constipation, abdominal pain, diarrhea, headache, fever, urinary tract infection, anemia, nausea, arthralgia, pain, and thrombocytopenia.
  • The most common (u226520%) adverse reactions observed with Rapamune 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.
  • The following adverse reactions resulted in a rate of discontinuation of >5% in clinical trials for renal transplant rejection prophylaxis: creatinine increased, hypertriglyceridemia, and TTP. In patients with LAM, 11% of subjects discontinued due to adverse reactions, with no single adverse reaction leading to discontinuation in more than one patient being treated with Rapamune.
  • Prophylaxis of organ rejection in patients receiving renal transplants: Most common adverse reactions (incidence u226530%) are peripheral edema, hypertriglyceridemia, hypertension, hypercholesterolemia, creatinine increased, abdominal pain, diarrhea, headache, fever, urinary tract infection, anemia, nausea, arthralgia, pain, and thrombocytopenia (.
  • Lymphangioleiomyomatosis: Most common adverse reactions (incidence u226520%) are stomatitis, diarrhea, abdominal pain, nausea, nasopharyngitis, acne, chest pain, peripheral edema, upper respiratory tract infection, headache, dizziness, myalgia, and hypercholesterolemia ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or .
  • 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 (, ).
  • See full prescribing information for complete list of clinically significant drug interactions ().
  • No data
  • Pregnancy: Based on animal data can cause fetal harm (, ).
  • Lactation: Potential for serious adverse effects in breastfed infants based on mechanism of action ().
  • Females and Males of Reproductive Potential: May impair fertility (. , ).
  • 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 [].
  • General supportive measures should be followed in all cases of overdose. Based on the low aqueous solubility and high erythrocyte and plasma protein binding of sirolimus, it is anticipated that sirolimus is not dialyzable to any significant extent. In mice and rats, the acute oral LD was greater than 800 mg/kg.
  • Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by . The chemical name of sirolimus (also known as rapamycin) is (3,6,7,9,10,12,14,15,17,19,21,23,26,27,34a)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1)-2-[(1,3,4)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4,6,31)-pentone. Its molecular formula is CHNO and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows.
  • Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile.
  • Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus.
  • The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% u2013 2.5% ethanol.
  • The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, -alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.
  • No data
  • Carcinogenicity studies were conducted in mice and rats. In an 86-week female mouse study at sirolimus doses 30 to 120 times higher than the 2 mg daily clinical dose (adjusted for body surface area), there was a statistically significant increase in malignant lymphoma at all dose levels compared with controls. In a second mouse study at dosages that were approximately 3 to 16 times the clinical dose (adjusted for body surface area), hepatocellular adenoma and carcinoma in males were considered sirolimus-related. In the 104-week rat study at dosages equal to or lower than the clinical dose of 2 mg daily (adjusted for body surface area), there were no significant findings.
  • Sirolimus was not genotoxic in the bacterial reverse mutation assay, the Chinese hamster ovary cell chromosomal aberration assay, the mouse lymphoma cell forward mutation assay, or the mouse micronucleus assay.
  • When female rats were treated by oral gavage with sirolimus and mated to untreated males, female fertility was decreased at 0.5 mg/kg (2.5-fold the clinical dose of 2 mg, on a body surface area basis) due to decreased implantation. In addition, reduced ovary and uterus weight were observed. The NOAEL for female rat fertility was 0.1 mg/kg (0.5-fold the clinical dose of 2 mg).
  • When male rats were treated by oral gavage with sirolimus and mated to untreated females, male fertility was decreased at 2 mg/kg (9.7-fold the clinical dose of 2 mg, on a body surface area basis). Atrophy of testes, epididymides, prostate, seminiferous tubules, and reduced sperm counts were observed. The NOAEL for male rat fertility was 0.5 mg/kg (2.5-fold the clinical dose of 2 mg).
  • Testicular tubular degeneration was also seen in a 4-week intravenous study of sirolimus in monkeys at 0.1 mg/kg (1-fold the clinical dose of 2 mg, on a body surface area basis).
  • No data
  • No data
  • 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 soap and water; rinse eyes with plain water.
  • Do not use RAPAMUNE after the expiration date. The expiration date refers to the last day of that month.
  • Advise patients, their families, and their caregivers to read the Medication Guide and Instructions for Use for the Oral Solution and assist them in understanding its contents. The complete text of the Medication Guide and Instructions for Use for the Oral Solution are reprinted at the end of the document.
  • See FDA-Approved Medication Guide and Instructions for Use for the Oral Solution.
  • This product's label may have been updated. For current Full Prescribing Information, please visit www.pfizer.com.
  • LAB-0473-14.0
  • No data
  • RAPAMUNE /n- mune/n- Oral Solution
  • Be sure that you read and understand the following instructions for the correct way to dilute and take RAPAMUNE Oral Solution. Ask your pharmacist or doctor if you are not sure. Important:
  • Each RAPAMUNE Oral Solution carton contains:
  • You will also need:
  • How should I store RAPAMUNE?
  • Keep RAPAMUNE and all medicines out of the reach of children.
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • LAB-0579-4.0Revised: January 2020
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0008-1030-04
  • Rapamunen (sirolimus)Oral Solution
  • 1 mg/mL
  • For oral use only.
  • Each mL of RAPAMUNE contains 1 mg sirolimus.1.5%-2.5% ethanolAlso contains a mixture of propylene glycol andphosphatidylcholine derived from soy lecithin(and other components) and polysorbate 80.
  • 60 mLRx only
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0008-1030-04
  • Rapamunen (sirolimus) Oral Solution
  • 1 mg/mL
  • For oral use only.
  • Each mL of RAPAMUNE contains 1 mgsirolimus.
  • 1.5%-2.5% ethanol
  • Also contains a mixture of propyleneglycol and phosphatidylcholine derivedfrom soy lecithin (and othercomponents) and polysorbate 80.
  • 60 mL bottleRx only
  • ttttttALWAYS DISPENSE WITH MEDICATION GUIDE tttttt
  • Pfizer tttttttNDC 0008-1030-06
  • tttttttRapamunen
  • ttttttt(sirolimus)Oral Solution tttttt
  • ttttttt1 mg/mL tttttt
  • tttttttFor oral use only. tttttt
  • Each mL of RAPAMUNE contains 1 mg sirolimus.1.5%-2.5% ethanol
  • Also contains a mixture of propylene glycol andphosphatidylcholine derived from soy lecithin (and othercomponents) and polysorbate 80.
  • 60 mL Patient KittttttttRx only tttttt
  • tttttttEach RAPAMUNE Oral Solution carton contains: tttttt
  • Also contains: Package Insert and Medication Guide
  • You will also need:
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0008-1040-05
  • Rapamunen (sirolimus) Tablets
  • 0.5 mg
  • For oral use only.
  • 100 TabletsRx only
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 0.5 MG TABLETS - REDIPAKn- BLISTER
  • NDC 0008-1040-10
  • Rapamune
  • 0.5 mg
  • Wyeth Sub of Pfizer Inc Phila, PA 19101
  • 13096000
  • EXP AND LOT AREA
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0008-1040-10
  • Rapamunen (sirolimus) Tablets
  • 0.5 mg
  • For oral use only.
  • Unit Dose - 100 Tablets(10 Blister Cards of 10 Tablets Each)
  • Rx only
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0008-1041-05
  • Rapamunen (sirolimus) Tablets
  • 1 mg
  • For oral use only.
  • 100 TabletsRx only
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 1 MG TABLETS - REDIPAKn- BLISTER
  • NDC 0008-1041-10
  • Rapamune
  • 1 mg
  • Wyeth Sub of Pfizer Inc Phila, PA 19101
  • 13096300
  • EXP AND LOT AREA
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0008-1041-10
  • Rapamunen (sirolimus) Tablets
  • 1 mg
  • For oral use only.
  • Unit Dose - 100 Tablets(10 Blister Cards of 10 Tablets Each)
  • Rx only
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0008-1042-05
  • Rapamunen (sirolimus) Tablets
  • 2 mg
  • For oral use only.
  • 100 TabletsRx only

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