Trade Name: Sirolimus

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: VistaPharm, Inc.

Presentation: SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 1 mg/mL

Storage and handling

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

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • 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 sirolimus 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 sirolimus in combination with tacrolimus was associated with excess mortality and graft loss in a study in de novo liver transplant patients. Many of these patients had evidence of infection at or near the time of death.
  • In this and another study in de novo liver transplant patients, the use of sirolimus 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 sirolimus 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.
  • Warnings and Precautions, Male Infertility ()u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a007/2019
  • Warnings and Precautions, Immunizations ()u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 07/2019n
  • Sirolimus is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged u226513 years receiving renal transplants.
  • u2212 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation ().u2212 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (). Safety and efficacy of CsA withdrawal has not been established in high risk patients (, , ).
  • Sirolimus Oral Solution is to be administered orally once daily, consistently with or without food [see Dosage and Administration (2.5), Clinical Pharmacology (12.3)].n
  • Renal Transplant Patients:
  • In renal transplant patients at low-to moderate-immunologic risk:
  • In renal transplant patients at high-immunologic risk:
  • Therapeutic drug monitoring is recommended for all patients (, ).
  • 60 mg per 60 mL in amber glass bottle.n
  • Oral Solution: 60 mg per 60 mL in amber glass bottle (3.1).n
  • Sirolimus Oral Solution is contraindicated in patients with a hypersensitivity to sirolimus [].n
  • Hypersensitivity to sirolimus ().n
  • 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:u00a0Can 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 sirolimusu00a0(, )
  • 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 (u2265 30%) adverse reactions observed with sirolimus 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 following adverse reactions resulted in a rate of discontinuation of > 5% in clinical trials for renal transplant rejection prophylaxis: creatinine increased, hypertriglyceridemia, and TTP.n
  • Prophylaxis of organ rejection in patients receiving renal transplants: Most common adverse reactions (incidence u2265 30%) are peripheral edema, hypertriglyceridemia, hypertension, hypercholesterolemia, creatinine increased, abdominal pain, diarrhea, headache, fever, urinary tract infection, anemia, nausea, arthralgia, pain, and thrombocytopenia ().
  • To report SUSPECTED ADVERSE REACTIONS, contact VistaPharm, Inc., at 1-888-655-1505 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • 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.n
  • 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 ().n
  • No data
  • Pregnancy: Based on animal data may 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 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 [].
  • 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.n
  • Sirolimus is an mTOR immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. 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 practically insoluble in water, but freely soluble in acetone, dimethyl sulfoxide and methanol.
  • Sirolimus is available for administration as an oral solution containing 1 mg/mL sirolimus.
  • The inactive ingredients in Sirolimus Oral Solution are Phosalu00ae 50 PG (alcohol, ascorbyl palmitate, phosphatidylcholine, propylene glycol, soy acid, soy lecithin, sunflower seed oil glyceride, and tocopherol) and polysorbate 80. Sirolimus Oral Solution contains 1.5% - 2.5% ethanol.
  • No data
  • Carcinogenicity studies were conducted in mice and rats. In an 86-week female mouse study at sirolimus doses 30 to 120 timeshigher 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 in vitro bacterial reverse mutation assay, the Chinese hamster ovary cell chromosomal aberration assay, the mouse lymphoma cell forward mutation assay, or the in vivo 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
  • Clinical Therapeutics, Volume 22, Supplement B, April 2000 [].
  • Since sirolimus 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 Sirolimus Oral Solution after the expiration date. The expiration date refers to the last day of that month.n
  • Sirolimus Oral Solution is a yellow colored solution.
  • Each Sirolimus Oral Solution carton, NDC 66689-347-02, contains one 2 oz (60 mL fill) amber glass bottle of sirolimus (concentration of 1 mg/mL), one oral syringe adapter for fitting into the neck of the bottle, sufficient disposable amber oral syringes and caps for daily dosing, and a carrying case.
  • Sirolimus Oral Solution bottles should be stored protected from light and refrigerated at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F). 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 25u00b0C (77u00b0F) for a short period of time (e.g., not more than 15 days for the bottles).
  • An amber syringe 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 25u00b0C (77u00b0F) or refrigerated at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F). 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.n
  • 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.
  • Sirolimus (sir-OH-li-mus) Oral Solution
  • What is the most important information I should know about sirolimus?
  • Sirolimus can cause serious side effects, including:
  • 1. Increased risk of getting infections.
  • 2. Increased risk of getting certain cancers.
  • Sirolimus has not been shown to be safe and effective in people who have had liver or lung transplants. Serious complications and death may happen in people who take sirolimus after a liver or lung transplant.
  • See the section u201cWhat are the possible side effects of sirolimus?u201d for information about other side effects of sirolimus.
  • What is sirolimus?
  • Sirolimus is a prescription medicine used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant. Rejection is when your bodyu2019s immune system recognizes the new organ as a u201cforeignu201d threat and attacks it.
  • Sirolimus is used with other medicines called cyclosporine (Gengraf, Neoral, Sandimmune), and corticosteroids. Your doctor will decide:
  • It is not known if sirolimus is safe and effective in children under 13 years of age.
  • Who should not take sirolimus?
  • Do not take Sirolimus Oral Solution if you are allergic to sirolimus or any of the other ingredients in Sirolimus Oral Solution. See the end of this leaflet for a complete list of ingredients in Sirolimus Oral Solution.
  • What should I tell my doctor before taking sirolimus?
  • Before taking sirolimus, tell your doctor if you:
  • Tell your doctor about all the medicines you take,
  • Sirolimus may affect the way other medicines work, and other medicines may affect how sirolimus works. Especially tell your doctor if you take:
  • How should I take sirolimus?
  • What should I avoid while taking Sirolimus Oral Solution?
  • What are the possible side effects of sirolimus?
  • Sirolimus may cause serious side effects, including:
  • The most common side effects of sirolimus in people with renal transplant include:
  • Other side effects that may occur with sirolimus:
  • Tell your doctor if you have any side effect that bothers you or that does not go away.
  • These are not all of the possible side effects of sirolimus. For more information ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store Sirolimus Oral Solution?
  • Do not use Sirolimus Oral Solution after the expiration date. The expiration date refers to the last day of that month. Safely throw away medicine that is out of date or no longer needed.
  • Keep Sirolimus Oral Solution and all medicines out of the reach of children.
  • General Information about the safe and effective use of Sirolimus Oral Solution.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Sirolimus Oral Solution for a condition for which it was not prescribed. Do not give Sirolimus Oral Solution to other people even if they have the same symptoms that you have. It may harm them.
  • This Medication Guide summarizes the most important information about Sirolimus Oral Solution. If you would like more information talk to your doctor. You can ask your pharmacist or doctor for information about Sirolimus Oral Solution that is written for health professionals.
  • What are the ingredients in Sirolimus Oral Solution?
  • Active ingredients: Sirolimus
  • Inactive ingredients: Phosalu00ae 50 PG (alcohol, ascorbyl palmitate, phosphatidylcholine, propylene glycol, soy acid, soy lecithin, sunflower seed oil glyceride, and tocopherol) and polysorbate 80. Sirolimus Oral Solution contains 1.5% - 2.5% ethanol.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:
  • Novitium Pharma LLC
  • 70 Lake Drive, East Windsor
  • New Jersey 08520n
  • Distributed by:
  • VistaPharm, Inc.
  • Largo, FL 33771 USAn
  • Trademarks are the property of their respective owners.n
  • Revised: March, 2020
  • LB4062-04
  • NDC 66689--02
  • 60 mL
  • Sirolimus Oral Solution
  • 1 mg/mL
  • For Oral Use Only.
  • Also contains a mixture of propylene glycol and phosphatidylcholine derived from soy lecithin (and other components) and polysorbate 80.u00a0
  • Pharmacist: Dispense the Medication Guide provided separately to each patientu00a0
  • VistaPharm
  • Rx Only
  • Arrayn- Array
  • NDC 66689--02
  • 60 mL Bottle
  • Sirolimus Oral Solution
  • 1 mg/mL
  • For Oral Use Only.
  • Each mL contains 1 mg sirolimus.
  • 1.5%-2.5% ethanol.u00a0
  • Also contains a mixture of propylene glycol and phosphatidylcholine derived from soy lecithin (and other components) and polysorbate 80.u00a0
  • Pharmacist: Dispense the Medication Guide provided separately to each patientu00a0
  • VistaPharm
  • Rx Only
  • NDC 66689--02
  • 60 mL Patient Kit
  • Sirolimus Oral Solution
  • 1 mg/mL
  • For Oral Use Only.
  • Each mL contains 1 mg sirolimus.
  • 1.5%-2.5% ethanol.u00a0
  • Also contains a mixture of propylene glycol and phosphatidylcholine derived from soy lecithin (and other components) and polysorbate 80.u00a0
  • Pharmacist:
  • VistaPharm
  • Rx Only

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