SIROLIMUS solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

SIROLIMUS (UNII: W36ZG6FT64) (SIROLIMUS - UNII:W36ZG6FT64)

Saatavilla:

Torrent pharmaceuticals limited

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Sirolimus oral solution is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving renal transplants. In patients at low-to moderate-immunologic risk , it is recommended that sirolimus oral solution be used initially in a regimen with cyclosporine and corticosteroids; cyclosporine should be withdrawn 2 to 4 months after transplantation [see Dosage and Administration ( 2.2)] . In patients at high-immunologic risk (defined as Black recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high panel-reactive antibodies [PRA;peak PRA level >80%]), it is recommended that sirolimus oral solution be used in combination with cyclosporine and corticosteroids for the first year following transplantation [see Dosage and Administration ( 2.3), Clinical Studies ( 14.3) ]. Cyclosporine withdrawal has not be

Tuoteyhteenveto:

Since sirolimus oral solution 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. Each Sirolimus Oral Solution carton, NDC 13668-658-87, 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 2 o C to 8 o C (36 o F to 46 o F).  Once the bottle is opened, the contents should be used within one month.  If necessary, the patient may store the bottles at 20 o to 25 o C (68 o to 77 o F) [see USP Controlled Room Temperature] 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 at 20 o to  25°C (68 o to 77°F) [see USP Controlled Room Temperature] or refrigerated at 2°C to 8°C (36°F to 46°F). 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Torrent pharmaceuticals limited
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MEDICATION GUIDE
Sirolimus (sir oh’ li mus ) Oral Solution
What is the most important information I should know about sirolimus
oral solution?
Sirolimus oral solution can cause serious side effects, including:
1. Increased risk of getting infections. Serious infections can happen
including infections caused by viruses,
bacteria, and fungi (yeast). Your doctor may put you on medicine to
help prevent some of these infections.
Call your doctor right away if you have symptoms of infection
including fever or chills while taking
sirolimus oral solution.
2. Increased risk of getting certain cancers. People who take
sirolimus oral solution have a higher risk of
getting lymphoma, and other cancers, especially skin cancer. Talk with
your doctor about your risk for
cancer.
Sirolimus oral solution 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 oral solution after a
liver or lung transplant. You should not take sirolimus oral solution
if you have had a liver or lung transplant
without talking with your doctor.
See the section “What are the possible side effects of sirolimus
oral solution?” for information about other
side effects of sirolimus oral solution.
What is sirolimus oral solution?
Sirolimus oral solution 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 body’s
immune system recognizes the new organ as a “foreign” threat and
attacks it.
Sirolimus oral solution is used with other medicines called
cyclosporine (Gengraf, Neoral, Sandimmune),
and corticosteroids. Your doctor will decide:
•
if sirolimus oral solution is right for you, and
•
how to best use it with cyclosporine and corticosteroids after your
transplant.
It is not known if sirolimus oral solution is safe and effective in
children under 13 years of age.
Who sh

Valmisteyhteenveto

SIROLIMUS- SIROLIMUS SOLUTION
TORRENT PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIROLIMUS ORAL
SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SIROLIMUS ORAL
SOLUTION.
SIROLIMUS ORAL SOLUTION
INITIAL U.S. APPROVAL: 1999
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 ( 5.1). 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.
THE SAFETY AND EFFICACY OF SIROLIMUS AS IMMUNOSUPPRESSIVE THERAPY HAVE
NOT BEEN
ESTABLISHED IN LIVER OR LUNG TRANSPLANT PATIENTS, AND THEREFORE, SUCH
USE IS NOT
RECOMMENDED ( 5.2, 5.3). -LIVER TRANSPLANTATION – EXCESS MORTALITY, GRAFT LOSS, AND HEPATIC
ARTERY
THROMBOSIS ( 5.2). -LUNG TRANSPLANTATION – BRONCHIAL ANASTOMOTIC DEHISCENCE ( 5.3).
INDICATIONS AND USAGE
Sirolimus oral solution is an mTOR inhibitor immunosuppressant
indicated for the prophylaxis of organ
rejection in patients aged ≥13 years receiving renal transplants:
o Patients at low- to moderate-immunologic risk: Use initially with
cyclosporine(CsA) and corticosteroids.
CsA withdrawal is recommended2 to 4 months after transplantation (
1.1).
o Patients at high-immunologic risk: Use in combination with CsA and
corticosteroids for the first 12
months following transplantation ( 1.1).Safety and efficacy of CsA
withdrawal has not been established in
high risk patients ( 1.1, 1.2, 14.3).
DOSAGE AND ADMINISTRATION
Renal Transplant Patients:
Administer once daily by mouth, consistently with or without food (
2).
Administer the initial dose as soon as possible after transplantation
and 4 hours after CsA ( 2.1, 7.1).
Adjust the sirolimus