Rapacan (Sirolimus) 1mg

Rapacan is also known as Indian Generic Sirolimus, is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants.

Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation.

 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.

Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis

Sirolimus Cost:

Sirolimus price is 946 USD Per 30 tablets. Sirolimus cost from India is only 7% of compare to previous one. 

Sirolimus dose:

Renal Transplant Patients:

 Administer once daily by mouth, consistently with or without food.

 Administer the initial dose as soon as possible after transplantation and 4 hours after CsA.

 Adjust the Rapamune maintenance dose to achieve sirolimus trough concentrations within the target-range.

 Hepatic impairment: Reduce maintenance dose in patients with hepatic impairment. In renal transplant patients at low-to moderate-immunologic risk:

 Rapacan and CsA Combination Therapy: One loading dose of 6 mg on day 1, followed by daily maintenance doses of 2 mg.

 Rapacan Following CsA Withdrawal: 2-4 months post-transplantation, withdraw CsA over 4-8 weeks. In renal transplant patients at high-immunologic risk:

 Rapacan and CsA Combination Therapy (for the first 12 months post- transplantation): One loading dose of up to 15 mg on day 1, followed by daily maintenance doses of 5 mg.

Lymphangioleiomyomatosis Patients:

 Administer once daily by mouth, consistently with or without food.

 Recommended initial Rapacan dose is 2 mg/day.

 Adjust the Rapacan dose to achieve sirolimus trough concentrations between 5-15 ng/mL.

 Hepatic impairment: Reduce maintenance dose in patients with hepatic impairment. Therapeutic drug monitoring is recommended for all patients

ADVERSE REACTIONS

Prophylaxis of organ rejection in patients receiving renal transplants: Most common adverse reactions (incidence ≥ 30%) 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 ≥ 20%) are stomatitis, diarrhea, abdominal pain, nausea, nasopharyngitis, acne, chest pain, peripheral edema, upper respiratory tract infection, headache, dizziness, myalgia, and hypercholesterolemia

RUG INTERACTIONS

 Avoid concomitant use with strong CYP3A4/P-gp inducers or strong CYP3A4/P-gp

Rapamune side effects & Sirolimus side effects:

1. increased risk of getting infections

2. increased risk of getting certain cancers

3. 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 Rapamune.

4. Increased risk of getting certain cancers. People who take Sirolimus have a higher risk of getting lymphoma, and other cancers, especially skin cancer. Talk with your doctor about your risk for cancer. 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 RAPAMUNE after a liver or lung transplant. You should not take Sirolimus if you have had a liver or lung transplant without talking with your doctor. 

Sirolimus Pi:

For more Prescribing information，please check the → “FDA Prescribing Information”.