Rapasin
Generic Name
Sirolimus
Manufacturer
Example Pharma Co.
Country
Varies by manufacturer
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rapasin 4 mg capsule | ৳ 12.00 | ৳ 120.00 |
Description
Overview of the medicine
Rapasin (Sirolimus) is an immunosuppressant medication used to prevent organ rejection in kidney transplant patients. It works by suppressing the body's immune system. It is also used to treat lymphangioleiomyomatosis (LAM).
Uses & Indications
Dosage
Adults
For transplant prophylaxis, initial loading dose of 6 mg on day 1, followed by a maintenance dose of 2 mg once daily. For LAM, 2 mg once daily. Doses should be adjusted based on therapeutic drug monitoring.
Elderly
Dosage should be individualized based on therapeutic drug monitoring; generally, no specific dosage adjustment needed solely based on age.
Renal_impairment
No dosage adjustment needed for patients with renal impairment.
How to Take
Take orally once daily, consistently with or without food, but never switch between taking with and without food. Do not crush, chew, or split the capsule. Administer 4 hours after cyclosporine.
Mechanism of Action
Sirolimus inhibits the mammalian target of rapamycin (mTOR), a key intracellular protein that regulates cell growth, proliferation, and survival. This inhibition leads to a block in T-lymphocyte activation and proliferation by preventing the progression from G1 to S phase of the cell cycle.
Pharmacokinetics
Onset
Immunosuppressive effects develop over several days to weeks.
Excretion
Primarily eliminated in feces (approx. 91%), with a small amount excreted in urine (approx. 2.2%).
Half life
Approximately 60-68 hours.
Absorption
Rapidly absorbed after oral administration, but with low and variable bioavailability. Peak plasma concentrations are reached in approximately 1-2 hours.
Metabolism
Extensively metabolized in the liver and intestinal wall by cytochrome P450 3A4 (CYP3A4) and P-glycoprotein.
Side Effects
Contraindications
- Hypersensitivity to sirolimus or any component of the formulation.
- Not recommended for use in liver transplant or lung transplant patients due to increased mortality and morbidity.
Drug Interactions
Cyclosporine
Co-administration significantly increases sirolimus concentrations. Administer sirolimus 4 hours after cyclosporine.
Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin)
Decrease sirolimus levels, requiring dosage increase.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Voriconazole)
Increase sirolimus levels, requiring dosage reduction.
Storage
Store at room temperature (20-25°C), away from light and moisture. Keep in original packaging to protect from light and moisture.
Overdose
Experience with overdose is limited. General supportive measures should be initiated. Sirolimus is not dialyzable. Therapeutic drug monitoring and appropriate supportive therapy are recommended.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether sirolimus is excreted in human milk; caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to sirolimus or any component of the formulation.
- Not recommended for use in liver transplant or lung transplant patients due to increased mortality and morbidity.
Drug Interactions
Cyclosporine
Co-administration significantly increases sirolimus concentrations. Administer sirolimus 4 hours after cyclosporine.
Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin)
Decrease sirolimus levels, requiring dosage increase.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Voriconazole)
Increase sirolimus levels, requiring dosage reduction.
Storage
Store at room temperature (20-25°C), away from light and moisture. Keep in original packaging to protect from light and moisture.
Overdose
Experience with overdose is limited. General supportive measures should be initiated. Sirolimus is not dialyzable. Therapeutic drug monitoring and appropriate supportive therapy are recommended.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether sirolimus is excreted in human milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory authorities (e.g., FDA)
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have established sirolimus's efficacy and safety in preventing organ rejection following renal transplantation and in treating LAM. Ongoing studies continue to explore its utility in other conditions and optimize its use.
Lab Monitoring
- Sirolimus whole blood trough concentrations (therapeutic drug monitoring).
- Serum creatinine and BUN (renal function).
- Lipid profile (cholesterol, triglycerides).
- Complete blood count (CBC).
- Liver function tests.
- Blood pressure.
Doctor Notes
- Emphasize the importance of therapeutic drug monitoring to maintain optimal sirolimus levels and minimize toxicity.
- Educate patients on infection prevention strategies and prompt reporting of any signs of infection.
- Careful monitoring of lipid profile, blood pressure, and renal function is crucial.
- Advise patients on consistent administration, either always with or always without food, and to avoid grapefruit products.
Patient Guidelines
- Take the medication at the same time each day to maintain consistent blood levels.
- Do not change the dosage or stop the medication without consulting your doctor.
- Report any signs of infection (fever, sore throat, unusual bruising/bleeding) immediately.
- Avoid grapefruit and grapefruit juice.
- Do not receive live vaccines while on sirolimus.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at once.
Driving Precautions
Rapasin may cause dizziness or visual disturbances. Patients should be cautious when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Avoid excessive sun exposure; use sunscreen and protective clothing due to increased risk of skin cancer.
- Follow a low-fat, low-cholesterol diet as advised by your doctor.
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