Renova
Generic Name
Everolimus
Manufacturer
Generic Pharma Ltd.
Country
India
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| renova 10 mg injection | ৳ 138.00 | N/A |
Description
Overview of the medicine
Everolimus is an mTOR inhibitor used in oncology for treating certain cancers and in transplantation for preventing organ transplant rejection.
Uses & Indications
Dosage
Adults
Dosage varies significantly based on indication. For oncology, typically 10 mg intravenously or subcutaneously, administered by a healthcare professional following a specific protocol. For transplant, lower doses are generally used, often orally, but specific IV regimens may exist for initial loading or specific situations. Consult specific guidelines for precise dosing.
Elderly
No specific dose adjustment is generally required in elderly patients, but close monitoring for adverse effects is advised.
Renal_impairment
No dose adjustment is necessary for patients with mild to moderate renal impairment. Caution is advised for severe renal impairment, and close monitoring is recommended.
How to Take
Administer intravenously or subcutaneously by a qualified healthcare professional. Reconstitute the powder for injection according to manufacturer's instructions before use. Do not administer intramuscularly.
Mechanism of Action
Everolimus inhibits mammalian target of rapamycin (mTOR), a serine-threonine kinase, which plays a central role in cell growth, proliferation, metabolism, and angiogenesis. By inhibiting mTOR, it reduces cell proliferation and suppresses immune responses.
Pharmacokinetics
Onset
Rapid onset, typically within hours for immunosuppression; anti-tumor effects develop over time with sustained therapy.
Excretion
Primarily excreted in the feces as metabolites; minor excretion via urine.
Half life
Approximately 30-40 hours (average), with variability depending on patient factors and concomitant medications.
Absorption
Rapidly absorbed after intravenous administration, achieving peak concentrations quickly. Oral bioavailability is low and variable.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4. Active metabolites are not significant.
Side Effects
Contraindications
- Hypersensitivity to everolimus, sirolimus, or any component of the formulation.
Drug Interactions
Live vaccines
Avoid co-administration due to immunosuppressive effects and increased risk of infection from live vaccines.
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir)
Significantly increase everolimus blood levels, requiring dose reduction.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort)
Significantly decrease everolimus blood levels, requiring dose increase.
Storage
Store at 2°C to 8°C (36°F to 46°F) in the original package to protect from light. Do not freeze. Reconstituted solution should be used immediately or stored for a short period as per specific instructions.
Overdose
Experience with overdose is limited. Symptomatic and supportive treatment should be initiated. Everolimus blood levels should be monitored.
Pregnancy & Lactation
Everolimus is not recommended during pregnancy due to potential for fetal harm. Women of childbearing potential should use effective contraception during treatment and for at least 8 weeks after the last dose. Avoid breastfeeding during treatment and for 2 weeks after the last dose.
Side Effects
Contraindications
- Hypersensitivity to everolimus, sirolimus, or any component of the formulation.
Drug Interactions
Live vaccines
Avoid co-administration due to immunosuppressive effects and increased risk of infection from live vaccines.
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir)
Significantly increase everolimus blood levels, requiring dose reduction.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John's Wort)
Significantly decrease everolimus blood levels, requiring dose increase.
Storage
Store at 2°C to 8°C (36°F to 46°F) in the original package to protect from light. Do not freeze. Reconstituted solution should be used immediately or stored for a short period as per specific instructions.
Overdose
Experience with overdose is limited. Symptomatic and supportive treatment should be initiated. Everolimus blood levels should be monitored.
Pregnancy & Lactation
Everolimus is not recommended during pregnancy due to potential for fetal harm. Women of childbearing potential should use effective contraception during treatment and for at least 8 weeks after the last dose. Avoid breastfeeding during treatment and for 2 weeks after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, when stored as recommended.
Availability
Hospitals, Specialized pharmacies
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Everolimus has undergone extensive clinical trials across various indications, including pivotal Phase III trials demonstrating its efficacy and safety in advanced renal cell carcinoma, pancreatic neuroendocrine tumors, breast cancer, and organ transplant rejection prevention.
Lab Monitoring
- Complete blood count (CBC) with differential
- Renal function tests (serum creatinine, BUN)
- Liver function tests (ALT, AST, bilirubin)
- Blood glucose and lipid levels
- Everolimus trough levels (especially in transplant patients or if interactions are suspected)
Doctor Notes
- Emphasize the importance of therapeutic drug monitoring (TDM) for optimizing everolimus exposure and minimizing toxicity, particularly in transplant patients.
- Educate patients about the signs and symptoms of infection and the need for prompt medical attention.
- Consider prophylactic antiviral and antifungal agents in high-risk transplant patients.
Patient Guidelines
- Report any signs of infection (fever, chills, sore throat) to your doctor immediately.
- Avoid live vaccines during treatment and for a period after treatment as advised by your doctor.
- Use effective contraception during treatment and for at least 8 weeks after the last dose.
- Maintain good oral hygiene to prevent or reduce stomatitis.
Missed Dose Advice
If a dose is missed, contact your doctor immediately for instructions. Do not administer a double dose to compensate for a missed dose.
Driving Precautions
Everolimus may cause fatigue, dizziness, or blurred vision. Patients should exercise caution when driving or operating machinery if they experience these symptoms.
Lifestyle Advice
- Avoid sun exposure and use sun protection (e.g., sunscreen, protective clothing) due to increased risk of skin cancer.
- Avoid eating grapefruit or drinking grapefruit juice.
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