Crilomus
Generic Name
Everolimus
Manufacturer
Reputed Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| crilomus 05 mg capsule | ৳ 28.00 | ৳ 280.00 |
Description
Overview of the medicine
Crilomus 0.5 mg capsule contains Everolimus, an immunosuppressant and antineoplastic agent. It is used to prevent organ rejection in transplant patients and to treat certain types of cancer.
Uses & Indications
Dosage
Adults
Varies significantly by indication. For transplant rejection prophylaxis, typically 0.75 mg or 1 mg twice daily. For oncology, 10 mg once daily.
Elderly
No specific dose adjustment generally required, but close monitoring advised.
Renal_impairment
No dose adjustment for mild to moderate renal impairment. Severe impairment, caution and monitoring.
How to Take
Take orally, once or twice daily, consistently at the same time each day, with or without food for transplant, but consistently with or without food. For cancer, usually once daily, on an empty stomach or with a light meal, but consistently. Do not crush, chew, or break capsules.
Mechanism of Action
Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine-threonine kinase. It forms a complex with the cytoplasmic protein FKBP12, which then binds to and inhibits mTOR, thereby blocking downstream signaling pathways critical for cell growth, proliferation, and angiogenesis.
Pharmacokinetics
Onset
Immunosuppressive effects begin shortly after administration, sustained with regular dosing. Antitumor effects vary.
Excretion
Primarily via feces (80%), with a small amount (5%) excreted renally.
Half life
Approximately 28-30 hours (variable).
Absorption
Rapidly absorbed, peak concentrations reached within 1-2 hours. Food high in fat reduces AUC and Cmax.
Metabolism
Primarily hepatic, extensively metabolized by CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to Everolimus, Sirolimus, or any excipients
- Pregnancy (unless benefits outweigh risks)
- Severe hepatic impairment (for some indications or with dose adjustment)
Drug Interactions
Live vaccines
Avoid concomitant use due to immunosuppression.
ACE inhibitors
Increased risk of angioedema.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, St. John's wort)
Significantly decrease everolimus levels.
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice)
Significantly increase everolimus levels.
Storage
Store at room temperature (below 30°C), away from moisture and light. Keep out of reach of children.
Overdose
Experience with overdose is limited. Symptomatic and supportive measures should be initiated. Regular monitoring of everolimus trough levels and blood counts is advised.
Pregnancy & Lactation
Category D in pregnancy (risk to fetus). Advise women of childbearing potential to use effective contraception during treatment and for 8 weeks after the last dose. Excreted in breast milk, avoid breastfeeding during treatment and for 2 weeks after the last dose.
Side Effects
Contraindications
- Hypersensitivity to Everolimus, Sirolimus, or any excipients
- Pregnancy (unless benefits outweigh risks)
- Severe hepatic impairment (for some indications or with dose adjustment)
Drug Interactions
Live vaccines
Avoid concomitant use due to immunosuppression.
ACE inhibitors
Increased risk of angioedema.
Strong CYP3A4 inducers (e.g., rifampicin, phenytoin, St. John's wort)
Significantly decrease everolimus levels.
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, grapefruit juice)
Significantly increase everolimus levels.
Storage
Store at room temperature (below 30°C), away from moisture and light. Keep out of reach of children.
Overdose
Experience with overdose is limited. Symptomatic and supportive measures should be initiated. Regular monitoring of everolimus trough levels and blood counts is advised.
Pregnancy & Lactation
Category D in pregnancy (risk to fetus). Advise women of childbearing potential to use effective contraception during treatment and for 8 weeks after the last dose. Excreted in breast milk, avoid breastfeeding during treatment and for 2 weeks after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 to 36 months
Availability
Pharmacies, Hospitals
Approval Status
Approved by regulatory bodies (e.g., FDA, DGDA)
Patent Status
Patent expired for original compound, generic versions available.
Clinical Trials
Everolimus has been studied in numerous clinical trials for its various indications, including efficacy and safety in transplant rejection prophylaxis and multiple cancer types.
Lab Monitoring
- Everolimus trough levels (blood concentration)
- Complete blood count (CBC)
- Renal function tests (creatinine, BUN)
- Liver function tests (ALT, AST, bilirubin)
- Lipid profile (cholesterol, triglycerides)
- Blood glucose levels
- Urinalysis for proteinuria
Doctor Notes
- Monitor everolimus trough levels, renal/hepatic function, blood lipids, and glucose regularly.
- Educate patients on infection risks and symptom reporting.
- Counsel on contraception and avoidance of live vaccines.
- Careful consideration for patients with pre-existing hepatic impairment or those on strong CYP3A4 modifiers.
Patient Guidelines
- Take medicine exactly as prescribed.
- Do not stop taking without consulting your doctor.
- Avoid grapefruit and St. John's wort.
- Report any signs of infection (fever, chills, sore throat) immediately.
- Use effective contraception if you are a woman of childbearing potential.
- Avoid live vaccines.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Everolimus may cause dizziness, fatigue, or visual disturbances. Patients should be cautious when driving or operating machinery if they experience these symptoms.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Avoid excessive sun exposure and use sunscreen due to increased skin cancer risk.
- Follow a healthy diet.
- Regular exercise as advised by your doctor.
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