📋 Indications & Clinical Dosage
*Treatment of advanced renal cell carcinoma when uncontrolled with vascular endothelial growth factor-targeted therapy, Treatment of unresectable or metastatic, differentiated neuroendocrine tumours of pancreatic origin, Treatment of hormone-receptor-positive, human epidermal growth factor-2 (HER-2) negative advanced breast cancer, in combination with exemestane, in post menopausal women:*
Adult: 10 mg once daily.
*Liver transplantation:*
Adult: Initially 1 mg twice daily, startedapproximately 4 weeks after transplantation; maintenance, dose adjusted according to response and whole blood everolimus concentration; dose adjustments every 4-5 days
Renal transplantation, Heart transplantation:*
Adult: Initially 750 mcg twice daily, started soon after transplantation; maintenance, dose adjusted according to response and whole blood everolimus concentration; dose adjustments every 4-5 days.
⛔ Contraindications
Hypersensitivity to everolimus, sirolimusor to any of the ingredients in the preparation, patients with rare hereditary problems of lactase deficiency or glucose-galactose mal-absorption should not take this medicine, severe hepatic impairment.
⚠️ Precautions & Warnings
Increased risk of developing lymphomas and other malignancies, particularly
of the skin, over suppression of the immune system with increased susceptibility to infection. Patients should be closely monitored. Use effective contraception, moderate hepatic impairment. Ensure any infection is resolved before starting treatment. Discontinue if invasive systemic fungal infection develops. Advise patient to report new or worsening respiratory symptoms, monitor renal function, fasting serum glucose and complete blood count. Ensure adequate contraception for women of childbearing age.
🔄 Drug Interactions
Rifampicin, rifabutin, ketoconazole, itracona-zole, voriconazole, clarithromycin, telithromycin, ritonavir, St. Johns Wort, erythromycin, fluconazole, phenytoin, carbamazepine, phenobarbital, calcium channel blockers, pro-tease inhibitors and anti-HIV drugs, Inhibitors or inducers of CYP3A4 or P-glycoprotein inhibitors (e.g. antifungal, macrolide, protease inhibitor, calcium channel blocker, cyclosporin), live vaccines
⚠️ Adverse Reactions / Side Effects
Abdominal pain, anorexia, arthralgia, asthenia, chest pain, convulsions, dehydration, diarrhoea, dry mouth, dysphagia, electrolyte disturbance, epistaxis, eyelid oedema, fatigue, hand-foot syndrome, headache, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertension, hypoglycaemia, increased susceptibility to aspergillosis, increased susceptibility to candidiasis, increased susceptibility to infections, increased susceptibility topneumonia, insomnia, interstitial lung disease, irritability, nail disorders, peripheral oedema,
pneumonitis, renal failure, skin disorders, taste disturbance, congestive heart failure, flushing, impaired wound healing, rhabdomyolysis, alopecia, bone-marrow suppression, haemorrhage, hepatitis B reactivation, hyperuricaemia, nausea, oral mucositis, thromboembolism, tumourlysis syndrome, vomiting
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated in pregnancy.
Lactation / Breastfeeding:
Contraindicated. Discontinue breast-feeding.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.