Medical Description: EVRALICARE 5 mg (Everolimus) — 30 Tablets

Prescription medicine | Antineoplastic agent | mTOR inhibitor

Active ingredient: Everolimus 5 mg per tablet Dosage form: Oral tablets Pack size: 30 tablets

Product Overview

EVRALICARE 5 mg contains everolimus, an oral targeted medicine belonging to the mammalian target of rapamycin (mTOR) inhibitor class. Everolimus works by inhibiting the mTOR signaling pathway, which plays an important role in cell growth, proliferation, metabolism, and blood vessel formation.

Depending on the approved product indication, everolimus may be used to treat certain cancers and tumors, as well as specific manifestations of tuberous sclerosis complex. Its immunosuppressive effects are also used in certain organ-transplant regimens, with different product-specific indications and dosing requirements.

Indications and Uses

Depending on the applicable approved formulation and prescribing information, everolimus may be indicated for:

• Advanced hormone receptor-positive, HER2-negative breast cancer, in combination with exemestane in eligible postmenopausal women after failure of previous treatment with letrozole or anastrozole.
• Advanced or metastatic neuroendocrine tumors, including certain tumors originating in the gastrointestinal tract, lungs, or pancreas, depending on the product label.
• Advanced renal cell carcinoma, in eligible patients following previous targeted therapy.
• Tuberous sclerosis complex (TSC)-associated tumors, including certain subependymal giant cell astrocytomas (SEGAs) and renal angiomyolipomas.
• Prevention of organ rejection in selected kidney or liver transplant recipients, when using an everolimus formulation specifically approved for this purpose.

Important: Not every indication applies to every everolimus product. The approved uses of EVRALICARE must be confirmed against its local registration and package leaflet.

Mechanism of Action

Everolimus inhibits mTOR, a key regulator of cellular growth and proliferation. This inhibition reduces signaling involved in protein synthesis, tumor-cell multiplication, and angiogenesis (the formation of new blood vessels that supply tumors).

In susceptible tumors, this activity may help slow disease progression. In transplant medicine, everolimus also suppresses immune-cell proliferation, helping reduce the risk of organ rejection when used as part of an appropriate immunosuppressive regimen.

Dosage and Administration

• Take everolimus exactly as prescribed by the treating specialist.
• The dose and treatment schedule depend on the specific indication, formulation, patient characteristics, and concomitant medications.
• For some oncology indications, adult treatment commonly uses once-daily dosing; however, 5 mg is not the standard dose for every indication.
• Swallow tablets according to the product leaflet and maintain a consistent relationship to food as directed.
• Do not change the dose, interrupt treatment, or switch between formulations without medical advice.
• Dose adjustments and blood-level monitoring may be required for transplant patients and certain patients with tuberous sclerosis complex.

Contraindications and Important Warnings

Everolimus requires specialist supervision because it can cause serious adverse effects.

• Infections: May increase susceptibility to bacterial, viral, fungal, and opportunistic infections.
• Lung toxicity: May cause non-infectious pneumonitis or other lung complications.
• Mouth ulcers: Stomatitis, mouth irritation, and oral ulceration are common adverse effects.
• Blood disorders: May cause anemia, low white blood cell counts, or low platelet counts.
• Metabolic effects: May increase blood glucose, cholesterol, and triglyceride levels.
• Kidney and liver effects: Renal function, liver function, and urine protein may require monitoring.
• Delayed wound healing: Treatment may interfere with wound healing and increase the risk of complications around surgery.
• Pregnancy: May cause fetal harm. Effective contraception and appropriate precautions during treatment should be discussed with the specialist.

Tell the treating physician about any active infection, planned surgery, existing medical conditions, or other medicines before starting treatment.

Possible Side Effects

Common or clinically significant adverse effects may include:

• Mouth ulcers, stomatitis, and oral pain.
• Skin rash, acne-like eruptions, or itching.
• Fatigue and weakness.
• Diarrhea, nausea, or vomiting.
• Reduced appetite and weight loss.
• Swelling of the extremities.
• Increased blood glucose and lipid levels.
• Anemia and other changes in blood counts.
• Increased risk of infections.

Seek urgent medical attention for difficulty breathing, severe or persistent fever, signs of a serious infection, severe allergic reactions, or other rapidly worsening symptoms.

Drug Interactions

Everolimus is affected by enzymes and transport proteins involved in drug metabolism, particularly CYP3A4 and P-glycoprotein.

• Strong CYP3A4/P-glycoprotein inhibitors may increase everolimus exposure.
• Strong enzyme inducers may reduce its effectiveness.
• Grapefruit and grapefruit juice may alter drug exposure and should be avoided unless the treating specialist advises otherwise.
• Live vaccines and some immunosuppressive medicines require special consideration.
• All prescription medicines, over-the-counter products, and herbal supplements should be reviewed by the treating physician or pharmacist.

Storage

Store EVRALICARE according to the manufacturer's instructions and the approved package leaflet. Keep tablets in their original packaging, protected from excessive heat and moisture, and out of the reach of children.

References

1. U.S. National Library of Medicine — DailyMed: Official prescribing information for everolimus tablets. DailyMed — Everolimus tablets
2. U.S. National Cancer Institute (NCI): Cancer medicines and treatment information. cancer.gov
3. U.S. Food and Drug Administration (FDA): Drug safety and prescribing information. FDA — Drugs@FDA
4. MedlinePlus, U.S. National Library of Medicine: Patient-oriented medicine information. medlineplus.gov

Patient Disclaimer

This information is intended for educational purposes only and does not diagnose, treat, cure, or prevent any disease. It is not a substitute for professional medical advice, diagnosis, or treatment. Everolimus is a prescription medicine that must be used under the supervision of a qualified specialist. Indications, dosage, contraindications, and precautions may vary according to the specific product and its approved labeling. Always consult your treating physician and read the approved package leaflet before use.