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Everbliss (5mg / 10mg) - Everolimus Tablets

Everbliss (5mg / 10mg) - Everolimus Tablets

Everbliss contains Everolimus, an oral mTOR inhibitor used to treat various cancers and non-cancerous tumors. It works by inhibiting cell growth, proliferation, and angiogenesis, and is indicated in multiple cancers including renal cell carcinoma, breast cancer, neuroendocrine tumors, and transplant rejection prevention.

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Description Product Details
General Information:
Generic Name: Everolimus
Brand Name: Everbliss
Packing: packs of 10 tablets
Strengths: 5 mg and 10 mg tablets
Manufacturer: Bdr Pharmaceuticals Internationals Pvt Ltd
Form: Oral tablets
Category:
mTOR Inhibitor
Antineoplastic Agent
Immunosuppressant
Product Intro:
Everbliss is a targeted oral therapy that inhibits the mTOR (mammalian target of rapamycin) pathway—a central regulator of cell growth, metabolism, and angiogenesis. It’s used primarily in oncology for hormone receptor-positive cancers and tumors with dysregulated mTOR signaling. It also has non-oncological uses in transplant immunosuppression and tuberous sclerosis complex (TSC).
Uses (Indications):
  1. Advanced Renal Cell Carcinoma (RCC):
    1. Used after failure of treatment with VEGF-targeted therapy like sunitinib or sorafenib.
  2. Hormone Receptor–Positive Breast Cancer:
    1. In combination with exemestane in postmenopausal women who are HER2-negative.
  3. Neuroendocrine Tumors (NET):
    1. Treatment of progressive, well-differentiated NET of pancreatic, gastrointestinal, or lung origin.
  4. Tuberous Sclerosis Complex (TSC):
    1. For subependymal giant cell astrocytoma (SEGA) or renal angiomyolipoma associated with TSC.
  5. Organ Transplantation:
    1. Used (at lower doses) for prevention of organ rejection, especially in kidney or liver transplants.
  6. Advanced Hepatocellular Carcinoma (under study):
    1. Investigational use in certain resistant liver cancers.
Storage Instructions:
  1. Store at 20–25 °C (68–77 °F) in a dry place.
  2. Keep tablets in the original blister pack until use.
  3. Avoid humidity and direct sunlight.
  4. Keep out of reach of children and pets.
How It Works (Mechanism of Action):
Everolimus is a selective inhibitor of mTOR (mammalian target of rapamycin), a serine/threonine kinase involved in regulating cell growth, proliferation, metabolism, and angiogenesis. By inhibiting mTORC1, Everolimus blocks the translation of key proteins required for cancer cell division and angiogenesis (e.g., VEGF). In transplant patients, it suppresses T-cell activation to prevent immune-mediated organ rejection.
Side Effects:
Common Side Effects:
  1. Mouth ulcers (stomatitis) – often the first and most common symptom.
  2. Rash and dry skin
  3. Fatigue, weakness
  4. Nausea, vomiting, or abdominal pain
  5. Anemia and leukopenia (low blood counts)
  6. Increased blood sugar and cholesterol
  7. Loss of appetite, weight loss
Severe or Serious Side Effects:
  1. Non-infectious pneumonitis: Dry cough, breathlessness—can be fatal if untreated.
  2. Infections: Due to immunosuppressive action, including bacterial, fungal, or viral infections.
  3. Renal dysfunction: Elevated creatinine, especially in transplant patients.
  4. Delayed wound healing
  5. Thrombocytopenia or severe anemia
Dosage (Typical Recommended Dose):
  1. Cancer Treatment:
    1. 10 mg orally once daily until disease progression or unacceptable toxicity.
  2. Tuberous Sclerosis (SEGA or angiomyolipoma):
    1. Starting dose based on body surface area (BSA) – titrated according to blood levels.
  3. Transplantation (maintenance dose):
    1. 0.75 mg twice daily, adjusted to maintain target blood concentration.
  4. Dose Modifications:
    1. Required for liver impairment, side effects, or in the presence of strong CYP3A4 interactions.
Method of Administration:
  1. Take Everbliss at the same time daily with or without food.
  2. Swallow tablets whole with water—do not crush, break, or chew.
  3. If vomiting occurs after a dose, do not take an extra dose. Wait for the next scheduled time.
  4. Avoid grapefruit juice, which affects drug metabolism.
Precautions:
  1. Monitor blood counts regularly—risk of cytopenias.
  2. Check renal and liver function during treatment.
  3. Monitor lipid and glucose levels periodically.
  4. Screen for infections before starting—latent tuberculosis, hepatitis B.
  5. Avoid live vaccines during and after therapy.
  6. Pregnancy risk (Category D): Use contraception; not recommended in pregnant or breastfeeding women.
  7. Surgical Wounds: Avoid use near major surgery due to impaired wound healing.
Drug Interactions:
  1. Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): Increase Everolimus blood levels—may require dose reduction.
  2. Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): Decrease effectiveness—may require dose increase.
  3. Immunosuppressants (e.g., cyclosporine): Increases risk of renal toxicity—careful monitoring needed.
  4. ACE inhibitors: May enhance the risk of angioedema.
  5. Live vaccines: Avoid due to increased risk of infection.
Allergies (Warnings for Allergic Reactions):
  1. Hypersensitivity reactions may include: Rash, facial swelling, hives, or difficulty breathing.
  2. Patients allergic to rapamycin derivatives (e.g., sirolimus) should avoid Everolimus.
  3. Stop immediately and seek emergency care if signs of anaphylaxis occur.
Overdose Information:
  1. Symptoms of overdose may include: Severe immunosuppression, mouth ulcers, low blood counts, or kidney dysfunction.
  2. No specific antidote is available.
  3. Supportive management includes: Hospitalization, IV fluids, blood count monitoring, and infection surveillance.
Missed Dose Instructions:
  1. If a dose is missed by less than 6 hours, take it as soon as remembered.
  2. If more than 6 hours have passed, skip the missed dose and take the next one at the usual time.
  3. Never double up on doses to make up for a missed one.
Additional Notes:
  1. Therapeutic drug monitoring (TDM) is essential in transplant patients—target trough concentration: 3–8 ng/mL.
  2. Mouth ulcers are manageable with alcohol-free mouthwashes or topical steroids.
  3. A non-steroidal prophylactic mouthwash (like dexamethasone rinse) can help reduce stomatitis.
  4. Avoid concurrent radiation therapy, which can increase toxicity.
  5. Monitor for signs of secondary malignancy, especially in long-term use.
  6. Regular imaging is required in patients with SEGA or cancer to assess tumor response.

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