Everolimus

Cancer

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Measures Everolimus levels.

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Everolimus Test Information Guide

Why is it done?
- Measures trough serum levels of everolimus, a mammalian target of rapamycin (mTOR) inhibitor used in immunosuppression and cancer therapy
- Monitor therapeutic drug levels in transplant recipients (kidney, heart, liver) to ensure adequate immunosuppression and prevent rejection
- Assess everolimus concentrations in cancer patients receiving this agent for renal cell carcinoma, breast cancer, or neuroendocrine tumors
- Evaluate drug efficacy and prevent toxicity by maintaining therapeutic concentrations
- Detect subtherapeutic levels that may lead to treatment failure or rejection episodes
- Identify supratherapeutic levels that increase risk of adverse effects including nephrotoxicity, hepatotoxicity, and hematologic complications
- Performed during initiation of therapy, dose adjustments, and routinely during maintenance therapy (typically at 5-7 days after starting or changing dose)
Normal Range
- Therapeutic Range: 3-8 ng/mL (nanograms/milliliter)
- Specific therapeutic targets may vary by indication: Transplant recipients typically target 3-8 ng/mL; Cancer patients may require individualized targets (typically 5-15 ng/mL depending on tumor type)
- Subtherapeutic Level: < 3 ng/mL (insufficient immunosuppression or drug effect)
- Supratherapeutic Level: > 15 ng/mL (increased risk of toxicity)
- Unit of Measurement: ng/mL or nmol/L (conversion: multiply ng/mL by 1.087 for nmol/L)
- Normal Result: Level within therapeutic range (3-8 ng/mL for most indications) indicates adequate drug exposure for therapeutic effect with acceptable safety profile
Interpretation
- Subtherapeutic Level (< 3 ng/mL):
  - Increased risk of graft rejection in transplant recipients or inadequate tumor response in cancer patients
  - Possible causes: poor medication adherence, drug interactions, malabsorption, or inadequate dosing
  - Recommendation: Increase dose and recheck level in 5-7 days; assess compliance and drug interactions
- Therapeutic Level (3-8 ng/mL):
  - Optimal drug exposure for transplant patients; associated with reduced rejection rates and acceptable toxicity profile
  - In cancer patients, may require adjustment based on efficacy and tolerance
  - Recommendation: Continue current dose; monitor for side effects; recheck level during maintenance (typically every 3-6 months or with dose changes)
- Supratherapeutic Level (> 15 ng/mL or above target range):
  - Increased risk of nephrotoxicity, hepatotoxicity, myelosuppression, and other dose-related adverse effects
  - May indicate over-dosing, drug interactions (particularly with CYP3A4 inhibitors), or decreased metabolic clearance
  - Recommendation: Reduce dose by 25-50% and recheck level in 5-7 days; monitor clinical parameters (renal function, liver function, complete blood count); review concurrent medications
- Factors Affecting Results:
  - CYP3A4 inhibitors (ketoconazole, erythromycin, cyclosporine) increase everolimus levels
  - CYP3A4 inducers (rifampin, phenytoin, carbamazepine) decrease everolimus levels
  - Grapefruit juice inhibits CYP3A4 and increases everolimus levels
  - Food effect: Take with or without food consistently; fatty meals may increase absorption variability
  - Gastrointestinal disorders (diarrhea, malabsorption) may reduce drug levels
  - Hepatic and renal impairment may affect metabolism and clearance
  - Patient adherence and consistency in dosing timing directly impact levels
Associated Organs
- Primary Organ Systems Involved:
  - Immune system (in transplant recipients, provides immunosuppression to prevent organ rejection)
  - Kidneys (affected by the drug and may experience nephrotoxicity)
  - Liver (site of drug metabolism via CYP3A4; affected by hepatotoxicity)
  - Bone marrow (myelosuppression leading to anemia, thrombocytopenia, leukopenia)
  - Cancer cells (mTOR pathway inhibition; therapeutic target in oncology)
- Conditions Associated with Abnormal Results:
  - Organ transplantation (kidney, heart, liver, lung) - uses everolimus for immunosuppression
  - Advanced renal cell carcinoma - treatment with everolimus after first-line therapy
  - Hormone receptor-positive, HER2-negative advanced breast cancer - used with hormonal therapy
  - Neuroendocrine tumors of pancreatic origin - everolimus used for advanced disease
  - Tuberous sclerosis complex - management of associated manifestations
- Potential Complications and Risks:
  - Low Levels: Acute rejection episodes in transplant recipients; tumor progression in cancer patients
  - High Levels: Nephrotoxicity with elevated creatinine and reduced glomerular filtration rate; hepatotoxicity with elevated liver enzymes; myelosuppression (anemia, thrombocytopenia, infection risk)
  - Metabolic complications: Hyperglycemia, dyslipidemia with chronic exposure
  - Opportunistic infections due to immunosuppression at therapeutic levels
  - Increased cancer risk in transplant patients with long-term immunosuppression
  - Wound healing complications and delayed recovery in transplant recipients
Follow-up Tests
- Renal Function Assessment:
  - Serum creatinine - baseline and with each everolimus level check
  - Blood urea nitrogen (BUN) - assess renal function deterioration
  - Estimated glomerular filtration rate (eGFR) - monitor kidney function
- Hepatic Function Assessment:
  - Aspartate aminotransferase (AST) - baseline and periodically
  - Alanine aminotransferase (ALT) - baseline and periodically
  - Bilirubin (total and direct) - assess for hepatotoxicity
  - Albumin - assess synthetic liver function
- Hematologic Monitoring:
  - Complete blood count (CBC) - detect myelosuppression including anemia, leukopenia, thrombocytopenia
  - Platelet count - assess thrombocytopenia risk
  - White blood cell (WBC) count - monitor infection risk
- Lipid Panel:
  - Total cholesterol, LDL, HDL, triglycerides - assess hyperlipidemia from everolimus
- Glucose Monitoring:
  - Fasting glucose or HbA1c - screen for hyperglycemia and new-onset diabetes
- Additional Repeat Everolimus Level Testing:
  - 5-7 days after initiating therapy or changing dose
  - Every 3-6 months during maintenance therapy for transplant recipients
  - When adding or discontinuing medications that interact with CYP3A4
  - If clinical signs of toxicity or rejection develop
  - If renal or hepatic function changes significantly
- Infectious Disease Monitoring:
  - Cytomegalovirus (CMV) screening - in transplant patients
  - BK virus monitoring - in renal transplant patients
Fasting Required?
- No, fasting is NOT required
  - Food intake does not significantly affect everolimus trough levels
  - Fasting recommendations apply to accompanying tests (lipid panel, glucose) if ordered simultaneously
- Timing of Blood Draw - Critical for Accurate Results:
  - Draw TROUGH level (immediately before next scheduled dose) - this is the standard for therapeutic drug monitoring
  - Consistent timing: Take blood sample at same time relative to last dose (typically upon awakening, before morning dose)
  - Allow at least 5-7 days at steady state before checking levels (longer recommended initially)
- Special Instructions for Medication Timing:
  - Take everolimus at the SAME TIME each day
  - Take with consistent food intake (either always with food or always without food)
  - Do NOT change brand/generic formulation without consulting healthcare provider
  - Take tablets with full glass of water
- Medications/Substances to Avoid or Report:
  - CYP3A4 Inhibitors (increase everolimus levels): Ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, cyclosporine, diltiazem, verapamil - inform laboratory/prescriber if taking
  - CYP3A4 Inducers (decrease everolimus levels): Rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort - inform prescriber if starting
  - Grapefruit or grapefruit juice - AVOID completely (CYP3A4 inhibition)
  - Live vaccines - contraindicated with everolimus; discuss vaccination with healthcare provider
  - NSAIDs - caution with long-term use due to nephrotoxicity risk
- Other Patient Preparation Requirements:
  - Wear light long-sleeved clothing to facilitate blood draw
  - Bring photo identification and insurance card
  - Arrive well-hydrated to facilitate blood draw
  - Inform phlebotomist of current medications, recent dosage changes, or new drug interactions
  - Maintain medication adherence schedule - do not skip doses to affect results
  - Report any gastrointestinal symptoms (diarrhea, vomiting) that could affect absorption

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