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SIROLIMUS, BLOOD BY LC MSMS

Blood
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Report in 192Hrs

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At Home

nofastingrequire

No Fasting Required

Details

Drug monitoring test.

₹5,846₹8,351

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SIROLIMUS, BLOOD BY LC MSMS - Comprehensive Medical Test Guide

  • Why is it done?
    • Test Purpose: Measures sirolimus (rapamycin) concentration in blood using Liquid Chromatography-Tandem Mass Spectrometry (LC-MSMS), a highly specific and sensitive analytical method for therapeutic drug monitoring
    • Primary Indications: Monitor therapeutic levels in solid organ transplant recipients (kidney, heart, liver, pancreas); assess immunosuppressive drug efficacy; manage patients on sirolimus-based immunosuppressive regimens
    • Clinical Applications: Prevent acute and chronic rejection episodes; optimize dosing to achieve therapeutic targets while minimizing adverse effects; detect subtherapeutic or toxic levels; monitor compliance with immunosuppressive therapy
    • Timing: Baseline testing initiated within 1-2 weeks after transplantation; periodic monitoring (typically monthly initially, then quarterly or as clinically indicated); dose adjustments made based on trough levels; increased frequency during therapy modifications or clinical changes
  • Normal Range
    • Reference Ranges: Therapeutic Range: 4-20 ng/mL (nanograms per milliliter) for most transplant patients; specific targets vary by institution, transplant type, and post-transplant timing; early post-transplant (0-3 months): typically 8-20 ng/mL; maintenance phase (>3 months): typically 4-15 ng/mL
    • Unit of Measurement: ng/mL (nanograms per milliliter); international units: nmol/L (nanomoles per liter) - conversion factor approximately 1.09 (ng/mL × 1.09 = nmol/L)
    • Below Therapeutic Range (<4 ng/mL): Subtherapeutic levels indicate insufficient immunosuppression; associated with increased risk of acute rejection, graft failure, and transplant loss; requires dose escalation
    • Within Therapeutic Range (4-20 ng/mL): Normal/target range representing optimal immunosuppressive coverage; balances rejection prevention with acceptable adverse effect profile; maintains therapeutic efficacy while minimizing toxicity
    • Above Therapeutic Range (>20 ng/mL): Supratherapeutic/toxic levels indicate excessive immunosuppression; associated with increased adverse effects including nephrotoxicity, hepatotoxicity, hematologic complications, infections, and metabolic disturbances; requires dose reduction or interval adjustment
    • Undetectable (<0.5 ng/mL): Patient not receiving sirolimus or complete non-compliance; extreme risk of acute rejection and graft loss in transplant recipients
  • Interpretation
    • Clinical Significance of Low Levels (<4 ng/mL): Indicates inadequate drug exposure; risk of transplant rejection (acute cellular rejection, humoral rejection); possible medication non-adherence; malabsorption issues; potential drug-drug interactions reducing sirolimus levels; requires investigation of absorption and compliance; dose increase typically necessary; increased monitoring frequency until therapeutic levels achieved
    • Clinical Significance of Therapeutic Levels (4-20 ng/mL): Optimal immunosuppressive coverage; adequate rejection prevention with acceptable safety profile; therapeutic equilibrium achieved; continue current dosing; maintain regular monitoring schedule; patient demonstrating good compliance and absorption; favorable graft outcome expected
    • Clinical Significance of High Levels (>20 ng/mL): Excessive drug exposure with increased toxicity risk; potential development of adverse effects (nephrotoxicity, thrombocytopenia, anemia, stomatitis, diarrhea); increased infection risk from over-immunosuppression; requires prompt dose reduction; possible dosing interval extension; reassessment for drug-drug interactions causing elevated levels (particularly CYP3A4 inhibitors); close clinical monitoring for signs of toxicity; repeat level measurement after dose adjustment
    • Factors Affecting Sirolimus Levels: CYP3A4 Inhibitors (diltiazem, verapamil, ketoconazole, itraconazole, ritonavir) increase sirolimus levels; CYP3A4 Inducers (rifampicin, phenytoin, carbamazepine) decrease sirolimus levels; P-glycoprotein modulators affect absorption and distribution; grapefruit juice inhibits metabolism increasing levels; food intake affects absorption (sirolimus should be taken consistently with or without food); gastrointestinal disorders and malabsorption decrease levels; genetic polymorphisms in CYP3A4 and P-glycoprotein affect metabolism; renal and hepatic dysfunction may impact clearance
    • Steady-State Considerations: Sirolimus has long half-life (60-100 hours); steady state achieved approximately 5-7 days after dose initiation or change; levels should be drawn 5+ days after dose adjustment to reflect true steady-state concentration; trough levels (immediately before next dose) are standard sampling method; initial loading dose often used for rapid therapeutic level achievement
    • Time-to-Sample Recommendations: Minimum 5-7 days after starting therapy or dose change; preferably 7+ days for accurate steady-state measurement; trough levels drawn immediately before next scheduled dose; consistent sampling time relative to dose administration ensures reliable trend monitoring
  • Associated Organs
    • Primary Organ System: Immune System (specifically T-cell mediated immunity); sirolimus is mammalian target of rapamycin (mTOR) inhibitor that suppresses T-lymphocyte proliferation and B-lymphocyte activation
    • Organs at Risk from Toxicity: Kidneys (nephrotoxicity, reduced glomerular filtration); Liver (hepatotoxicity, elevated liver enzymes); Bone Marrow (thrombocytopenia, anemia, leukopenia); Gastrointestinal Tract (stomatitis, diarrhea, constipation, abdominal pain); Skin (rash, acne); Vascular System (hypertension, thrombotic microangiopathy)
    • Transplanted Organs Monitored: Kidney transplants (most common indication); Heart transplants; Liver transplants; Pancreas transplants; Lung transplants; sirolimus prevents rejection by suppressing immune response against foreign graft antigens
    • Conditions Associated with Abnormal Results: Subtherapeutic Levels: Acute cellular rejection, antibody-mediated rejection, graft failure, graft loss; Supratherapeutic Levels: Drug-induced nephrotoxicity, thrombotic microangiopathy, hepatotoxicity, hematologic complications, severe infections, delayed wound healing
    • Potential Complications Related to Abnormal Levels: Low Levels: Acute rejection (cellular or antibody-mediated), chronic rejection, graft vasculopathy, graft failure, need for retransplantation; High Levels: Acute kidney injury, proteinuria, hypertension, thrombocytopenia, anemia, leukopenia, opportunistic infections, increased malignancy risk, delayed graft function, poor wound healing, increased mortality from infectious complications
    • Interaction with Other Immunosuppressants: Often used in combination with calcineurin inhibitors (tacrolimus, cyclosporine), mycophenolate derivatives, and/or corticosteroids; potential for additive toxicity and drug-drug interactions; dose adjustments often necessary when used in combination regimens; monitoring of multiple immunosuppressive drug levels may be required
  • Follow-up Tests
    • Routine Monitoring Tests: Complete Blood Count (CBC) - monitor for thrombocytopenia, anemia, leukopenia; Comprehensive Metabolic Panel (CMP) - assess renal function (creatinine, BUN) and hepatic function (liver enzymes, bilirubin); Lipid Panel - sirolimus causes hyperlipidemia requiring monitoring and possible statin therapy; Urinalysis with Proteinuria - detect sirolimus-induced nephrotoxicity and proteinuria
    • Tests Based on Abnormal Sirolimus Levels: If Low Levels: Repeat sirolimus level after 7 days (assess steady-state achievement); assess medication adherence (pill counts, patient interview); evaluate gastrointestinal absorption issues; check for drug-drug interactions; if rejection suspected: Graft biopsy, donor-specific antibody testing, allograft function assessment; If High Levels: Repeat sirolimus level to confirm; renal function panel (creatinine, BUN, GFR) to assess nephrotoxicity; liver function tests if hepatotoxicity suspected; CBC to monitor bone marrow effects
    • Other Immunosuppressive Drug Monitoring: Tacrolimus level (if used concurrently) - monitor for interactions; Cyclosporine level (if used concurrently); Mycophenolic acid (MPA) level (if mycophenolate derivatives used); Corticosteroid adjustments may be needed based on sirolimus levels
    • Graft Function Assessment: Estimated Glomerular Filtration Rate (eGFR) - assess renal graft function; 24-hour urine creatinine clearance; serum creatinine trending; Doppler ultrasound of transplanted organ if acute dysfunction suspected; Graft biopsy if acute rejection suspected or chronic changes developing
    • Rejection Assessment Tests: Panel-Reactive Antibody (PRA) testing; Donor-Specific Antibody (DSA) testing - detects antibody-mediated rejection risk; Molecular Microscopy Assay (MMA) - detects rejection-associated transcripts; Allograft Biopsy - gold standard for rejection diagnosis; Flow Cytometry - detects circulating donor-specific T-cell responses
    • Monitoring Schedule: Immediate Post-Transplant (0-3 months): Weekly sirolimus level monitoring; CBC and CMP twice weekly to weekly; Monthly monitoring phase (3-12 months): Monthly sirolimus levels; monthly CBC and CMP; Maintenance phase (>12 months): Quarterly sirolimus levels; quarterly CBC and CMP; Increased frequency (any time): During dose adjustments (5-7 days after change); during clinical complications; suspected rejection episodes; medication changes affecting sirolimus metabolism
  • Fasting Required?
    • Fasting Requirement: NO - Fasting is NOT required for sirolimus blood level measurement; test can be performed regardless of meal status or food intake
    • Important Dosing Considerations: Sirolimus dose should be taken CONSISTENTLY with regard to food (either always with food or always without food); grapefruit and grapefruit juice must be AVOIDED - they inhibit CYP3A4 and significantly increase sirolimus levels; consistency in meal-taking pattern is more important than fasting status for maintaining stable drug levels
    • Medications and Supplements to Avoid/Monitor: CYP3A4 Inhibitors (increase sirolimus levels): Diltiazem, verapamil, ketoconazole, itraconazole, fluconazole, clarithromycin, erythromycin, ritonavir, lopinavir, nelfinavir, amiodarone; CYP3A4 Inducers (decrease sirolimus levels): Rifampicin, rifabutin, phenytoin, phenobarbital, carbamazepine, St. John's Wort; Other medications affecting absorption: Antacids, H2-blockers, proton pump inhibitors (may reduce absorption); Grapefruit and grapefruit juice (ABSOLUTELY CONTRAINDICATED); ACE inhibitors and ARBs (may increase risk of angioedema when combined with sirolimus)
    • Special Preparation Instructions: Preferred sampling time: Trough level (immediately before next scheduled sirolimus dose) for standardization; sample should be drawn 5+ days after dose initiation or dose change to ensure steady-state; patient should take sirolimus dose at same time each day; no special preparation required other than standard blood draw procedures; inform laboratory of current sirolimus dose and time of last dose; notify physician of any new medications, supplements, or dietary changes that might affect sirolimus metabolism
    • Sample Collection Requirements: Whole blood collection in appropriate tube (typically ethylenediaminetetraacetic acid [EDTA] or lithium heparin per laboratory specification); minimum volume usually 3-5 mL; sample should be processed promptly; stable at room temperature or refrigerated per laboratory protocol; do not freeze unless long-term storage required; document exact time of collection and time of last sirolimus dose

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