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Authoritative Clinical Reference
Schedule H
Intravenous
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
Calvert Formula-Based Dosing (Preferred):
Total Dose (mg) = Target AUC × (GFR + 25)
Parameter Recommendation
Starting dose AUC 5–6 IV on Day 1 (first-line with paclitaxel)
Titration Not applicable
Usual maintenance dose AUC 5–6 IV every 21 days
Maximum dose AUC 7.5 (single agent); typically AUC 5–6 in combination
Duration: 6 cycles (first-line); 4–6 cycles (recurrent platinum-sensitive)
Clinical Notes:
Parameter Recommendation
Starting dose AUC 5–6 IV on Day 1
Titration Not applicable
Usual maintenance dose AUC 5–6 IV every 21 days
Maximum dose AUC 6 per cycle
Duration: 4–6 cycles
Clinical Notes:
Parameter Recommendation
Starting dose AUC 5–6 IV on Day 1
Titration Not applicable
Usual maintenance dose AUC 5 IV every 21–28 days
Maximum dose AUC 6 per cycle
Duration: 4–6 cycles
Clinical Notes:
(When cisplatin not tolerable)
Parameter Recommendation
Starting dose AUC 5 IV on Day 1 of each week OR AUC 6 IV every 21 days
Titration Not applicable
Usual maintenance dose AUC 5 weekly OR AUC 6 every 21 days during radiotherapy
Maximum dose AUC 6 per cycle
Duration: During radiotherapy course (typically 6–7 weeks)
Clinical Notes:
Secondary Indications — Adults (Off-label)
Indication Dose Duration Notes
Triple-Negative Breast Cancer (Neoadjuvant) AUC 5–6 IV every 21 days 4–6 cycles OFF-LABEL • Specialist only • Combined with taxanes • Meta-analysis support; Indian comprehensive cancer centre protocols
Glioblastoma Multiforme (Recurrent) AUC 5 IV every 21 days Response-guided OFF-LABEL • Specialist only • Neuro-oncology supervision • Limited RCT evidence
Endometrial Carcinoma (Advanced) AUC 5 IV on Day 1 with paclitaxel 6 cycles OFF-LABEL • Specialist only • TC regimen • Indian tertiary oncology practice
Cervical Cancer (Recurrent/Metastatic) AUC 5 IV every 21 days with paclitaxel Response-guided OFF-LABEL • Specialist only • Alternative to cisplatin-based regimens
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
Parameter Recommendation
Starting dose 560 mg/m² IV on Day 1
Titration Not applicable
Usual maintenance dose 560 mg/m² IV every 21–28 days
Maximum dose 560 mg/m² per cycle
Duration: 6 cycles typically (VEC regimen: vincristine, etoposide, carboplatin)
Clinical Notes:
AUC-Based Dosing (Preferred when GFR available):
Parameter Recommendation
Starting dose AUC 5–6 IV on Day 1
Titration Not applicable
Usual maintenance dose AUC 5–6 IV every 21–28 days
Maximum dose AUC 6 per cycle
BSA-Based Dosing (Alternative):
Parameter Recommendation
Starting dose 400–500 mg/m² IV on Day 1
Titration Not applicable
Usual maintenance dose 400–500 mg/m² IV every 21–28 days
Maximum dose 600 mg/m² per cycle
Duration: Per multi-agent protocol (typically 4–8 cycles)
Clinical Notes:
Parameter Recommendation
Starting dose AUC 5–6 IV on Day 1 OR 400–500 mg/m² IV
Titration Not applicable
Usual maintenance dose AUC 5–6 IV every 21 days
Maximum dose AUC 6 per cycle
Duration: 3–4 cycles (part of JEB or carboplatin-based regimens)
Safety Monitoring (All Paediatric Indications):
Secondary Indications — Paediatric (Off-label)
Indication Dose Duration Notes
Neuroblastoma (Recurrent/Refractory) AUC 5–6 IV OR 400–600 mg/m² IV every 21 days Per protocol OFF-LABEL • Specialist only • Intensive monitoring required
Hepatoblastoma 500 mg/m² IV on Day 1 Per SIOPEL/COG protocols OFF-LABEL • Specialist only • Combined with cisplatin and doxorubicin
Osteosarcoma (Salvage) AUC 5–6 IV every 21 days Response-guided OFF-LABEL • Specialist only • Limited efficacy data
Age Restrictions:
| eGFR (ml/min/1.73m²) | Recommendation |
|---|
Total Dose (mg) = Target AUC × (GFR + 25)
GFR (mL/min) Dose Recommendation
≥60 Full calculated dose (AUC 5–6)
40–59 Calculated dose with AUC 4–5
20–39 Reduce target AUC to 3–4; use with caution
<20 Avoid — use only under specialist supervision with significantly reduced AUC
GFR Calculation Notes:
Haemodialysis:
Peritoneal Dialysis:
| Severity | Recommendation |
|---|---|
| Mild impairment (Bilirubin ≤1.5× ULN) | No dose adjustment required |
| Moderate impairment (Bilirubin 1.5–3× ULN) | Use with caution; monitor for enhanced toxicity |
| Severe impairment (Bilirubin >3× ULN) | Limited data; avoid if possible or use under specialist supervision only |
Note: Carboplatin is primarily renally excreted — hepatic impairment has less impact on pharmacokinetics than renal impairment.
Parameter Information
Risk Category Category D — documented fetal harm; teratogenic and embryotoxic
Overall Safety Avoid during first trimester; may be considered in 2nd/3rd trimester for life-threatening malignancy
Preferred Alternatives Single-agent taxane or anthracycline regimens after first trimester (if applicable)
When May Be Used Life-threatening malignancy where platinum is essential — joint oncology-perinatology decision with documented informed consent
Monitoring Detailed fetal anomaly scan; fetal growth surveillance; maternal haematological parameters
Parameter Information
Compatibility Not compatible — breastfeeding contraindicated
Expected Milk Levels Unknown; presumed significant due to low molecular weight
Preferred Alternatives None — breastfeeding must be discontinued
Decision Stop breastfeeding during therapy and for at least 7 days after last dose
Infant Monitoring Not applicable — exposure must be avoided
Parameter Recommendation
Starting dose Lower target AUC (4–5); calculate GFR accurately using Cockcroft-Gault formula
Titration Not applicable
Special considerations Age-related decline in GFR — serum creatinine alone underestimates renal impairment
Extra monitoring CBC with differential — slower marrow recovery; electrolytes; audiometry if symptoms
Risk factors Higher susceptibility to thrombocytopenia; increased infection risk; pre-existing neuropathy may worsen
Interacting Drug Effect & Mechanism Management
Aminoglycosides (amikacin, gentamicin) Additive nephrotoxicity and ototoxicity Avoid concurrent use; if essential, monitor renal function and audiometry closely
Amphotericin B Additive nephrotoxicity Avoid concurrent use if possible; use liposomal formulation; monitor renal function
Loop diuretics (furosemide) Increased ototoxicity risk Avoid concurrent high-dose diuretics; if essential, monitor hearing
Live vaccines Risk of disseminated infection due to immunosuppression Avoid live vaccines during and for 3–6 months after treatment
Other myelosuppressive agents (zidovudine) Additive bone marrow suppression Monitor CBC closely; may require growth factor support
Interacting Drug Effect Management
Phenytoin Reduced phenytoin absorption/levels Monitor phenytoin levels; adjust dose as needed
Warfarin Variable INR changes Monitor INR frequently during chemotherapy cycles
NSAIDs Potential additive renal toxicity Avoid concurrent use during treatment cycles; use paracetamol for analgesia
Taxanes (paclitaxel, docetaxel) Additive myelosuppression (standard combination) Monitor CBC; dose adjustments as per protocol
Aprepitant May alter chemotherapy metabolism Use standard antiemetic protocols; no major dose adjustments typically needed
Adverse Effect Clinical Action
Severe thrombocytopenia (<25,000/mm³) with bleeding Hold therapy; platelet transfusion if indicated; delay next cycle until recovery
Febrile neutropenia / Neutropenic sepsis Hospitalisation; broad-spectrum antibiotics; G-CSF support
Anaphylaxis / Severe hypersensitivity (typically after ≥4 cycles) Immediate discontinuation; resuscitation; avoid rechallenge; consider desensitisation only in specialised centres
Ototoxicity (permanent hearing loss, tinnitus) Audiometry; discontinue if significant; audiology referral
Severe nephrotoxicity Hold therapy; supportive care; reassess GFR before resuming
Haemolytic uraemic syndrome (rare) Discontinue permanently; haematology/nephrology consultation
Pulmonary fibrosis (rare) Discontinue; pulmonology referral
| Timing | Parameters |
|---|---|
| Baseline | GFR (measured or calculated — Cockcroft-Gault), CBC with differential, electrolytes (Mg²⁺, K⁺, Ca²⁺, Na⁺), LFTs, audiometry (if high-risk or paediatric) |
Before each cycle GFR recalculation, CBC with differential, electrolytes — do not administer if platelets <75,000/mm³ or ANC <1500/mm³ without protocol guidance
During cycle Monitor for signs of infection; bleeding precautions if thrombocytopenic
Periodic (every 2–3 cycles) Audiometry (especially in paediatrics and elderly); cumulative dose tracking
Long-term (survivors) Annual audiometry for paediatric patients; renal function monitoring
FDCs: Not applicable
| Formulation | Approximate Price (per tablet) |
|---|---|
| Injection 150 mg vial ₹500–₹1,200 | |
| Injection 450 mg vial ₹1,500–₹3,000 | |
| Injection 600 mg vial ₹2,000–₹4,000 |
Note: Included in NLEM 2022; prices may be NPPA-controlled. Available in government cancer centres under national cancer programmes. Significant price variation between brands and procurement channels.
Carboplatin; platinum chemotherapy; antineoplastic; ovarian cancer; lung cancer; NSCLC; SCLC; AUC dosing; Calvert formula; thrombocytopenia; retinoblastoma; paediatric oncology; NLEM India; GFR-based dosing
RxIndia v1.0 — 05 Jan 2025
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