Schedule H

Intravenous

• Caspofungin 50 mg powder for reconstitution (IV injection)

• Caspofungin 70 mg powder for reconstitution (IV injection)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Invasive Candidiasis (including candidemia) — Adults

Parameter Recommendation

Starting dose 70 mg IV once on Day 1

Titration Not applicable

Usual maintenance dose 50 mg IV once daily from Day 2 onwards

Maximum dose 70 mg/day

Duration Minimum 14 days after last positive blood culture and clinical resolution

Clinical Notes:

• In moderate hepatic impairment (Child-Pugh B): reduce maintenance to 35 mg/day

• In neutropenic patients: continue therapy until neutropenia resolves

• Infuse over minimum 1 hour — avoid bolus administration

1. Invasive Aspergillosis (Salvage Therapy) — Adults

Parameter Recommendation

Starting dose 70 mg IV once on Day 1

Titration Not applicable

Usual maintenance dose 50 mg IV once daily

Maximum dose 70 mg/day

Duration Minimum 2 weeks; guided by clinical and radiological response

Clinical Notes:

• Reserved for patients intolerant or refractory to primary agents (voriconazole, amphotericin B)

• Not first-line therapy — use only as salvage option

• Fungistatic against Aspergillus (not fungicidal)

1. Empirical Antifungal Therapy in Febrile Neutropenia — Adults

Parameter Recommendation

Starting dose 70 mg IV once on Day 1

Titration Not applicable

Usual maintenance dose 50 mg IV once daily

Maximum dose 70 mg/day

Duration Minimum 7 days; continue until neutropenia resolves and symptoms abate

Clinical Notes:

• Preferred in patients with prior azole exposure or azole-resistant risk

• Monitor for breakthrough infections during prolonged therapy

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Chronic Disseminated Candidiasis (Hepatosplenic) 70 mg IV Day 1, then 50 mg IV daily Prolonged until radiological resolution OFF-LABEL • Specialist only • Indian tertiary centre practice

Oropharyngeal/Esophageal Candidiasis (fluconazole-resistant) 50 mg IV once daily 7–14 days (oropharyngeal); up to 21 days (esophageal) OFF-LABEL • When azoles contraindicated • Indian ID practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Invasive Candidiasis and Candidemia (Age ≥3 months)

Patient Weight Starting Dose (Day 1) Maintenance Dose (Day 2 onwards) Maximum Dose

3.5 kg to <50 kg 70 mg/m² IV once 50 mg/m² IV once daily 70 mg/day

≥50 kg 70 mg IV once 50 mg IV once daily 70 mg/day

Duration: Minimum 14 days after blood culture clearance and clinical resolution

Safety Monitoring:

• Baseline and periodic liver function tests

• Monitor for infusion-related reactions

• Assess for hepatotoxicity if co-administered with cyclosporine

1. Empirical Antifungal in Febrile Neutropenia (Age ≥3 months)

Patient Weight Starting Dose (Day 1) Maintenance Dose Maximum Dose

3.5 kg to <50 kg 70 mg/m² IV once 50 mg/m² IV once daily 70 mg/day

≥50 kg 70 mg IV once 50 mg IV once daily 70 mg/day

Duration: Until neutropenia resolves and clinical improvement observed

Secondary Indications — Paediatric (Off-label)

Indication Dose Duration Notes

Invasive Aspergillosis (Salvage therapy) 70 mg/m² IV Day 1, then 50 mg/m² IV daily (max 70 mg/day) Guided by clinical response OFF-LABEL • Specialist only • Limited Indian paediatric data

Age Restrictions:

• Not recommended in infants <3 months except under specialist infectious diseases supervision

• Neonatal use: extremely limited data — paediatric ID consultation mandatory

• Known hypersensitivity to caspofungin or any echinocandin

• History of anaphylaxis with echinocandin class agents

• Bolus IV injection (must be administered as slow infusion over ≥1 hour)

• Hepatic dysfunction — monitor liver enzymes; dose reduction required in moderate impairment

• Prior allergic reactions to other echinocandins (cross-reactivity possible)

• Concurrent cyclosporine therapy — increased risk of hepatotoxicity

• Prolonged therapy — monitor for breakthrough infections with resistant organisms

• Co-administration with enzyme inducers (rifampicin, carbamazepine) — reduced efficacy

Parameter Information

Risk Category Limited human data; animal studies show embryotoxicity

Overall Safety Use only when potential benefit clearly justifies fetal risk

Preferred Alternatives Liposomal amphotericin B (better documented safety profile in pregnancy)

When May Be Used Life-threatening invasive fungal infection unresponsive to alternatives — specialist decision only

Monitoring Maternal hepatic function; fetal growth surveillance

Parameter Information

Compatibility Unknown — no human lactation data available

Expected Milk Levels Unknown; animal studies show excretion in milk

Preferred Alternatives Liposomal amphotericin B if antifungal needed during lactation

Decision Avoid unless no suitable alternatives; risk-benefit discussion mandatory

Infant Monitoring Oral thrush, gastrointestinal disturbance, poor weight gain

Parameter Recommendation

Starting dose Standard adult dosing (no age-based adjustment)

Titration Not applicable

Special considerations Assess baseline hepatic function; elderly patients more likely to have underlying hepatic impairment

Extra monitoring Liver function tests; watch for slower drug clearance

Risk factors Co-morbidities affecting hepatic reserve; polypharmacy increasing interaction risk

Interacting Drug Effect & Mechanism Management

Cyclosporine Increases caspofungin AUC by ~35%; elevated hepatotoxicity risk Monitor LFTs closely; consider avoiding combination if alternative exists

Rifampicin Strong enzyme inducer — reduces caspofungin levels significantly Increase caspofungin maintenance dose to 70 mg daily

Carbamazepine Enzyme induction — decreased caspofungin concentrations Increase caspofungin maintenance dose to 70 mg daily

Efavirenz Enzyme induction — reduced caspofungin efficacy Increase caspofungin maintenance dose to 70 mg daily

Phenytoin Enzyme induction — may lower caspofungin levels Consider dose increase to 70 mg daily; monitor response

Interacting Drug Effect Management

Tacrolimus Slight reduction in tacrolimus levels (~20%) Monitor tacrolimus trough levels; adjust dose if needed

Dexamethasone May reduce caspofungin concentrations via mild induction Assess clinical antifungal response

Amphotericin B No pharmacokinetic interaction but additive toxicity monitoring required Monitor renal and hepatic parameters when used sequentially

Azole antifungals (fluconazole, voriconazole) No clinically significant interaction Safe for concurrent use if clinically indicated

• Fever

• Phlebitis and infusion site reactions

• Elevated hepatic transaminases (ALT/AST)

• Headache

• Nausea and vomiting

• Diarrhoea

• Hypokalaemia

• Rash

Adverse Effect Clinical Action

Anaphylaxis/Severe hypersensitivity Immediate discontinuation; supportive management

Severe hepatotoxicity Discontinue therapy; hepatology consultation

Stevens-Johnson Syndrome/TEN Immediate discontinuation; dermatology and ICU involvement

Haemolytic anaemia Discontinue; haematology referral

Severe infusion reactions (bronchospasm, hypotension, facial oedema) Stop infusion; provide symptomatic treatment; avoid rechallenge

After initiation Repeat LFTs at 3–5 days

During therapy Weekly LFTs if treatment exceeds 2 weeks

Throughout Monitor for clinical signs of infusion reactions; assess treatment response with repeat cultures

• Cancidas (MSD)

• Caspocan (Biocon)

• Funfi (Glenmark)

• Kosfung (Synokem)

• Casfung (Mylan)

• Caspogen (Hetero)

Note: Not included in NLEM 2022; prices vary considerably between brands and procurement channels (hospital vs retail).

• Caspofungin demonstrates fungicidal activity against Candida species but is only fungistatic against Aspergillus — hence reserved as salvage therapy for aspergillosis

• Preferred first-line agent for invasive candidiasis caused by fluconazole-resistant species (C. glabrata, C. krusei)

• Has no activity against Cryptococcus neoformans or Mucorales — do not use for cryptococcal meningitis or mucormycosis

• Must always be infused slowly over ≥1 hour to minimise histamine-mediated reactions

• When used with strong enzyme inducers (rifampicin, phenytoin), increase maintenance dose to 70 mg/day to maintain therapeutic levels

• Loading dose (70 mg) remains unchanged even in hepatic impairment — only maintenance dose requires reduction

Caspofungin; antifungal; echinocandin; invasive candidiasis; candidemia; aspergillosis salvage; fluconazole-resistant; febrile neutropenia; IV-only; hepatotoxicity monitoring

RxIndia v1.0 — 05 Jan 2025

• CDSCO Approved Drug Formulations Database

• Indian Pharmacopoeia 2022

• National Formulary of India 2021

• AIIMS Antifungal Treatment Protocols

• API Textbook of Medicine, 11th Edition

• ICMR Guidelines for Management of Invasive Fungal Infections

• Harrison's Principles of Internal Medicine, 21st Edition

• Indian Paediatric Infectious Diseases Expert Consensus (off-label paediatric uses)