Schedule H

Intravenous (IV), Oral

• Injection: 0.25 mg/5 mL vial (IV)

• Injection: 0.075 mg/1.5 mL vial (IV) — for PONV

• Capsule: 0.5 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) — Moderate to Highly Emetogenic Chemotherapy

A. Intravenous Route (Adults)

Step Dose Clinical Notes

Starting dose 0.25 mg IV single dose Administer as slow IV push over 30 seconds

Titration Not applicable Single-dose regimen

Usual maintenance dose 0.25 mg per chemotherapy cycle Given approximately 30 minutes before chemotherapy

Maximum dose 0.25 mg per cycle Do not repeat within 7 days

B. Oral Route (Adults)

Step Dose Clinical Notes

Starting dose 0.5 mg orally as single dose For moderately emetogenic chemotherapy

Titration Not applicable Single-dose regimen

Usual maintenance dose 0.5 mg per chemotherapy cycle Given approximately 1 hour before chemotherapy

Maximum dose 0.5 mg per day Do not exceed one dose per cycle

Key points:

• Prolonged half-life (~40 hours) provides coverage for both acute (0–24 hours) and delayed (24–120 hours) phases of CINV

• Often combined with dexamethasone ± NK1 receptor antagonist (aprepitant) for highly emetogenic regimens

• More effective than ondansetron for delayed CINV prevention

1. Prevention of Post-Operative Nausea and Vomiting (PONV)

Intravenous Route (Adults)

Step Dose Clinical Notes

Starting dose 0.075 mg IV single dose Administer as IV push over 10 seconds

Titration Not applicable Single-dose regimen

Usual maintenance dose 0.075 mg per surgical procedure Given immediately before induction of anaesthesia

Maximum dose 0.075 mg per procedure Do not repeat within same procedure

Key points:

• Superior efficacy for delayed PONV (24–72 hours post-surgery) compared to ondansetron

• PONV dose (0.075 mg) is NOT interchangeable with CINV dose (0.25 mg)

• Particularly useful in patients at high risk for PONV (female, non-smoker, history of motion sickness, opioid use)

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Radiation-Induced Nausea and Vomiting (RINV) 0.25 mg IV 30 min before radiotherapy Per radiotherapy session (as needed) OFF-LABEL; Specialist only; Evidence: Extrapolated from CINV data; some Indian oncology centres use for high-risk RINV (total body irradiation, upper abdominal radiation)

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Prevention of CINV in Children (≥1 month of age)

Intravenous Route — Weight/Age-Based Dosing

1 month to <6 months 10 mcg/kg IV single dose 0.25 mg

6 months to 17 years 20 mcg/kg IV single dose 1.5 mg

Administration:

• Administer as IV infusion over 15 minutes

• Give approximately 30 minutes before chemotherapy

• Usually combined with dexamethasone as part of antiemetic regimen

Safety monitoring:

• ECG monitoring recommended (QT interval) especially in patients with electrolyte abnormalities

• Monitor hepatic enzymes in patients receiving multiple cycles

• Observe for hypersensitivity reactions during first administration

Secondary Indications — Paediatrics (Off-label)

Indication Dose Duration Notes

PONV prophylaxis 1–1.5 mcg/kg IV (limited data) Single dose pre-induction OFF-LABEL; Specialist anaesthesia input required; Evidence: Limited paediatric trials; not well established in Indian paediatric protocols

Minimum age: Not recommended below 1 month of age due to insufficient safety and pharmacokinetic data

Notes:

• Palonosetron is not significantly removed by haemodialysis

• No supplemental dosing required in dialysis patients

• Timing of administration relative to dialysis is not critical

• Known hypersensitivity to palonosetron or other 5-HT3 receptor antagonists

• Concurrent use with apomorphine (risk of profound hypotension and loss of consciousness)

• QT interval prolongation or history of cardiac arrhythmias — palonosetron can prolong QTc; use with caution

• Concurrent use of other QT-prolonging drugs (antipsychotics, fluoroquinolones, antiarrhythmics)

• Electrolyte disturbances (hypokalaemia, hypomagnesaemia) — correct before administration

• Patients with intestinal obstruction or ileus — may mask symptoms due to antiemetic effect

• Serotonin syndrome risk when combined with serotonergic agents

• May impair alertness — advise caution with driving or operating machinery

Parameter Recommendation

Safety category Limited human data; animal studies did not show teratogenicity; use with caution

Preferred alternatives Ondansetron (more extensive pregnancy safety data in Indian obstetric practice); metoclopramide for mild nausea

When it may be used May be used if ondansetron ineffective or contraindicated; benefit should outweigh potential risk; oncologist input essential

Monitoring Maternal cardiac status (QT interval if risk factors); fetal growth monitoring with repeated exposure

Parameter Recommendation

Compatibility Unknown — excretion in human breast milk not established; likely low risk with single-dose use

Drug levels in milk Expected to be low (based on pharmacokinetic profile)

Preferred alternatives Ondansetron (more lactation-specific safety data available)

Infant monitoring If used, observe infant for irritability, feeding difficulties, sedation

• Recommended starting dose: No dose adjustment required; use standard adult doses

• Titration: Not applicable (single-dose regimen)

• Additional risks:

• Higher prevalence of QT prolongation and concurrent QT-prolonging medications

• Increased susceptibility to constipation

• More likely to have electrolyte disturbances — correct hypokalaemia/hypomagnesaemia before use

• Polypharmacy concerns — review concurrent medications

• Monitoring: ECG in patients with cardiac risk factors; assess bowel function

Drug Interaction Management

Apomorphine Risk of profound hypotension and loss of consciousness CONTRAINDICATED — do not use together

QT-prolonging drugs (haloperidol, droperidol, amiodarone, sotalol, quinidine, levofloxacin, moxifloxacin) Additive QT prolongation → increased risk of torsades de pointes Avoid concurrent use where possible; if essential, monitor ECG and electrolytes closely

Other 5-HT3 antagonists (ondansetron, granisetron) No additional antiemetic benefit; potential additive QT risk Avoid duplication of therapy

Drug Interaction Management

Serotonergic drugs (SSRIs, SNRIs, tramadol, fentanyl) Rare risk of serotonin syndrome Monitor for symptoms (agitation, hyperthermia, tremor, hyperreflexia); use with caution

Dexamethasone Commonly co-administered; additive hyperglycaemia and hypertension possible Standard combination for CINV prophylaxis; monitor blood glucose in diabetics

Anthracyclines (doxorubicin) Both may prolong QT interval Monitor ECG; ensure electrolyte balance

Metoclopramide Antagonistic effects on dopamine and serotonin receptors Generally avoid combination; choose one antiemetic agent

• Headache (most common)

• Constipation

• Fatigue

• Dizziness

• Diarrhoea

• Injection site reactions (IV administration)

Reaction Action Required

QT interval prolongation / Torsades de pointes Discontinue; ECG monitoring; correct electrolytes; cardiology input

Anaphylaxis / Severe hypersensitivity reaction Discontinue permanently; emergency management

Serotonin syndrome Discontinue serotonergic agents; supportive care; may require hospitalisation

Severe constipation / Ileus Symptomatic management; rule out obstruction

Transient hepatic enzyme elevation Monitor LFTs; usually self-limiting

During/After administration Vital signs within 1–2 hours of IV administration; observe for hypersensitivity during first dose

Long-term Not typically required due to single-dose regimen per cycle; reassess antiemetic efficacy each chemotherapy cycle

Single-ingredient:

• Palnox (Fresenius Kabi)

• Aloxi (Mylan/Viatris)

• Palzen (Sun Pharma)

• Paloset (Cipla)

• Grafnox (Glenmark)

• Ponfra (Intas)

Fixed-dose combinations:

NLEM status: Not included in NLEM 2022 — not under NPPA price ceiling

• Prolonged action advantage: Single pre-chemotherapy dose provides both acute and delayed CINV protection; eliminates need for multi-day dosing unlike ondansetron

• Dose differentiation: CINV dose (0.25 mg IV) and PONV dose (0.075 mg IV) are distinct — ensure correct dose for indication

• Combination therapy: For highly emetogenic chemotherapy (cisplatin, anthracycline-cyclophosphamide), combine with dexamethasone ± aprepitant for optimal control

• Not a rescue antiemetic: Palonosetron is for prevention only; do not use to treat established nausea and vomiting

• QT awareness: Lower QT prolongation risk compared to ondansetron, but still requires caution in at-risk patients

• Cost consideration: More expensive than ondansetron; reserve for moderate-highly emetogenic regimens or patients with inadequate response to ondansetron

chemotherapy; CINV; PONV; antiemetic; 5-HT3 antagonist; oncology; delayed emesis; renal-safe; QT prolongation; paediatric oncology

RxIndia v1.1 — 14 Jun 2025

• CDSCO Approved Product Information

• Indian Pharmacopoeia 2022

• API Textbook of Medicine (11th Edition)

• AIIMS Oncology Supportive Care Protocols

• AIIMS Anaesthesia PONV Guidelines

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (13th Edition)

• Harrison's Principles of Internal Medicine (21st Edition)

• MASCC/ESMO Antiemetic Guidelines (supportive reference for CINV risk stratification)