Paloxi0.5 mg

Chemotherapy-Induced Nausea and Vomiting (CINV) — Established, Adults

Intravenous Paloxi is indicated for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy, and for the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. The oral (tablet/capsule) formulation of Paloxi is indicated for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy in adults; it is not established for the delayed phase or for highly emetogenic regimens.

Postoperative Nausea and Vomiting (PONV) — Established, Adults

Intravenous Paloxi is indicated for the prevention of postoperative nausea and vomiting for up to 24 hours following surgery.

Chemotherapy-Induced Nausea and Vomiting (CINV) — Established, Pediatric Patients

Intravenous Paloxi is indicated in pediatric patients 1 month to less than 17 years of age for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy. A pediatric indication for the oral formulation and for PONV prevention has not been established.

Palonosetron (as Palonosetron Hydrochloride) — available as IV injection 0.075 mg/1.5 mL and 0.25 mg/5 mL single-use vials, and as an oral tablet/capsule containing 0.5 mg.

Paloxi is a prescription antiemetic medicine used to prevent the nausea and vomiting that can occur with certain cancer chemotherapy regimens and, in its injectable form, after surgery. It belongs to a class of medicines called 5-HT3 receptor antagonists, which work by blocking a chemical in the body (serotonin) that triggers the vomiting reflex. Paloxi is usually given as a single dose timed around the chemotherapy session or surgical procedure rather than as an ongoing daily medicine. It is available in Bangladesh both as an intravenous injection, typically given by a healthcare professional, and as an oral tablet/capsule. Because dosing and formulation depend on the exact clinical situation, Paloxi should only be used under medical supervision.

Antiemetic (5-HT3 Receptor Antagonist)

Palonosetron is a highly selective serotonin 5-HT3 receptor antagonist. Compared with older agents in its class, Palonosetron has a notably long elimination half-life of approximately 40 hours in adults, which is believed to contribute to its sustained antiemetic effect across both the acute and delayed phases of chemotherapy-induced nausea and vomiting. It undergoes partial hepatic metabolism (via CYP2D6 as the primary pathway, with lesser contribution from CYP3A4 and CYP1A2) to largely inactive metabolites, and approximately 40% is excreted unchanged in the urine.

The intravenous form of Paloxi is administered by a healthcare professional as a slow IV push (10 or 30 seconds, depending on indication) or, for the pediatric CINV dose, as a 15-minute IV infusion; it is supplied as a ready-to-use solution that does not require dilution for the standard IV push doses. If given through an existing IV line, the line should be flushed with normal saline before and after administration. The oral tablet/capsule form of Paloxi is swallowed by mouth with or without food, timed before the chemotherapy session as directed by the prescriber. Because the correct formulation, dose, and timing depend on the indication, Paloxi should be given strictly according to the prescriber's instructions.

• Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs, tramadol, fentanyl): concomitant use with Paloxi carries a reported risk of serotonin syndrome; see Precautions and Warnings for the full clinical explanation.
• QT-interval–prolonging drugs or conditions: caution is advised with concomitant use, although dedicated studies have not shown a clinically significant QT effect with Paloxi itself; see Precautions and Warnings.
• CYP2D6, CYP3A4, and CYP1A2 substrates/inhibitors/inducers: Paloxi does not significantly inhibit or induce these major hepatic enzymes, and clinically significant pharmacokinetic interactions have not been demonstrated.
• Corticosteroids, analgesics, other antiemetics, and anticholinergics: no clinically significant interaction was observed when these were co-administered with Paloxi in clinical trials.

Common Side Effects

Headache, constipation, dizziness, diarrhea, and fatigue are the most commonly reported side effects of Paloxi.

Serious Side Effects — Seek Medical Attention

Seek prompt medical attention for signs of a hypersensitivity reaction (including anaphylaxis), such as rash, swelling of the face/throat, severe itching, or difficulty breathing, which have been reported with intravenous Paloxi. Also seek medical attention for symptoms suggestive of serotonin syndrome or for palpitations, irregular heartbeat, dizziness, or fainting that could indicate a cardiac rhythm disturbance — see Precautions and Warnings for details on both.

Pregnancy

There are no adequate and well-controlled studies of Paloxi in pregnant women. Animal reproduction studies did not show evidence of harm to the fetus, but these were conducted at exposures many times higher than the recommended human dose, and animal data do not reliably predict human response. As with other 5-HT3 receptor antagonists, Paloxi should be used during pregnancy only if the potential benefit justifies the potential unknown risk to the fetus, and only under a physician's guidance.

Breastfeeding

It is not known whether Paloxi is excreted in human breast milk. Because many drugs pass into breast milk, a decision should be made, in consultation with a physician, whether to discontinue breastfeeding or discontinue Paloxi, weighing the benefit of treatment against the potential unknown risk to the nursing infant.

• Serotonin syndrome: Concomitant use of Paloxi with other serotonergic drugs (such as SSRIs, SNRIs, MAOIs, tramadol, or fentanyl) has been associated with reports of serotonin syndrome. Symptoms can include mental status changes (agitation, hallucinations, delirium, coma), autonomic instability (tachycardia, labile blood pressure, diaphoresis, hyperthermia), neuromuscular symptoms (tremor, rigidity, myoclonus, hyperreflexia, incoordination), and seizures, sometimes with gastrointestinal symptoms. Patients should be monitored, and Paloxi should be discontinued if these symptoms occur.
• Cardiac (QT interval) effects: As a class, 5-HT3 receptor antagonists have been associated with changes in cardiac conduction. For Paloxi specifically, a dedicated thorough QT study found no clinically significant effect on the QTc interval at doses up to 2.25 mg (several times the highest recommended dose), and in postoperative nausea and vomiting trials its effect on the QTc interval was no different from placebo. Nonetheless, caution is advised when using Paloxi in patients with electrolyte abnormalities (hypokalemia or hypomagnesemia), congenital long QT syndrome, concomitant use of other QT-prolonging drugs, or cumulative high-dose anthracycline exposure.
• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported with intravenous Paloxi, including in patients without a known prior reaction to other 5-HT3 receptor antagonists. Discontinue immediately and provide appropriate medical management if a reaction occurs.
• Not for repeated short-interval dosing: Repeating a Paloxi dose within 7 days is not recommended, as safety and efficacy data supporting repeated dosing in this interval are insufficient.

There is no specific antidote for Paloxi overdose; management should be symptomatic and supportive. In clinical studies, intravenous doses up to 25 times the recommended dose did not reveal a clear dose-related pattern of adverse effects beyond those seen at recommended doses. Because Paloxi is typically administered by a healthcare professional in a clinical setting (hospital, chemotherapy unit, or operating theatre), accidental overdose by patients is uncommon. If an overdose is suspected, contact a physician, hospital emergency department, or the National Poison Information Centre promptly for guidance; do not attempt to induce vomiting unless specifically directed by a healthcare professional. Given Paloxi's large volume of distribution, hemodialysis is not expected to be an effective means of removing the drug.

Store Paloxi according to the instructions on the specific product label, out of reach of children. For reference, the manufacturer's prescribing information for the injection and oral capsule formulations specifies storage at 20–25°C (68–77°F), with excursions permitted to 15–30°C (59–86°F); the product should be protected from light, and the injection should additionally be protected from freezing. Always check the storage instructions printed on the pack of the specific brand dispensed.

Children

The intravenous form of Paloxi is established for the prevention of acute chemotherapy-induced nausea and vomiting (including with highly emetogenic chemotherapy) in pediatric patients aged 1 month to less than 17 years, at a weight-based dose (20 mcg/kg, maximum 1.5 mg). Use for postoperative nausea and vomiting, and use of the oral tablet/capsule formulation, have not been established in pediatric patients.

Elderly

No dose adjustment of Paloxi is required based on age alone. Clinical studies have not shown clinically meaningful differences in safety or effectiveness between elderly and younger adult patients.

Renal Impairment

No dose adjustment is required in patients with mild to moderate renal impairment. In severe renal impairment, exposure to Paloxi is increased by approximately 28%, which is not considered clinically meaningful, and no dose adjustment is recommended.

Hepatic Impairment

Hepatic impairment does not significantly affect the clearance of Paloxi, and no dose adjustment is recommended.

Paloxi is typically given as a single dose per chemotherapy cycle (before each cycle) or as a single dose before a surgical procedure, rather than as a continuous or daily medicine. Repeat dosing within 7 days is not recommended.

5-HT3 (Serotonin Type 3) Receptor Antagonist; Antiemetic

Palonosetron selectively binds to and antagonizes serotonin type 3 (5-HT3) receptors located on vagal nerve afferents in the periphery and in the chemoreceptor trigger zone of the central nervous system. By blocking these receptors, Palonosetron prevents serotonin released during chemotherapy or surgery from triggering the vomiting reflex.

The intravenous formulation of Paloxi has established safety and efficacy for the prevention of acute chemotherapy-induced nausea and vomiting, including with highly emetogenic chemotherapy, in pediatric patients from 1 month up to less than 17 years of age, using a weight-based dose (20 mcg/kg, maximum 1.5 mg). Paloxi has not been established as safe and effective for postoperative nausea and vomiting in pediatric patients, and the oral tablet/capsule formulation of Paloxi has not been established for use in children below 18 years of age.