- Indications and Usage Highly Emetic Chemotherapy: Indicated for the prevention of acute and delayed nausea and vomiting (ANV and DNV) associated with initially administered highly emetogenic chemotherapy (HEC). Moderately Emetic Chemotherapy: Indicated for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic chemotherapy (MEC).
- Dosage and Administration Recommended Dosage: The recommended dosage for adults is one hard capsule (containing 300 mg netupitant and 0.5 mg palonosetron hydrochloride). Timing: Administer orally approximately 1 hour prior to the start of chemotherapy. Dexamethasone Dose Adjustment: When used in combination with chemotherapy, the recommended oral dose of dexamethasone must be reduced by approximately 50% to avoid drug-drug interactions. Administration Details: The hard capsule should be swallowed whole. It can be taken with or without food.
- Mechanism of Action NK-1 Receptor Antagonism: Netupitant is a potent, selective antagonist of the neurokinin-1 (NK-1) receptor, which blocks substance P (the primary ligand) from binding, thereby inhibiting the signaling pathway that triggers nausea and vomiting. 5-HT3 Receptor Antagonism: Palonosetron is a selective 5-hydroxytryptamine-3 (5-HT3) receptor antagonist with a unique binding mode that provides a longer duration of action and prevents serotonin-mediated emetic signaling. Synergistic Effect: The combination provides comprehensive antiemetic protection against both acute and delayed phases of chemotherapy-induced nausea and vomiting.
- Safety and Warnings Cardiac Toxicity: Palonosetron, like other 5-HT3 receptor antagonists, may cause QT/QTc interval prolongation. Caution is advised in patients with a history of arrhythmia or those taking medications known to prolong the QT interval. Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. Constipation: Severe constipation and ileus can occur due to the pharmacological action of both agents on the gastrointestinal tract. Severe Hepatic Impairment: There is limited clinical data on the use of this combination in patients with severe hepatic impairment (Child-Pugh score ≥9); therefore, it should be used with caution in this population.
- Adverse Reactions and Clinical Research Most Common Adverse Reactions: The most frequently reported adverse reactions include headache, constipation, fatigue, and asthenia. Clinical Research Highlights: Clinical trials demonstrated that the combination of netupitant and palonosetron with dexamethasone significantly improved the complete response rates (absence of vomiting and severe nausea) for both acute and delayed CINV compared to control regimens.
- Drug Interactions CYP3A4 Inhibitors and Inducers: Netupitant is metabolized by CYP3A4. Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole) can increase netupitant plasma concentrations, while strong CYP3A4 inducers (e.g., rifampin, carbamazepine) can decrease them. Dexamethasone: As netupitant is a moderate CYP3A4 inhibitor, it can significantly increase the plasma exposure of dexamethasone. Mandatory dose reduction of dexamethasone is required when co-administered.
- Pharmaceutical Information Chemical Composition: Active ingredients: Netupitant and Palonosetron hydrochloride. Appearance: Hard gelatin capsules with a black cap and a caramel-colored body, printed with “HE1” in white ink. The contents consist of three tablets of netupitant and one soft capsule of palonosetron hydrochloride. Packaging: Supplied in blister packs (e.g., 1 or 4 capsules per pack). Storage: Store at room temperature (15°C to 30°C). Keep the capsules in the original package to protect from moisture and light.
Aokangze Netupitant and Palonosetron Hydrochloride Capsules
Brand Name:奥康泽 ®（Aokangze®）
Generic Name: Netupitant and Palonosetron Hydrochloride
Strength: Per capsule: Netupitant 0.3 g, Palonosetron Hydrochloride 0.5 mg; 1 capsule per box
Manufacturer: Helsinn Birex Pharmaceuticals Ltd.
Marketing Authorization Holder: Helsinn Healthcare SA
Approval Date in China: August 2, 2019
Registration Number: 国药准字HJ20190046
Storage: Store at controlled room temperature (15–30°C), protected from light and moisture. Do not freeze. Refer to the full package insert for detailed storage specifications.
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