palonosetron

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Indications ⬇

REMS

Prevention of acute and delayed nausea and vomiting caused by initial or repeat courses of moderately or highly emetogenic chemotherapy (moderately emetogenic chemotherapy for adults only).
Prevention of postoperative nausea and vomiting for up to 24 hr after surgery.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity; cross sensitivity with other 5-HT₃ antagonists may occur.

Use Cautiously in:

OB: Safety not established in pregnancy
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
Pedi: Neonates <1 mo (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

GI: constipation, diarrhea.

Neuro: dizziness, headache.

Interactions ⬆ ⬇

Drug-Drug:

Drugs that affect serotonergic neurotransmitter systems, including SSRIs, SNRIs, tricyclic antidepressants, MAO inhibitors, fentanyl, lithium, buspirone, tramadol, methylene blue, and triptans ↑ risk of serotonin syndrome

Availability ⬆ ⬇

(Generic available)

Solution for injection: 0.05 mg/mL;
In combination with: fosnetupitant (Akynzeo); netupitant (Akynzeo); see Appendix [not included in this PDA edition].

Route/Dosage ⬆ ⬇

Prevention of Chemotherapy-Induced Nausea/Vomiting
IV (Adults): 0.25 mg given 30 min before start of chemotherapy.
IV (Children 1 mo–<17 yr): 20 mcg/kg (max dose = 1.5 mg) given 30 min before start of chemotherapy.
Prevention of Postoperative Nausea/Vomiting
IV (Adults): 0.075 mg given immediately before induction of anesthesia.

US Brand Names ⬆ ⬇

~~Aloxi~~

Action ⬆ ⬇

Blocks the effects of serotonin at receptor sites (selective antagonist) located in vagal nerve terminals and in the chemoreceptor trigger zones in the CNS.
Therapeutic Effects:
Decreased incidence and severity of nausea and vomiting following emetogenic chemotherapy or surgery.

Classifications ⬆ ⬇

Therapeutic Classification: antiemetics
Pharmacologic Classification: five ht3 antagonists

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.
Distribution: Well distributed to tissues.
Metabolism/Excretion: 50% metabolized by the liver via the CYP1A2, CYP2D6, and CYP3A4 isoenzymes to inactive metabolites; 40% excreted unchanged in urine.
Half-life: 40 hr.

Time/Action Profile ⬆ ⬇

ROUTE ONSET PEAK DURATION
IV within 30 min unknown 7 days

Patient/Family Teaching ⬆ ⬇

Inform patient of purpose of medication.
Advise patient to notify health care professional if nausea or vomiting occur.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

pa-lone-O-se-tron

Code ⬆

NDC Code^*
0143- West-Ward Pharmaceuticals Corp
0143-9513- Palonosetron Hydrochloride 0143-9513-01- 2 mL in 1 VIAL (0143-9513-01)
0409- Hospira, Inc.
0409-2504- Palonosetron Hydrochloride 0409-2504-10- 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-2504-10) > 5 mL in 1 VIAL, SINGLE-DOSE
0703- Teva Parenteral Medicines, Inc.
0703-4094- Palonosetron Hydrochloride 0703-4094-01- 1 VIAL, SINGLE-USE in 1 CARTON (0703-4094-01) > 5 mL in 1 VIAL, SINGLE-USE
0781- Sandoz Inc
0781-3312- Palonosetron Hydrochloride 0781-3312-75- 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3312-75) > 5 mL in 1 VIAL, SINGLE-DOSE
0781- Sandoz Inc
0781-3415- Palonosetron Hydrochloride 0781-3415-75- 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-75) > 5 mL in 1 VIAL, SINGLE-DOSE
16714- NorthStar Rx LLC
16714-834- Palonosetron 16714-834-01- 1 VIAL, SINGLE-USE in 1 CARTON (16714-834-01) > 5 mL in 1 VIAL, SINGLE-USE
16729- Accord Healthcare, Inc.
16729-365- palonosetron hydrochloride 16729-365-66- 1 VIAL in 1 CARTON (16729-365-66) > 5 mL in 1 VIAL
25021- Sagent Pharmaceuticals
25021-783- palonosetron hydrochloride 25021-783-05- 1 VIAL in 1 CARTON (25021-783-05) > 5 mL in 1 VIAL
25021- Sagent Pharmaceuticals
25021-788- palonosetron hydrochloride 25021-788-74- 5 SYRINGE in 1 CARTON (25021-788-74) > 5 mL in 1 SYRINGE
55111- Dr.Reddy's Laboratories Limited
55111-694- Palonosetron 55111-694-07- 1 VIAL, SINGLE-USE in 1 CARTON (55111-694-07) > 5 mL in 1 VIAL, SINGLE-USE
55111- Dr.Reddy's Laboratories Limited
55111-694- Palonosetron 55111-694-19- 5 VIAL, SINGLE-USE in 1 CARTON (55111-694-19) > 1.5 mL in 1 VIAL, SINGLE-USE (55111-694-15)
55150- AuroMedics Pharma LLC
55150-186- Palonosetron Hydrochloride 55150-186-05- 1 VIAL, SINGLE-USE in 1 CARTON (55150-186-05) > 5 mL in 1 VIAL, SINGLE-USE
60505- Apotex Corp.
60505-6193- Palonosetron 60505-6193-1- 1 VIAL in 1 CARTON (60505-6193-1) > 5 mL in 1 VIAL
63323- Fresenius Kabi USA, LLC
63323-673- Palonosetron 63323-673-89- 10 SYRINGE, PLASTIC in 1 CARTON (63323-673-89) > 5 mL in 1 SYRINGE, PLASTIC (63323-673-21)
63323- Fresenius Kabi USA, LLC
63323-673- Palonosetron 63323-673-05- 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-673-05) > 5 mL in 1 VIAL, SINGLE-DOSE
63323- Fresenius Kabi USA, LLC
63323-942- Palonosetron 63323-942-05- 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-942-05) > 5 mL in 1 VIAL, SINGLE-DOSE (63323-942-41)
63323- Fresenius Kabi USA, LLC
63323-942- Palonosetron 63323-942-90- 10 SYRINGE in 1 CARTON (63323-942-90) > 5 mL in 1 SYRINGE (63323-942-42)
67184- Qilu Pharmaceutical Co., Ltd.
67184-0514- Palonosetron 67184-0514-1- 1 VIAL in 1 CARTON (67184-0514-1) > 5 mL in 1 VIAL
67184- Qilu Pharmaceutical Co., Ltd.
67184-0515- Palonosetron 67184-0515-2- 5 VIAL in 1 CARTON (67184-0515-2) > 1.5 mL in 1 VIAL (67184-0515-1)
67457- Mylan Institutional LLC
67457-317- Palonosetron Hydrochloride 67457-317-25- 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-317-25) > 5 mL in 1 VIAL, SINGLE-DOSE
68001- BluePoint Laboratories
68001-355- Palonosetron 68001-355-25- 1 VIAL, SINGLE-USE in 1 CARTON (68001-355-25) > 5 mL in 1 VIAL, SINGLE-USE
69097- Cipla USA Inc.
69097-927- palonosetron hydrochloride 69097-927-35- 1 VIAL in 1 CARTON (69097-927-35) > 5 mL in 1 VIAL
69543- Virtus Pharmaceuticals, LLC
69543-371- Palonosetron hydrochloride 69543-371-10- 10 CARTON in 1 BOX (69543-371-10) > 1 VIAL in 1 CARTON (69543-371-01) > 5 mL in 1 VIAL
69639- Helsinn Therapeutics (U.S.), Inc.
69639-103- Aloxi 69639-103-01- 1 VIAL in 1 CARTON (69639-103-01) > 5 mL in 1 VIAL
69639- Helsinn Therapeutics (U.S.), Inc.
69639-103- Aloxi 69639-103-05- 1 VIAL in 1 CARTON (69639-103-05) > 1.5 mL in 1 VIAL