palonosetron

Therapeutic Classification: antiemetics

Pharmacologic Classification: five ht3 antagonists

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.

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.

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.

ROUTE	ONSET	PEAK	DURATION
IV	within 30 min	unknown	7 days

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).

Drug-drug:

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

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.

(Generic available)

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

Assess for nausea, vomiting, abdominal distention, and bowel sounds before and following administration.
Assess for signs/symptoms of serotonin syndrome (confusion, delirium, agitation, coma, dilated pupils, tachycardia, hyperthermia, shivering, hyperreflexia, muscle rigidity, hypertension, vomiting, diarrhea, seizures). ↑ risk of serotonin syndrome with concurrent use of other serotonergic drugs (SSRIs, SNRIs, triptans). If serotonin syndrome suspected, discontinue palonosetron.

Lab Test Considerations:

May transiently ↑ bilirubin, AST, and ALT.

1st dose is administered prior to emetogenic event.
- Repeated dose within a 7-day period is not recommended.

IV Administration:

IV Push: Administer dose undiluted 30 min before chemotherapy or immediately prior to the induction of anesthesia. Flush line before and after administration with 0.9% NaCl. Do not administer solutions that are discolored or contain particulate matter.
Rate: In adults, administer over 30 sec 30 min before starting chemotherapy and over 10 sec for postoperative nausea and vomiting. In children, administer over 15 min 30 min before starting chemotherapy.
Y-Site Compatibility:
- alemtuzumab
- amikacin
- aminocaproic acid
- aminophylline
- amiodarone
- amphotericin B liposomal
- ampicillin
- ampicillin/sulbactam
- anidulafungin
- argatroban
- atropine
- azithromycin
- aztreonam
- bivalirudin
- bleomycin
- bumetanide
- buprenorphine
- busulfan
- butorphanol
- calcium acetate
- calcium chloride
- calcium gluconate
- carboplatin
- carmustine
- caspofungin
- cefazolin
- cefepime
- cefotaxime
- cefotetan
- cefoxitin
- ceftazidime
- ceftriaxone
- cefuroxime
- chloramphenicol
- chlorpromazine
- ciprofloxacin
- cisatracurium
- cisplatin
- clindamycin
- cyclophosphamide
- cyclosporine
- cytarabine
- dacarbazine
- dactinomycin
- dantrolene
- daptomycin
- daunorubicin
- dexamethasone
- dexmedetomidine
- dexrazoxane
- digoxin
- diltiazem
- diphenhydramine
- dobutamine
- docetaxel
- dopamine
- doxorubicin hydrochloride
- doxorubicin liposomal
- droperidol
- enalaprilat
- ephedrine
- epinephrine
- epirubicin
- eptifibatide
- erythromycin
- esmolol
- etoposide
- etoposide phosphate
- famotidine
- fentanyl
- fluconazole
- fludarabine
- fluorouracil
- fosaprepitant
- foscarnet
- fosphenytoin
- furosemide
- gemcitabine
- gentamicin
- glycopyrrolate
- haloperidol
- heparin
- hydralazine
- hydrocortisone
- hydromorphone
- idarubicin
- ifosfamide
- insulin regular
- irinotecan
- isoproterenol
- ketorolac
- labetalol
- leucovorin
- levofloxacin
- lidocaine
- linezolid
- lorazepam
- magnesium sulfate
- mannitol
- melphalan
- meperidine
- meropenem
- mesna
- methadone
- methotrexate
- metoclopramide
- metoprolol
- metronidazole
- midazolam
- milrinone
- mitomycin
- mitoxantrone
- morphine
- moxifloxacin
- nalbuphine
- naloxone
- neostigmine
- nicardipine
- nitroglycerin
- nitroprusside
- norepinephrine
- octreotide
- oxaliplatin
- oxytocin
- paclitaxel
- paclitaxel protein bound
- pamidronate
- phenobarbital
- phentolamine
- phenylephrine
- piperacillin/tazobactam
- potassium acetate
- potassium chloride
- potassium phosphates
- procainamide
- prochlorperazine
- promethazine
- propofol
- propranolol
- remifentanil
- rocuronium
- sodium acetate
- sodium bicarbonate
- sodium phosphates
- succinylcholine
- sufentanil
- tacrolimus
- theophylline
- thiotepa
- tigecycline
- tirofiban
- tobramycin
- topotecan
- trimethoprim/sulfamethoxazole
- vancomycin
- vasopressin
- vecuronium
- verapamil
- vinblastine
- vincristine
- vinorelbine
- zidovudine
Y-Site Incompatibility:
- acyclovir
- allopurinol
- amphotericin B deoxycholate
- diazepam
- doxycycline
- ganciclovir
- gemtuzumab ozogamicin
- imipenem/cilastatin
- letermovir
- methylprednisolone
- minocycline
- nafcillin
- pantoprazole
- pentamidine
- pentobarbital
- phenytoin

Explain the purpose and side effects of palonosetron. Advise patient to read Medication Guide before starting and periodically during therapy in case of changes.
Advise patient to notify health care provider if nausea or vomiting occur.
Counsel patient to report symptoms of serotonin syndrome (confusion, sweating, fast heartbeat, fever, vomiting, hallucinations, muscle spasms, tremors, twitching).
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy or surgery.

NDC Code

0143- West-Ward Pharmaceuticals Corp
- 0143-9513- Palonosetron Hydrochloride
  - 0143-9513-01- 2 mL in 1 VIAL (0143-9513-01)

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
- 0781-3312- Palonosetron Hydrochloride
  - 0781-3312-95- 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3312-95) / 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

0781- Sandoz Inc
- 0781-3415- Palonosetron Hydrochloride
  - 0781-3415-95- 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-95) / 5 mL in 1 VIAL, SINGLE-DOSE

11014- Catalent Pharma Solutions, LLC
- 11014-0199-
  - 11014-0199-1- 1 BAG in 1 CARTON (11014-0199-1) / 10000 CAPSULE in 1 BAG

14593- Emcure Pharmaceuticals Limited
- 14593-846-
  - 14593-846-01- 5 kg in 1 JAR (14593-846-01)

14593- Emcure Pharmaceuticals Limited
- 14593-846-
  - 14593-846-02- 15 kg in 1 DRUM (14593-846-02)

14593- Emcure Pharmaceuticals Limited
- 14593-846-
  14593-846-03- 50 kg in 1 DRUM (14593-846-03)

14593- Emcure Pharmaceuticals Limited
- 14593-846-
  14593-846-04- 6 kg in 1 DRUM (14593-846-04)

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

25021- Sagent Pharmaceuticals
- 25021-783- palonosetron hydrochloride
  - 25021-783-05- 1 VIAL in 1 CARTON (25021-783-05) / 5 mL in 1 VIAL

36000- Baxter Healthcare Corporation
- 36000-326- Palonosetron Hydrochloride
  - 36000-326-02- 1 VIAL in 1 CARTON (36000-326-02) / 5 mL in 1 VIAL (36000-326-01)

47848- Teva Czech Industries s.r.o
- 47848-027-
  - 47848-027-00- 1 kg in 1 CARTON (47848-027-00)

53104- Cipla Ltd.
- 53104-7733-
  53104-7733-1- 25 kg in 1 CONTAINER (53104-7733-1)

54893- MSN Laboratories Private Limited
- 54893-0013-
  54893-0013-6- 3 kg in 1 DRUM (54893-0013-6)

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)

55111- Dr.Reddy's Laboratories Limited
- 55111-914-
  - 55111-914-00- 1 kg in 1 DRUM (55111-914-00)

55150- Eugia US 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

58175- Wavelength Enterprises LTD
- 58175-0543-
  - 58175-0543-0- 1 BAG in 1 DRUM (58175-0543-0) / 50 kg in 1 BAG

60505- Apotex Corp.
- 60505-6193- Palonosetron
  60505-6193-1- 1 VIAL in 1 CARTON (60505-6193-1) / 5 mL in 1 VIAL

60505- Apotex Corp.
- 60505-6193- Palonosetron
  - 60505-6193-4- 10 VIAL in 1 CARTON (60505-6193-4) / 5 mL in 1 VIAL

60862- TYCHE INDUSTRIES LIMITED
- 60862-003-
  - 60862-003-01- 1 BAG in 1 BOTTLE (60862-003-01) / 1 kg in 1 BAG

60862- TYCHE INDUSTRIES LIMITED
- 60862-003-
  60862-003-02- 1 BAG in 1 BOTTLE (60862-003-02) / .75 kg in 1 BAG

60862- TYCHE INDUSTRIES LIMITED
- 60862-003-
  60862-003-03- 1 BAG in 1 BOTTLE (60862-003-03) / .5 kg in 1 BAG

60862- TYCHE INDUSTRIES LIMITED
- 60862-003-
  60862-003-04- 1 BAG in 1 BOTTLE (60862-003-04) / .25 kg in 1 BAG

60862- TYCHE INDUSTRIES LIMITED
- 60862-003-
  60862-003-05- 1 BAG in 1 BOTTLE (60862-003-05) / .1 kg in 1 BAG

62147- USV Private Limited
- 62147-0218-
  62147-0218-0- 25 kg in 1 DRUM (62147-0218-0)

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
- 63323-673- Palonosetron
  - 63323-673-89- 10 SYRINGE, PLASTIC in 1 CARTON (63323-673-89) / 5 mL in 1 SYRINGE, PLASTIC (63323-673-21)

63827- Rolabo Outsourcing S.L.
- 63827-1011-
  - 63827-1011-1- 1 BAG in 1 DRUM (63827-1011-1) / .1 kg in 1 BAG

65862- Aurobindo Pharma Limited
- 65862-736-
  65862-736-37- 50 kg in 1 DRUM (65862-736-37)

67184- Qilu Pharmaceutical Co. Ltd.
- 67184-0013-
  67184-0013-1- 1 kg in 1 DRUM (67184-0013-1)

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)

67262- HAS Healthcare Advanced Synthesis SA
- 67262-0001-
  - 67262-0001-1- 1 kg in 1 JAR (67262-0001-1)

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

71288- Meitheal Pharmaceuticals Inc.
- 71288-409- Palonosetron Hydrochloride
  - 71288-409-05- 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-409-05) / 5 mL in 1 VIAL, SINGLE-DOSE

83634- Avenacy, Inc.
- 83634-777- Palonosetron Hydrochloride
  - 83634-777-05- 1 VIAL, SINGLE-DOSE in 1 CARTON (83634-777-05) / 5 mL in 1 VIAL, SINGLE-DOSE

83831- Avyxa Pharma, LLC
- 83831-105- posfrea
  - 83831-105-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE

84644- TAPI Czech Industries s.r.o.
- 84644-027-
  - 84644-027-00- 1 kg in 1 CARTON (84644-027-00)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆