palonosetron


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palonosetron

(pa-lone-o-se-tron) ,

Aloxi

(trade name)

Classification

Therapeutic: antiemetics
Pharmacologic: five ht3 antagonists
Pregnancy Category: B

Indications

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

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.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability; oral bioavailability = 97%.
Distribution: Unknown.
Metabolism and Excretion: 50% metabolized; 40% excreted unchanged in urine.
Half-life: 40 hr.

Time/action profile

ROUTEONSETPEAKDURATION
IVwithin 30 minunknown7 days
POwithin 1 hrunknown7 days

Contraindications/Precautions

Contraindicated in: Hypersensitivity; cross sensitivity with other 5-HT3 antagonists may occur; Lactation: Lactation.
Use Cautiously in: Obstetric / Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache

Gastrointestinal

  • constipation
  • diarrhea

Interactions

Drug-Drug interaction

None significant.

Route/Dosage

Intravenous (Adults) Prevention of chemotherapy-induced nausea/vomiting—0.25 mg 30 min before start of chemotherapy; Prevention of PONV—0.075 mg given immediately before induction of anesthesia.
Oral (Adults) 0.5 mg given 1 hr before start of chemotherapy.

Availability (generic available)

Solution for IV injection: 0.05 mg/mL
Capsules: 0.5 mg

Nursing implications

Nursing assessment

  • Assess patient for nausea, vomiting, abdominal distention, and bowel sounds prior to and following administration.
  • Lab Test Considerations: May cause transient ↑ in serum bilirubin, AST, and ALT levels.

Potential Nursing Diagnoses

Imbalanced nutrition: less than body requirements (Indications)
Diarrhea (Side Effects)
Constipation (Side Effects)

Implementation

  • First dose is administered prior to emetogenic event.
    • Repeated dose within a 7-day period is not recommended.
  • Oral: May be administered with or without food 1 hr prior to the start of chemotherapy.
  • Intravenous Administration
  • pH: 4.5–5.5.
  • Administer dose undiluted 30 min prior to chemotherapy or immediately prior to the induction of anesthesia. Flush line prior to and after administration with 0.9% NaCl. Do not administer solutions that are discolored or contain particulate matter.
  • Concentration: 0.05 mg/mL.
  • Rate: Administer over 30 seconds for chemotherapy and over 10 seconds for postoperative nausea and vomiting.
  • Syringe Compatibility: dexamethasone
  • Y-Site Compatibility: alfentanil, amifostine, amikacin, aminocaproic acid, aminophylline, amiodarone, amphotericin B liposome, ampicillin, ampicillin/sulbactam, atracurium, 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 sodium phosphate, dexmedetomidine, dexrazoxane, digoxin, diltiazem, diphenhydramine, dobutamine, docetaxel, dopamine, doxacurium, doxorubicin hydrochloride, droperidol, enalaprilat, ephedrine, epinephrine, epirubicin, eptifibitide, erythromycin, esmolol, etoposide, etoposide phosphate, famotidine, fenoldopam, fentanyl, fluconazole, fludarabine, fluorouracil, foscarnet, fosphenytoin, furosemide, gemcitabine, gentamicin, glycopyrrolate, haloperidol, heparin, hydralazine, hydrocortisone, hydromorphone, idarubicin, ifosfamide, insulin, irinotecan, isoproterenol, ketorolac, labetalol, leucovorin, levofloxacin, lidocaine, linezolid, lorazepam, magnesium sulfate, mannitol, mechlorethamine, melphalan, meperidine, meropenem, mesna, metaraminol, methotrexate, methyldopate, metoclopramide, metoprolol, metronidazole, midazolam, milrinone, mitomycin, mitoxantrone, morphine, nalbuphine, naloxone, neostigmine, nesiritide, nicardipine, nitroglycerin, nitroprusside, norepinephrine, octreotide, oxaliplatin, oxytocin, paclitaxel, pamidronate, pancuronium, pentazocine, phenobarbital, phentolamine, phenylephrine, piperacillin/tazobactam, potassium acetate, potassium chloride, potassium phosphates, procainamide, prochlorperazine, promethazine, propranolol, quinupristin/dalfopristin, ranitidine, remifentanil, rocuronium, sodium acetate, sodium bicarbonate, sodium phosphates, streptozocin, succinylcholine, sufentanil, tacrolimus, teniposide, theophylline, thiotepa, ticarcillin/clavulanate, tigecycline, tirofiban, tobramycin, topotecan, trimethoprim/sulfamethoxazole, vancomycin, vasopressin, vecuronium, verapamil, vinblastine, vincristine, vinorelbine, zidovudine
  • Y-Site Incompatibility: acyclovir, allopurinol, amphotericin B colloidal, diazepam, doxycycline, ganciclovir, imipenem/cilastatin, methylprednisolone, minocycline, nafcillin, pantoprazole, pentamidine, pentobarbital, phenytoin, thiopental

Patient/Family Teaching

  • Inform patient of purpose of medication.
  • Advise patient to notify health care professional if nausea or vomiting occur.

Evaluation/Desired Outcomes

  • Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy or surgery.
References in periodicals archive ?
Bala I et al [19] found the requirement of rescue antiemetic was 9 (21.4%) vs 4 (9.6%) in palonosetron group and palonosetron-dexamethasone group during 0-2 hrs.
(Headquarters: Lugano, Switzerland, CEO: Riccardo Braglia, "Helsinn") in the patent infringement lawsuit for antiemetic agent ALOXI (palonosetron hydrochloride) brought by Helsinn together with Roche Palo Alto LLC (Roche) against Teva Pharmaceuticals USA, Inc.
Four of the approvals involved drug combinations: Zerbaxa (ceftolozane, a cephalosporin and tazobactam, a beta-lactamase inhibitor) for complicated intra-abdominal or urinary tract infections; Viekira Pak (ombitasvir, paritaprevir, and ritonavir copackaged with dasabuvir) for treatment of chronic hepatitis C virus genotype 1 infection; Akynzeo (netupitant and palonosetron) for nausea and vomiting due to cancer chemotherapy; and Harvoni (ledipasvir and sofosbuvir) for chronic hepatitis C virus genotype 1 infection.
The UK firm has also agreed to buy Helsinna[euro](tm)s licensing rights to fixed dose combination of netupitant and palonosetron (NETU-PALO FDC), a treatment for the prevention of nausea and vomiting associated with chemotherapy, for a total of EUR3m, including milestone payments of EUR2.5m.Country: , IrelandSector: Wholesale/Retail, PharmaceuticalsTarget: Helsinn Birex Therapeutics LtdBuyer: IS Pharma PlcVendor: Helsinn Healthcare SADeal size in USD: 5.7mType: Corporate acquisitionFinancing: Cash & StockStatus: Agreed
The first packaging run has been completed for a study involving the Groups lead compound Palonosetron (ALOXI, ONICIT).
The Food and Drug Administration has approved a capsule formulation of palonosetron for prevention of chemotherapy-induced nausea and vomiting, according to the drug's manufacturer, Eisai Co.
Sales of Aloxi(R) (palonosetron hydrochloride) Injection are expected to total approximately $63 million for the first quarter of 2006.
Helsinn Healthcare SA, Switzerland and Biovitrum AB, Sweden have signed an agreement granting Biovitrum the exclusive license and distribution rights of Aloxi (Palonosetron hydrochloride) in the Nordic territory.
(NYSE and TASE: TEVA) has launched a generic version of Aloxi (palonosetron HCI) injection, 0.25 mg/5 mL, in the US, the company said.
ALOXI (palonosetron) is a 5-HT3 receptor antagonist indicated as single agent for the prevention of CINV, while AKYNZEO is the first fixed combination oral agent that targets two critical signalling pathways that are associated with CINV.