Aloxi


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palonosetron hydrochloride

Aloxi

Pharmacologic class: Selective serotonin subtype 3 (5-HT3) receptor antagonist

Therapeutic class: Antiemetic

Pregnancy risk category B

Action

Selectively binds to and antagonizes 5-HT3 receptors on vagal nerve terminals and in chemoreceptor trigger zone. This action blocks serotonin release, reducing the vomiting reflex.

Availability

Solution for injection: 0.25 mg (free base) in 5-ml single-use vial

Indications and dosages

To prevent nausea and vomiting caused by cancer chemotherapy

Adults: 0.25 mg I.V. as a single dose 30 minutes before chemotherapy. Repeated doses within 7 days aren't recommended.

To prevent postoperative nausea and vomiting

Adults: 0.075 mg I.V. as a single dose given over 10 seconds immediately before anesthesia induction

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• hypersensitivity to other 5-HT3 receptor antagonists
• diabetes mellitus, hepatic dysfunction
• pregnant or breastfeeding patients
• children.

Administration

• Flush I.V. line with normal saline solution before and after giving.
• Deliver into I.V. line over 30 seconds. Don't mix with other drugs.

Adverse reactions

CNS: headache, fatigue, insomnia, dizziness, anxiety

CV: hypotension, vein discoloration and distention, nonsustained tachycardia, bradycardia

GI: constipation, diarrhea, abdominal pain, anorexia

GU: glycosuria

Metabolic: fluctuating electrolyte levels, hyperglycemia, metabolic acidosis, hyperkalemia

Musculoskeletal: joint pain

Other: fever, flulike symptoms

Interactions

Drug-diagnostic tests:Alanine aminotransferase, aspartate aminotransferase, bilirubin, blood and urine glucose, potassium: increased levels

Patient monitoring

• Monitor vital signs and ECG. Watch closely for tachycardia, bradycardia, and hypotension.
• Watch electrolyte levels for fluctuations (especially hyperkalemia and metabolic acidosis).
• Evaluate temperature. Stay alert for flulike symptoms.
• Closely monitor blood and urine glucose levels in diabetic patients. Stay alert for hyperglycemia.

Patient teaching

• Explain that drug helps prevent nausea and vomiting caused by chemotherapy.
• Teach patient to recognize and report signs and symptoms of hyperkalemia and metabolic acidosis.
• Advise patient to report flulike symptoms.
• Instruct diabetic patient to closely watch blood and urine glucose levels.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.

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.

Aloxi

a trademark for palonosetron.
References in periodicals archive ?
collectively Teva ) in the United States, where it was determined that certain formulation patent claims for ALOXI are valid and infringed.
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.
to resolve certain patent litigations relating to Helsinn Healthcare's Aloxi (palonosetron HCl injection) in the United States, where it is currently distributed by Helsinn Healthcare's marketing partner, Eisai Inc.
Currently STA markets two world leading cancer and cancer supportive care therapies, ABRAXANE and ALOXI (palonosetron) respectively.
8 million in the same period in 2005, primarily due to the deployment and expansion of the acute care field organization, investment in the Aloxi brand, and increased administrative costs.
This is due to the patent expiries of Aloxi and Emend, and the subsequent launch of generics in the forecast period.
Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") announced today that the antiemetic agent ALOXI (generic name: palonosetron HCI) has been approved in the U.
The company had previously indicated that it did not expect Aloxi Injection sales to increase from the fourth quarter of 2005 to the first quarter of 2006, and had anticipated a net loss for the first quarter of 2006.
Helsinn and Biovitrum enter a license agreement for Nordic marketing of Aloxi, a drug that prevents nausea and vomiting in cancer patients
ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components
Aloxi (palonosetron), Zofran generic (ondansetron), Kytril generic (granisetron), Emend (aprepitant) and Akynzeo (netupitant-palonosetron FDC) are the examples of currently available drugs to manage both CINV subtypes.