Hizentra
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Questions & Answers
Side Effects & Adverse Reactions
Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists.
ECG changes including QT interval prolongation has been seen in patients receiving ondansetron. In addition, post-marketing cases of Torsade de Pointes have been reported in patients using ondansetron. Avoid ondansetron hydrochloride in patients with congenital long QT syndrome. ECG monitoring is recommended in patients with electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias or patients taking other medicinal products that lead to QT prolongation.
The development of serotonin syndrome has been reported with 5-HT3 receptor antagonists alone. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors, mirtazapine, fentanyl, lithium, tramadol, and intravenous methylene blue). Some of the reported cases were fatal. Serotonin syndrome occurring with overdose of ondansetron hydrochloride alone has also been reported. The majority of reports of serotonin syndrome related to 5-HT3 receptor antagonist use occurred in a post-anesthesia care unit or an infusion center.
Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, with or without gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome, especially with concomitant use of ondansetron hydrochloride and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue ondansetron hydrochloride and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ondansetron hydrochloride is used concomitantly with other serotonergic drugs (see PRECAUTIONS and OVERDOSAGE).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- 1.
- Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m 2.
- 2.
- Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
- 3.
- Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen.
- 4.
- Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron hydrochloride tablets, ondansetron orally disintegrating tablets, and ondansetron hydrochloride oral solution are recommended even where the incidence of postoperative nausea and/or vomiting is low.
History
There is currently no drug history available for this drug.
Other Information
The active ingredient in ondansetron orally disintegrating tablets, USP is ondansetron base, the racemic form of ondansetron, and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1 H-imidazol- 1-yl)methyl]-4H-carbazol-4-one. It has the following structural formula:
The molecular formula is C18H19N3O representing a molecular weight of 293.4.
USP disintegration test pending.
Each ondansetron orally disintegrating tablet, USP intended for oral administration contains 4 mg or 8 mg of ondansetron base. In addition, each ondansetron orally disintegrating tablet, USP contains the following inactive ingredients: aspartame, calcium stearate, colloidal silicon dioxide, mannitol, microcrystalline cellulose, polacrilin potassium, sodium starch glycolate, strawberry flavor and talc. Ondansetron orally disintegrating tablets, USP are a orally administered formulation of ondansetron which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.
Sources
Hizentra Manufacturers
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Csl Behring Ag
![Hizentra (Human Immunoglobulin G) Liquid [Csl Behring Ag]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Hizentra | Pd-rx Pharmaceuticals, Inc.
Instructions for Use/Handling Ondansetron Orally Disintegrating TabletsDo not attempt to push ondansetron orally disintegrating tablets, USP through the foil backing. With dry hands, PEEL BACK the foil backing of 1 blister and GENTLY remove the tablet. IMMEDIATELY place the ondansetron orally disintegrating tablet on top of the tongue where it will dissolve in seconds, then swallow with saliva. Administration with liquid is not necessary.
Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy
The recommended adult oral dosage of ondansetron hydrochloride is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m2. Multiday, single-dose administration of a 24 mg dosage has not been studied.
Pediatric Use
There is no experience with the use of a 24 mg dosage in pediatric patients.
Geriatric Use
The dosage recommendation is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy
The recommended adult oral dosage is one 8-mg ondansetron orally disintegrating tablet, USP given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron orally disintegrating tablet, USP should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
Pediatric Use
For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron orally disintegrating tablet, USP given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron orally disintegrating tablet, USP should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy.
Geriatric Use
The dosage is the same as for the general population.
Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen
The recommended oral dosage is one 8 mg ondansetron orally disintegrating tablet, USP given 3 times a day.
For total body irradiation
One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before each fraction of radiotherapy administered each day.
For single high-dose fraction radiotherapy to the abdomen
One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy.
For daily fractionated radiotherapy to the abdomen
One 8-mg ondansetron orally disintegrating tablet, USP should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Pediatric Use
There is no experience with the use of, ondansetron orally disintegrating tablets, USP, in the prevention of radiation-induced nausea and vomiting in pediatric patients.
Geriatric Use
The dosage recommendation is the same as for the general population.
Postoperative Nausea and Vomiting
The recommended dosage is 16 mg given as two 8-mg ondansetron orally disintegrating tablets, USP 1 hour before induction of anesthesia.
Pediatric Use
There is no experience with the use of ondansetron orally disintegrating tablets, USP in the prevention of postoperative nausea and vomiting in pediatric patients.
Geriatric Use
The dosage is the same as for the general population.
Dosage Adjustment for Patients With Impaired Renal Function
The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron.
Dosage Adjustment for Patients With Impaired Hepatic Function
In patients with severe hepatic impairment (Child-Pugh2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.
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