Posfrea Drug Information
Generic name: PALONOSETRON
Uses of Posfrea
- is indicated in adults for prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). acute nausea and vomiting associated with initial and repeat courses highly emetogenic cancer chemotherapy (HEC). postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated. As with other antiemetics, routine prophylaxis is not recommended in patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and vomiting must be avoided during the postoperative period, POSFREA is recommended even where the incidence of postoperative nausea and/or vomiting is low. POSFREA is indicated in pediatric patients 1 month to less than 17 years of age for prevention of: acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy. POSFREA is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in: Adults for prevention of : acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated Pediatric patients 1 month to less than 17 years of age for prevention of: acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy (HEC).
Dosage & Administration of Posfrea
| Age | Dose* |
|---|---|
| Adults | |
| Pediatrics (1 month to less than 17 years) | |
Side Effects of Posfrea
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of POSFREA has been established from adequate and well-controlled studies of another intravenous formulation of palonosetron . Below is a display of the adverse reactions of palonosetron in these adequate and well-controlled studies. Chemotherapy-Induced Nausea and Vomiting (CINV) Adults In double-blind randomized clinical trials for the prevention of nausea and vomiting induced by MEC or HEC, 1374 adult patients received a single dose of palonosetron, ondansetron (Studies 1 and 3) or dolasetron (Study 2) administered intravenously 30 minutes prior to chemotherapy . Adverse reactions were similar in frequency and severity in all three treatment groups.
Common adverse reactions reported in at least 2% of patients in these trials are shown in Table 2. Table 2: Common Adverse Reactions* in Adults with Receiving MEC (Studies 1 and 2) or HEC (Study 3) *Reported in at least 2% of patients in any treatment group Adverse Reaction Palonosetron 0.25 mg intravenously (N=633) Ondansetron 32 mg intravenously (N=410) Dolasetron 100 mg intravenously (N=194) Headache 9% 8% 16% Constipation 5% 2% 6% Diarrhea 1% 2% 2% Dizziness 1% 2% 2% Fatigue < 1% 1% 2% Abdominal Pain < 1% < 1% 2% Insomnia < 1% 1% 2% Less common adverse reactions, reported in 1% or less of patients in any treatment group, in Studies 1, 2 and 3 were: Cardiac disorders : non-sustained tachycardia, bradycardia, myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles. Skin & subcutaneous tissue disorders : allergic dermatitis, rash. Ear &labyrinth disorders : motion sickness, tinnitus.
Gastrointestinal disorders : diarrhea, dyspepsia, abdominal pain, dry mouth, hiccups and flatulence. General disorders and administration site conditions : weakness, fatigue, fever, hot flash, flu-like syndrome. Investigations : QT prolongation, transient, asymptomatic increases in AST and/or ALT and bilirubin and these changes occurred predominantly in patients receiving HEC. Metabolism and nutrition disorders : hyperkalemia, electrolyte fluctuations, hyperglycemia, metabolic acidosis, appetite decrease, anorexia.
Musculoskeletal and connective tissue disorders : arthralgia. Nervous System disorders : dizziness, somnolence, insomnia, hypersomnia, paresthesia. Psychiatric disorders : anxiety, euphoric mood.
Renal and urinary disorders : urinary retention, glycosuria. Vascular disorders : vein discoloration, vein distention, hypotension, hypertension. In other studies, two subjects experienced severe constipation following a single dose of approximately 0.75 mg (three times the recommended dose). Pediatrics Aged 2 Months to 17 Years In a pediatric clinical trial, 163 pediatric cancer patients with a mean age of eight years received a single 20 mcg/kg (maximum 1.5 mg) intravenous infusion of palonosetron 30 minutes before beginning the first cycle of emetogenic chemotherapy . Adverse reactions were evaluated in pediatric patients receiving palonosetron for up to four chemotherapy cycles.
The following adverse reactions were reported in less than 1% of palonosetron-treated patients: Nervous System disorders : headache, dizziness, dyskinesia. General disorders and administration site conditions : infusion site pain. Skin and subcutaneous tissue disorders : allergic dermatitis, skin disorder.
Postoperative Nausea and Vomiting (PONV) The most common adverse reactions reported in at least 2% of adults receiving palonosetron 0.075 mg intravenously immediately before induction of anesthesia in three randomized placebo-controlled trials are shown in Table 3. Rates of adverse reactions between palonosetron and placebo groups were similar. Some events are known to be associated with, or may be exacerbated by, concomitant perioperative and intraoperative medications administered in this surgical population. A thorough QT/QTc study demonstrated palonosetron does not prolong the QT interval to any clinically relevant extent . Table 3: Common Adverse Reactions* in Trials of Adults with Postoperative Nausea and Vomiting *Reported in at least 2% of patients in any treatment group Adverse Reaction Palonosetron 0.075 mg intravenously (N=336) Placebo (N=369) Electrocardiogram QT prolongation 5% 3% Bradycardia 4% 4% Headache 3% 4% Constipation 2% 3% Less common adverse reactions, reported in 1% or less of patients, in these PONV clinical trials were: Cardiac disorders : sinus bradycardia, tachycardia, arrhythmia, ventricular extrasystoles.
The frequency of these adverse effects did not appear to be different from placebo. Skin and subcutaneous tissue disorders : pruritus. Gastrointestinal disorders : flatulence, dry mouth, upper abdominal pain, salivary hypersecretion, dyspepsia, diarrhea, intestinal hypomotility.
General disorders and administration site conditions : chills, generalized edema. Investigations : increases in AST and/or ALT, hepatic enzyme increased, QTc prolongation, blood pressure decreased, platelet count decreased, T wave amplitude decreased. Metabolism and nutrition disorders : hypokalemia, anorexia.
Nervous System disorders : dizziness. Respiratory, thoracic and mediastinal disorders : hypoventilation, laryngospasm. Renal and urinary disorders : Urinary retention.
Vascular disorders : Hypotension, Hypertension.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of palonosetron. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity reactions : including dyspnea, bronchospasm, swelling/edema, erythema, pruritus, rash, urticaria, anaphylaxis and anaphylactic shock Injection site reactions : including burning, induration, discomfort and pain
Warnings & Cautions for Posfrea
Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported
with administration of palonosetron . These reactions occurred in patients with or without known hypersensitivity to other 5-HT 3 receptor antagonists. If hypersensitivity reactions occur, discontinue POSFREA and initiate appropriate medical treatment. Do not reinitiate POSFREA in patients who have previously experienced symptoms of hypersensitivity .
Serotonin Syndrome
The development of serotonin syndrome has been reported with 5-HT 3 receptor antagonists. 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 another 5-HT 3 receptor antagonist alone has also been reported.
The majority of reports of serotonin syndrome related to 5-HT 3 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 POSFREA and other serotonergic drugs. If symptoms of serotonin syndrome occur, discontinue POSFREA and initiate supportive treatment.
Patients should be informed of the increased risk of serotonin syndrome, especially if POSFREA is used concomitantly with other serotonergic drugs .
Drug Interactions with Posfrea
Serotonergic Drugs
Serotonin syndrome (including altered mental status, autonomic instability, and neuromuscular symptoms) has been described following the concomitant use of 5-HT 3 receptor antagonists and other serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs). Monitor for the emergence of serotonin syndrome. If symptoms occur, discontinue POSFREA and initiate supportive treatment .
Pregnancy Safety for Posfrea
Pregnancy Risk Summary There are no available data on palonosetron use in pregnant women to inform a drug-associated risk. In animal reproduction studies, no effects on embryo-fetal development were observed with the administration of oral palonosetron during the period of organogenesis at doses up to 1,894 and 3,789 times the recommended human intravenous dose in rats and rabbits, respectively (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In animal reproduction studies, no effects on embryo-fetal development were observed in pregnant rats given oral palonosetron at doses up to 60 mg/kg/day (1,894 times the recommended human intravenous dose based on body surface area) or pregnant rabbits given oral doses up to 60 mg/kg/day (3,789 times the recommended human intravenous dose based on body surface area) during the period of organogenesis.
Pediatric Use of Posfrea
Pediatric Use Chemotherapy-Induced Nausea and Vomiting (CINV) Safety and effectiveness of POSFREA have been established in pediatric patients aged 1 month to less than 17 years for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including HEC. Use is supported by a clinical trial where 165 pediatric patients aged two months to less than 17 years were randomized to receive a single dose of palonosetron 20 mcg/kg (maximum 1.5 mg) administered as an intravenous infusion 30 minutes prior to the start of emetogenic chemotherapy . While this study demonstrated that pediatric patients require a higher palonosetron dose than adults to prevent chemotherapy-induced nausea and vomiting, the safety profile is consistent with the established profile in adults . Safety and effectiveness of POSFREA in neonates (less than 1 month of age) have not been established. Postoperative Nausea and Vomiting Studies (PONV) Safety and effectiveness have not been established in pediatric patients for PONV. Two pediatric trials were performed. Pediatric Study 1, a dose finding study was conducted to compare two doses of palonosetron, 1 mcg/kg (maximum 0.075 mg) versus 3 mcg/kg (maximum 0.25 mg). A total of 150 pediatric surgical patients participated, age range one month to less than 17 years.
No dose response was observed. Pediatric Study 2, a multicenter, double-blind, double-dummy, randomized, parallel group, active control, single-dose non-inferiority study, compared intravenous palonosetron (1 mcg/kg, maximum 0.075 mg) versus intravenous ondansetron. A total of 670 pediatric surgical patients participated, age 30 days to less than 17 years.
The primary efficacy endpoint, Complete Response (CR: no vomiting, no retching, and no antiemetic rescue medication) during the first 24 hours postoperatively was achieved in 78.2% of patients in the palonosetron group and 82.7% in the ondansetron group. Given the pre-specified non-inferiority margin of -10%, the stratum adjusted Mantel-Haenszel statistical non-inferiority confidence interval for the difference in the primary endpoint, complete response (CR), was, therefore non-inferiority was not demonstrated. Adverse reactions to palonosetron were similar to those reported in adults.
Contraindications for Posfrea
is contraindicated in patients known to have hypersensitivity to palonosetron . Hypersensitivity to palonosetron or any of its components.
Overdosage Information for Posfrea
There is no known antidote to palonosetron. Overdose should be managed with supportive care. Dialysis studies have not been performed, however, due to the large volume of distribution, dialysis is unlikely to be an effective treatment for palonosetron overdose.
A single intravenous dose of palonosetron at 30 mg/kg (947 and 474 times the human dose for rats and mice, respectively, based on body surface area) was lethal to rats and mice. The major signs of toxicity were convulsions, gasping, pallor, cyanosis and collapse.
Clinical Studies of Posfrea
Prevention of Nausea and Vomiting Associated with
MEC and HEC in Adults Efficacy of a single intravenous dose of palonosetron in preventing acute and delayed nausea and vomiting associated with MEC or HEC were studied in four trials. In these double-blind studies, complete response rates (no emetic episodes and no rescue medication) and other efficacy parameters were assessed through at least 120 hours after administration of chemotherapy. The safety and efficacy of palonosetron in repeated courses of chemotherapy was also assessed.
Moderately Emetogenic Chemotherapy Two double-blind trials (Study 1 and Study 2) involving 1132 patients compared a single dose of palonosetron with either a single-dose of ondansetron (Study 1) or dolasetron (Study 2) given 30 minutes prior to MEC, including carboplatin, cisplatin ≤ 50 mg/m 2, cyclophosphamide <1500 mg/m 2, doxorubicin > 25 mg/m 2, epirubicin, irinotecan, and methotrexate >250 mg/m 2. Concomitant corticosteroids were not administered prophylactically in Study 1 and were only used by 4 to 6% of patients in Study 2. The majority of patients in these studies were women (77%), White (65%) and naïve to previous chemotherapy (54%). The mean age was 55 years. Highly Emetogenic Chemotherapy A double-blind, dose-ranging trial evaluated the efficacy of a single intravenous dose of palonosetron from 0.3 to 90 mcg/kg (equivalent to < 0.1 mg to 6 mg fixed dose) in 161 chemotherapy-naïve adult cancer patients receiving HEC, either cisplatin ≥ 70 mg/m 2 or cyclophosphamide > 1100 mg/m 2. Concomitant corticosteroids were not administered prophylactically. Analysis of data from this trial indicates that 0.25 mg is the lowest effective dose in preventing acute nausea and vomiting associated with HEC. A double-blind trial involving 667 patients compared a single intravenous dose of palonosetron with a single intravenous dose of ondansetron (Study 3) given 30 minutes prior to HEC, including cisplatin ≥ 60 mg/m 2, cyclophosphamide > 1500 mg/m 2, and dacarbazine.
Corticosteroids were co-administered prophylactically before chemotherapy in 67% of patients. Of the 667 patients, 51% were women, 60% White, and 59% naïve to previous chemotherapy. The mean age was 52 years.
Efficacy Results Studies 1, 2 and 3 show that palonosetron was effective in the prevention of nausea and vomiting associated with initial and repeat courses of MEC and HEC in the acute phase (0 to 24 hours). Clinical superiority over other 5-HT 3 receptor antagonists has not been adequately demonstrated in the acute phase. In Study 3, efficacy was greater when prophylactic corticosteroids were administered concomitantly. Studies 1 and 2 show that palonosetron was effective in the prevention of nausea and vomiting associated with initial and repeat course of MEC in the delayed phase (24 to 120 hours) and overall phase (0 to 120 hours). Table 5: Prevention of Acute Nausea and Vomiting (0 to 24 Hours) in Adults with Nausea and Vomiting Associated with MEC or HEC in Studies 1, 2 and 3: Complete Response Rates a Intent-to-treat cohort b 2-sided Fisher's exact test.
Significance level at α=0.025. c These studies were designed to show non-inferiority. A lower bound greater than –15% demonstrates non-inferiority between palonosteron and comparator. d Ondansetron 32 mg intravenously was used in the clinical trial. Although this dose was used in the trial, it is no longer the currently recommended dose.
Refer to the ondansetron prescribing information for the current recommended dose. Chemotherapy Study Treatment Group N a % with Complete Response p-value b 97.5% Confidence Interval Palonosetron minus Comparator c Moderately Emetogenic 1 Palonosetron 0.25 mg intravenously 189 81 0.009 Ondansetron 32 mg intravenously d 185 69 2 Palonosetron 0.25 mg intravenously 189 63 NS Dolasetron 100 mg intravenously 191 53 Highly Emetogenic 3 Palonosetron 0.25 mg intravenously 223 59 NS Ondansetron 32 mg intravenously d 221 57 Table 6: Prevention of Delayed Nausea and Vomiting (24 to 120 Hours) Associated with MEC in Adults in Studies 1 and 2: Complete Response Rates a Intent-to-treat cohort b 2-sided Fisher's exact test. Significance level at α=0.025. c These studies were designed to show non-inferiority.
A lower bound greater than–15% demonstrates non-inferiority between palonosetron and comparator. d Ondansetron 32 mg intravenously was used in the clinical trial. Although this dose was used in the trial, it is no longer the currently recommended dose. Refer to the ondansetron prescribing information for the current recommended dose.
Chemotherapy Study Treatment Group N a % with Complete Response p-value b 97.5% Confidence Interval Palonosetron minus Comparator c Moderately Emetogenic 1 Palonosetron 0.25 mg intravenously 189 74 <0.001 Ondansetron 32 mg intravenously d 185 55 2 Palonosetron 0.25 mg intravenously 189 54 0.004 Dolasetron 100 mg intravenously 191 39 Table 7: Prevention of Overall Nausea and Vomiting (0 to 120 Hours) Associated with MEC in Adults in Studies 1 and 2: Complete Response Rates a Intent-to-treat cohort b 2-sided Fisher's exact test. Significance level at α=0.025. c These studies were designed to show non-inferiority. A lower bound greater than –15% demonstrates non-inferiority between palonosetron and comparator. d Ondansetron 32 mg intravenously was used in the clinical trial.
Although this dose was used in the trial, it is no longer the currently recommended dose. Refer to the ondansetron prescribing information for the current recommended dose. Chemotherapy Study Treatment Group N a % with Complete Response p-value b 97.5% Confidence Interval Palonosetron minus Comparator c Moderately Emetogenic 1 Palonosetron 0.25 mg intravenously 189 69 <0.001 Ondansetron 32 mg intravenously d 185 50 2 Palonosetron 0.25 mg intravenously 189 46 0.021 Dolasetron 100 mg intravenously 191 34
Prevention of Nausea and Vomiting Associated with Emetogenic Chemotherapy, Including
HEC in Pediatric Patients One double-blind, active-controlled clinical trial was conducted in pediatric cancer patients. The total population (N = 327) had a mean age of 8.3 years (range two months to 16.9 years) and were 53% male; and 96% white. Patients were randomized and received a 20 mcg/kg (maximum 1.5 mg) intravenous infusion of palonosetron 30 minutes prior to the start of emetogenic chemotherapy (followed by placebo infusions four and eight hours after the dose of palonosetron) or 0.15 mg/kg of intravenous ondansetron 30 minutes prior to the start of emetogenic chemotherapy (followed by ondansetron 0.15 mg/kg infusions four and eight hours after the first dose of ondansetron, with a maximum total dose of 32 mg). Emetogenic chemotherapies administered included doxorubicin, cyclophosphamide (<1500 mg/m 2 ), ifosfamide, cisplatin, dactinomycin, carboplatin, and daunorubicin.
Adjuvant corticosteroids, including dexamethasone, were administered with chemotherapy in 55% of patients. Complete Response in the acute phase of the first cycle of chemotherapy was defined as no vomiting, no retching, and no rescue medication in the first 24 hours after starting chemotherapy. Efficacy was based on demonstrating non-inferiority of intravenous palonosetron compared to intravenous ondansetron.
Non-inferiority criteria were met if the lower bound of the 97.5% confidence interval for the difference in Complete Response rates of intravenous palonosetron minus intravenous ondansetron was larger than -15%. The non-inferiority margin was 15%. Efficacy Results As shown in Table 8, intravenous palonosetron 20 mcg/kg (maximum 1.5 mg) demonstrated non-inferiority to the active comparator during the 0 to 24-hour time interval. Table 8: Prevention of Acute Nausea and Vomiting (0 to 24 Hours) Associated with Emetogenic Chemotherapy in Pediatric Patients: Complete Response Rates a To adjust for multiplicity of treatment groups, a lower-bound of a 97.5% confidence interval was used to compare to -15%, the negative value of the non-inferiority margin. Palonosetron 20 mcg/kg intravenously (N=165) Ondansetron 0.15 mg/kg for three intravenous doses (N=162) Difference a : Palonosetron minus intravenous Ondansetron Comparator 59.4% 58.6% 0.36% In patients that received palonosetron at a lower dose than the recommended dose of 20 mcg/kg, non-inferiority criteria were not met.
Prevention of Postoperative Nausea and Vomiting in Adults
In a multicenter, randomized, stratified, double-blind, parallel-group, clinical trial, palonosetron was compared to placebo for PONV in 546 patients undergoing abdominal and gynecological surgery. All patients received general anesthesia. The trial was conducted predominantly in the US in the out-patient setting for patients undergoing elective gynecologic or abdominal laparoscopic surgery and stratified at randomization for the following risk factors: gender, non-smoking status, history of PONV and/or motion sickness.
Patients were randomized to receive a single dose of palonosetron 0.025 mg, 0.050 mg or 0.075 mg or placebo, each given intravenously immediately prior to induction of anesthesia. Antiemetic activity of was evaluated during the 0 to 72-hour time period after surgery. Of the 138 patients treated with palonosetron 0.075 mg and evaluated for efficacy, 96% were women; 66% had a history of PONV or motion sickness; 85% were non-smokers.
As for race, 63% were White, 20% were Black, 15% were Hispanic, and 1% were Asian. The age of patients ranged from 21 to 74 years, with a mean age of 38 years. Three patients were greater than 65 years of age.
Co-primary efficacy measures were Complete Response (CR) defined as no emetic episode and no use of rescue medication in 0 to 24 hours and 24 to 72 hours postoperatively. Secondary efficacy endpoints included: Complete Response (CR) 0 to 48 hours and 0 to 72 hours Complete Control (CC) defined as CR and no more than mild nausea Severity of nausea (none, mild, moderate, severe) The primary hypothesis was that at least one of the three palonosetron doses were superior to placebo. Complete Response Rates for palonosetron 0.075 mg and placebo in this trial are described in the Table 9. Table 9: Prevention of Postoperative Nausea and Vomiting in Adults: Complete Response Rates a To reach statistical significance for each co-primary endpoint, the required significance limit for the lowest p- value was p<0.017. Δ Difference (%): palonosetron 0.075 mg minus placebo Treatment n/N (%) Palonosetron vs Placebo Δ p-value a Co-primary Endpoints Complete Response Rate (0 to 24 hours) Palonosetron 0.075 mg intravenously 59/138 (42.8%) 16.8% 0.004 Placebo 35/135 (25.9%) Complete Response Rate (24 to 72 hours) Palonosetron 0.075 mg intravenously 67/138 (48.6%) 7.8% 0.188 Placebo 55/135 (40.7%) Palonosetron as a single dose of 0.075 mg reduced the severity of nausea compared to placebo.
Analyses of other secondary endpoints indicate that palonosetron 0.075 mg was numerically better than placebo, however, statistical significance was not formally demonstrated. A randomized, double-blind, multicenter, placebo-controlled, dose ranging study was performed to evaluate palonosetron for PONV following abdominal or vaginal hysterectomy. Five intravenous doses (0.1, 0.3, 1.0, 3.0 and 30 mcg/kg) were evaluated in a total of 381 intent-to-treat patients.
The primary efficacy measure was the proportion of patients with CR in the first 24 hours after recovery from surgery. The lowest effective dose of palonosetron was 1 mcg/kg (approximately 0.075 mg) which had a CR rate of 44% versus 19% for placebo, p=0.004 and significantly reduced the severity of nausea versus placebo, p=0.009. Image Image Image
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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