1.2. Pediatrics
Aprepitant capsules are FDA-approved for use in children and adolescents 12 years of age and older to prevent acute and delayed nausea and vomiting associated with initial and repeat courses of moderately to highly emetogenic chemotherapy (includes high-dose cisplatin). Aprepitant oral suspension is FDA-approved to prevent acute and delayed nausea and vomiting seen with initial and repeat courses of highly emetogenic chemotherapy (includes high-dose cisplatin) as well as nausea and vomiting associated with moderately emetogenic chemotherapy in pediatric patients 6 months of age and older weighing at least 6 kg or pediatric patients of any age weighing at least 6 kg who cannot swallow capsules [1-3]. Rolapitant is not yet approved for use in pediatric patients, as safety and efficacy have not been established [1, 4]. Combination therapy with netupitant and palonosetron is not FDA-approved in patients less than 18 years of age as safety and efficacy have not been established in this patient population [1,5]. Pediatric aprepitant dosages are summarized in Table 3. Aprepitant dosages exceeding these recommendations in pediatric patients will be reviewed.
| Treatment Indication | Patient Characteristics | Usual Dosage/Dosage Form | Maximum Recommended Dosage |
|---|---|---|---|
| CINV: Moderate to highly emetogenic chemotherapy – day 1 | 6 months to less than 12 years (at least 6 kg) | 3 mg/kg on day 1 (as suspension)*! | 125 mg on day 1 |
| CINV: Moderate to highly emetogenic chemotherapy – days 2 and 3 | 6 months to less than 12 years (at least 6 kg) | 2 mg/kg on days 2 and 3 (as suspension)+! | 80 mg on days 2 and 3 |
| CINV: Moderate to highly emetogenic chemotherapy – day 1 | pediatric patients any age (at least 6 kg) unable to swallow capsules | 3 mg/kg on day 1 (as suspension)*! | 125 mg on day 1 |
| CINV: Moderate to highly emetogenic chemotherapy – days 2 and 3 | pediatric patients any age (at least 6 kg) unable to swallow capsules | 2 mg/kg on days 2 and 3 (as suspension)+! | 80 mg on days 2 and 3 |
| moderately to highly emetogenic chemotherapy – day 1 | greater than or equal to 12 years of age | 125 mg on day 1 one hour before chemotherapy (as capsule)*! | 125 mg on day 1 |
| moderately to highly emetogenic chemotherapy – days 2 and 3 | greater than or equal to 12 years of age | 80 mg on days 2 and 3 (as capsule)+! | 80 mg on days 2 and 3 |
Legend:
- * in conjunction with a 5-HT3 receptor antagonist plus dexamethasone on day 1 (product labeling)
- + in conjunction with dexamethasone on days 2-3; dexamethasone also given on day 4 (product labeling)
- ! for moderate emetic risk regimens, a two-drug combination of a 5-HT3 receptor antagonist and dexamethasone should be offered. If a pediatric patient is unable to take dexamethasone, a two-drug combination of a 5-HT3 receptor antagonist and aprepitant should be offered (guideline recommendation)8