Fosaprepitant

Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. • delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use • Fosaprepitant for injection has not been studied for the treatment of established nausea and vomiting. …

• Recommended Adult Dosage Fosaprepitant for injection 150 mg on Day 1 as an intravenous infusion over 20 to 30 minutes
• Complete the infusion approximately 30 minutes prior to chemotherapy
• Recommended Dosage for Pediatric Patients (6 months to 17 years) Weighing at Least 6 kg See Full Prescribing Information for pediatric dosage regimens by age
• For single dose chemotherapy regimens: single dose of fosaprepitant for injection on Day 1
• For single or multi-day chemotherapy regimens: 3-day fosaprepitant for injection regimen of fosaprepitant for injection on Days 1, 2, and 3
• Aprepitant capsules or fosaprepitant for oral suspension may be used as an alternative on Days 2 and 3
• Administer fosaprepitant for injection through a central venous catheter as an intravenous infusion over 30 minutes (12 years to 17 years) or 60 minutes (6 months to less than 12 years)
• Complete the infusion approximately 30 minutes prior to chemotherapy
• Concomitant Antiemetics See Full Prescribing Information for additional information
• Prevention of Nausea and Vomiting Associated with HEC and MEC in Adult Patients The recommended dosage of fosaprepitant for injection, dexamethasone, and a 5-HT 3 antagonist for the prevention of nausea and vomiting associated with administration of HEC or MEC
• In adults is shown in Table 1 or Table 2, respectively
• Administer fosaprepitant for injection as an intravenous infusion on Day 1 over 20 to 30 minutes, completing the infusion approximately 30 minutes prior to chemotherapy. …

Fosaprepitant for injection:150 mg fosaprepitant, white to off white cake or powder in single-dose glass vial for reconstitution. Fosaprepitant for injection: 150 mg fosaprepitant, lyophilized cake or powder in single-dose vial for reconstitution. (3)

• The safety and effectiveness of a single dose and a 3-day regimen of fosaprepitant have been established
• In pediatric patients 6 months to 17 years for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of HEC and MEC
• Use of fosaprepitant in this age group is supported by evidence from adequate and well-controlled studies of fosaprepitant for injection
• In adults, with additional safety, efficacy and pharmacokinetic data
• In pediatric patients 6 months to 17 years. …

Of the 1649 adult cancer patients treated with intravenous fosaprepitant in HEC and MEC clinical studies, 27% were aged 65 and over, while 5% were aged 75 and over. Other reported clinical experience with fosaprepitant has not identified differences in responses between elderly and younger patients. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Hypersensitivity Advise patients that hypersensitivity reactions, including anaphylaxis and anaphylactic shock, have been reported in patients taking fosaprepitant
• Advise patients to seek immediate medical attention if they experience signs or symptoms of a hypersensitivity reaction, such as hives, rash and itching, skin peeling or sores, flushing, difficulty in breathing or swallowing, or dizziness, rapid or weak heartbeat or feeling faint [see Warnings and Precautions ]. …

• Fosaprepitant is contraindicated in patients: who are hypersensitive to any component of the product
• Hypersensitivity reactions including anaphylactic reactions, flushing, erythema, and dyspnea have been reported [ see Warnings and Precautions , Adverse Reactions ]. taking pimozide. …

See Full Prescribing Information for a list of clinically significant drug interactions. ( 4 , 5.1 , 5.4 , 5.5 , 7.1 , 7.2 ) 7.1 Effect of Fosaprepitant/Aprepitant on the Pharmacokinetics of Other Drugs When administered intravenously, fosaprepitant, a prodrug of aprepitant, is converted to aprepitant within 30 minutes. Therefore, drug interactions following administration of fosaprepitant for injection are likely to occur with drugs that interact with oral aprepitant. Fosaprepitant, given as a single 150-mg dose, is a weak inhibitor of CYP3A4, and the weak inhibition of CYP3A4 continues for 2 days after single dose administration. Single dose fosaprepitant does not induce CYP3A4. …

CYP3A4 Interactions: Fosaprepitant is a weak inhibitor of CYP3A4, and aprepitant, the active moiety, is a substrate, inhibitor, and inducer of CYP3A4; see Full Prescribing Information for recommendations regarding contraindications, risk of adverse reactions, and dosage adjustment of fosaprepitant and concomitant drugs. ( 4 , 5.1 , 7.1 , 7.2 ) Hypersensitivity Reactions (including anaphylaxis and anaphylactic shock) : May occur during or soon after infusion. If symptoms occur, discontinue the drug. Do not reinitiate fosaprepitant if symptoms occur with previous use. …

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Infusion Site Reactions [see Warnings and Precautions (5.3)] Most common adverse reactions in adults (≥2%) are: fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity. (6.1) Adverse reactions in pediatrics are similar to adults. To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals Inc. at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . …

8.1 Pregnancy Risk Summary There are insufficient data on use of fosaprepitant in pregnant women to inform a drug associated risk. In animal reproduction studies, no adverse developmental effects were observed in rats or rabbits exposed during the period of organogenesis to systemic drug levels (AUC) approximately equivalent to the exposure at the recommended human dose (RHD) of 150 mg [see Data] . …

There is no specific information on the treatment of overdosage with fosaprepitant or aprepitant. In the event of overdose, fosaprepitant should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of fosaprepitant, drug-induced emesis may not be effective in cases of fosaprepitant overdosage. Aprepitant is not removed by hemodialysis.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.