Fosaprepitant

FOSAPREPITANT- fosaprepitant dimeglumine injection, powder, lyophilized, for solution
Lupin Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

Fosaprepitant for injection, in combination with other antiemetic agents, is indicated in adults 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.

Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2 DOSAGE AND ADMINISTRATION

2.1 Prevention of Nausea and Vomiting Associated with HEC and MEC in Adult Patients

The recommended dosage of fosaprepitant for injection, dexamethasone, and a 5-HT3 antagonist in adults 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.

Table 1: Recommended Adult Dosing for the Prevention of Nausea and Vomiting Associated with HEC

* Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. Also administer dexamethasone in the evenings on Days 3 and 4. A 50% dosage reduction of dexamethasone on Days 1 and 2 is recommended to account for a drug interaction with fosaprepitant for injection [see CLINICAL PHARMACOLOGY (12.3) ].

Day 1 Day 2 Day 3 Day 4
Fosaprepitant for injection 150 mg intravenously over 20 to 30 minutes none none none
Dexamethasone* 12 mg orally 8 mg orally 8 mg orally twice daily 8 mg orally twice daily
5-HT3 antagonist See selected 5-HT3 antagonist prescribing information for the recommended dosage none none none
Table 2: Recommended Adult Dosing for the Prevention of Nausea and Vomiting Associated with MEC

* Administer dexamethasone 30 minutes prior to chemotherapy treatment on Day 1. A 50% dosage reduction of dexamethasone is recommended to account for a drug interaction with fosaprepitant for injection [see CLINICAL PHARMACOLOGY (12.3) ].

Day 1
Fosaprepitant for injection 150 mg intravenously over 20 to 30 minutes
Dexamethasone* 12 mg orally
5-HT3 antagonist See selected 5-HT3 antagonist prescribing information for the recommended dosage

Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.3 Preparation of Fosaprepitant for injection

Table 3: Preparation Instructions for fosaprepitant for injection (150 mg)
Step 1 Aseptically inject 5 mL 0.9% Sodium Chloride Injection, USP into the vial. Assure that 0.9% Sodium Chloride Injection, USP is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting 0.9% Sodium Chloride Injection, USP into the vial.
Step 2 Aseptically prepare an infusion bag filled with 145 mL of 0.9% Sodium Chloride Injection, USP.
Step 3 Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 145 mL of 0.9% Sodium Chloride Injection, USP to yield a total volume of 150 mL and a final concentration of 1 mg/mL.
Step 4 Gently invert the bag 2 to 3 times.
Step 5 Adults The entire volume of the prepared infusion bag (150 mL) should be administered.
Step 6 Before administration, inspect the bag for particulate matter and discoloration. Discard the bag if particulate and/or discoloration are observed.

Caution

Do not mix or reconstitute fosaprepitant for injection with solutions for which physical and chemical compatibility have not been established. Fosaprepitant for injection is incompatible with any solutions containing divalent cations (e.g., Ca2+ , Mg2+), including Lactated Ringer’s Solution and Hartmann’s Solution.

Storage

The reconstituted final drug solution is stable for 24 hours at ambient room temperature [at or below 25°C (77°F)].

Pediatric use information is approved for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s Emend (fosaprepitant) for injection. However, due to Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

3 DOSAGE FORMS AND STRENGTHS

Fosaprepitant for injection: 150 mg, white to off-white lyophilized solid with friable lumps or powder in single-dose glass vial for reconstitution.

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