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Fosamac 150 Lyophilized Injection

Generic Name – Fosaprepitant

Drug Class- Antiemetic agent

Fosaprepitant is a prodrug formulation of aprepitant, an oral neurokinin-1 (NK1) receptor antagonist. It has been approved by FDA for prevention of acute nausea and vomiting associated with the use of highly and moderately emetogenic chemotherapeutic agents. It decreases the likelihood of vomiting induced by chemotherapeutic agents such as cisplatin by blocking substance P activity at NK1 receptors in the brain.

Product Description

Fosamac 150 (Fosaprepitant for injection) is a lyophilized powder available as 150mg in single-dose vial for reconstitution.

Indications and Usage

Fosaprepitant is indicated in adults and pediatric patients 6 months of age and older, in combination with other antiemetic agents, 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 has not been studied for treatment of established nausea and vomiting

Dosage and Administration

  • Recommended dose for adults: 150 mg on day 1, as an intravenous infusion over 20 to 30 minutes
  • Recommended dose for pediatrics (6 months to 17 years):
  1. Administer a single-day fosaprepitant for injection on day 1 (for single dose chemotherapy regimens) or a 3- day regimen of fosaprepitant for injection on day 1 and fosaprepitant capsules or oral suspension on days 2 and 3 (for single or multi-day chemotherapy regimens)
  2. Administer fosaprepitant injection on Day 1 as intravenous infusion over 30 minutes (12-17 years) years to or 60 minutes (6 months to less than 12 years) completing the infusion approximately 30 minutes prior to chemotherapy. However, administer fosaprepitant through a central venous catheter in pediatrics

Dosage Form and Strength

  • Supplied as a single dose vial containing lyophilized powder for intravenous infusion
  • Available as 150 mg for injection

Clinical Efficacy

    • Effective, safe and well tolerated in the control of chemotherapy induced nausea and vomiting in patients receiving MEC and HEC3
    • Offers potential benefit for patients who may be unable to tolerate oral administration of antiemetic during an episode of nausea or vomiting1
    • Improves control of emesis and nausea and reduces the need of rescue medications, when added to standard antiemetic therapy with dexamethasone in patients receiving MEC and HEC1

    Adverse Reactions

    • The most common adverse events following administration of fosaprepitant in adults and pediatrics are: fatigue, diarrhea, neutropenia, leucopenia, asthenia, anemia, peripheral neuropathy, pain in extremity, dyspepsia, and urinary tract infection

    Contraindications

    • It is contraindicated in patients with a known hypersensitivity to fosaprepitant and any component of this drug
    • It is contraindicated in patients receiving pimozide as combined use results in serious and life threatening reactions

Special Precautions

  • Patients should be closely monitored for hypersensitivity reactions during and after infusion of fosaprepitant. Discontinue treatment, if any signs of hypersensitivity occurs
  • Severe infusion site reactions (ISR) such as thrombophlebitis may develop with fosaprepitant use, so patients should be evaluated carefully. If signs of ISR develops, discontinue the infusion and administer appropriate medical treatment
  • Monitor international normalized ratio in patients on chronic warfarin therapy in the 2-week period, particularly at 7 to 10 days, following initiation of fosaprepitant with each chemotherapy cycle
  • Patients should be advised to use effective alternative of contraception during treatment with fosaprepitant and 1 month following administration, as it may reduce efficacy of hormonal contraceptives
  • Caution should be used while dosing elderly patients as they have a greater frequency of decreased hepatic, renal or cardiac function and concomitant disease or other drug therapy
  • Additional monitoring for adverse reactions in pregnant women, breast feeding mothers and patients with severe renal impairment is warranted as there is no clinical data available for use of fosaprepitant in these patients
Fosamac 150 Lyophilized Injection - ADMAC Life Science