Fresenius Kabi USA LLC

13/11/2019 | Press release | Archived content

Fresenius Kabi Announces Availability of Fosaprepitant for Injection 150 mg per vial

Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. To learn more about Fresenius Kabi, including its expanding U.S. centers for pharmaceutical research, manufacturing and distribution, please visit www.fresenius-kabi.com/us.

About Fosaprepitant for Injection

Fosaprepitant for Injection is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, 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 for Injection has not been studied for treatment of established nausea and vomiting.

Important Safety Information

Fosaprepitant for Injection is contraindicated in patients with known hypersensitivity to any component of this drug and concurrent use with pimozide.

CYP3A4 Interactions: Fosaprepitant is a weak inhibitor of CYP3A4, and aprepitant, the active moiety, is a substrate, inhibitor, and inducer of CYP3A4.

Hypersensitivity Reactions (including anaphylaxis and anaphylactic shock): May occur during or soon after infusion. If symptoms occur, discontinue the drug. Do not reinitiate Fosaprepitant for Injection if symptoms occur with previous use.

Infusion Site Reactions (including thrombophlebitis, necrosis, and vasculitis): Majority of reactions reported in patients receiving vesicant chemotherapy. Avoid infusion into small veins. Discontinue infusion and administer treatment if a severe reaction develops.

Warfarin (a CYP2C9 substrate): Risk of decreased INR of prothrombin time; monitor INR in 2−week period, particularly at 7 to 10 days, following initiation of Fosaprepitant for Injection.

Hormonal Contraceptives: Efficacy of contraceptives may be reduced during and for 28 days following administration of Fosaprepitant for Injection. Use effective alternative or back-up methods of contraception.

Most common adverse reactions in adults (≥2%) are: fatigue, diarrhea, neutropenia, asthenia, anemia, peripheral neuropathy, leukopenia, dyspepsia, urinary tract infection, pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This Important Safety Information does not include all the information needed to use Fosaprepitant for Injection safely and effectively. Please see the full prescribing information for Fosaprepitant for Injection at https://tinyurl.com/yjhz4l42. Full prescribing information is also available at www.fresenius-kabi.com/us.