Fosaprepitant (Page 8 of 8)

Patient Information

FOSAPREPITANT for injection (FOS a PRE pi tant)

for intravenous use

What is Fosaprepitant for Injection?

Fosaprepitant for Injection is a prescription medicine used with other medicines that treat nausea and vomiting in adults to prevent nausea and vomiting caused by certain anti-cancer (chemotherapy) medicines.

  • Fosaprepitant for Injection is not used to treat nausea and vomiting that you already have.
  • It is not known if Fosaprepitant for Injection is safe and effective in children.

Do not receive Fosaprepitant for Injection if you:

  • are allergic to fosaprepitant, aprepitant, or any of the ingredients in Fosaprepitant for Injection. See the end of this leaflet for a complete list of the ingredients in Fosaprepitant for Injection.
  • are taking pimozide (ORAP).

Before receiving Fosaprepitant for Injection, tell your healthcare provider about all your medical conditions including, if you:

  • have liver problems.
  • are pregnant or plan to become pregnant. It is not known if Fosaprepitant for Injection can harm your unborn baby.
    • Women who use birth control medicines containing hormones to prevent pregnancy (birth control pills, skin patches, implants, and certain IUDs) should also use a backup method of birth control that does not contain hormones, such as condoms or spermicides, during treatment with Fosaprepitant for Injection and for 1 month after receiving the last dose of Fosaprepitant for Injection.
  • are breastfeeding or plan to breastfeed. It is not known if Fosaprepitant for Injection passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive Fosaprepitant for Injection.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Fosaprepitant for Injection may affect the way other medicines work, and other medicines may affect the way Fosaprepitant for Injection works , causing serious side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How will I receive Fosaprepitant for Injection?

Fosaprepitant for Injection will be given on Day 1 of chemotherapy treatment. It will be given to you by intravenous (IV) infusion in your vein about 50 to 60 minutes before you start your chemotherapy treatment.

If you take the blood thinner medicine warfarin sodium (COUMADIN, JANTOVEN), your healthcare provider may do blood tests after you receive Fosaprepitant for Injection to check your blood clotting.

What are the possible side effects of Fosaprepitant for Injection?

Fosaprepitant for Injection may cause serious side effects, including:

  • Serious allergic reactions. Allergic reactions can happen with Fosaprepitant for Injection and may be serious. Tell your healthcare provider or nurse right away if you have hives, rash, itching, flushing or redness of your face or skin, trouble breathing or swallowing, dizziness, a rapid or weak heartbeat, or you feel faint during or soon after you receive Fosaprepitant for Injection, as you may need emergency medical care.
  • Severe skin reactions, which may include rash, skin peeling, or sores, may occur. Get medical care right away if you have signs of a severe skin reaction.
  • Infusion site reactions (ISR) at or near the infusion site have happened with Fosaprepitant for Injection.

Most severe ISR have happened with a certain type of chemotherapy medicine that can burn or blister your skin (vesicant) with side effects, including pain, swelling and redness. Death of skin tissue (necrosis) has happened in some people getting this type of chemotherapy medicine. Most ISR can happen with the first, second, or third dose and some can last up to 2 weeks or longer. Tell your healthcare provider right away if you get any infusion site side effects.

The most common side effects of Fosaprepitant for Injection include:

  • tiredness
  • feeling weak or numb in your arms and legs
  • diarrhea
  • indigestion or heartburn
  • low white blood cell and red blood cell counts
  • urinary tract infection
  • weakness
  • pain in your arms and legs

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Fosaprepitant for Injection. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Fosaprepitant for Injection.

If you would like more information about Fosaprepitant for Injection, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Fosaprepitant for Injection that is written for health professionals. For more information about Fosaprepitant for Injection call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872.

What are the ingredients in Fosaprepitant for Injection?

Active ingredient: fosaprepitant dimeglumine

Inactive ingredients: edetate disodium, meglumine, povidone k12, and water for injection. Hydrochloric acid and/or meglumine may have been added for pH adjustment.

Brands listed are trademarks of their respective owners.

Manufactured by: Actavis Italy, S.p.A., Via Pasteur 10, Nerviano, Italy 20014 or Sindan Pharma SRL , 11th Ion Mihalache Blvd., Bucharest 1, Romania 011171

Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454

This Patient Information has been approved by the U.S. Food and Drug Administration. Iss. 9/2019

PRINCIPAL DISPLAY PANEL

NDC 0591-4385-79
Rx only
Fosaprepitant for Injection
150 mg/vial
Sterile Lyophilized Powder for Intravenous Use Only After Reconstitution and Dilution
DO NOT USE WITH SOLUTIONS CONTAINING DIVALENT CATIONS (e.g., Ca2+ , Mg2+) INCLUDING LACTATED RINGER’S SOLUTION AND HARTMANN’S SOLUTION.
Each vial contains:
Fosaprepitant…………….150 mg
(equivalent to 245.3 mg of fosaprepitant dimeglumine)
Single-Dose Vial
Discard Unused PortionTeva

carton
(click image for full-size original)
FOSAPREPITANT fosaprepitant injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-4385
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSAPREPITANT DIMEGLUMINE (APREPITANT) FOSAPREPITANT 150 mg
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
MEGLUMINE
POVIDONE K12
WATER
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-4385-79 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210064 09/19/2019
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 09/2019 Actavis Pharma, Inc.

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