Fosaprepitant Teva

What is Fosaprepitant?

Fosaprepitant Teva 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.

Description

Fosaprepitant injection is a sterile, lyophilized formulation containing fosaprepitant dimeglumine, a prodrug of aprepitant, a substance P/neurokinin-1 (NK₁) receptor antagonist, an antiemetic agent, chemically described as 1-Deoxy-1-(methylamino)-D-glucitol[3-[[(2R,3S)-2-[(1R)-1-[3,5bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-morpholinyl]methyl]-2,5-dihydro-5-oxo-1H-1,2,4triazol-1-yl]phosphonate (2:1) (salt).

Its empirical formula is C₂₃H₂₂F₇N₄O₆P • 2(C₇H₁₇NO₅) and its structural formula is:

Fosaprepitant dimeglumine is a white to off-white amorphous powder with a molecular weight of 1004.83. It is freely soluble in water.

Each vial of EMEND for injection for administration as an intravenous infusion contains 150 mg of fosaprepitant (equivalent to 245.3 mg of fosaprepitant dimeglumine) and the following inactive ingredients: edetate disodium (5.4 mg), polysorbate 80 (75 mg), lactose anhydrous (375 mg), sodium hydroxide and/or hydrochloric acid (for pH adjustment).

Who should not use Fosaprepitant?

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 guide for a complete list of the ingredients in Fosaprepitant for Injection.
• are taking pimozide (ORAP).

What should I tell my healthcare provider before using Fosaprepitant?

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 should I use Fosaprepitant?

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?

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

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?

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.