Fosaprepitant

What it is used for

Fosaprepitant for Injection is a prescription medicine used with other medicines that treat nausea and vomiting in patients 6 months of age and older 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 less than 6 months of age.

Side effects, and when to stop

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 doctor 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.
• 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.

In adults, the most common side effects of Fosaprepitant for Injection include:

In children 6 months to 17 years of age, the most common side effects of Fosaprepitant for Injection include:

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. For more information ask your healthcare provider or pharmacist.

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 go to www.baxter.com.

Who should not take it

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 ® )

What to say before you start

Before receiving Fosaprepitant for Injection, tell your healthcare provider 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.
  • o 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 and spermicides, during treatment with Fosaprepitant for Injection and for 1 month after receiving 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?

Adults 18 years of age and older:

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.

Children 6 months to 17 years of age:

Fosaprepitant for Injection will be given to your child by intravenous (IV) infusion into a large vein through a type of IV line called a central venous catheter, about 1 hour to 1½; hours before the start of their chemotherapy treatment. Depending on the chemotherapy treatment, there are 2 ways that Fosaprepitant for Injection may be given:

• 1. Fosaprepitant for Injection is given on Day 1 only (single day of chemotherapy).
• 2. Fosaprepitant for Injection is given on Days 1, 2, and 3 (single or multiple days of chemotherapy).
• Your child may receive capsules of aprepitant or an oral suspension of aprepitant instead of Fosaprepitant for Injection on Days 2 and 3. If your child will receive either of these, see the Patient Information for aprepitant capsules or aprepitant for oral suspension for further information.

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.