
Patient Information FOCINVEZ (FOR sin vez) (fosaprepitant injection), for intravenous use
Read this Patient Information before you start receiving FOCINVEZ and each time you are scheduled to receive FOCINVEZ. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is FOCINVEZ? FOCINVEZ 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. FOCINVEZ is not used to treat nausea and vomiting that you already have. It is not known if FOCINVEZ is safe and effective in children less than 6 months of age.
Who should not receive FOCINVEZ? Do not receive FOCINVEZ if you: are allergic to fosaprepitant, aprepitant, or any of the ingredients in FOCINVEZ. See the end of this patient information leaflet for a complete list of the ingredients in FOCINVEZ. are taking pimozide (ORAP)
What should I tell my healthcare provider before receiving FOCINVEZ? Before receiving FOCINVEZ, tell your healthcare provider if you: have liver problems. are pregnant or plan to become pregnant. It is not known if FOCINVEZ 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 and spermicides, during treatment with FOCINVEZ and for 1 month after receiving the last dose of fosaprepitant or aprepitant. are breastfeeding or plan to breastfeed. It is not known if FOCINVEZ passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive FOCINVEZ. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. FOCINVEZ may affect the way other medicines work, and other medicines may affect the way FOCINVEZ 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 FOCINVEZ? Adults 18 years of age and older: FOCINVEZ 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: FOCINVEZ 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 1 ½ hours before the start of their chemotherapy treatment. Depending on the chemotherapy treatment, there are 2 ways that FOCINVEZ may be given: FOCINVEZ is given on Day 1 only (single day of chemotherapy). FOCINVEZ is given on Day 1 (single or multiple days of chemotherapy). Your child may also receive capsules of aprepitant or an oral suspension of aprepitant 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 FOCINVEZ to check your blood clotting.
What are the possible side effects of FOCINVEZ? FOCINVEZ may cause serious side effects, including: Serious allergic reactions.Allergic reactions can happen with FOCINVEZ 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 FOCINVEZ, 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 FOCINVEZ. 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 FOCINVEZ include:
tiredness diarrhea low white blood cell and red blood cell counts weakness feeling weak or numb in your arms and legs	painful, difficult, or changes in your digestion (dyspepsia) urinary tract infection pain in your arms and legs
In children 6 months to 17 years of age, the most common side effects of FOCINVEZ include:
low red blood cell count low white blood cell count	low blood platelet count low white blood cell count with a fever
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 FOCINVEZ. 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 FOCINVEZ. If you would like more information about FOCINVEZ, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about FOCINVEZ that is written for health professionals. For more information about FOCINVEZ call 1-888-278-1784.
What are the ingredients in FOCINVEZ? Active ingredient: fosaprepitant Inactive ingredients: betadex sulfobutyl ether sodium, edetate disodium, sodium hydroxide (for pH adjustment) and water for injection Additional pediatric use information is approved for Merck Sharp & Dohme LLC’s EMEND (fosaprepitant) for injection. However, due to Merck Sharp & Dohme LLC’s marketing exclusivity rights, this drug product is not labeled with that information Manufactured for: Steriscience Pte. Limited Manufactured by: Steriscience Specialties Private Limited- Sterile Product Division Opp IIM, Bilekahalli, Bannerghatta Road, Bengaluru, Karnataka 560076, India.
This Patient Information has been approved by the U.S. Food and Drug Administration	Issue Date: 08/2023

fosaprepitant

Product monograph

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