: Coherus BioSciences, Inc., Redwood City, California 94065-1442
U.S. License No. 2023
© 2018 Coherus BioSciences Inc. All rights reserved.
For more information, go to www.UDENYCA.com or call 1-800-4UDENYCA (1-800-483-3692)
PMD-0004, Version 01
Patient Information
UDENYCATM (yoo-den-i-kah)
(pegfilgrastim-cbqv)
Injection
Single-Dose Prefilled Syringe
What is UDENYCA?
UDENYCA is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by
the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body’s fight againstinfection.
Do not take UDENYCA if you have had a serious allergic reaction to pegfilgrastim or filgrastim products.
Before you receive UDENYCA, tell your healthcare provider about all of your medical conditions, including ifyou:
• have a sickle cell disorder.
• have kidney problems.
• are pregnant or plan to become pregnant. It is not known if UDENYCA will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if UDENYCA passes into your breast milk.
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-countermedicines, vitamins, and herbal supplements.
How will I receive UDENYCA?
• UDENYCA is given as an injection under your skin (subcutaneous injection) by a healthcare provider.
Ifyour healthcare provider decides that the subcutaneous injections can be given at home by you or yourcaregiver, follow the detailed “Instructions for Use” that comes with your UDENYCA for information onhow to prepare and inject a dose of UDENYCA.
• You and your caregiver will be shown how to prepare and inject UDENYCA before you use it.
• You should not inject a dose of UDENYCA to children weighing less than 45kg from a UDENYCA prefilled syringe.
A dose less than 0.6 mL (6mg) cannot be accurately measured using the UDENYCA prefilled syringe.
• If you are receiving UDENYCA because you are also receiving chemotherapy, the last dose of UDENYCA shouldbe injected at least 14 days before and 24 hours after your dose of chemotherapy.
• If you miss a dose of UDENYCA, talk to your healthcare provider about when you should give your next dose.
What are possible side effects of UDENYCA?
UDENYCA may cause serious side effects, including:
• Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Callyour healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.
• A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Call your healthcare provideror get emergency care right away if you have shortness of breath with or without a fever, trouble breathing, or afast rate of breathing.
• Serious allergic reactions. UDENYCA can cause serious allergic reactions. These reactions can cause a rashover your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heartrate, and sweating. If you have any of these symptoms, stop using UDENYCA and call your healthcare provider or
get emergency medical help right away.
• Sickle cell crises. You may have a serious sickle cell crisis if you have a sickle cell disorder and receiveUDENYCA. Serious sickle cell crises have happened in people with sickle cell disorders receiving pegfilgrastimthat has sometimes led to de |
