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You may infuse ESPEROCT® at a hemophilia treatment Cap Color Indicator Nominal Strength
center, at your healthcare provider’s office or in your Red 500 IU per vial
home. You should be trained on how to do infusions
by your hemophilia treatment center or healthcare
Brief Summary information about provider. Many people with hemophilia A learn to infuse Green 1000 IU per vial
ESPEROCT® [antihemophilic Factor the medicine by themselves or with the help of a family Gray 1500 IU per vial
(recombinant), glycopegylated-exei] member. Yellow 2000 IU per vial
Your healthcare provider will tell you how much Black 3000 IU per vial
This information is not comprehensive. ESPEROCT® to use based on your weight, the severity
of your hemophilia A, and where you are bleeding. Your Always check the actual dosage strength printed on
• Talk to your healthcare provider or pharmacist dose will be calculated in international units, IU. the label to make sure you are using the strength
• Visit www.novo-pi.com/esperoct.pdf to obtain Call your healthcare provider right away if your prescribed by your healthcare provider.
bleeding does not stop after taking ESPEROCT®. How should I store ESPEROCT®?
FDA-approved product labeling
• Call 1-800-727-6500 Prior to Reconstitution (mixing the dry powder in the
vial with the diluent):
Patient Information If your bleeding is not adequately controlled, it could
be due to the development of Factor VIII inhibitors. This
ESPEROCT® should be checked by your healthcare provider. You Protect from light. Do not freeze ESPEROCT®.
[antihemophilic factor (recombinant),
glycopegylated-exei] might need a higher dose of ESPEROCT® or even a ESPEROCT® can be stored in refrigeration at 36°F
different product to control bleeding. Do not increase to 46°F (2°C to 8°C) for up to 30 months until the
Read the Patient Information and the Instructions the total dose of ESPEROCT® to control your bleeding
For Use that come with ESPEROCT® before you without consulting your healthcare provider. expiration date stated on the label. During the 30 month
start taking this medicine and each time you get Use in children shelf life, ESPEROCT® may be kept at room temperature
a refill. There may be new information. (not to exceed 86°F/30°C) for up to 12 months, or up
ESPEROCT® can be used in children. Your healthcare to 104°F (40°C) for no longer than 3 months.
This Patient Information does not take the place of provider will decide the dose of ESPEROCT® you will If you choose to store ESPEROCT® at room
talking with your healthcare provider about your medical temperature:
condition or treatment. If you have questions about receive. • Record the date when the product was removed
ESPEROCT® after reading this information, ask your If you forget to use ESPEROCT®
from the refrigerator.
healthcare provider. If you forget a dose, infuse the missed dose when you • Do not return the product to the refrigerator.
What is the most important information I need to discover the mistake. Do not infuse a double dose to • Do not use after 12 months if stored up to 86°F
know about ESPEROCT®? make up for a forgotten dose. Proceed with the next (30°C) or after 3 months if stored up to 104°F
Do not attempt to do an infusion yourself unless infusions as scheduled and continue as advised by your (40°C) or the expiration date listed on the vial,
you have been taught how by your healthcare healthcare provider. whichever is earlier.
provider or hemophilia treatment center. If you stop using ESPEROCT®
You must carefully follow your healthcare provider’s Do not stop using ESPEROCT® without consulting your Do not use this medicine after the expiration date which
instructions regarding the dose and schedule for healthcare provider. is on the outer carton and the vial. The expiration date
infusing ESPEROCT® so that your treatment will work If you have any further questions on the use of this refers to the last day of that month.
best for you. product, ask your healthcare provider.
What if I take too much ESPEROCT®? After Reconstitution:
What is ESPEROCT®? The reconstituted (the final product once the powder is
mixed with the diluent) ESPEROCT® should appear clear
and colorless without visible particles.
ESPEROCT® is an injectable medicine used to replace Always take ESPEROCT® exactly as your healthcare The reconstituted ESPEROCT® should be used
clotting Factor VIII that is missing in patients with provider has told you. You should check with your immediately.
hemophilia A. Hemophilia A is an inherited bleeding
disorder in all age groups that prevents blood from healthcare provider if you are not sure. If you infuse If you cannot use the reconstituted ESPEROCT®
clotting normally. more ESPEROCT® than recommended, tell your immediately, it must be used within 4 hours when
healthcare provider as soon as possible. stored at or below 86ºF (30°C) or within 24 hours when
stored in a refrigerator at 36°F to 46°F (2°C to 8°C).
ESPEROCT® is used to treat and prevent or reduce What are the possible side effects of Store the reconstituted product in the vial.
the number of bleeding episodes in people with ESPEROCT®? Keep this medicine out of the sight and out of reach of
hemophilia A. Common Side Effects Include: children.
Your healthcare provider may give you ESPEROCT®
when you have surgery. • rash or itching
What else should I know about ESPEROCT® and
• swelling, pain, rash or redness at the location of hemophilia A?
Who should not use ESPEROCT®? infusion Medicines are sometimes prescribed for purposes other
than those listed here. Do not use ESPEROCT® for a
You should not use ESPEROCT® if you Other Possible Side Effects: condition for which it is not prescribed. Do not share
• are allergic to Factor VIII or any of the other You could have an allergic reaction to coagulation Factor ESPEROCT® with other people, even if they have the
VIII products. Call your healthcare provider right same symptoms that you have.
ingredients of ESPEROCT® away or get emergency treatment right away if
• if you are allergic to hamster proteins you get any signs of an allergic reaction, such as: Revised: 10/2019
If you are not sure, talk to your healthcare provider hives, chest tightness, wheezing, dizziness, difficulty ESPEROCT® is a trademark of
before using this medicine. breathing, and/or swelling of the face. Novo Nordisk Health Care AG.
For Patent Information, refer to: http://novonordisk-us.
Tell your healthcare provider if you are pregnant or Your body can also make antibodies called “inhibitors” com/patients/products/product-patents.html
nursing because ESPEROCT® might not be right for you. against ESPEROCT®, which may stop ESPEROCT® from More detailed information is available upon
working properly. Your healthcare provider may need to
What should I tell my healthcare provider before I test your blood for inhibitors from time to time.
use ESPEROCT®?
You should tell your healthcare provider if you:
• Have or have had any medical conditions. These are not all of the possible side effects from request. Available by prescription only.
• Take any medicines, including non-prescription ESPEROCT®. Ask your healthcare provider for more Manufactured by:
medicines and dietary supplements. information. You are encouraged to report side effects Novo Nordisk A/S
to FDA at 1-800-FDA-1088. Novo Allé
• Are nursing.
Tell your healthcare provider about any side effect that DK-2880 Bagsværd, Denmark
• Are pregnant or planning to become pregnant.
• Have been told that you have inhibitors to Factor VIII. bothers you or that does not go away. For information about ESPEROCT® contact:
How should I use ESPEROCT®? What are the ESPEROCT® dosage strengths? Novo Nordisk Inc.
Treatment with ESPEROCT® should be started by a ESPEROCT® comes in five different dosage strengths. 800 Scudders Mill Road
healthcare provider who is experienced in the care of The actual number of international units (IU) of Factor Plainsboro, NJ 08536, USA
patients with hemophilia A. VIII in the vial will be imprinted on the label and on the 1-800-727-6500
© 2019 Novo Nordisk
ESPEROCT® is given as an infusion into the vein. box. The five different strengths are as follows: US19ESP00168 December 2019
