Page 6 - HFA Dateline 2020-2021 Special Issue
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B:9"
T:8.5"
S:7.5"
You may infuse ESPEROCT at a hemophilia treatment Cap Color Indicator Nominal Strength
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center, at your healthcare provider’s office or in your
home. You should be trained on how to do infusions Red 500 IU per vial
by your hemophilia treatment center or healthcare Green 1000 IU per vial
provider. Many people with hemophilia A learn to infuse Gray 1500 IU per vial
Brief Summary information about the medicine by themselves or with the help of a family
ESPEROCT [antihemophilic Factor member. Yellow 2000 IU per vial
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(recombinant), glycopegylated-exei] Your healthcare provider will tell you how much Black 3000 IU per vial
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This information is not comprehensive. ESPEROCT to use based on your weight, the severity
• Talk to your healthcare provider or pharmacist of your hemophilia A, and where you are bleeding. Your Always check the actual dosage strength printed on
the label to make sure you are using the strength
• Visit www.novo-pi.com/esperoct.pdf to obtain dose will be calculated in international units, IU. prescribed by your healthcare provider.
FDA-approved product labeling Call your healthcare provider right away if your
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• Call 1-800-727-6500 bleeding does not stop after taking ESPEROCT . How should I store ESPEROCT ?
If your bleeding is not adequately controlled, it could Prior to Reconstitution (mixing the dry powder in the
Patient Information be due to the development of Factor VIII inhibitors. This vial with the diluent):
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ESPEROCT should be checked by your healthcare provider. You Protect from light. Do not freeze ESPEROCT .
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[antihemophilic factor (recombinant), might need a higher dose of ESPEROCT or even a ESPEROCT can be stored in refrigeration at 36°F
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glycopegylated-exei] 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 expiration date stated on the label. During the 30 month
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For Use that come with ESPEROCT before you without consulting your healthcare provider. shelf life, ESPEROCT may be kept at room temperature
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start taking this medicine and each time you get Use in children (not to exceed 86°F/30°C) for up to 12 months, or up
a refill. There may be new information. ESPEROCT can be used in children. Your healthcare to 104°F (40°C) for no longer than 3 months.
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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
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talking with your healthcare provider about your medical receive. temperature:
condition or treatment. If you have questions about • Record the date when the product was removed
ESPEROCT after reading this information, ask your If you forget to use ESPEROCT ® from the refrigerator.
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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
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infusions as scheduled and continue as advised by your
(40°C) or the expiration date listed on the vial,
Do not attempt to do an infusion yourself unless healthcare provider. whichever is earlier.
you have been taught how by your healthcare Do not use this medicine after the expiration date which
provider or hemophilia treatment center. If you stop using ESPEROCT ® is on the outer carton and the vial. The expiration date
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You must carefully follow your healthcare provider’s Do not stop using ESPEROCT without consulting your refers to the last day of that month.
instructions regarding the dose and schedule for healthcare provider. After Reconstitution:
infusing ESPEROCT so that your treatment will work If you have any further questions on the use of this
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best for you. product, ask your healthcare provider. The reconstituted (the final product once the powder is S:9.875" T:11" B:11.5"
mixed with the diluent) ESPEROCT should appear clear
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What is ESPEROCT ? What if I take too much ESPEROCT ? and colorless without visible particles.
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ESPEROCT is an injectable medicine used to replace Always take ESPEROCT exactly as your healthcare The reconstituted ESPEROCT should be used
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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 healthcare provider if you are not sure. If you infuse If you cannot use the reconstituted ESPEROCT
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disorder in all age groups that prevents blood from more ESPEROCT than recommended, tell your immediately, it must be used within 4 hours when
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clotting normally. healthcare provider as soon as possible. stored at or below 86ºF (30°C) or within 24 hours when
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ESPEROCT is used to treat and prevent or reduce What are the possible side effects of stored in a refrigerator at 36°F to 46°F (2°C to 8°C).
the number of bleeding episodes in people with ESPEROCT ? Store the reconstituted product in the vial.
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hemophilia A. Keep this medicine out of the sight and out of reach of
Your healthcare provider may give you ESPEROCT Common Side Effects Include: children.
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when you have surgery. • rash or itching What else should I know about ESPEROCT and
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Who should not use ESPEROCT ? • swelling, pain, rash or redness at the location of hemophilia A?
infusion
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You should not use ESPEROCT if you Other Possible Side Effects: Medicines are sometimes prescribed for purposes other
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• are allergic to Factor VIII or any of the other than those listed here. Do not use ESPEROCT for a
ingredients of ESPEROCT ® You could have an allergic reaction to coagulation Factor condition for which it is not prescribed. Do not share
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• if you are allergic to hamster proteins VIII products. Call your healthcare provider right ESPEROCT with other people, even if they have the
same symptoms that you have.
If you are not sure, talk to your healthcare provider away or get emergency treatment right away if
you get any signs of an allergic reaction, such as:
before using this medicine. hives, chest tightness, wheezing, dizziness, difficulty
Tell your healthcare provider if you are pregnant or breathing, and/or swelling of the face. Revised: 10/2019
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nursing because ESPEROCT might not be right for you. ESPEROCT is a trademark of
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Your body can also make antibodies called “inhibitors” Novo Nordisk Health Care AG.
What should I tell my healthcare provider before I against ESPEROCT , which may stop ESPEROCT from For Patent Information, refer to: http://novonordisk-us.
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use ESPEROCT ? working properly. Your healthcare provider may need to com/patients/products/product-patents.html
You should tell your healthcare provider if you: test your blood for inhibitors from time to time. More detailed information is available upon
• 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:
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medicines and dietary supplements. information. You are encouraged to report side effects Novo Nordisk A/S
• Are nursing. to FDA at 1-800-FDA-1088. Novo Allé
• Are pregnant or planning to become pregnant. Tell your healthcare provider about any side effect that DK-2880 Bagsværd, Denmark
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• Have been told that you have inhibitors to Factor VIII. bothers you or that does not go away. For information about ESPEROCT contact:
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How should I use ESPEROCT ? What are the ESPEROCT dosage strengths? Novo Nordisk Inc.
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800 Scudders Mill Road
Treatment with ESPEROCT should be started by a ESPEROCT comes in five different dosage strengths. Plainsboro, NJ 08536, USA
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healthcare provider who is experienced in the care of The actual number of international units (IU) of Factor 1-800-727-6500
patients with hemophilia A. VIII in the vial will be imprinted on the label and on the © 2019 Novo Nordisk
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ESPEROCT is given as an infusion into the vein. box. The five different strengths are as follows: US19ESP00168 December 2019