Page 3 - HFA Dateline 2022 Special Edition

T:8.5"
T:8.5"
S:7.5"
S:7.5"
When it comes to your hemophilia A treatment B:8.75" B:8.75"
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You may infuse ESPEROCT at a hemophilia treatment Cap Color Indicator Nominal Strength
Move beyond the threshold a 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 Green 1000 IU per vial
Esperoct can give you high factor levels for longer. b provider. Many people with hemophilia A learn to infuse Gray 1500 IU per vial
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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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Extend half-life beyond the standard 22-hour average half-life in adults c [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
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FOR ADULTS AND ADOLESCENTS 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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Switching made easy High factor levels Flexible on the go For Use that come with ESPEROCT before you without consulting your healthcare provider. shelf life, ESPEROCT may be kept at room temperature
(not to exceed 86°F/30°C) for up to 12 months, or up
start taking this medicine and each time you get
Use in children
with a standard 50 IU/kg dose every 4 days At or above 3% The ONLY extended half-life 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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If you choose to store ESPEROCT at room
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-50% fewer infusions if you previously infused for 100% of the time d,e product that can be stored This Patient Information does not take the place of provider will decide the dose of ESPEROCT you will temperature:
talking with your healthcare provider about your medical
every other day At or above 5% up to 104°F g condition or treatment. If you have questions about receive. ® • Record the date when the product was removed
If you forget to use ESPEROCT
from the refrigerator.
Please see Brief Summary for
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-40% fewer infusions if you previously infused 3x a week for 90% of the time d,f complete storage instructions. ESPEROCT after reading this information, ask your If you forget a dose, infuse the missed dose when you • Do not return the product to the refrigerator.
healthcare provider.
Safety Proven across 5 studies, the largest and longest EHL clinical trial program 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
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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know about ESPEROCT ?
whichever is earlier.
a Of 1% trough factor levels for standard half-life (SHL) products in adults and adolescents. 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,
healthcare provider.
b Compared with SHL products. you have been taught how by your healthcare Do not use this medicine after the expiration date which

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c Data shown are from 42 adults who received a pharmacokinetic (PK) assessment around the first Esperoct 50 IU/kg dose. 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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d Trough level goal is 1% for prophylaxis. You must carefully follow your healthcare provider’s Do not stop using ESPEROCT without consulting your refers to the last day of that month.
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e Data shown are from a study where 175 previously treated adolescents and adults received routine prophylaxis with Esperoct 50 IU/kg every 4 days. instructions regarding the dose and schedule for healthcare provider. After Reconstitution:
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Pre-dose factor activity (trough) levels were evaluated at follow-up visits. Mean trough levels for adolescents (12-<18 years) were 2.7 IU/dL. infusing ESPEROCT so that your treatment will work If you have any further questions on the use of this The reconstituted (the final product once the powder is
f Steady-state FVIII activity levels were estimated in 143 adults and adolescents using pharmacokinetic modeling. best for you. product, ask your healthcare provider. ®
g For up to 3 months. S:9.875" T:11" B:11.25" What is ESPEROCT ? What if I take too much ESPEROCT ? mixed with the diluent) ESPEROCT should appear clear S:9.875" T:11" B:11.25"
and colorless without visible particles.
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What is Esperoct ? What should I tell my healthcare provider before 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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Esperoct [antihemophilic factor (recombinant), glycopegylated- using Esperoct ? clotting Factor VIII that is missing in patients with provider has told you. You should check with your immediately. ®
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hemophilia A. Hemophilia A is an inherited bleeding
If you cannot use the reconstituted ESPEROCT
healthcare provider if you are not sure. If you infuse
exei] is an injectable medicine to treat and prevent or reduce • Before taking Esperoct , you should tell your healthcare 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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the number of bleeding episodes in people with hemophilia A. provider if you have or have had any medical conditions, take clotting normally. 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).
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Your healthcare provider may give you Esperoct when you any medicines (including non-prescription medicines and ESPEROCT is used to treat and prevent or reduce What are the possible side effects of Store the reconstituted product in the vial.
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the number of bleeding episodes in people with
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have surgery dietary supplements), are nursing, pregnant or planning to hemophilia A. ESPEROCT ? Keep this medicine out of the sight and out of reach of
Common Side Effects Include:
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• Esperoct is not used to treat von Willebrand Disease become pregnant, or have been told that you have inhibitors Your healthcare provider may give you ESPEROCT • rash or itching children. ®
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to factor VIII when you have surgery. • swelling, pain, rash or redness at the location of What else should I know about ESPEROCT and
IMPORTANT SAFETY INFORMATION • Your body can make antibodies called “inhibitors” against Who should not use ESPEROCT ? infusion hemophilia A?
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Who should not use Esperoct ? Esperoct , which may stop Esperoct from working properly. You should not use ESPEROCT if you Other Possible Side Effects: Medicines are sometimes prescribed for purposes other
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than those listed here. Do not use ESPEROCT for a
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• are allergic to Factor VIII or any of the other
• You should not use Esperoct if you are allergic to factor VIII Call your healthcare provider right away if your 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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ESPEROCT with other people, even if they have the
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or any of the other ingredients of Esperoct or if you are bleeding does not stop after taking Esperoct ® • if you are allergic to hamster proteins VIII products. Call your healthcare provider right same symptoms that you have.
away or get emergency treatment right away if
allergic to hamster proteins What are the possible side effects of Esperoct ? If you are not sure, talk to your healthcare provider you get any signs of an allergic reaction, such as:
before using this medicine.
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What is the most important information I need to know • Common side effects of Esperoct include rash or itching, Tell your healthcare provider if you are pregnant or hives, chest tightness, wheezing, dizziness, difficulty Revised: 10/2019
breathing, and/or swelling of the face.
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about Esperoct ? and swelling, pain, rash or redness at the location of infusion nursing because ESPEROCT might not be right for you. Your body can also make antibodies called “inhibitors” ESPEROCT is a trademark of
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Novo Nordisk Health Care AG.
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• Do not attempt to do an infusion yourself unless you 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 ?
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have been taught how by your healthcare provider or Please see Brief Summary of Prescribing Information You should tell your healthcare provider if you: working properly. Your healthcare provider may need to com/patients/products/product-patents.html
test your blood for inhibitors from time to time.
hemophilia treatment center on the following page. • Have or have had any medical conditions. These are not all of the possible side effects from More detailed information is available upon
request. Available by prescription only.
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• Call your healthcare provider right away or get • Take any medicines, including non-prescription ESPEROCT . Ask your healthcare provider for more Manufactured by:
medicines and dietary supplements.
emergency treatment right away if you get any signs of • Are nursing. information. You are encouraged to report side effects Novo Nordisk A/S
to FDA at 1-800-FDA-1088.
Novo Allé
an allergic reaction, such as: hives, chest tightness, wheezing, Discover more at Esperoct.com. • Are pregnant or planning to become pregnant. Tell your healthcare provider about any side effect that DK-2880 Bagsværd, Denmark
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dizziness, dif culty breathing, and/or swelling of the face • 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.
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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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Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, healthcare provider who is experienced in the care of 1-800-727-6500
New Jersey 08536 U.S.A. patients with hemophilia A. The actual number of international units (IU) of Factor © 2019 Novo Nordisk
VIII in the vial will be imprinted on the label and on the
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Esperoct is a registered trademark of Novo Nordisk Health Care AG. ESPEROCT is given as an infusion into the vein. box. The five different strengths are as follows: US19ESP00168 December 2019
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Novo Nordisk is a registered trademark of Novo Nordisk A/S.
© 2020 Novo Nordisk Printed in the USA. US20ESP00014 February 2020
PREPARED BY PREPARED BY
11648998 N8 GP PATIENT JOURNAL AD RESIZE M2FR 11648998 N8 GP PATIENT JOURNAL AD RESIZE M2FR
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