Page 6 - HFA Dateline 2020-2021 Special Issue
P. 6

B:9"
                                                             T:8.5"
                                                            S:7.5"
                                             You may infuse ESPEROCT  at a hemophilia treatment   Cap Color Indicator  Nominal Strength
                                                             ®
                                             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
                  ®
           (recombinant), glycopegylated-exei]  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
            • 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
                                                                                                    ®
                                                                            ®
            • 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):
                 ®
          ESPEROCT                           should be checked by your healthcare provider. You   Protect from light. Do not freeze ESPEROCT .
                                                                                                          ®
          [antihemophilic factor (recombinant),   might need a higher dose of ESPEROCT  or even a   ESPEROCT  can be stored in refrigeration at 36°F
                                                                     ®
                                                                                      ®
          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
                                                              ®
                                                                                            ®
          For Use that come with ESPEROCT  before you   without consulting your healthcare provider.  shelf life, ESPEROCT  may be kept at room temperature
                                 ®
          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.
                                                    ®
                                                                                                    ®
          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   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.
                 ®
          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
                          ®
                                             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
                                                              ®
          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
                      ®
          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
                                                                                                    ®
                       ®
          What is ESPEROCT ?                 What if I take too much ESPEROCT ?  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   healthcare provider if you are not sure. If you infuse   If you cannot use the reconstituted ESPEROCT
                                                                                                           ®
          disorder in all age groups that prevents blood from   more ESPEROCT  than recommended, tell your   immediately, it must be used within 4 hours when
                                                       ®
          clotting normally.                 healthcare provider as soon as possible.  stored at or below 86ºF (30°C) or within 24 hours when
                 ®
          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.
                                                    ®
          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.
                                        ®
          when you have surgery.              • rash or itching                 What else should I know about ESPEROCT  and
                                                                                                            ®
                               ®
          Who should not use ESPEROCT ?       • swelling, pain, rash or redness at the location of   hemophilia A?
                                               infusion
                             ®
          You should not use ESPEROCT  if you  Other Possible Side Effects:     Medicines are sometimes prescribed for purposes other
                                                                                                           ®
           • 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
                                                                                      ®
           • 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
                                                                                      ®
          nursing because ESPEROCT  might not be right for you.                 ESPEROCT  is a trademark of
                           ®
                                             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.
                                                                          ®
                                                        ®
                    ®
          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:
                                                    ®
            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
                                                                                                    ®
           • 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.
                                                             ®
                                                                                800 Scudders Mill Road
          Treatment with ESPEROCT  should be started by a   ESPEROCT  comes in five different dosage strengths.   Plainsboro, NJ 08536, USA
                          ®
                                                    ®
          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
                 ®
          ESPEROCT  is given as an infusion into the vein.  box. The five different strengths are as follows:  US19ESP00168     December 2019
   1   2   3   4   5   6   7   8   9   10   11