Page 16 - HFA Dateline 2020-2021 Special Issue

PATIENT PRODUCT INFORMATION CONTACT YOUR HEALTHCARE PROVIDER IF YOU:
SEVENFACT ® (SEV-en-fact) coagulation factor VIIa (recombinant)-jncw • Miss a dose, or
• Administer more than your prescribed dose, or
For Intravenous Injection After Reconstitution Only
• Think your bleed is not controlled within the expected time frame discussed with
PLEASE READ PATIENT PRODUCT INFORMATION AND THE INSTRUCTIONS FOR
your healthcare provider.
USE THAT COME WITH SEVENFACT BEFORE YOU START TAKING THIS MEDICINE
WHAT SHOULD I AVOID WHILE USING SEVENFACT?
AND EACH TIME YOU GET A REFILL. THERE MAY BE NEW INFORMATION.
• Avoid activity that can create more bleeding once you have completed your
This Patient Product Information does not take the place of talking with your healthcare SEVENFACT infusion
provider about your medical condition and treatment. If you have questions about
SEVENFACT after reading this information, ask your healthcare provider. • Avoid mixing SEVENFACT with other medications
• Avoid infusing SEVENFACT and other factor-containing therapies [such as activated
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW prothrombin complex concentrate (aPCC) or other recombinant Factor VIIa products]
ABOUT SEVENFACT?
at the same time. This increases your risk of having a disabling blood clot.
The most serious possible side effect of SEVENFACT is abnormal blood clotting involving WHAT ARE THE POSSIBLE SIDE EFFECTS OF SEVENFACT?
blockage of blood vessels, which include stroke, blockage of the main blood vessel to the
lung, and deep vein blood clots. The most common adverse reactions reported in clinical trials for SEVENFACT were
headache, dizziness, infusionsite discomfort, infusion-site hematoma, infusion-related
You should know the signs of abnormal clotting (thrombosis) described below and seek reaction and fever.
medical help immediately if they occur.
A serious allergic reaction to SEVENFACT may occur. If you experience the severe symptoms
New onset of swelling and pain in the limbs or abdomen, new onset of chest pain, shortness of an allergic reaction after infusing SEVENFACT, seek immediate medical attention. Severe
of breath, loss of sensation or motor power, and altered consciousness or speech can all be symptoms occur when your immune system reacts very strongly to foreign proteins or drugs.
signs of clot formation in places other than your site of bleeding. Seek immediate medical
attention if you experience one or more of these symptoms. • Hives, itching, rash, difficulty breathing with cough or wheezing, swelling around the
mouth and throat, tightness of the chest, dizziness or fainting, and low blood pressure
SEVENFACT should be used as prescribed and directed by your healthcare provider.
are all symptoms of a severe allergic reaction (anaphylaxis). Call 911 should you
WHAT IS SEVENFACT? experience one or more of these symptoms.
SEVENFACT is a recombinant human Factor VIIa protein for injection. SEVENFACT can allow These are not all the possible side effects of SEVENFACT. For more information, ask
adolescents and adults with Hemophilia A or B with inhibitors to create clotting at the site of your healthcare provider or pharmacist.
bleeding without needing Coagulation Factor VIII or IX replacement.
Call your healthcare provider for medical advice about side effects. You may report
SEVENFACT, coagulation factor VIIa (recombinant)-jncw, is indicated for the treatment and side effects to FDA at 1- 800-FDA-1088.
control of bleeding episodes occurring in adults and adolescents 12 years of age and older
with Hemophilia A or B with inhibitors. HOW SHOULD I STORE SEVENFACT?
Injecting medications requires special training. Do not attempt to self-infuse unless you have • SEVENFACT should be stored in its product packaging to protect from light.
been taught how by your health care provider or hemophilia treatment center. Once trained, • Prior to reconstitution, the SEVENFACT kit should be stored at room temperature
you will need additional infusion materials along with your SEVENFACT so that you can but can be stored between 36°F to 86°F (2°C to 30°C).
successfully treat your bleeding episodes at home. Be sure to collect all necessary infusion
materials before starting the reconstitution process. • After reconstitution, SEVENFACT should be stored at room temperature but can be
stored between 36°F to 86°F (2°C to 30°C), for up to 4 hours.
SEVENFACT comes in a sterile dry powdered dosage form that must be reconstituted with
sterile Water for Injection. • SEVENFACT should not be frozen.
It is not known if SEVENFACT is safe and effective in children under 12 years of age. GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF SEVENFACT
This leaflet summarizes the most important information about SEVENFACT.
WHO SHOULD NOT USE SEVENFACT?
Do not use SEVENFACT for a condition for which it was not prescribed. Do not give
You should not use SEVENFACT if you:
SEVENFACT to other people even if they have the same symptoms you have. It may harm
• Are allergic to rabbits. them.
• Have known allergies to SEVENFACT or any of its components. You can ask your pharmacist or healthcare provider for information about SEVENFACT that
Tell your doctor prior to infusing SEVENFACT if you have begun treatment of a bleeding is written for health professionals.
episode with another bypassing agent such as activated prothrombin complex concentrate For more information, go to www.SEVENFACT.com or call 855.718.HEMA (4362).
(FEIBA ).
®
WHAT ARE THE INGREDIENTS IN SEVENFACT?
WHAT SHOULD I TELL MY HEALTHCARE PROVIDER BEFORE I USE SEVENFACT? Active ingredient: coagulation factor VIIa (recombinant)-jncw
Tell your healthcare provider if you: INACTIVE INGREDIENTS: ARGININE HYDROCHOLORIDE, GLYCINE, ISOLEUCINE,
• Are pregnant, planning to become pregnant or nursing, as SEVENFACT has not been LYSINE HYDROCHLORIDE, POLYSORBATE 80, TRISODIUM CITRATE DIHYDRATE,
studied in patients with Hemophilia A or B with inhibitors who are pregnant or nursing. HYDROCHLORIC ACID, NITROGEN AND WATER FOR INJECTION.
• Had prior blood clots, heart disease, heart failure, abnormal heart rhythms, prior FOR INFORMATION CONTACT:
pulmonary clots or heart surgery. HEMA Biologics, LLC
• Have or have had any other medical conditions. 4441 Springdale Road
You and your doctor can then decide whether SEVENFACT is the right treatment for you, as Louisville, Kentucky 40241-1086
well as the proper timing and doses you will need for SEVENFACT to control your bleeding Manufactured by:
episodes at home. Laboratoire Francais du Fractionnement et des Biotechnologies S.A. (LFB S.A.)
Les Ulis, 91940
HOW SHOULD I USE SEVENFACT?
France
Treatment with SEVENFACT should be started by a healthcare provider who is experienced Distributed by:
in the care of patients with Hemophilia A or B with inhibitors.
HEMA Biologics
SEVENFACT is given as an injection into your vein. Louisville, KY 40241
You may infuse SEVENFACT at a hemophilia treatment center, at your healthcare provider’s U.S. License No. 2061
office, or in your home. You should be trained on how to infuse by your healthcare provider All trademarks are the property of their respective owners.
or hemophilia treatment center. Many people with inhibitors learn to infuse by themselves or
with the help of a family member. “SEVENFACT” is a trademark of LFB S.A.
Treating at first sign of a bleed is important for bleed management. Your healthcare provider PATENT Information: https://hemabiodup.wpengine.com/patents/
will tell you how much Approved 04/2020
SEVENFACT to use based on your weight and when to administer SEVENFACT.
To administer SEVENFACT:
• Collect all materials needed for your prescribed dose
• Follow the Instructions For Use guide to reconstitute the prescribed number
of SEVENFACT vials SEVENFACT is a registered trademark of LFB S.A.
I
• nfuse following your healthcare provider’s instructions, using infusion materials HEMA Biologics, LLC is the exclusive licensee and distributor
from your pharmacy of SEVENFACT in the United States and its territories.
©2020 HEMA Biologics, LLC HBSEV-00015. All rights reserved.

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