Page 14 - HFA Dateline 2019-2020 Special Issue

T:8.5"
S:7"

Medication Guide B:8.75"
• Your healthcare provider should show you or your caregiver how
HEMLIBRA (hem-lee-bruh) to prepare, measure, and inject your dose of HEMLIBRA before
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(emicizumab-kxwh) you inject yourself for the first time.
injection, for subcutaneous use • Do not attempt to inject yourself or another person unless you
have been taught how to do so by a healthcare provider.
What is the most important information I should know about • Your healthcare provider will prescribe your dose based on your
HEMLIBRA? weight. If your weight changes, tell your healthcare provider.
• You will receive HEMLIBRA 1 time a week for the first four
HEMLIBRA increases the potential for your blood to clot. weeks. Then you will receive a maintenance dose as prescribed
Carefully follow your healthcare provider’s instructions by your healthcare provider.
regarding when to use an on-demand bypassing agent or • If you miss a dose of HEMLIBRA on your scheduled day, you
factor VIII (FVIII) and the recommended dose and schedule to should give the dose as soon as you remember. You must give
use for breakthrough bleed treatment. the missed dose as soon as possible before the next scheduled
HEMLIBRA may cause the following serious side effects when dose, and then continue with your normal dosing schedule.
used with activated prothrombin complex concentrate (aPCC; Do not give two doses on the same day to make up for a
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FEIBA ), including: missed dose.
• Thrombotic microangiopathy (TMA). This is a condition • HEMLIBRA may interfere with laboratory tests that measure how
well your blood is clotting and may cause a false reading. Talk to
involving blood clots and injury to small blood vessels that your healthcare provider about how this may affect your care.
may cause harm to your kidneys, brain, and other organs. Get
medical help right away if you have any of the following signs What are the possible side effects of HEMLIBRA?
or symptoms during or after treatment with HEMLIBRA: • See “What is the most important information I should know
– confusion – stomach (abdomen) about HEMLIBRA?”
– weakness or back pain
– swelling of arms and legs – nausea or vomiting The most common side effects of HEMLIBRA include:
– yellowing of skin and eyes – feeling sick • redness, tenderness, warmth, or itching at the site of injection
– decreased urination • headache
• Blood clots (thrombotic events). Blood clots may form in • joint pain
blood vessels in your arm, leg, lung, or head. Get medical These are not all of the possible side effects of HEMLIBRA.
help right away if you have any of these signs or symptoms of
blood clots during or after treatment with HEMLIBRA: Call your doctor for medical advice about side effects. You may
– swelling in arms or legs – cough up blood report side effects to FDA at 1-800-FDA-1088.
– pain or redness in your – feel faint How should I store HEMLIBRA?
arms or legs – headache
– shortness of breath – numbness in your face • Store HEMLIBRA in the refrigerator at 36°F to 46°F (2°C to 8°C).
– chest pain or tightness – eye pain or swelling Do not freeze.
– fast heart rate – trouble seeing • Store HEMLIBRA in the original carton to protect the vials
from light.
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If aPCC (FEIBA ) is needed, talk to your healthcare provider in • Do not shake HEMLIBRA.
case you feel you need more than 100 U/kg of aPCC (FEIBA ) • If needed, unopened vials of HEMLIBRA can be stored out of
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total. the refrigerator and then returned to the refrigerator. HEMLIBRA
See “What are the possible side effects of HEMLIBRA?” for should not be stored out of the refrigerator for more than a total
more information about side effects. of 7 days or at a temperature greater than 86°F (30°C).
• After HEMLIBRA is transferred from the vial to the syringe, S:9.5" T:11" B:11.25"
What is HEMLIBRA? HEMLIBRA should be used right away.
HEMLIBRA is a prescription medicine used for routine prophylaxis • Throw away (dispose of) any unused HEMLIBRA left in the vial.
to prevent or reduce the frequency of bleeding episodes in Keep HEMLIBRA and all medicines out of the reach of children.
adults and children, ages newborn and older, with hemophilia A
with or without factor VIII inhibitors. General information about the safe and effective use of
Hemophilia A is a bleeding condition people can be born with HEMLIBRA.
where a missing or faulty blood clotting factor (factor VIII) Medicines are sometimes prescribed for purposes other than those
prevents blood from clotting normally. listed in a Medication Guide. Do not use HEMLIBRA for a
condition for which it was not prescribed. Do not give HEMLIBRA
HEMLIBRA is a therapeutic antibody that bridges clotting factors to other people, even if they have the same symptoms that you
to help your blood clot. have. It may harm them. You can ask your pharmacist or healthcare
Before using HEMLIBRA, tell your healthcare provider about provider for information about HEMLIBRA that is written for health
all of your medical conditions, including if you: professionals.
• are pregnant or plan to become pregnant. It is not known if What are the ingredients in HEMLIBRA?
HEMLIBRA may harm your unborn baby. Females who are Active ingredient: emicizumab-kxwh
able to become pregnant should use birth control
(contraception) during treatment with HEMLIBRA. Inactive ingredients: L-arginine, L-histidine, poloxamer 188, and
• are breastfeeding or plan to breastfeed. It is not known if L-aspartic acid.
HEMLIBRA passes into your breast milk.
Manufactured by: Genentech, Inc., A Member of the Roche Group,
Tell your healthcare provider about all the medicines you 1 DNA Way, South San Francisco, CA 94080-4990
U.S. License No. 1048
take, including prescription medicines, over-the-counter HEMLIBRA ® is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan
medicines, vitamins, or herbal supplements. Keep a list of them ©2018 Genentech, Inc. All rights reserved.
to show your healthcare provider and pharmacist when you get a For more information, go to www.HEMLIBRA.com or call 1-866-HEMLIBRA.
new medicine. This Medication Guide has been approved by the U.S. Food and Drug Administration
Revised: 10/2018
How should I use HEMLIBRA?
See the detailed “Instructions for Use” that comes with your
HEMLIBRA for information on how to prepare and inject a
dose of HEMLIBRA, and how to properly throw away
(dispose of) used needles and syringes.
• Use HEMLIBRA exactly as prescribed by your healthcare
provider.
• Stop (discontinue) prophylactic use of bypassing agents © 2019 Genentech USA, Inc. All rights reserved. EMI/061818/0106a(2)
the day before starting HEMLIBRA prophylaxis. HEMLIBRA is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
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• You may continue prophylactic use of FVIII for the first The HEMLIBRA logo is a trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
week of HEMLIBRA prophylaxis.
• HEMLIBRA is given as an injection under your skin The Genentech logo is a registered trademark of Genentech, Inc.
(subcutaneous injection) by you or a caregiver. All other trademarks are the property of their respective owners.
14 HEMOPHILIA FEDERATION OF AMERICA < www.hemophiliafed.org