utions (5.3)]
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Increased heart rate, fatigue, yellowing of the skin or eyes, and dark-colored urine. [see Warnings and Precautions (5.5)]
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Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath. [see Warnings and Precautions (5.6)]
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Trouble breathing, chest pain, blue lips or extremities, or fever that can occur 1 to 6 hours after an infusion of HYQVIA. [see Warnings and Precautions (5.8)]
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Inform patients that HYQVIA is made from human plasma and may contain infectious agents that can cause disease (e.g., viruses and, theoretically, the vCJD agent). Patients should report any symptoms that concern them which might be caused by virus infections. [see Warnings and Precautions (5.9)]
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Inform the female patient of the possibility of participating in the pregnancy registry. [see Use in Specific Populations (8.1)]
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Inform patients that HYQVIA can interfere with their immune response to live viral vaccines such as measles, mumps, rubella, and varicella, and instruct patients to notify their healthcare professional of this potential interaction when they are receiving vaccinations [see Drug Interactions (7)].
Self-administration – If self-administration is deemed appropriate by the physician, give clear instructions and training on how to administer HYQVIA. Document their ability to independently administer HYQVIA.
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Ensure the patient understands the importance of following regularly scheduled infusions to maintain appropriate steady IgG levels.
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Instruct the patient to keep a treatment infusion log. This infusion log should include information about each infusion such as, the lot number(s), infusion site location, the time, date, dose, and any reactions.
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Inform the patient that due to the volume that can be infused, swelling is common with HYQVIA. Mild to moderate local infusion-site reactions (e.g., swelling and redness) are common side effects of facilitated subcutaneous treatment with HYQVIA. Instruct the patient to contact their healthcare professional if a local reaction increases in severity or persists for more than a few days.
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Instruct the patient on the importance of following the directions for the pump for infusion of the Immune Globulin Infusion 10% (Human) of HYQVIA.
Baxalta and Hyqvia are trademarks of Baxalta Incorporated.
Patented: please see www.baxalta.com/productpatents/
Baxalta US Inc.
Westlake Village, CA 91362 USA
U.S. License No. 2020
Information For Patients
HYQVIA
Immune Globulin Infusion 10% (Human)
Recombinant Human Hyaluronidase
For Subcutaneous Administration
The following summarizes important information about HYQVIA (pronounced Hi-Q-via). Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare professional, and it does not include all of the important information about HYQVIA. If you have any questions after reading this, ask your healthcare professional.
What is the most important information that I should know about HYQVIA?
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HYQVIA can cause blood clots.
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Call your healthcare professional if you have pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s), unexplained shortness of breath, chest pain or disc
