Important Safety Information (continued)
HYQVIA can cause serious side effects. Call your healthcare professional or go to
your emergency department right away if you get:
• Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or
dizziness. These could be signs of a serious allergic reaction.
• Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These
could be signs of swelling in your brain.
• Reduced urination, sudden weight gain, or swelling in your legs. These could be signs
of a kidney problem.
• Pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the
infusion site(s). These could be signs of a blood clot.
• Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver
or blood problem.
• Chest pain or trouble breathing, blue lips or extremities. These could be signs of
a lung problem.
What are the possible or reasonably likely side effects of HYQVIA?
• After HYQVIA infusion a temporary, soft swelling may occur around the infusion site,
which may last 1 to 3 days, due to the volume of fluid infused. Mild or moderate pain,
redness, swelling, or itching may occur at the site of infusion and generally go away
in a few hours. Local reactions are less likely after the first few infusions.
• The most common side effects of HYQVIA are headache, fatigue, nausea, fever,
and vomiting.
• Antibodies to the hyaluronidase component of HYQVIA were formed in some patients
taking HYQVIA. It is not known if there is any long term effect. In theory, these
antibodies could react with your body’s own PH20. PH20 is present in the male
reproductive tract. So far, these antibodies have not been associated with increased
or new side effects.
These are not all the possible side effects with HYQVIA. Talk to your healthcare
professional about any side effects that bother you or that don’t go away.
Before starting HYQVIA
, tell your healthcare professional if you:
• Have or had any kidney, liver, or heart problems or history of blood clots because
HYQVIA can make these problems worse.
• Have IgA deficiency or a history of severe allergic reactions to IgG or other blood
products.
• Are pregnant, trying to become pregnant or are breast feeding.
You are encouraged to report suspected side effects by contacting
FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Shire Drug Safety
at 1-800-999-1785.
Please click for
, including Warning about Blood Clots,
and discuss with your healthcare provider.