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side effects.1

SIDE EFFECTS

What side effects do I need to watch for?

Any time you’re learning about a new medication, make sure to ask your doctor about potential side effects. It’s an important part of the conversation. And it’s important for you to understand both the benefits and the risks that can come with introducing a new treatment to your PI management plan.

CUVITRU can cause the following serious reactions:

Severe allergic reactions causing difficulty in breathing or skin rashes; decreased kidney function or kidney failure; blood clots in the heart, brain, lungs, or elsewhere in the body; severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting; dark colored urine, swelling, fatigue, or difficulty breathing.

Do not use CUVITRU if you:

Have a known history of a severe allergic reaction to immune globulin or other blood products. If you have such a history, discuss this with your healthcare provider to determine if CUVITRU can be given to you. Tell your healthcare provider if you have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

What should I avoid while taking CUVITRU [Immune Globulin Subcutaneous (Human)] 20%?1

  • CUVITRU can make vaccines (like measles/mumps/rubella or chickenpox vaccines) not work as well for you. Before you get any vaccines, tell your healthcare provider (HCP) that you take CUVITRU.
  • Tell your HCP if you are pregnant, or plan to become pregnant, or if you are nursing.

What are the possible or reasonably likely side effects of CUVITRU?1

CUVITRU can cause serious side effects. If any of the following problems occur after starting CUVITRU, stop the infusion immediately and contact your HCP or call emergency services1:

  • 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 irritation and swelling of the lining around 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. 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, or blue lips or extremities. These could be signs of a serious heart or lung problem.
  • Fever over 100°F. This could be sign of an infection.

The following one or more possible side effects may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions.1

  • Mild or moderate pain
  • Redness
  • Itching

The most common side effects that may occur are1:

  • Headache
  • Nausea
  • Fatigue
  • Diarrhea
  • Vomiting

These are not all the possible side effects. Talk to your HCP about any side effect that bothers you or that does not go away.1

For additional safety information, click for Information For Patients and discuss with your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

  1. CUVITRU [Prescribing Information]. Lexington, MA: Baxalta US Inc.