What is CUVITRU?
- CUVITRU is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection.
- CUVITRU is indicated for the treatment of primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.
- CUVITRU is made from human plasma that is donated by healthy people. CUVITRU contains antibodies collected from these healthy people that replace the missing antibodies in PI patients.
- CUVITRU is given under the skin (subcutaneously).
- Most of the time infusions under the skin are given at home by self infusion or by caregivers. Only use CUVITRU by yourself after you have been instructed by your healthcare provider.
Important Risk Information
What is the most important information that I should know about CUVITRU?
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
Who should not use CUVITRU?
Do not use CUVITRU if you:
- Are allergic to immune globulin or other blood products.
- Have selective (or severe) immunoglobulin A (IgA) deficiency with antibodies to IgA.
CUVITRU can cause serious side effects. Call your healthcare professional or go to the 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 irritation 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 100ºF. This could be sign of an infection.
What are the possible or reasonably likely side effects of CUVITRU?
The following one or more possible side effects may occur at the site of infusion: mild or moderate pain, redness, and itching. These generally go away within a few hours, and are less likely after the first few infusions.
The most common side effects that may occur are: headache, nausea, fatigue, diarrhea, and vomiting.
These are not all the possible side effects. Talk to your healthcare professional about any side effects that bother you or that don‘t go away.
You are encouraged to report suspected side effects by contacting FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Shire at 1-800-999-1785.
The risk information provided here is not comprehensive. To learn more, talk about CUVITRU with your healthcare provider or pharmacist. The FDA-approved product labeling can be found accessed by clicking here.