How do subQ IG and IVIG therapies differ?

IG therapy can be given one of two ways, subQ infusion or IV infusion.SubQ stands for subcutaneous, meaning under the skin. IV stands for intravenous, meaning into the vein. So, the two categories of IG therapy are known as:

Important terms related to CUVITRU^® and PI

Here are definitions of important words and phrases that are used on this site and that you’ll come across a lot in other information about CUVITRU and PI.

Acute serious bacterial infections (ASBIs):

Short-term but serious infections that require immediate medical care

Antibodies:

Proteins made by the body to help fight infections

Chronic disorder:

Disease or condition that usually lasts for 3 months or longer and may get worse

over time

Immune system:

Helps your body fight infection

Infusion:

Method of administering fluids into the bloodstream

Local side effects:

Occur on the body where the medicine is given; these generally go away within a few hours and are less likely after the first few infusions

Patient-year:

Patient experience in a clinical trial over the course of 1 year. One patient-year is equal to, for example, the experience of 2 patients for 6 months, or 12 patients for 1 month each

Primary immunodeficiency:

A term used to describe a group of mostly genetic disorders that cause the immune system to not work correctly

Subcutaneous (subQ):

Under the skin

Systemic side effects:

Happen throughout the body, such as a headache or feeling tired

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IMPORTANT SAFETY INFORMATION and serious warnings regarding blood clots

What is CUVITRU?

CUVITRU is a ready-to-use liquid medicine that is given under the skin (subcutaneously) to treat primary immunodeficiency (PI) in people 2 years and older.

IMPORTANT SAFETY 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.

What is the most important information I need to 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:

Have had a severe allergic reaction to immune globulin or other blood products.
Have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

What should I avoid while taking CUVITRU?

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?

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 services:

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.

Mild or moderate pain
Redness
Itching

The most common side effects that may occur are:

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.

For additional safety information, including Warning about Blood Clots, 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.