Cuvitru (for injection under the skin) is used to treat primary immunodeficiency diseases.

Cuvitru is also used to treat chronic inflammatory demyelinating polyneuropathy (an autoimmune disorder in which the immune system attacks the nerves, causing muscle weakness and numbness).

Cuvitru may also be used for purposes not listed in this medication guide.

This medicine can cause blood clots. The risk is highest in older adults or in people who have had blood clots, heart problems, or blood circulation problems. Blood clots are also more likely during long-term bedrest, while using birth control pills or hormone replacement therapy, or while having a central intravenous (IV) catheter in place.

Call your doctor at once if you have chest pain, trouble breathing, fast heartbeats, numbness or weakness, or swelling and warmth or discoloration in an arm or leg.

This medicine can also harm your kidneys, especially if you have kidney disease or if you also use certain medicines. Tell your doctor right away if you have signs of kidney problems, such as swelling, rapid weight gain, and little or no urination.

Cuvitru is injected under the skin using an infusion pump. The medicine enters the body through a catheter placed under your skin. A healthcare provider may teach you how to properly use the medication by yourself.

Cuvitru is sometimes given daily, and sometimes once every 1 to 2 weeks. Use this medicine at regular intervals to keep a steady amount of the drug in your body at all times. If you use this medication at home, keep a diary of the days and times you gave the injection and where you injected it on your body.

Cuvitru must be given slowly, and you may need to use up to 8 different catheters to infuse this medicine into different body areas at the same time. Your healthcare provider will show you where on your body to inject this medicine. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine has is cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Do not shake the medication bottle or you may ruin the medicine.

Do not inject Cuvitru into a vein.

You will need frequent blood tests. This medicine can affect the results of certain other medical tests you may need. Tell any doctor who treats you that you are using Cuvitru.

Store Cuvitru in the original carton at room temperature. Protect from heat and light.

You may also store this medicine in its original carton in the refrigerator. Do not freeze Cuvitru, and throw the medicine away if it has frozen.

You will need to use your medicine within a certain number months. This will depend on the how you store the medicine (at room temperature, or in a refrigerator). Carefully follow the storage instructions provided with your medicine. Ask your pharmacist if you have questions.

Throw away any unused medication after the expiration date on the label has passed.

Each vial (bottle) is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use disposable injection items (needle, catheter, tubing) only once only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You should not use Cuvitru if:

• you have had an allergic reaction to an Cuvitru or blood product; or

• you have Cuvitru A (IgA) deficiency with antibody to IgA.

You may not be able to use Cuvitru if you have ever had an allergic reaction to polysorbate 80, or if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood).

This medicine can cause blood clots or kidney problems, especially in older adults or in people with certain conditions. Tell your doctor if you have ever had:

• heart problems, blood circulation problems, or "thick blood";

• a stroke or blood clot;

• kidney disease;

• diabetes;

• an infection called sepsis;

• if you use estrogens (birth control pills or hormone replacement therapy);

• if you have been on long-term bedrest; or

• if you have a central intravenous (IV) catheter in place.

You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.

Tell your doctor if you are pregnant or breastfeeding.

Do not give this medicine to a child without medical advice.

Cuvitru is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Cuvitru. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Stop using Cuvitru and get emergency medical help if you have signs of an allergic reaction: hives; wheezing, chest tightness, difficult breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Cuvitru may cause serious side effects. Call your doctor at once if you have:

• a blood cell disorder--pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• kidney problems--little or no urination, swelling, rapid weight gain, feeling short of breath;

• lung problems--chest pain, trouble breathing, blue colored lips, fingers, or toes;

• signs of a new infection--fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light; or

• signs of a blood clot--shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling and warmth or discoloration in an arm or leg.

Common side effects of Cuvitru may include:

• wheezing, trouble breathing;

• pain, redness, bruising, itching, swelling, or a hard lump where the medicine was injected;

• fever, tiredness, dizziness;

• nausea, vomiting, diarrhea, bloating, stomach pain;

• itching, rash, or other skin problems;

• cold or flu symptoms such as stuffy nose, sneezing, sore throat, cough;

• headache, migraine; or

• pain anywhere in your body.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cuvitru can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may affect Cuvitru, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.