When This Medicine Should Not Be Used:
This medicine is not right for everyone. You should not receive this medicine if you have had an allergic reaction to plasma, fresh frozen plasma, plasma protein, or plasma-derived products.

How to Use This Medicine:
Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider will give you this medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have liver disease or have had a liver transplant. Tell your doctor about any bleeding or clotting problems you have, such as immunoglobulin A (IgA) deficiency or protein S deficiency.
• This medicine may cause the following problems:
  
  • Congestive heart failure
  • Pulmonary edema
  • Blood clots
• This medicine is made from donated human blood. Some human blood products have transmitted viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, coughing up blood
• Confusion, numbness or tingling around the mouth, fingertips, or feet
• Lightheadedness, dizziness, or fainting
• Muscle spasms, unusual tiredness or weakness
• Pain in your lower leg (calf)
• Rapid weight gain, swelling in your hands, ankles, or feet

If you notice these less serious side effects, talk with your doctor:

• Headache, nausea
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088