Plasma (Intravenous)

Plasma injection is used to replace several coagulation (clotting) factors in patients who have acquired deficiencies from liver disease, or who are having heart surgery or a liver transplant. This medicine is also used in plasma exchange for patients with thrombotic thrombocytopenic purpura (TTP).

This medicine should only be given by a doctor or under the direct supervision of a doctor.

Your doctor will closely monitor your progress while you are getting this medicine. This will help your doctor determine if the medicine is effective and if you should keep receiving it.

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Call your doctor right away if you experience a rash, itching, lightheadedness or dizziness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Inform your doctor immediately if you have chest pain, noisy breathing, swelling of the face, fingers, feet, or lower legs, difficulty breathing, or weight gain. These could be signs of heart failure and pulmonary edema.

Contact your doctor right away if you notice tenderness, pain, swelling, warmth, skin discoloration, or prominent superficial veins at the injection site. These could indicate a blood clotting problem due to low levels of Protein S.

Taking too much of this medicine may lead to citrate toxicity or hypocalcemia (low calcium in the blood). Notify your doctor immediately if you experience confusion, convulsions, muscle spasms, numbness or tingling around the mouth, fingertips, or feet, or unusual tiredness or weakness.

This medicine is made from donated human blood. Some human blood products have transmitted viruses to recipients, although the risk is low. Both human donors and donated blood are tested for viruses to minimize this risk. Discuss this concern with your doctor if you are worried.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, think about the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to see how age affects the results of plasma injection in children. Safety and effectiveness have not been confirmed.

Geriatric

Studies have not been done to see how age affects the results of plasma injection in older adults. Safety and effectiveness have not been confirmed.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if interactions could happen. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Allergy to fresh frozen plasma (FFP) or plasma-derived products (e.g., plasma protein), history of or
• Immunoglobulin A (IgA) deficiency or
• Severe protein S deficiency—Should not be used in patients with these conditions.

• Bleeding problems or
• Heart failure or
• Pulmonary edema (fluid in the lungs)—Use with caution. May make side effects worse.

• Liver disease—Use with caution. May increase the risk of more serious side effects.

• Liver transplant—Patients with this condition should be monitored for increased bleeding.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings

Incidence not known

• Dizziness, faintness, or lightheadedness when standing up suddenly from a lying or sitting position
• fast heartbeat
• hives, itching, or rash
• muscle cramps in the hands, arms, feet, legs, or face
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• tightness in the chest
• unusual tiredness or weakness

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Headache
• nausea

Incidence not known

• Bleeding, blistering, discomfort, infection, itching, lumps, numbness, pain, rash, redness, stinging, swelling, tenderness, tingling, or warmth at the injection site

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Octaplas

Available Dosage Forms:

• Solution

Therapeutic Class: Blood Modifier Agent

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Your doctor may want you to have blood tests before receiving this medicine. This medicine is given only based on ABO-blood group compatibility.