Pronunciation:

PLAZ-ma

Brand Names:

• Octaplas

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Blood Modifier Agent

Uses of This Medicine:

Plasma injection is used as a replacement of multiple coagulation (clotting) factors in patients with acquired deficiencies due to liver disease, or undergoing heart surgery or liver transplant. This medicine is also used in plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of plasma injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of plasma injection in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to fresh frozen plasma (FFP) or plasma-derived products (eg, plasma protein), history of or
• Immunoglobulin A (IgA) deficiency or
• Protein S deficiency, severe—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 cause side effects to become worse.

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

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

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

Tell your doctor right away if you have a chest pain, difficult noisy breathing, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain. These could be symptoms of heart failure and pulmonary edema.

Tell your doctor right away if you have tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins at the injection site. These could be symptoms of a blood clotting problem caused by low levels of Protein S.

Using too much of this medicine may cause citrate toxicity or hypocalcemia (low calcium in the blood). Tell your doctor right away if you have confusion, convulsions, muscle spasms, numbness or tingling sensation 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 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately 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 getting 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 occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or 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 occur 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.