Fresh Frozen Plasma

Fresh frozen plasma is used for management and prevention of bleeding, as a coagulation factors replacement, and to treat thrombotic thrombocytopenic purpura (TTP).

Fresh frozen plasma is available under the following different brand names: FFP and Octaplas.

Dosages of Fresh Frozen Plasma:

Pooled Human Plasma Solution (Octaplas)

• 45-70mg/mL (as human plasma protein)

Dosage Considerations – Should be Given as Follows:

Management/Prevention of Bleeding

• FFP: 10-20 mL/kg of body weight will increase factor levels by 20-30%
• Frequency of transfusion depends on the half-life of the deficient factor(s)
• In adults and large children, dosing is rounded to the nearest number of units
• Number of units = Desired dose (mL) / 200 mL/unit

Octaplas: Safety and efficacy in children not established.

Neonates and small children

• FFP: 10-15 mL/kg of body weight will increase factor levels by 15-25%
• Transfusion frequency depends on the half-life of the deficient factor(s)
• Depending on the dose requested, an aliquot of 1 unit, a whole unit or more than 1 unit of plasma may be issued
• Specific volume to be transfused should be specified to the transfusionist to prevent volume overload in neonates and small children or those at increased risk of volume overload

Large children

• See adult dosing

Coagulation Factors Replacement

• Indicated for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease or those undergoing cardiac surgery or liver transplantation
• Octaplas: 10-15 mL/kg intravenously (IV) initially; this should increase plasma coagulation factors by approximately 15-25%
• If hemostasis not achieved, use higher doses and adjust dose based on desired clinical response
• Monitor response, including measurement of aPTT, PT, and/or specific coagulation factors

Thrombotic Thrombocytopenic Purpura (TTP)

• Indicated for plasma exchange in patients with TTP
• Octaplas: Completely replace plasma volume removed during plasmapheresis with Octaplas; generally, 1-1.5 plasma volumes correspond to 40-60 mL/kg IV

Administration (Octaplas)

• Administer via infusion set with filter
• Inspect visually for particulates and discoloration; do not use if turbid
• Avoid shaking
• Not to exceed IV infusion rate of 1 mL/kg/min

Dosing Considerations

• Administer based on ABO-blood group compatibility

Other Indications and Uses

Fresh Frozen Plasma, Plasma Frozen within 24 hours, Thawed Plasma, Liquid Plasma (FFP, P24, TP, LP) may be used to treat bleeding due to acquired multiple factor deficiencies such as seen due to large volume bleeding or DIC.

Plasma transfusion is indicated for

• Management of bleeding or to prevent bleeding prior to an urgent invasive procedure in patients requiring replacement of multiple coagulation factors
• Massively transfused patients who have clinically significant coagulation deficiencies and hypovolemia
• Patients on warfarin therapy with bleeding or that need to undergo an invasive procedure before vitamin K could reverse the effects of warfarin or who need only transient reversal of warfarin effects
• For transfusion or plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP) and some cases of hemolytic uremic syndrome (HUS)
• Management of patients with selected coagulation factor deficiencies, congenital or acquired, for which no specific coagulation concentrates are available (i.e., factors II (2), V (5), VII (7), X (10), XI (11), Proteins C or S*
• Management of patients with rare specific plasma protein deficiencies, such as C1 inhibitor, when recombinant products are unavailable*
• FFP is the product of choice for patients specifically requiring replacement of the labile clotting factors or other proteins with poor storage stability because the other plasma products may be deficient in these factors during liquid storage; deficiencies due to consumption/hemodilution rarely fall to levels that are inadequately treated with non-FFP plasma components; consultation with a hematologist or transfusion medicine physician is recommended for assistance with indications 3-6

Side effects of Fresh Frozen Plasma may include:

• Headache
• Numbness and tingling
• Nausea
• Itching
• Hives
• Hemolytic Transfusion Reactions
• Febrile Non-Hemolytic Reactions
• Allergic Reactions ranging from hives to anaphylaxis
• Septic Reactions
• Transfusion Related Acute Lung Injury (TRALI)
• Circulatory Overload
• Transfusion Associated Graft Versus Host Disease
• Post-transfusion red or purple spots on the skin (purpura)

Postmarketing side effects of fresh frozen plasma reported include:

• Blood system disorders: Hyperfibrinolysis
• Immune system disorders: Hypersensitivity reactions including anaphylactoid and allergic type of reactions
• Metabolic and nutritional disorders: Alkalosis
• Cardiovascular disorders: Cardiac arrest, circulatory overload, thromboembolism, tachycardia
• Respiratory, thoracic and mediastinal disorders: Respiratory arrest or failure, bronchospasm, pulmonary edema, dyspnea, tachypnea
• Gastrointestinal disorders: Abdominal pain, vomiting
• Skin and subcutaneous tissue disorders: Rash, erythema
• General disorders and administration site conditions: Fever and/or chills, chest discomfort or pain
• Investigations: Seroconversions (passive transfer of antibodies)
• Injury, poisoning and procedural complications: Citrate toxicity

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Fresh Frozen Plasma has no listed severe interactions with other drugs.
• Fresh Frozen Plasma has no listed serious interactions with other drugs.
• Fresh Frozen Plasma has no listed moderate interactions with other drugs.
• Fresh Frozen Plasma has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains fresh frozen plasma. Do not take FFP or Octaplas if you are allergic to fresh frozen plasma or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• FFP should not be used solely for volume expansion, or to "correct" a mildly prolonged PT or PTT without active bleeding; patients may have a mildly prolonged PT or PTT and yet have hemostatically stable levels of coagulation factors
• Plasma should not be given for replacement of isolated factor or specific protein deficiencies if the appropriate factor concentrates are available
• Plasma should not be given for vitamin K deficiency or warfarin reversal if correction can safely be achieved using vitamin K supplementation

Octaplas

• IgA deficiency
• Severe protein S deficiency
• History of hypersensitivity to fresh frozen plasma (FFP) or to plasma-derived products including any plasma protein
• History of hypersensitivity reaction to Octaplas

Effects of Drug Abuse

• No information available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Fresh Frozen Plasma?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Fresh Frozen Plasma?"

Cautions

FFP

• If a transfusion reaction is suspected, the transfusion should be stopped, the patient assessed and stabilized, the blood bank notified, and a transfusion reaction investigation initiated
• Massive or rapid transfusion may lead to arrhythmias, hypothermia, hyperkalemia, hypocalcemia, dyspnea, and/or heart failure
• Many blood banks utilize P24 and/or thawed plasma interchangeably with FFP; if FFP is specifically needed, it is advisable to inform your institution’s blood bank at the time of request to ensure appropriate product transfusion
• Plasma components contain a significant number of antibodies against the ABO blood group antigens and ABO compatible plasma must be used
• Liquid plasma (please see pharmacology for description) may have a significant number of viable lymphocytes and should be irradiated if the patient is at increased risk of TA-GVHD (see the irradiated blood product monograph)
• All transfusions must be given via blood administration sets containing 170- to 260-micron filters or 20- to 40-micron microaggregate filters unless transfusion is given via a bedside leukocyte reduction filter; no other medications or fluids other than normal saline should be simultaneously given through the same line without prior consultation with the medical director of the blood bank
• Patient’s should be monitored for signs of a transfusion reaction including vitals pre, during, and post transfusion.
• Non-septic infectious risks include transmission of HIV (approximately 1:2 mill), HCV (approximately 1:1.5 mill), HBV (1:300k), HTLV, WNV, CMV, parvovirus B19, Lyme disease, babesiosis, malaria, Chagas disease, vCJD
• Consult with blood bank medical director or hematologist if you have questions regarding special transfusion requirements

Octaplas

Citrate toxicity

Pregnancy and Lactation

There is no information available about use of fresh frozen plasma during pregnancy or while breastfeeding. Consult your doctor.

• Transfusion reaction may occur with ABO mismatch
• High infusion rates can induce hypervolemia with consequent pulmonary edema or cardiac failure
• Excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha2-antiplasmin (i.e., plasmin inhibitor); monitor for signs of excessive bleeding in patients undergoing liver transplantation
• Thrombosis can occur due to low levels of Protein S
• Octaplas is made from human plasma, it may carry a risk of transmitting infectious agents (e.g., viruses, vCJD agent); undergoes solvent-detergent purification
• Do not inject drugs containing calcium in the same IV line (precipitant may occur)
  • Citrate toxicity can occur with volumes exceeding 1 mL/kg/min of Octaplas
  • Do not exceed infusion rate of 0.02-0.025 mmol/kg/min of citrate (i.e., less than 1 mL/kg/min Octaplas)
  • Symptoms attributable to citrate toxicity (hypocalcaemia) include fatigue, paresthesia, and muscle spasms, especially in patients with liver function disorders
  • Administer calcium gluconate IV into another vein in order to minimize citrate toxicity