Octaplas

What is Octaplas?

• Octaplas is a solvent/detergent (S/D) treated, pooled human plasma.

What are the uses of this medicine?

Octaplas is a solvent / detergent (S/D) treated, pooled human plasma indicated for:

• Replacement of multiple coagulation factors in patients with acquired deficiencies
• due to liver disease
• undergoing cardiac surgery and liver transplantation
• Plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP)

How does this medicine work?

• Octaplas replaces human plasma proteins.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

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

What drug interactions can this medicine cause?

• Do not inject drugs containing calcium in the same intravenous line with Octaplas because precipitants may block the line.

Is this medicine FDA approved?

• Initial U.S. Approval: 2013

How should this medicine be used?

• For intravenous use only
• Administer Octaplas based on ABO-blood group compatibility.

Recommended Dosage: Replacement of coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant:

• Initially infuse of 10 to 15 mL Octaplas per kilogram body weight. This should increase the patient’s plasma coagulation factor levels by approximately 15-25%. If hemostasis is not achieved, use higher doses.
• Adjust dose based on desired clinical response.
• Monitor response, including measurement of activated partial thromboplastin time (aPTT), prothrombin time (PT) and/or specific coagulation factors.

Plasma exchange in patients with TTP:

• Completely replace plasma volume removed during plasmapheresis with Octaplas. Generally, 1 to 1.5 plasma volumes correspond to 40 to 60 milliliters per kg.

Administration

• Administer Octaplas after thawing using an infusion set with a filter.
• Octaplas should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if turbid.
• Avoid shaking.

Steps for Thawing: For water bath:

• Thaw in the outer wrapper in a circulating water bath at +30°C to +37°C (86°F to 98.6°F). An overwrap bag may be used to provide further protection of contents if appropriate.
• Prevent water from contaminating the entry port.
• The minimum thawing time is 30 minutes at 37°C (98.6°F). The thawing time depends on the number of bags in the water bath. If more than one plasma bag is thawed in the same water bath, then the thawing time can be prolonged, but should not exceed 60 minutes.

For dry tempering system:

• Place the Octaplas bags between the heating plates according to the manufacturer’s instructions.
• Thaw plasma following manufacturer directions between +30°C to +37°C (86°F to 98.6°F). Remove the product when the thawing process is completed. The thawing process may be monitored and recorded using the thawing device printer or barcode scanner recommended by the device manufacturer.
• Monitor the thawing process and record using the thawing device printer or barcode scanner recommended by the device manufacturer.
• Do not freeze Octaplas. Discard unused product.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Solution for infusion containing 45 to 70 mg human plasma protein per mL in a 200 mL volume.

This medicine is available in fallowing brand namesː

• Octaplas

What side effects can this medication cause?

The most common side effects of this medicine include:

• pruritis
• urticaria
• nausea
• headache
• paresthesia

Serious adverse reactions may include:

• anaphylactic shock
• citrate toxicity
• hypotension

What special precautions should I follow?

• Transfusion reactions can occur with ABO blood group mismatches. Administration of Octaplas must be based on ABO-blood group compatibility.
• High infusion rates can induce hypervolemia with consequent pulmonary edema or heart failure. Monitor patients for signs and symptoms of pulmonary edema or heart failure and institute appropriate management.
• Excessive bleeding due to hyperfibrinolysis can occur due to low levels of alpha 2-antiplasmin. Monitor for signs of excessive bleeding in patients undergoing liver transplantation.
• Thrombosis can occur due to low levels of Protein S. Monitor for signs and symptoms of thrombosis in patients at risk.
• Citrate toxicity can occur with volumes exceeding one milliliter of Octaplas per kg per minute
• Octaplas is made from human blood and may carry the risk of transmitting infectious agents, e.g., viruses and theoretically, the variant Creutzfeldt-Jakob disease and Creutzfeldt-Jakob disease agent.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• It is not known whether Octaplas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Octaplas should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Octaplas was evaluated in 91 pediatric patients (age range 0-20 years) in two post-marketing requirement studies.

What are the active and inactive ingredients in this medicine?

Active Ingredient: PLASMA PROTEIN FRACTION (HUMAN)

Who manufactures and distributes this medicine?

• Packager: Octapharma USA Inc

What should I know about storage and disposal of this medication?

• Store at (-18°C (-0.4°F) for 3 years from the date of manufacture.
• Store protected from light.
• Thaw product according to instructions in section 2.2.
• Use thawed product within 24 hr. if stored at 1 - 6°C (33.8°F to 42.8°F) or within 8 hr. if stored at 20 - 25°C (68°F to 77°F).
• Do not refreeze thawed product.
• Do not use product that is cloudy or has deposits.
• Discard product after the expiration date printed on the container label.

• Dailymed label info on Octaplas
• FDA Octaplas

Octaplas Resources
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