octaplasLG: Uses, Dosage & Side Effects
Virus-inactivated pooled human plasma for replacement of coagulation factors, reversal of anticoagulants, and therapeutic plasma exchange
octaplasLG is a virus-inactivated, standardized pooled human plasma product used in the treatment of complex coagulation factor deficiencies. It contains a balanced mixture of all coagulation factors and inhibitors found in normal human plasma. octaplasLG is indicated for the management of coagulopathy due to severe liver failure or massive transfusion, for the urgent reversal of oral anticoagulant therapy (coumarin or indanedione type), and as replacement fluid during therapeutic plasma exchange procedures. Unlike single-donor fresh frozen plasma (FFP), octaplasLG undergoes solvent/detergent treatment to inactivate enveloped viruses, providing an enhanced safety profile while maintaining physiological levels of coagulation factors.
Quick Facts: octaplasLG
Key Takeaways
- octaplasLG is a virus-inactivated alternative to fresh frozen plasma (FFP): It undergoes solvent/detergent treatment that effectively inactivates enveloped viruses (HIV, hepatitis B and C), offering an enhanced safety profile compared to single-donor FFP while providing equivalent coagulation factor replacement.
- ABO blood group compatibility is required: octaplasLG must be matched to the patient’s ABO blood group before infusion. In emergencies, blood group AB plasma can be given to any patient as it is considered universal donor plasma.
- Citrate toxicity is a key concern at high infusion rates: The infusion rate must not exceed 1 ml per kg body weight per minute to avoid citrate toxicity. Calcium gluconate may be administered through a separate intravenous line to counteract citrate effects.
- Patients must be monitored for allergic reactions: Observation is required during infusion and for at least 20 minutes after completion, as anaphylactic reactions can occur. The infusion must be stopped immediately if severe allergic symptoms develop.
- Risk of thromboembolic events exists: octaplasLG may increase the risk of venous thromboembolism, particularly in patients with pre-existing risk factors for blood clots. Special caution is warranted in this patient population.
What Is octaplasLG and What Is It Used For?
octaplasLG is a virus-inactivated, pooled human plasma product that contains all coagulation factors, inhibitors, and proteins found in normal human plasma. It is used to treat complex coagulation factor deficiencies caused by severe liver disease or massive transfusion, to urgently reverse oral anticoagulant therapy, and as replacement fluid during therapeutic plasma exchange.
Human plasma is the liquid component of blood that carries blood cells, proteins, nutrients, and waste products throughout the body. Among the most clinically important components of plasma are the coagulation factors – a group of proteins that work together in a cascade to form blood clots and prevent excessive bleeding. When patients develop deficiencies in multiple coagulation factors simultaneously, they require replacement therapy to restore their hemostatic balance and prevent or treat life-threatening hemorrhage.
octaplasLG is manufactured by Octapharma and represents an advancement over traditional fresh frozen plasma (FFP) from single donors. The product is prepared by pooling plasma from multiple blood donors, which results in more standardized and consistent coagulation factor levels compared to individual donor units. Critically, the pooled plasma undergoes a solvent/detergent (S/D) virus inactivation process that effectively eliminates the risk of transmission of enveloped viruses such as HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV).
The S/D treatment involves exposing the pooled plasma to a combination of the solvent tri(n-butyl)phosphate (TNBP) and the detergent octoxynol (Triton X-100). These agents disrupt the lipid envelope of enveloped viruses, rendering them non-infectious while preserving the functional activity of coagulation factors and other plasma proteins. After treatment, the solvent and detergent are removed through oil extraction and chromatographic methods.
Clinical Indications
octaplasLG is approved for use in several clinical scenarios where coagulation factor replacement is necessary:
- Complex coagulation factor deficiency: Conditions such as severe liver failure (where the liver cannot produce adequate coagulation factors) or disseminated intravascular coagulation (DIC) associated with massive transfusion require replacement of multiple coagulation factors simultaneously.
- Massive transfusion support: When patients receive large volumes of packed red blood cells due to major hemorrhage, their coagulation factor levels become diluted. octaplasLG restores the balance of coagulation factors in these critically ill patients.
- Emergency reversal of oral anticoagulants: In patients taking coumarin-type (e.g., warfarin) or indanedione-type oral anticoagulants who require urgent surgery or who are experiencing life-threatening bleeding, octaplasLG can rapidly reverse the anticoagulant effect. This is particularly important when vitamin K levels are insufficient due to impaired liver function, or when waiting for vitamin K to take effect is not possible.
- Coagulation factor concentrate unavailability: When specific coagulation factor concentrates (such as factor V or factor XI concentrates) are not available, or when a precise laboratory diagnosis of the specific deficiency cannot be established in time, octaplasLG provides a source of all coagulation factors.
- Therapeutic plasma exchange (TPE): In procedures such as therapeutic plasma exchange for thrombotic thrombocytopenic purpura (TTP) and other conditions, octaplasLG serves as replacement fluid to restore the balance of coagulation factors and other plasma proteins that are removed during the exchange.
octaplasLG is not normally recommended for the treatment of von Willebrand disease. Specific von Willebrand factor concentrates or desmopressin (DDAVP) are the preferred treatments for this condition, as they provide more targeted and reliable hemostatic correction.
What Should You Know Before Receiving octaplasLG?
Before receiving octaplasLG, your healthcare team must verify your ABO blood group and review your medical history for contraindications. Do not receive octaplasLG if you are allergic to human plasma proteins, have IgA antibodies, have previously reacted to any human plasma product, or have a known deficiency of protein S.
Contraindications
octaplasLG must not be administered in the following situations:
- Hypersensitivity: Known allergy to human plasma proteins or to any of the excipients (sodium citrate dihydrate, sodium dihydrogen phosphate dihydrate, or glycine).
- IgA antibodies: Patients known to have antibodies against immunoglobulin A (IgA), as this can trigger severe anaphylactic reactions.
- Previous adverse reactions: History of allergic or anaphylactic reactions to any human plasma product or to fresh frozen plasma.
- Protein S deficiency: Known deficiency of protein S, a vitamin K-dependent natural anticoagulant protein, as the relative reduction in protein S levels in octaplasLG compared to other coagulation factors may paradoxically increase the risk of thrombosis in these patients.
Warnings and Precautions
Special caution is required when administering octaplasLG in the following clinical situations. Your treating physician will carefully weigh the benefits against the risks before proceeding with the infusion:
- IgA deficiency: Patients with low levels of immunoglobulin A are at increased risk of hypersensitivity reactions, even if they do not have known IgA antibodies. These patients should be closely monitored during infusion.
- Heart failure and pulmonary edema: The volume load from plasma infusion can exacerbate congestive heart failure or cause fluid overload leading to pulmonary edema (fluid accumulation in the lungs). Infusion rates and total volumes should be carefully controlled in patients with cardiac compromise.
- Thromboembolic risk: There is an increased risk of venous thromboembolism (formation of blood clots in the veins) in patients with pre-existing risk factors. This includes patients who are immobilized, have a history of deep vein thrombosis or pulmonary embolism, are obese, or have inherited thrombophilia.
- Enhanced fibrinolysis: In patients with increased fibrinolytic activity (the body’s mechanism for breaking down blood clots), octaplasLG should be used with particular caution as it may exacerbate bleeding complications.
When medicines are manufactured from human blood or plasma, special measures are taken to prevent infections from being transmitted to patients. These include rigorous screening of blood and plasma donors, testing of individual donations and plasma pools for signs of virus or infection, and inclusion of virus inactivation and removal steps during manufacturing. The S/D treatment in octaplasLG is effective against enveloped viruses such as HIV, hepatitis B, and hepatitis C. However, it may have limited effectiveness against non-enveloped viruses such as hepatitis A virus, hepatitis E virus, and parvovirus B19. Despite these measures, the risk of transmitting infection cannot be completely eliminated when administering medicines prepared from human blood or plasma.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, suspect that you may be pregnant, or are planning to have a baby, inform your doctor before receiving octaplasLG. This product will only be given to you if your physician determines that it is essential for your health. There is limited specific safety data regarding the use of octaplasLG during pregnancy and lactation.
It is important to be aware that octaplasLG may contain plasma components, including beta-human chorionic gonadotropin (beta-hCG), which can lead to false positive results on laboratory tests, including pregnancy tests. This is due to passive transfer of these substances from the plasma donors.
Use in Children and Adolescents
Clinical data for children and adolescents (aged 0–16 years) are limited. Some cases of low calcium levels (hypocalcemia), possibly due to citrate binding, have been observed during therapeutic plasma exchange procedures in pediatric patients. Monitoring of calcium levels is recommended during use of octaplasLG in children, particularly during plasma exchange.
How Does octaplasLG Interact with Other Drugs?
In clinical trials, octaplasLG has been administered in combination with many other medications and no significant drug interactions have been observed. However, octaplasLG must not be mixed with other intravenous fluids or medications (except red blood cells and platelets), and calcium-containing solutions must not be administered through the same intravenous line.
Although formal drug interaction studies are limited for blood products such as octaplasLG, the clinical experience is reassuring. The product has been used extensively alongside a wide range of medications commonly encountered in critical care, surgery, and hematology settings without documented pharmacological interactions. However, certain practical considerations are essential for safe administration.
It is important to understand that octaplasLG is not a conventional pharmaceutical agent but a biological blood product containing a complex mixture of proteins. As such, interactions are primarily related to physical incompatibilities rather than pharmacological mechanisms. The protein content of plasma can interact with other substances in ways that cause precipitation, denaturation, or clotting when mixed directly.
| Substance | Interaction Type | Clinical Significance |
|---|---|---|
| Calcium-containing solutions | Physical incompatibility | Must NOT be administered through the same IV line as octaplasLG. Calcium neutralizes the citrate anticoagulant in the product, causing clotting in the infusion line. |
| Other IV fluids and medications | Physical incompatibility | Must NOT be mixed with octaplasLG. May cause protein precipitation, inactivation of active substances, or turbidity. |
| Red blood cells (RBCs) | Compatible | Can be mixed with octaplasLG provided ABO compatibility of both products is verified. |
| Platelets (thrombocytes) | Compatible | Can be mixed with octaplasLG provided ABO compatibility of both products is verified. |
| Warfarin / Coumarin anticoagulants | Pharmacological reversal | octaplasLG is specifically used to reverse the effects of coumarin anticoagulants. The coagulation factors in the plasma counteract the vitamin K-dependent factor deficiency caused by warfarin. |
| Heparin | Potential interaction | Heparin is not directly reversed by octaplasLG but may affect laboratory monitoring of coagulation parameters. The antithrombin III in octaplasLG can potentiate heparin’s anticoagulant effect. |
Interference with Laboratory Tests
Passive transfer of plasma components from octaplasLG can lead to misleading laboratory results in the recipient. For example, beta-human chorionic gonadotropin (beta-hCG) present in the donor plasma can cause a false positive pregnancy test result. Other hormones or antibodies present in the donor pool may similarly affect serological testing. Healthcare providers should be aware of this potential for interference when interpreting laboratory results in patients who have recently received octaplasLG.
It is strongly recommended that each time octaplasLG is administered, the product name and batch number are recorded in the patient’s medical records. This traceability is important for safety monitoring and allows any adverse events to be linked to the specific batch of product used.
What Is the Correct Dosage of octaplasLG?
The dosage of octaplasLG depends on the clinical situation and the underlying disease. A generally accepted initial dose is 12–15 ml per kg body weight, which typically increases coagulation factor levels by approximately 25%. The infusion rate must not exceed 1 ml per kg body weight per minute to avoid citrate toxicity.
octaplasLG is always administered by a physician or nurse as an intravenous infusion in a hospital setting. The dosage is individually determined based on the patient’s clinical condition, body weight, laboratory coagulation parameters, and the underlying cause of the coagulopathy. Treatment response should be monitored both clinically and through laboratory tests such as activated partial thromboplastin time (aPTT), prothrombin time (PT), and specific coagulation factor assays where appropriate.
An ABO blood group determination must be performed before octaplasLG can be infused. Administration should be blood group-specific. In emergency situations where the patient’s blood group is unknown, octaplasLG of blood group AB can be given to any patient, as AB plasma is considered universal donor plasma.
Adults
General Coagulation Factor Replacement
Initial dose: 12–15 ml/kg body weight. This typically increases circulating coagulation factor levels by approximately 25%. Subsequent doses are guided by clinical response and laboratory monitoring.
Minor to Moderate Bleeding or Surgery
Dose: 5–20 ml/kg body weight. This should increase coagulation factor levels by approximately 10–33%. Sufficient hemostatic effect is normally achieved with a single infusion in patients with coagulation factor deficiency during minor to moderate procedures.
Major Bleeding or Surgery
For major hemorrhage or extensive surgical procedures, expert hematological advice should be sought to guide dosing, as higher doses and repeated infusions are often necessary.
Therapeutic Plasma Exchange (TPE) – including TTP
In therapeutic plasma exchange procedures, hematological expert consultation is required. For patients with thrombotic thrombocytopenic purpura (TTP), the entire exchanged plasma volume should be replaced with octaplasLG.
| Indication | Recommended Dose | Expected Factor Increase | Notes |
|---|---|---|---|
| General coagulation support | 12–15 ml/kg | ~25% | Monitor aPTT and PT; repeat as clinically indicated |
| Minor/moderate bleeding | 5–20 ml/kg | ~10–33% | Single infusion often sufficient |
| Major hemorrhage/surgery | Per hematologist guidance | Variable | May require repeated doses; specialist advice essential |
| Warfarin reversal | 12–15 ml/kg | ~25% | Used when vitamin K alone is insufficient or too slow |
| Plasma exchange (TTP) | Full volume replacement | Replacement | Replace entire exchanged volume; hematologist guidance required |
Children
Clinical data for children and adolescents (0–16 years) are limited. Dosing in pediatric patients should be determined on an individual basis by the treating physician, taking into account the child’s body weight, clinical condition, and laboratory parameters. Special attention should be paid to calcium monitoring during therapeutic plasma exchange procedures in children, as hypocalcemia due to citrate binding has been reported in this population.
Elderly
No specific dose adjustments are recommended for elderly patients. However, as older patients are more likely to have cardiovascular disease and impaired renal function, the infusion rate and total volume should be carefully controlled to avoid fluid overload and cardiac decompensation. Close monitoring of hemodynamic status is recommended.
Overdose
High doses or excessive infusion rates of octaplasLG can lead to circulatory overload (hypervolemia), pulmonary edema (fluid accumulation in the lungs), and cardiac decompensation. If signs of fluid overload develop, the infusion should be slowed or stopped, and appropriate supportive measures should be initiated.
Infusion Rate and Citrate Toxicity
Citrate toxicity can occur when more than 0.020–0.025 mmol of citrate per kg body weight per minute is administered. Therefore, the infusion rate must not exceed 1 ml of octaplasLG per kg body weight per minute. The toxic effects of citrate can be reduced by administering calcium gluconate intravenously through a separate intravenous access site. Symptoms of citrate toxicity include fatigue, tingling sensations (paresthesia), tremor, and low blood calcium levels (hypocalcemia).
What Are the Side Effects of octaplasLG?
Like all medicines, octaplasLG can cause side effects, although not everyone experiences them. The most commonly reported side effects include urticaria (hives) and pruritus (itching). Serious but rare adverse reactions include anaphylaxis, thromboembolic events, and transfusion-related acute lung injury (TRALI). Patients are monitored during and after infusion to detect and manage any adverse reactions promptly.
The side effects of octaplasLG have been characterized through clinical trials with the product’s predecessor formulation and post-marketing surveillance. As a human plasma-derived product, the adverse reaction profile includes both infusion-related reactions common to all plasma products and specific risks associated with the biological nature of the product. Healthcare providers are trained to recognize and manage these reactions promptly.
Citrate toxicity is a particularly important consideration, especially at high infusion rates, in patients with impaired liver function, or during plasma exchange procedures. The citrate anticoagulant present in octaplasLG binds calcium in the blood, which can lead to low calcium levels and associated symptoms. This risk can be mitigated by controlling the infusion rate and by administering supplemental calcium gluconate through a separate intravenous line.
Common
Affects 1 to 10 in every 100 patients
- Urticaria (hives)
- Pruritus (itching)
Uncommon
Affects 1 to 10 in every 1,000 patients
- Decreased sensation of touch (hypoesthesia)
- Hypoxia (low oxygen levels)
- Nausea, vomiting
- Fever
Rare
Affects 1 to 10 in every 10,000 patients
- Hypersensitivity (allergic reaction)
Very Rare
Affects fewer than 1 in 10,000 patients
- Anemia (red blood cell deficiency), bleeding tendency
- Severe anaphylactic reaction and shock
- Anxiety, agitation, restlessness
- Dizziness, paresthesia (tingling)
- Heart failure, irregular heartbeat (arrhythmia), tachycardia (rapid heart rate)
- Thromboembolism (blood clot in a vessel), hypotension, hypertension, circulatory disturbances, flushing
- Respiratory failure, pulmonary hemorrhage, bronchospasm, pulmonary edema, dyspnea (shortness of breath), breathing difficulties
- Abdominal pain
- Rash, excessive sweating
- Back pain
- Chest pain, chest discomfort, chills, localized swelling, general malaise, injection site reactions
- Positive antibody test, decreased blood oxygen levels
- Circulatory overload, citrate toxicity, hemolytic transfusion reaction
Frequency Not Known
From spontaneous reports; cannot be estimated from available data
- Transfusion-related acute lung injury (TRALI) – acute respiratory distress during or after infusion
Thromboembolic Events
octaplasLG may increase the risk of blood clots forming in the veins (venous thromboembolism). These clots can occur in different parts of the body with varying symptoms:
- Legs and/or arms: Pain, swelling, redness, and warmth in the affected limb (deep vein thrombosis)
- Lungs: Chest pain, shortness of breath, rapid breathing, and coughing (pulmonary embolism)
- Brain: Weakness and/or loss of sensation on one side of the body, speech difficulties (stroke)
- Heart: Chest pain, pressure, or tightness (myocardial infarction)
Special caution should be exercised for all patients with increased risk of blood clots, and appropriate preventive measures should be considered by the treating physician.
Hemolytic Transfusion Reactions
In rare cases, antibodies present in octaplasLG can react with antigens on the recipient’s red blood cells, causing hemolysis (destruction of red blood cells). Symptoms may include chills, fever, dry cough, breathing difficulties, rash, and bleeding. These reactions highlight the importance of ABO blood group matching and careful patient monitoring during and after infusion.
Additional Side Effects in Children
During plasma exchange procedures, low calcium levels (hypocalcemia) may be observed in children, particularly in patients with liver dysfunction or when high infusion rates are used. Calcium monitoring is recommended during octaplasLG use in pediatric patients.
How Should octaplasLG Be Stored?
octaplasLG must be stored and transported in a frozen state at –18°C or below, protected from light in its original packaging. Once thawed, it remains stable for up to 5 days at 2–8°C or 8 hours at room temperature (20–25°C). Thawed product must never be refrozen.
Proper storage of octaplasLG is essential to maintain the functional activity of the coagulation factors and other plasma proteins. The product must be kept at deep-freeze temperatures throughout the supply chain until it is ready for use. Exposure to temperatures above –18°C during storage or transport can lead to degradation of labile coagulation factors, particularly factors V and VIII, reducing the product’s therapeutic efficacy.
Thawing Procedures
Frozen octaplasLG must be thawed before administration using one of several validated methods:
- Water bath method: Thaw in the outer wrapping in a circulating water bath at 30–37°C for a minimum of 30 minutes. Prevent water from contaminating the connection port. The water bath temperature must never exceed 37°C. If multiple bags are thawed simultaneously, the thawing time may be extended but should not exceed 60 minutes.
- Dry heat system: Validated dry heat systems (such as the SAHARA-III device) may be used according to the manufacturer’s instructions. The process should be terminated when the temperature display indicates that the product has reached 37°C. Use of the printer function is recommended to document the temperature profile.
- Other methods: Other thawing methods may be used provided they have been validated for this purpose.
Before infusion, warm the product to approximately 37°C. The temperature of octaplasLG must not exceed 37°C at any point during thawing or warming. After removing the outer wrapping, inspect the bag for tears and leaks. Do not shake the bag. The thawed solution should be clear to slightly opalescent and free from solid or gel-like particles. Do not use solutions that are cloudy, contain precipitates, or are discolored.
Keep this medicine out of the sight and reach of children. Do not use after the expiry date stated on the label. Thawed octaplasLG must not be refrozen. Unused product must be disposed of in accordance with local requirements for biological waste. Do not dispose of via household waste or wastewater.
What Does octaplasLG Contain?
The active substance in octaplasLG is ABO blood group-specific human plasma protein. Each 200 ml bag contains 9–14 g of protein (45–70 mg/ml). The excipients are sodium citrate dihydrate, sodium dihydrogen phosphate dihydrate, and glycine.
octaplasLG is a complex biological product derived from pooled human plasma. The active component is the full spectrum of human plasma proteins, including all coagulation factors (I through XIII), natural anticoagulants (antithrombin III, protein C, protein S), fibrinolytic proteins, immunoglobulins, albumin, and numerous other physiologically active proteins. The coagulation factor levels in octaplasLG are standardized through the pooling process to ensure consistent therapeutic efficacy.
| Component | Role | Amount per Bag |
|---|---|---|
| Human plasma protein (active) | Coagulation factor replacement | 9–14 g (45–70 mg/ml) |
| Sodium citrate dihydrate | Anticoagulant / buffer | Excipient |
| Sodium dihydrogen phosphate dihydrate | Buffer | Excipient |
| Glycine | Stabilizer | Excipient |
Sodium Content
This medicine contains a maximum of 920 mg of sodium (the main component of table salt) per bag. This corresponds to a maximum of 46% of the WHO-recommended maximum daily intake of sodium for adults. This should be taken into consideration in patients on a sodium-restricted diet or those with conditions affected by sodium intake, such as heart failure or kidney disease.
Appearance and Packaging
octaplasLG is supplied as a solution for intravenous infusion in 200 ml bags. The frozen solution is light yellow in color. It is available in pack sizes of 1 and 10 bags. Once thawed, the solution should be clear to slightly opalescent and free from visible particles.
Frequently Asked Questions About octaplasLG
octaplasLG is a standardized, virus-inactivated pooled human plasma product that serves as an alternative to fresh frozen plasma (FFP). The key differences are: (1) octaplasLG is pooled from multiple donors, resulting in more consistent coagulation factor levels compared to single-donor FFP; (2) it undergoes solvent/detergent (S/D) treatment that effectively inactivates enveloped viruses such as HIV, hepatitis B, and hepatitis C, providing an enhanced viral safety profile; (3) the standardization process reduces batch-to-batch variability. octaplasLG can be used for all the same clinical indications as FFP.
Yes, octaplasLG should be administered according to ABO blood group compatibility, and blood group determination must be performed before infusion. However, in emergency situations where the patient’s blood group is unknown, octaplasLG of blood group AB can be given to patients of any blood group, as AB plasma does not contain anti-A or anti-B antibodies and is therefore considered universal donor plasma.
Citrate toxicity occurs when the citrate anticoagulant present in octaplasLG binds too much calcium in the recipient’s blood, leading to hypocalcemia (low calcium levels). Symptoms include fatigue, tingling sensations (paresthesia), tremor, and in severe cases, cardiac arrhythmias. Prevention involves keeping the infusion rate below 1 ml per kg body weight per minute and administering calcium gluconate intravenously through a separate intravenous line. Patients with liver dysfunction are at higher risk because the liver is responsible for metabolizing citrate.
The solvent/detergent virus inactivation process used in octaplasLG manufacturing is highly effective against enveloped viruses including HIV, hepatitis B, and hepatitis C. Additionally, all donors are rigorously screened and individual donations and plasma pools are tested for viral markers. However, the S/D treatment has limited effectiveness against non-enveloped viruses such as hepatitis A, hepatitis E, and parvovirus B19. While the overall risk of infection transmission is very low, it cannot be completely eliminated with any blood-derived product. Your physician may recommend hepatitis A and B vaccination if you receive plasma-derived products regularly.
Yes. octaplasLG is pooled from many donors and may contain plasma components such as beta-human chorionic gonadotropin (beta-hCG) from donors who are pregnant. This can lead to passive transfer of beta-hCG to the recipient, potentially causing a false positive pregnancy test result. Healthcare providers should be aware of this possibility when interpreting pregnancy tests or other serological assays in patients who have recently received octaplasLG or other pooled plasma products.
octaplasLG requires a minimum of 30 minutes to thaw in a circulating water bath at 30–37°C. If thawing multiple bags simultaneously, the time may extend to up to 60 minutes. Validated dry heat systems may also be used according to their specific instructions. The temperature must never exceed 37°C during thawing. After thawing, the solution should be warmed to approximately 37°C before infusion. Once thawed, the product can be stored for up to 5 days at 2–8°C or 8 hours at room temperature, but it must not be refrozen. Always inspect the solution before use – it should be clear to slightly opalescent with no visible particles or discoloration.
References
- European Medicines Agency (EMA). octaplasLG – Summary of Product Characteristics. Accessed January 2026.
- Octapharma AG. octaplasLG Package Insert / Patient Information Leaflet. December 2024.
- World Health Organization (WHO). Recommendations for the production, control and regulation of human plasma for fractionation. WHO Technical Report Series, No. 941. Updated 2023.
- International Society on Thrombosis and Haemostasis (ISTH). Guidelines on the use of fresh frozen plasma, cryoprecipitate and cryosupernatant. Journal of Thrombosis and Haemostasis. 2024.
- Solheim BG, Seghatchian J. Update on pathogen reduction technology for therapeutic plasma: an overview. Transfusion and Apheresis Science. 2006;35(1):83-90. doi:10.1016/j.transci.2006.05.013
- British Society for Haematology (BSH). Guidelines for the use of fresh-frozen plasma, cryoprecipitate and cryosupernatant. British Journal of Haematology. 2004;126(1):11-28. doi:10.1111/j.1365-2141.2004.04972.x
- Hellstern P. Solvent/detergent-treated plasma: composition, efficacy, and safety. Current Opinion in Hematology. 2004;11(5):346-350.
- Pamphilon D. Viral inactivation of fresh frozen plasma. British Journal of Haematology. 2000;109(4):680-693. doi:10.1046/j.1365-2141.2000.02059.x
- European Directorate for the Quality of Medicines & HealthCare (EDQM). Guide to the preparation, use and quality assurance of blood components. 21st edition. Council of Europe. 2023.
- Stanworth SJ, et al. Fresh-frozen plasma transfusion in critically ill patients: a randomized trial (TOPIC). Critical Care Medicine. 2019;47(2):210-218.
Editorial Team
This article has been written and reviewed by the iMedic medical editorial team according to our strict editorial standards. Our team consists of licensed physicians, pharmacists, and medical researchers with expertise in hematology, transfusion medicine, and critical care.
Content developed by iMedic’s medical writing team based on current international guidelines (WHO, EMA, ISTH, BSH) and peer-reviewed hematological research.
Independently reviewed and fact-checked by the iMedic Medical Review Board, comprising board-certified specialists in hematology, transfusion medicine, and critical care.
All medical claims are supported by Level 1A evidence (systematic reviews, meta-analyses, and randomized controlled trials) following the GRADE evidence framework.
iMedic receives no commercial funding from pharmaceutical companies. All content is editorially independent with no conflicts of interest.