OCTAPLAS Solution for infusion (2021)
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Octapharma USA Inc
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1. Indications and Usage
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 ...
2. Dosage and Administration
<b>For intravenous use only</b> Administer Octaplas based on ABO-blood group compatibility. 2.1 Dose Replacement of coagulation factors in patients with acquired deficiencies due to liver disease or undergoing ...
3. Dosage Forms and Strengths
Solution for infusion containing 45 to 70 mg human plasma proteins per mL in a 200 mL volume.
4. Contraindications
Do not use Octaplas 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 ...
5. Warnings and Precautions
5.1 Transfusion reactions Transfusion reactions can occur with ABO blood group mismatches. Administration of Octaplas must be based on ABO-blood group compatibility. 5.2 Hypervolemia High infusion rates ...
6. Adverse Reactions
Serious adverse reactions seen in clinical trials were anaphylactic shock, citrate toxicity and severe hypotension. The most common adverse reactions observed in ≥1% of subjects included pruritis, urticaria, ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug ...
6.2. Postmarketing Experience
Because post-marketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish ...
7. Drug Interactions
Do not inject drugs containing calcium in the same intravenous line with Octaplas because precipitants may block the line. Passive transmission of analytes (e.g., β-human chorionic gonadotropin) may result ...
8.1. Pregnancy
Risk Summary Animal reproduction studies have not been conducted with Octaplas. It is not known whether Octaplas can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ...
8.2. Lactation
Risk Summary Efficacy and safety of Octaplas in lactating women is unknown.
8.4. Pediatric Use
Octaplas was evaluated in 91 pediatric patients (age range 0-20 years) in two post-marketing requirement studies. Patients were dosed based on body weight and doses were adjusted as needed. There were ...
8.5. Geriatric Use
Clinical studies of Octaplas did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience ...
11. Description
Octaplas is a sterile, pyrogen free, frozen solution of solvent/detergent (S/D) treated pooled human plasma. The active ingredient comprises plasma proteins such as albumin, immunoglobulins, other globulins, ...
12.1. Mechanism of Action
Octaplas replaces human plasma proteins.
12.2. Pharmacodynamics
Coagulation factor activities in the final product are controlled to obtain levels within the range of normal human plasma. Protein S and alpha 2-antiplasmin, which are labile to S/D treatment, are controlled ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
TNBP and Octoxynol used in the manufacturing process for viral inactivation may be present in the final product at levels not exceeding 2.0 µg/mL for TNBP and 5.0 µg/mL for Octoxynol. Toxicity No evidence ...
14. Clinical Studies
The Octaplas predecessor product was studied in healthy volunteers and in subjects with liver disease, liver transplantation, cardiac surgery and TTP. A prospective, open-label, parallel group, non-randomized ...
15. References
Hellstern, P., et al. Practical guidelines for the clinical use of plasma. Thromb Res. 107 Suppl 1 (2002): S53-S57. Scully, M., et al. Guidelines on the diagnosis and management of thrombotic thrombocytopenic ...
16.1. How Supplied
Octaplas is supplied in polyvinyl chloride blood bags containing 200 mL frozen solution and has a slightly yellow appearance. NDC Number Blood group 68982-952 01 Blood group A 68982-953 01 Blood ...
16.2. Storage and Handling
<u>Storage and Handling:</u> 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 ...
17. Patient Counseling Information
Inform patients to report: Early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, or anaphylaxis. Development of edema or volume ...