Octaplas

Last updated on RxList: 2/4/2020
Octaplas Side Effects Center

What Is Octaplas?

Octaplas, Pooled Plasma (human) is a solvent/detergent (S/D) treated, pooled human plasma used for replacement of multiple coagulation factors in patients with acquired deficiencies due to liver disease, undergoing cardiac surgery, or liver transplant; and for plasma exchange in patients with thrombotic thrombocytopenic purpura (TTP).

What Are Side Effects of Octaplas?

Side effects of Octaplas include:

  • itching,
  • hives,
  • nausea,
  • headache, and
  • numbness and tingling

Dosage for Octaplas

The dosage of Octaplas for replacement of multiple coagulation factors in patients with acquired deficiencies is 10 to 15 milliliters per kg. Adjust the dose based on the desired clinical response. The dosage of Octaplas for plasma exchange in patients with TTP is 1 to 1.5 plasma volumes (40 to60 milliliters per kg).

Octaplas In Children

The efficacy and safety of Octaplas have not been evaluated in pediatric patients.

What Drugs, Substances, or Supplements Interact with Octaplas?

Octaplas may interact with other medicines such as:

  • drugs containing calcium injected in the same intravenous line.

Tell your doctor all medications and supplements you use.

Octaplas During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Octaplas; it is unknown how it would affect a fetus. It is unknown if Octaplas passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Octaplas, Pooled Plasma (human), Solvent/Detergent Treated Solution for Intravenous Infusion Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Long-term heavy alcohol consumption can cause: See Answer
Octaplas Professional Information

SIDE EFFECTS

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, nausea, headache, and paresthesia.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adverse reactions observed in clinical trials derive from 9 clinical trials. The mean dose administered ranged from 6 to 15 milliliters/kg body weight; when used in plasma exchange the dose was between 15 to 75 milliliters/kg. Two of the studies were conducted in healthy volunteers (n=90).

In total, 359 subjects received about 600 transfusion episodes in these trials

The following table shows the adverse reactions observed in ≥ 1% of subjects in order of severity:

Nervous System Disorders

Headache, paresthesia

Gastrointestinal Disorders

Nausea

Skin and Subcutaneous Tissue Disorders

Pruritis, urticaria

Post-Marketing 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 a causal relationship to product exposure.

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, tachypnoea

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

Read the entire FDA prescribing information for Octaplas (Pooled Plasma (Human) Solvent/Detergent)

SLIDESHOW

Hepatitis C, Hep B, Hep A: Symptoms, Causes, Treatment See Slideshow

© Octaplas Patient Information is supplied by Cerner Multum, Inc. and Octaplas Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors