Octaplex (Protein C Concentrate derived from human plasma) is indicated in the treatment of purpura fulminant and venous thrombosis secondary to protein C deficiency.

Octaplex (Protein C Concentrate) Uses:

• Severe congenital protein C deficiency:

  • It is used for the prevention and treatment of venous thrombosis and purpura fulminans in adults as well as pediatric patients with severe congenital protein C deficiency.

Octaplex (Protein C Concentrate) Dose in Adults

• Patient variables (including age, clinical condition, the severity of protein C deficiency, and plasma levels of protein C) will affect the dosing and duration of therapy.
• Individualize frequency, duration, and dose based upon protein C activity and patient pharmacokinetic profile.

Octaplex (Protein C Concentrate) Dose in the treatment of severe congenital protein C deficiency:

• Acute episode/short-term prophylaxis:

  • Initial dose:
    • at 100 to 120 units/kg (for determination of recovery and half-life)
    • Subsequent 3 doses: at 60 to 80 units/kg every 6 hours (adjust to maintain peak protein C activity of 100%)
  • Maintenance dose:
    • at 45 to 60 units/kg every 6 or 12 hours (adjust to maintain recommended maintenance trough protein C activity levels about >25%)

• Long-term prophylaxis:

  • Maintenance dose:
    • 45 to 60 units/kg every 12 hours (recommended maintenance trough protein C activity levels >25%)

Note:

• Target peak protein C activity of 100% should be maintained during acute episodes and short-term prophylaxis.
• After resolution of the acute episode or for long-term prophylaxis, maintain trough levels of protein C activity more than 25%.
• Higher peak levels of protein C may be required in prophylactic therapy of patients at high risk for thrombosis (eg, infection, trauma, or surgical intervention).
• If a patient is shifted to an oral anticoagulant, continue protein C replacement until the stable anticoagulation level is obtained.
• Initiate the oral anticoagulant initially at a low dose and adjust incrementally, rather than using a standard loading dose.

Octaplex (Protein C Concentrate) Dose in Childrens

Note:

• Patient variables (including age, clinical condition, and plasma levels of protein C) will affect dosing and duration of therapy.
• Individualize dosing based upon protein C activity and patient's pharmacokinetic profile.

Octaplex (Protein C Concentrate) Dose in the treatment of severe congenital protein C deficiency:

• Infants, Children, and Adolescents:

  • Acute episode/ short-term prophylaxis:

    • Initial dose:
      • 100-120 units/kg/dose (for determination of recovery and half-life) followed by subsequent 3 doses: at 60-80 units/kg/dose every 6 hours adjusted to maintain peak protein C activity of 100%
    • Maintenance dose:
      • at 45-60 units/kg/dose every 6 or 12 hours titrated to maintain recommended maintenance trough protein C activity levels >25%

  • Long-term prophylaxis:

    • Maintenance dose: at 45-60 units/kg/dose every 12 hours (recommended maintenance trough protein C activity levels >25%)

Note:

• Target peak protein C activity of 100% should be maintained during acute episodes and short-term prophylaxis.
• Maintain trough levels of protein C activity >25%.
• Higher peak levels of protein C may be required in prophylactic therapy of patients at high risk for thrombosis (eg, infection, trauma, surgical intervention).

Purpura fulminans secondary to meningococcemia:

• Infants >1month, Children, and Adolescents:

  • IV: at 100-150 units/kg/dose every 6 hours for 72 hours then at 50-150 units/kg/dose every 12 hours until target symptom/sign resolution or treatment duration reaches 7 days.

Pregnancy Risk category C

• Purified human plasma contains Protein C Concentrate.

Protein C use during breastfeeding:

• Purified human plasma contains Protein C Concentrate.
• According to the drug manufacturer breastfeeding during treatment should be considered in light of the risks to infants and the benefits to mothers.

Octaplex (Protein C Concentrate) Dose in Kidney disease:

• There are no dosage adjustments provided in the drug manufacturer's labeling (has not been studied); monitor closely for sodium overload.

Octaplex (Protein C Concentrate) Dose in Liver disease:

• There are no dosage adjustments provided in the drug manufacturer's labeling.

Side effects of Octaplex (Protein C Concentrate):

• Hematologic & oncologic:

  • Major hemorrhage

• Hypersensitivity:

  • Hypersensitivity reaction

Contraindications to Octaplex (Protein C concentrate):

• The labeling of the drug manufacturer does not list any contraindications.

Warnings and precautions

• Heparin-induced hemocytopenia (HIT).

  • If there are trace amounts of heparin in the formulation, it may cause HIT. In such cases, an evaluation of platelet count is performed.

• Hypersensitivity reactions

  • It may contain trace or very little mouse protein and/or Heparin. Discontinue use in the presence of hypersensitivity/allergic reactions.

• Renal impairment

  • Patients with impaired renal function should be cautious; patients are closely monitored for sodium overload.

Monitoring parameters:

• Protein C activity (chromogenic assay) before and during therapy;
• signs and symptoms of bleeding;
• hemoglobin/hematocrit,
• PT/INR,
• platelet count;
• signs and symptoms of sodium overload in patients with renal disorder.

How to administer Octaplex (Protein C Concentrate)?

IV:

• Administer by intravenous injection at a rate not to exceed than 2 mL/minute.
• In infants and children <10 kg, the administration should not exceed a rate of 0.2 mL/kg/minute.
• The administration must be completed within 3 hours of solution preparation.

Mechanism of action of Octaplex (Protein C Concentrate):

• Converted to activated proteins C (APC).
• APC is a serine protease which inactivates factors VIIIa and Va, limiting the formation of thrombotic plaques.
• In vitro data suggest that inhibition of plasminogen activate inhibitor-1 (PAF-1) may result in profibrinolytic activities, inhibition of macrophages producing tumor necrosis factors, blocking of leukocyte adhesion and limitation of thrombin-induced inflammation.

Notice:

• There are limited data suggesting that infants and very young kids may have a quicker clearance, lower serum concentration and AUC, greater volume of distribution and a shorter half-life.

The onset of action:

• 30 minutes

Metabolism:

• Activated protein C (APC) inactivated by plasma protease inhibitors

Half-life elimination:

• Median: 9.8 hours;
• range: 4.9 to 14.7 hours

Time to peak plasma concentrations:

• 0.5 hours;
• range: 0.17 to 1.33 hours

International Brands of Protein C concentrate:

• Ceprotin
• Octaplex
• Protexel

Protein C concentrate Brand Names in Pakistan:

No Brands Available in Pakistan.