CEPROTIN Dosing & Administration

CEPROTIN® [Protein C Concentrate (Human)] is a sterile, white or cream-colored lyophilized powder supplied in convenient, single-dose vials with nominal strengths of 500 IU and 1000 IU for intravenous administration.1

CEPROTIN 500 IU
CEPROTIN 1000 IU
CEPROTIN Reconstitution Instructions1

Always use aseptic technique when reconstituting CEPROTIN. After reconstitution, the solution should be colorless to slightly yellowish and clear to slightly opalescent and free of visible particles. Do not use the solution if it does not meet these criteria—call Shire Customer Service at 1‑888‑CEPROTIN (1‑888‑237‑7684) to report any issues.

Not more than 3 hours
Administer at room temperature not more than 3 hours after reconstitution.

1.Bring the CEPROTIN (powder) and Sterile Water for Injection, USP (diluent) to room temperature.

2.Remove caps from the CEPROTIN and diluent vials.

3.Cleanse stoppers with germicidal solution, and allow them to dry prior to use.

4.Remove protective covering from one end of the double-ended transfer needle and insert exposed needle through the center of the diluent vial stopper.

5.Remove protective covering from the other end of the double-ended transfer needle. Invert diluent vial over the upright CEPROTIN vial; then rapidly insert the free end of the needle through the CEPROTIN vial stopper at its center. The vacuum in the vial will draw in the diluent. If there is no vacuum in the vial, do not use the product, and contact Shire Customer Service at 1‑888‑CEPROTIN (1‑888‑237‑7684).

6.Disconnect the two vials by removing the needle from the diluent vial stopper. Then, remove the transfer needle from the CEPROTIN vial.

7.Gently swirl the vial until all powder is dissolved. Be sure that CEPROTIN is completely dissolved; otherwise, active materials will be removed by the filter needle. After reconstitution, the solution should be colorless to slightly yellowish and clear to slightly opalescent and free of visible particles.
Do not use the solution if it does not meet these criteria.

For a single dose of human Protein C at a concentration of 100 IU/mL1
CEPROTIN Dosing Schedule and Administration

Treatment with CEPROTIN should be initiated under the supervision of a physician experienced in replacement therapy with coagulation factors/inhibitors where monitoring of Protein C activity is feasible. CEPROTIN is for intravenous administration only.1

The dose, administration frequency, and duration of treatment with CEPROTIN depend on the:1

  • Severity of the Protein C deficiency
  • Patient's age
  • Clinical condition of the patient
  • Patient's plasma level of Protein C

These dosing guidelines are also recommended for neonatal and pediatric patients. Administer CEPROTIN at a maximum injection rate of 2 mL per minute except for children with a body weight of < 10 kg, where the injection rate should not exceed a rate of 0.2 mL/kg/minute.1

Target Peak Protein C Activity Dose
Initial dosea,b 100% 100-120 IU/kg
Subsequent 3 dosesa,b 100% 60-80 IU/kg every 6h
Short-term prophylaxis
or maintenance dosea‑c
> 25% 45-60 IU/kg every 6h or 12h
Long-term prophylaxisa > 25% 45-60 IU/kg every 12h

a Dosing is based upon a pivotal clinical trial of 15 patients.

b The dose regimen should be adjusted according to the pharmacokinetic profile for each individual.

c CEPROTIN should be continued until desired anticoagulation is achieved.

Prophylactic administration

In patients receiving prophylactic administration of CEPROTIN, higher peak Protein C activity levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention). Maintenance of trough Protein C activity levels above 25% is recommended.1

See the full Prescribing Information for important information about Protein C activity monitoring and initiation of vitamin K antagonists.
CEPROTIN Storage

Store at 2°C-8°C (36°F-46°F) and protect from light. Do not freeze.1

    REFERENCES:
  1. Baxalta. CEPROTIN [Protein C Concentrate (Human)]: Prescribing information.

Indication and Important Safety Information

WARNINGS and PRECAUTIONS
  • Hypersensitivity/Allergic reactionsCEPROTIN® [Protein C Concentrate (Human)] may contain trace amounts of mouse protein and/or heparin as a result of the manufacturing process. Allergic reactions to mouse protein and/or heparin cannot be ruled out. In case of hypersensitivity/allergic reaction, discontinue CEPROTIN administration immediately and institute appropriate treatment.
  • Transmission of infectious agentsCEPROTIN is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • Bleeding episodesSeveral bleeding episodes have been observed in clinical studies. Concurrent anticoagulant medication may have been responsible for these bleeding episodes. CEPROTIN administration may have further contributed to these bleeding events. Simultaneous administration of CEPROTIN and tissue plasminogen activator (tPA) may further increase the risk of bleeding from tPA.
  • Heparin-induced thrombocytopenia (HIT)CEPROTIN contains trace amounts of heparin that may lead to HIT, which can be associated with a rapid decrease of thrombocytes. If HIT is suspected, determine the platelet count immediately and discontinue CEPROTIN administration.
  • Low sodium diet/Renal impairmentPatients on a low sodium diet or who have renal impairment should be informed that the quantity of sodium in the maximum daily dose of CEPROTIN exceeds 200 mg. Monitor patients with renal impairment closely for sodium overload.
ADVERSE REACTIONS

The common adverse reactions related to CEPROTIN treatment observed in clinical trials were the following hypersensitivity or allergic reactions: lightheadedness, itching and rash.

Indication

CEPROTIN® [Protein C Concentrate (Human)] is indicated for pediatric and adult patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans

Please review the CEPROTIN Prescribing Information for full prescribing details.