Ceprotin

Ceprotin Manufacturers

• Baxter Healthcare Corporation
  

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  Ceprotin | Baxter Healthcare Corporation

  

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  2.1 General

  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 administered by intravenous injection after reconstitution of the powder for solution for injection with Sterile Water for Injection. Allergic type hypersensitivity reactions are possible. See WARNINGS/PRECAUTIONS: Hypersensitivity/Allergic Reactions (5.1).

  The dose, administration frequency and duration of treatment with CEPROTIN depends on the severity of the protein C deficiency, the patient’s age, the clinical condition of the patient and the patient’s plasma level of protein C. Therefore, the dose regimen should be adjusted according to the pharmacokinetic profile for each individual patient. See DOSAGE AND ADMINISTRATION: Protein C Activity Monitoring (2.2).

  Table 1 provides the CEPROTIN dosing schedule for acute episodes, short-term prophylaxis and long-term prophylaxis.

  Table 1: CEPROTIN Dosing Schedule for Acute Episodes, Short-term Prophylaxis and Long-term Prophylaxis* NA = Not applicable; Q = every. * Dosing is based upon a pivotal clinical trial of 15 patients. † The dose regimen should be adjusted according to the pharmacokinetic profile for each individual (2.1, 2.2) ‡ CEPROTIN should be continued until desired anticoagulation is achieved. Initial Dose† Subsequent 3
  Doses† Maintenance
  Dose† Acute Episode /
  Short-term Prophylaxis‡ 100-120 IU/kg 60 - 80 IU/kg
  Q 6 hours 45 - 60 IU/kg
  Q 6 or 12 hours Long-term Prophylaxis NA NA 45 - 60 IU/kg
  Q 12 hours

  An initial dose of 100-120 IU/kg for determination of recovery and half-life is recommended for acute episodes and short-term prophylaxis. Subsequently, the dose should be adjusted to maintain a target peak protein C activity of 100 %. After resolution of the acute episode, continue the patient on the same dose to maintain trough protein C activity level above 25% for the duration of treatment.

  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.

  These dosing guidelines are also recommended for neonatal and pediatric patients. See USE IN SPECIFIC POPULATIONS: Pediatric Use (8.4) and CLINICAL PHARMACOLOGY: Pharmacokinetics (12.3).

  2.2 Protein C Activity Monitoring

  The measurement of protein C activity using a chromogenic assay is recommended for the determination of the patient’s plasma level of protein C before and during treatment with CEPROTIN. The half-life of CEPROTIN may be shortened in certain clinical conditions such as acute thrombosis, purpura fulminans and skin necrosis. SeeCLINICAL PHARMACOLOGY: Pharmacokinetics (12.3). In the case of an acute thrombotic event, it is recommended that protein C activity measurements be performed immediately before the next injection until the patient is stabilized. After the patient is stabilized, continue monitoring the protein C levels to maintain the trough protein C level above 25%.

  Patients treated during the acute phase of their disease may display much lower increases in protein C activity. Coagulation parameters should also be checked; however, in clinical trials data were insufficient to establish correlation between protein C activity levels and coagulation parameters.

  2.3 Initiation of Vitamin K Antagonists

  In patients starting treatment with oral anticoagulants belonging to the class of vitamin K antagonists, a transient hypercoagulable state may arise before the desired anticoagulant effect becomes apparent. This transient effect may be explained by the fact that protein C, itself a vitamin K-dependent plasma protein, has a shorter half-life than most of the vitamin K-dependent proteins (i.e. Factor II, IX and X).

  In the initial phase of treatment, the activity of protein C is more rapidly suppressed than that of the procoagulant factors. For this reason, if the patient is switched to oral anticoagulants, protein C replacement must be continued until stable anticoagulation is obtained. Although warfarin-induced skin necrosis can occur in any patient during the initiation of treatment with oral anticoagulant therapy, individuals with severe congenital protein C deficiency are particularly at risk.

  During the initiation of oral anticoagulant therapy, it is advisable to start with a low dose of the anticoagulant and adjust this incrementally, rather than use a standard loading dose of the anticoagulant.

  2.4 Preparation of CEPROTIN [Protein C Concentrate (Human)]

  Reconstitution: Use Aseptic Technique

   Bring the CEPROTIN (powder) and Sterile Water for Injection, USP (diluent) to room temperature. Remove caps from the CEPROTIN and diluent vials. Cleanse stoppers with germicidal solution, and allow them to dry prior to use. Remove protective covering from one end of the double-ended transfer needle and insert exposed needle through the center of the diluent vial stopper. 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 Baxter Customer Service at 1-888-CEPROTIN (237-7684). Disconnect the two vials by removing the needle from the diluent vial stopper. Then, remove the transfer needle from the CEPROTIN vial. 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. 2.5 Administration of CEPROTIN [Protein C Concentrate (Human)]

  Administration: Use Aseptic Technique

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

  After reconstitution, the solution is colorless to slightly yellowish and clear to slightly opalescent and essentially free from visible particles. Do not use the product if the solution does not meet these criteria. CEPROTIN should be administered at room temperature not more than 3 hours after reconstitution.

  Attach the filter needle to a sterile, disposable syringe and draw back the plunger to admit air into the syringe. Insert the filter needle into the vial of reconstituted CEPROTIN. Inject air into the vial and then withdraw the reconstituted CEPROTIN into the syringe. Remove and discard the filter needle in a hard-walled Sharps container for proper disposal. Filter needles are intended to filter the contents of a single vial of CEPROTIN only. Attach a suitable needle or infusion set with winged adapter, and inject intravenously as instructed below under Administration by infusion.

  Administration by Infusion

  CEPROTIN should be administered 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.

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• Baxter Healthcare Corporation
  

  ×

  Ceprotin | Baxter Healthcare Corporation

  

  ---

  2.1 General

  For intravenous administration only.

  Initiate treatment with CEPROTIN under the supervision of a physician experienced in replacement therapy with coagulation factors/inhibitors where monitoring of protein C activity is feasible.

  The dose, administration frequency and duration of treatment with CEPROTIN depends on the severity of the protein C deficiency, the patient’s age, the clinical condition of the patient and the patient’s plasma level of protein C. Therefore, adjust the dose regimen according to the pharmacokinetic profile for each individual patient. [see DOSAGE AND ADMINISTRATION: Protein C Activity Monitoring (2.2)].

  Table 1 provides the CEPROTIN dosing schedule for acute episodes, short-term prophylaxis and long-term prophylaxis.

  Table 1 CEPROTIN Dosing Schedule for Acute Episodes, Short-term Prophylaxis and Long-term Prophylaxis* * Dosing is based upon a pivotal clinical trial of 15 patients. † The dose regimen should be adjusted according to the pharmacokinetic profile for each individual. (2.1, 2.2) ‡ CEPROTIN should be continued until desired anticoagulation is achieved. § NA = Not applicable; Q = every.

  Initial Dose†

  Subsequent 3
  Doses†

  Maintenance
  Dose†

  Acute Episode /
  Short-term Prophylaxis‡

  100-120 IU/kg

  60 - 80 IU/kg
  Q 6 hours

  45 - 60 IU/kg
  Q 6 or 12 hours

  Long-term Prophylaxis

  NA§

  NA§

  45 - 60 IU/kg
  Q 12 hours

  An initial dose of 100-120 IU/kg for determination of recovery and half-life is recommended for acute episodes and short-term prophylaxis. Subsequently, adjust the dose to maintain a target peak protein C activity of 100 %. After resolution of the acute episode, continue the patient on the same dose to maintain trough protein C activity level above 25% for the duration of treatment.

  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.

  These dosing guidelines are also recommended for neonatal and pediatric patients. [see USE IN SPECIFIC POPULATIONS: Pediatric Use (8.4) and CLINICAL PHARMACOLOGY: Pharmacokinetics (12.3)].

  2.2 Protein C Activity Monitoring

  The measurement of protein C activity using a chromogenic assay is recommended for the determination of the patient’s plasma level of protein C before and during treatment with CEPROTIN. The half-life of CEPROTIN may be shortened in certain clinical conditions such as acute thrombosis, purpura fulminans and skin necrosis. [see CLINICAL PHARMACOLOGY: Pharmacokinetics (12.3)]. In the case of an acute thrombotic event, it is recommended that protein C activity measurements be performed immediately before the next injection until the patient is stabilized. After the patient is stabilized, continue monitoring the protein C levels to maintain the trough protein C level above 25%.

  Patients treated during the acute phase of their disease may display much lower increases in protein C activity. Coagulation parameters should also be checked; however, in clinical trials data were insufficient to establish correlation between protein C activity levels and coagulation parameters.

  2.3 Initiation of Vitamin K Antagonists

  In patients starting treatment with oral anticoagulants belonging to the class of vitamin K antagonists, a transient hypercoagulable state may arise before the desired anticoagulant effect becomes apparent. This transient effect may be explained by the fact that protein C, itself a vitamin K-dependent plasma protein, has a shorter half-life than most of the vitamin K-dependent proteins (i.e. Factor II, IX and X).

  In the initial phase of treatment, the activity of protein C is more rapidly suppressed than that of the procoagulant factors. For this reason, if the patient is switched to oral anticoagulants, protein C replacement must be continued until stable anticoagulation is obtained. Although warfarin-induced skin necrosis can occur in any patient during the initiation of treatment with oral anticoagulant therapy, individuals with severe congenital protein C deficiency are particularly at risk.

  During the initiation of oral anticoagulant therapy, it is advisable to start with a low dose of the anticoagulant and adjust this incrementally, rather than use a standard loading dose of the anticoagulant.

  2.4 Preparation of CEPROTIN [Protein C Concentrate (Human)]

  Reconstitution: Use Aseptic Technique

  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 Baxter Customer Service at 1-888-CEPROTIN (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. 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. 2.5 Administration of CEPROTIN [Protein C Concentrate (Human)]

  Administration: Use Aseptic Technique

  Visually inspect CEPROTIN for particulate matter and discoloration prior to administration.

  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 this criteria. Administer CEPROTIN at room temperature not more than 3 hours after reconstitution.

  1. Attach the filter needle to a sterile, disposable syringe and draw back the plunger to admit air into the syringe. 2. Insert the filter needle into the vial of reconstituted CEPROTIN. 3. Inject air into the vial and then withdraw the reconstituted CEPROTIN into the syringe. 4. Remove and discard the filter needle in a hard-walled Sharps container for proper disposal. Filter needles are intended to filter the contents of a single vial of CEPROTIN only. 5. Attach a suitable needle or infusion set with winged adapter, and inject intravenously as instructed below under Administration by infusion.

  Record the name and batch number of the product every time CEPROTIN is administered to a patient.

  Administration by Infusion

  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.

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