Ceprotin (GREEN BAR) (protein C, human)
Protein C Replacement Intravenous Vial (EA)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Protein C, a naturally occurring precursor of a vitamin K-dependent serine protease, is an anticoagulant. Protein C (human) is a lyophilized concentrate of protein C prepared from pooled human plasma.
Commercially available protein C (human) is a sterile lyophilized concentrate of highly purified protein C prepared from pooled human plasma. Endogenous protein C is an inactive precursor to a vitamin K-dependent anticoagulant serine protease, activated protein C (APC). APC generally inhibits coagulation by inactivating activated coagulation factors V (Va) and VIII (VIIIa).
In addition, APC facilitates fibrinolysis.
Protein C is converted to APC by the thrombin/thrombomodulin complex on the endothelial cell surface. APC in conjunction with its cofactor, protein S, inactivates factors Va and VIIIa, which results in inhibition of the conversion of prothrombin to thrombin. In individuals with severe protein C deficiency, disruption of the protein C anticoagulant pathway results in impaired regulation of thrombin generation and associated thrombophilia.
The median half-life of protein C (human) is 9.8 hours (range: 4.9-14.7 hours) based on the noncompartmental method. In patients with acute thrombosis, purpura fulminans, or skin necrosis, the half-life of protein C (human) may be shortened. In addition, the magnitude of increase in plasma protein C concentrations may be reduced in individuals with acute thrombosis.
USES: Protein C is a natural substance in your body that helps to decrease clotting in the blood vessels. This medication is used to prevent and treat blood clots (such as venous thrombosis, purpura fulminans) in people who are born with a severe lack of protein C.
Generic name: protein C, human
Drug class: Protein C Replacement
Therapeutic class: Hematological Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Ceprotin (GREEN BAR)
Indications
The following indications are listed for Ceprotin (GREEN BAR):
- Protein C Deficiency Disease
Dosing
Potency of protein C (human) is determined by chromogenic assay and is expressed in international units (IU, units) as tested against the activity of the World Health Organization reference standard. One unit is approximately equivalent to the protein C activity (as measured by an amidolytic assay) present in 1 mL of plasma. The number of units of protein C is indicated on the label of each vial.
Dosage and duration of protein C (human) therapy is dependent on the severity of protein C deficiency, the plasma protein C concentration, and the patient's age and clinical condition. Dosage of protein C (human) should be individualized based on measured protein C activity, expressed as a percentage of normal plasma protein C concentrations, and adjusted according to the pharmacokinetic profile for each individual patient.
Plasma protein C concentrations should be determined before and during therapy with protein C (human) using a chromogenic assay to measure the level of protein C activity. During acute thrombotic episodes, protein C activity should be measured immediately before administration until the patient is stabilized; protein C concentrations should continue to be monitored after the patient is stabilized. The magnitude of increase in plasma protein C activity achieved with the drug may be substantially reduced during acute thrombotic episodes. (See Description.) Coagulation parameters also should be monitored; however, data from clinical studies were insufficient to establish correlation between levels of protein C activity and coagulation parameters.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Ceprotin 800-1,200 Unit Vial | Maintenance | Infuse 45 unit/kg by intravenous route every 12 hours. |
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies have been performed to date.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
The manufacturer states that there are no known contraindications to the use of protein C (human).
- Heparin-induced thrombocytopenia
There are no severe contraindications for this drug.
- Kidney disease with reduction in glomerular filtration rate (GFr)
Adverse reactions
The most common adverse effects reported in clinical studies of protein C (human) are hypersensitivity or allergic reactions (e.g., itching, rash) and lightheadedness.
Rare or Very Rare
- Hemorrhage
- Heparin-induced thrombocytopenia
- Hypersensitivity drug reaction
- Hypotension
- Injection site sequelae
More Frequent
- Dizziness
- Pruritus of skin
- Skin rash
Rare or Very Rare
- Fever
- Hyperhidrosis
- Nervousness
Precautions
No enhanced messaging available.
Safety and efficacy of protein C (human) have been established in several retrospective and prospective studies in children 2 days of age and older.
The pharmacokinetic profile of protein C (human) has not been established in pediatric patients. Limited data suggest that systemic exposure to protein C (human) may be reduced in very young children compared with older individuals because the protein may have a shorter half-life, a larger volume of distribution, and/or more rapid clearance in very young children; clinicians should consider this fact when selecting a dosage regimen for children, and dosage of protein C (human) should be individualized based on measured protein C activity. (See Dosage and Administration: Dosage.)
Category C. (See Users Guide.)
Exposure to protein C (human) during labor and delivery has been reported without adverse effects in at least one case. However, protein C (human) has not been studied for use during labor and delivery.
It is not known whether protein C (human) is distributed into milk in humans. Protein C (human) has not been studied for use in nursing women.
Experience in patients 65 years of age or older is insufficient to determine whether they respond differently than younger adults.
ICD codes
| Code | Type | Description |
|---|---|---|
| Protein C deficiency disease | ||
| D68.59 | ICD10CM | Other primary thrombophilia |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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