Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in one clinical study of a drug cannot be directly compared with rates in the clinical studies of the same drug or another drug and may not reflect the rates observed in practice.
The safety profile of CEPROTIN was based on 121 patients from clinical studies and compassionate use in severe congenital Protein C deficiency. Duration of exposure ranged from 1 day to 8 years. One patient experienced hypersensitivity/allergic reactions (itching and rash) and lightheadedness which were determined by the investigator to be related to CEPROTIN.
No inhibiting antibodies to CEPROTIN have been observed in clinical studies. However, the potential for developing antibodies cannot be ruled out.
The following adverse reactions have been identified during postapproval use of CEPROTIN:
Psychiatric Disorders: Restlessness
Skin and Subcutaneous Tissue Disorders: Hyperhydrosis
General Disorders and Administration Site Conditions: Injection Site Reaction
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Read the Ceprotin (protein c concentrate) Side Effects Center for a complete guide to possible side effects
No formal drug interaction studies have been conducted.
See DOSAGE AND ADMINISTRATION: Initiation of Vitamin K Antagonists for information regarding use of CEPROTIN and vitamin K antagonists.
Read the Ceprotin Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/17/2016
Additional Ceprotin Information
- Ceprotin Drug Interactions Center: protein c concentrate, human iv
- Ceprotin Side Effects Center
- Ceprotin FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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