Ceprotin

SIDE EFFECTS

Clinical Studies Experience

The most serious and common adverse reactions related to CEPROTIN (protein c concentrate) treatment observed were hypersensitivity or allergic reactions (itching and rash) and lightheadedness.

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 (protein c concentrate) 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 (protein c concentrate) .

No inhibiting antibodies to CEPROTIN (protein c concentrate) have been observed in clinical studies. However, the potential for developing antibodies cannot be ruled out.

Post-marketing Experience

The following adverse reactions have been identified during postapproval use of CEPROTIN (protein c concentrate) : hemothorax, hypotension, hyperhydrosis, fever and restlessness. 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

DRUG INTERACTIONS

No formal drug interaction studies have been conducted.

See WARNINGS AND PRECAUTIONS: Bleeding Episodes for information regarding simultaneous administration of CEPROTIN (protein c concentrate) and tissue plasminogen activator (tPA).

See DOSAGE AND ADMINISTRATION: Initiation of Vitamin K Antagonists for information regarding use of CEPROTIN (protein c concentrate) and vitamin K antagonists.

Read the Ceprotin Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 5/18/2007
This monograph has been modified to include the generic and brand name in many instances.

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