Ceprotin

Ceprotin

Ceprotin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Ceprotin [protein C concentrate (human)] is made from human plasma and is used for patients with severe congenital Protein C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans. Ceprotin is used as a replacement therapy for pediatric and adult patients. This medication is available in generic form. Common side effects include hypersensitivity, allergic reactions (itching and rash), and lightheadedness.

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. Ceprotin may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Ceprotin should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Ceprotin [protein C concentrate (human)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ceprotin FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Ceprotin (Protein C Concentrate) »

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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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