Drug information of ceprotin

Converted to activated protein C (APC). APC is a serine protease which inactivates factors Va and VIIIa, limiting thrombotic formation. In vitro data also suggest inhibition of plasminogen activator inhibitor-1 (PAF-1) resulting in profibrinolytic activity, inhibition of macrophage production of tumor necrosis factor, blocking of leukocyte adhesion, and limitation of thrombin-induced inflammatory responses.

Vd: Median: 0.074L/kg (range: 0.044 to 0.165 L/kg)

Activated protein C (APC) inactivated by plasma protease inhibitors

30 minutes

Plasma: Tmax: 0.5 hours; range: 0.17 to 1.33 hours

Median: 9.8 hours; range: 4.9 to 14.7 hours

Severe congenital protein C deficiency: Prevention and treatment of venous thrombosis and purpura fulminans in adults and pediatric patients with severe congenital protein C deficiency.

There are no contraindications listed in the manufacturer’s labeling.

Side effects requiring immediate medical attention

Along with its needed effects, protein c may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking protein c:

More common

• Fainting or loss of consciousness
• fast or irregular breathing
• itching
• lightheadedness
• skin rash
• swelling of eyes or eyelids
• tightness in chest and/or wheezing
• trouble with breathing

Incidence not known

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fever
• sweating
• unusual tiredness or weakness

Side effects not requiring immediate medical attention

Some side effects of protein c may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Increased sweating
• restlessness

Before taking this medicine

• If you are allergic to heparinor mouse proteins, talk with the doctor.
• If you are allergic to protein C concentrate (human); any part of protein C concentrate (human); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

• Tell all of your health care providers that you take protein C concentrate (human). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you are on a low-sodium or sodium-free diet, talk with your doctor. Some of these products have sodium.
• This medicine has small amounts of heparin in it. This may lead to a very bad blood problem called heparin-induced thrombocytopenia(HIT). If this happens, bleeding could happen more easily. Talk with the doctor.
• This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

Use protein C concentrate (human) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

It is given into a vein for a period of time.

If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.

Wash your hands before and after use.

This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.

Let protein C concentrate (human) come to room temperature before mixing. Do not heat protein C concentrate (human).

Do not shake the solution.

Use within 3 hours of making.

Do not use if the solution is cloudy, leaking, or has particles.

This medicine is colorless to a faint yellow. Do not use if the solution changes color.

Each vial is for one use only. Throw away any part not used after the dose is given.

Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

Storage

Store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Administer within 3 hours of reconstitution and discard any unused portion.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.