Ceprotin

Generic name: Protein C concentrate (human)

What is Ceprotin?

Ceprotin is used to treat patients with severe congenital protein C deficiency for the prevention and treatment of venous thrombosis (blood clot in the vein), and purpura fulminans (blood spots, bruising and discoloring to skin as a result of clotting of small blood vessels in the skin).

What is the most important information I should know about Ceprotin?

Ceprotin may cause an allergic reaction. Ceprotin contains small amounts of heparin and/or mouse protein as a result of the manufacturing process. If you are known to have allergic-type reactions to mouse protein or to heparin, you should talk to your doctor before using this product. You should be aware of the early signs of allergic reaction. These include rash, hives, itching, throat tightness, and low blood pressure. The signs and symptoms of low blood pressure can include a weak pulse, feeling lightheaded or dizzy when you stand, and possible shortness of breath. If you experience any of these symptoms while being treated with Ceprotin, quickly stop the treatment and contact your doctor.

Ceprotin can cause an infectious disease since this drug product is made from human plasma. However, there are steps in the collection of the plasma and in the making of Ceprotin to lessen this possibility. For example, blood and plasma donors are screened for certain viral infections.

Ceprotin may cause an infection with a virus called Human Parvovirus B19 (B19 Virus). Fetuses are at risk to the B19 virus. The symptoms of the virus include fever, drowsiness, chills and runny nose followed about two weeks later by a rash and joint pain. Pregnant women should discuss this risk with their doctor.

Although there are steps taken during the making of Ceprotin to reduce the risk of getting Hepatitis A and B, your doctor may recommend that you be vaccinated against these viruses.

Who should not take Ceprotin?

You should not use Ceprotin unless your doctor confirms that you have severe congenital Protein C deficiency.

What should I tell my doctor before I take the first dose of Ceprotin?

Tell your doctor about all prescription, over-the-counter, and herbal medication you are taking before beginning treatment with Ceprotin. Also, talk to your doctor about your complete medical history, especially if you have kidney problems, or are pregnant or breastfeeding.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

An initial dose of 100-120 IU per 2.2 pounds of body weight for recovery is recommended for acute episodes and short-term treatment. Subsequently, the dose should be adjusted to maintain a target peak protein C activity of 100%. The recommended subsequent 3 doses are 60-80IU per 2.2 pounds of body weight every six hours. The recommended maintenance dosage is 45-60IU per 2.2 pounds of body weight every 6 hours or 12 hours.

For long-term treatment, the maintenance dosage is 45-60IU per 2.2 pounds of body weight every 12 hours.

Your dosage will vary depending upon your condition, your age, and your body weight. Your doctor may require that you have blood taken to help determine the dose of Ceprotin that you should receive.

These dosing guidelines are also recommended for newborn infants and children.

How should I take Ceprotin?

Ceprotin is given by intravenous administration (infusion into a vein). It is given to you under the close supervision of your doctor who is experienced in replacement therapy of coagulation factors/inhibitors and where monitoring of Protein C activity is possible.

What should I avoid while taking Ceprotin?

Avoid skipping doses or doubling up on doses.

What are possible food and drug interactions associated with Ceprotin?

No significant interactions have been reported at this time. However, always tell your doctor about any medicines you are taking, including over-the-counter drugs, vitamins, and herbal supplements.

What are the possible side effects of Ceprotin?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include:allergic reactions (rash and itching), lightheadedness, low blood pressure, fever, restlessness, increased sweating

Can I receive Ceprotin if I am pregnant or breastfeeding?

The effects of Ceprotin during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

What should I do if I miss a dose of Ceprotin?

Your dosing schedule will be determined by your doctor. Speak to him or her in the case of any missed dose.

How should I store Ceprotin?

This medication will be stored by your healthcare provider.