C1 Esterase Inhibitor, Human (Intravenous Route)

People who have HAE have low levels of C1 esterase inhibitor in their body . This medicine works by improving your immune system and clotting system .

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of C1 esterase inhibitor in children younger than 9 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of C1 esterase inhibitor in the geriatric population. Safety and efficacy have not been established.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots, history ofa€”Use with caution. May make this condition worse.

Proper Use

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention . Call your doctor or nurse right away if you or your child have a rash; itching; hives; hoarseness; chest tightness; lightheadedness, dizziness, or fainting; wheezing; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you or your child have swelling and pain in your arms, legs, or stomach; chest pain; shortness of breath; loss of sensation; confusion; or problems with muscle control or speech.

This medicine is made from donated human blood . Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Side Effects

Along with its needed effects, a medicine 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:

More common

• Chest pain


• Chills


• Cough


• Ear congestion or pain


• Fever


• Head congestion


• Headache


• Hoarseness or other voice changes


• Nasal congestion


• Pain or tenderness around the eyes and cheekbones


• Rash


• Runny nose


• Shortness of breath or troubled breathing


• Sneezing


• Sore throat


• Stuffy or runny nose


• Tightness of the chest or wheezing

Incidence not known

• Dark urine


• Difficulty with swallowing


• Dizziness


• Fast heartbeat


• General tiredness and weakness


• Hives


• Itching


• Light-colored stools


• Nausea and vomiting


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Unusual tiredness or weakness


• Upper right abdominal pain


• Yellow eyes and skin

Some side effects 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:

More common

• Abdominal or stomach pain


• Diarrhea


• Muscle spasms


• Pain

Less common

• Change in taste


• Loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.