C1 Esterase Inhibitor [recombinant]

C1 Esterase Inhibitor [recombinant] is a prescription medication used for the treatment of acute attacks (rapid swelling of the hands, feet, limbs, face, intestinal tract, or airway) in adult and adolescent patients with hereditary angioedema (HAE). HAE is caused by a shortage of a protein called C1 esterase inhibitor, that is present in the blood and helps control inflammation (swelling) and parts of the immune system. A shortage of C1 esterase inhibitor can lead to repeated acute attacks. 

C1 Esterase Inhibitor [recombinant] comes as a powder that is dissolved in sterile water and is slowly injected into a vein (intravenous injection). A single dose is usually enough to treat an attack, but a second dose may be needed.

Common side effects include headache, nausea, and diarrhea.

C1 Esterase Inhibitor [recombinant] is a prescription medication used to treat acute angioedema attacks in adult and adolescent patients with Hereditary Angioedema (HAE).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

C1 Esterase Inhibitor [recombinant] may be found in some form under the following brand names:

• Ruconest

Allergic reactions may occur. Get medical treatment immediately if you have any of the following symptoms after receiving this medication:

• wheezing
• difficulty breathing
• chest tightness
• turning blue (look at lips and gums)
• fast heartbeat
• swelling
• faintness
• rash
• hives

In clinical studies, the most severe side effect reported in a person who received this medication was a severe allergic reaction in a subject who was allergic to rabbits.

Other side effects patients experienced during clinical research studies include:

• headache
• nausea
• diarrhea

These are not all the possible side effects of C1 Esterase Inhibitor [recombinant]. Ask your doctor or pharmacist for more information.

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

No drug interactions have been reported. Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.

You should not use C1 Esterase Inhibitor [recombinant] if you have a known or suspected allergy (hypersensitivity) to rabbits or rabbit-derived products.

You should not use this medication if you have experienced life-threatening immediate hypersensitivity reactions, including anaphylaxis, to C1 Esterase Inhibitor [recombinant] or to any other C1 esterase inhibitor product.

C1 Esterase Inhibitor [recombinant] is not indicated for use in children under the age of 13 years.

Medicines can interact with certain foods. In some cases this may be harmful and your doctor may advise you to avoid certain foods. In the case of C1 Esterase Inhibitors [recombinant], there are no specific foods you must exclude.

Tell your healthcare provider about all of your medical conditions, including if you:

• have an allergy to rabbits since this can put you at high risk of a serious allergic reaction. These allergy symptoms could include runny nose, itchy nose, sneezing, coughing, wheezing, difficulty breathing or watery eyes when you are near rabbits.
• are pregnant or planning to become pregnant. It is not known if C1 Esterase Inhibitor [recombinant] can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if C1 Esterase Inhibitor [recombinant] passes to your milk and if it can harm your baby.

Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

C1 Esterase Inhibitor [recombinant] falls into category B. There are no well-done studies that have been done in humans with C1 Esterase Inhibitor [recombinant]. But in animal studies, pregnant animals were given this medication, and investigators could not exclude an effect on embryofetal development. 

The safety and efficacy of this medication prior to or during labor and delivery have not been established. Use only if clearly needed.

The first treatment is typically under the supervision of a qualified healthcare professional experienced in the treatment of HAE.

Appropriately trained patients may self-administer upon recognition of an HAE attack.

The recommended dose of C1 Esterase Inhibitor [recombinant] is 50 IU per kg with a maximum of 4200 IU to be administered as a slow intravenous injection over approximately 5 minutes.

If the attack symptoms persist, an additional (second) dose can be administered at the recommended dose level. Do not exceed 4200 IU per dose. No more than two doses should be administered within a 24 hour period.