C1 Esterase Inhibitor Recombinant

C1 Esterase Inhibitor Recombinant is a prescription medication used for the treatment of hereditary angioedema. 

• C1 Esterase Inhibitor Recombinant is available under various brand names: Ruconest

Common side effects of C1 Esterase Inhibitor Recombinant include:

• headache
• nausea
• diarrhea
• sneezing
• skin burning sensation or rash
• back pain
• changes in taste, and
• spinning sensation (vertigo)

Serious side effects of C1 Esterase Inhibitor Recombinant include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• chest tightness,
• fast heartbeats,
• lightheadedness,
• wheezing,
• blue lips or gums,
• sudden numbness or weakness (on one side of the body),
• pain, swelling, warmth, or redness in an arm or leg,
• sudden severe headache,
• confusion,
• problems with vision, speech, or balance,
• chest pain while taking deep breaths, and
• fast heart rate

Rare side effects of C1 Esterase Inhibitor Recombinant include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Lyophilized powder for reconstitution

• 2100 IU/vial

Hereditary Angioedema

Adult dosage

• Below 84 kg: 50 IU/kg infused over 5 minutes; not to exceed 4200 IU/dose
• Above 84 kg: 4200 IU IV infused over 5 min
• If the attack symptoms persist, may administer a second dose at the recommended dose level (not to exceed 4200 IU/dose)
• Not to exceed 2 doses/24 hr

Pediatric dosage

• Infants and children: Safety and efficacy not established

Adolescents

• Below 84 kg: 50 IU/kg infused over 5 minutes; not to exceed 4200 IU/dose
• Above 84 kg: 4200 IU IV infused over 5 min
• If the attack symptoms persist, may administer a second dose at the recommended dose level (not to exceed 4200 IU/dose)
• Not to exceed 2 doses/24 hr

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• C1 Esterase Inhibitor Recombinant has no noted severe interactions with any other drugs.
• C1 Esterase Inhibitor Recombinant has no noted serious interactions with any other drugs.
• C1 Esterase Inhibitor Recombinant has no noted moderate interactions with any other drugs.
• C1 Esterase Inhibitor Recombinant has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• History of allergy to rabbits or rabbit-derived products
• History of life-threatening immediate hypersensitivity reactions to C1 esterase inhibitor preparations, including anaphylaxis

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using C1 Esterase Inhibitor Recombinant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using C1 Esterase Inhibitor Recombinant?”

Cautions

• Severe hypersensitivity reactions may occur during or after injection; signs and symptoms include hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and/or anaphylaxis
• Serious arterial and venous thromboembolic (TE) events were reported at recommended doses of plasma-derived C1-esterase inhibitor products in patients with risk factors; risk factors include indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, and immobility

Pregnancy & Lactation

• Category: B; may use during pregnancy if needed
• Studies performed in rats and rabbits at doses up to 12.5 times the human could not exclude an effect on embryo-fetal development; no adequate and well-controlled studies in pregnant women
• Lactation
  • Unknown if distributed in human breast milk