Haegarda

Generic name: C1 Esterase Inhibitor Subcutaneous (human)
Drug class: Hereditary angioedema agents

Usage of Haegarda

Haegarda is a man-made form of a protein in blood that helps control swelling in the body. People with a condition called Hereditary Angioedema (HAE) do not have enough of this protein. Hereditary Angioedema can cause attacks of swelling and symptoms such as stomach problems or trouble breathing.

Haegarda is an injectable medicine used to prevent swelling and/or painful attacks in patients 6 years of age and older with Hereditary Angioedema.

Haegarda should not be used to treat an acute HAE attack. In case of an acute HAE attack, initiate individualized treatment as discussed with your health care professional.

Haegarda side effects

Get emergency medical help if you have signs of an allergic Reaction to Haegarda: hives; chest tightness, fast heartbeats, feeling light-headed; wheezing or difficult breathing, blue lips or gums; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • 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; or
  • fast heart rate.

    • Common Haegarda side effects may include:

  • unusual or unpleasant taste in your mouth;
  • headache, dizziness;
  • nausea, vomiting;
  • pain, bruising, itching, swelling, bleeding, warmth, or a hard lump where the medicine was injected;
  • stuffy nose, sore throat;
  • rash; or
  • fever.

    • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Haegarda

    You should not use Haegarda if have ever HAD a life-threatening allergic reaction to c1 esterase inhibitor.

    To make sure Haegarda is safe for you, tell your doctor if you have:

  • a stroke or blood clot;
  • heart problems; or
  • an "in-dwelling" catheter.

    • Tell your doctor if you are pregnant or breast-feeding.

    Haegarda is made from donated human plasma and may contain viruses or other infectious agents. Donated plasma is tested and treated to reduce the risk of contamination, but there is still a small possibility it could transmit disease. Ask your doctor about any possible risk.

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    How to use Haegarda

    Usual Adult Dose for Hereditary Angioedema:

    Haegarda is intended for self-administration after reconstitution at a dose of 60 International Units (IU) per kg body weight by suBCUTAneous (S.C.) injection twice weekly (every 3 or 4 days). The patient or caregiver should be trained on how to administer the subcutaneous injection.

    Use: routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks 

    Usual Pediatric Dose for Hereditary Angioedema:

    Haegarda is intended for self-administration after reconstitution at a dose of 60 International Units (IU) per kg body weight by subcutaneous (S.C.) injection twice weekly (every 3 or 4 days). The patient or caregiver should be trained on how to administer the subcutaneous injection.

    Use: routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older

    Warnings

    You should not use Haegarda if you have experienced life-threatening immediate hypersensitivity reactions (allergic reactions), including anaphylaxis, to the product.

    What other drugs will affect Haegarda

    Tell your doctor about all your other medicines, especially:

  • Testosterone; or
  • birth control pills.

    • This list is not complete. Other drugs interact with c1 esterase inhibitor, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

    Disclaimer

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