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HAEGARDA C1 ESTERASE INHIBITOR SUBCUTANEOUS (HUMAN)- human c1-esterase inhibitor kit


  1. Patient Information
  2. Inform Patients/caregivers To Immediately Report The Following To Their Physician:
  3. Inform All Patients/caregivers:
  4. Advise Female Patients:

Patient Information 

SeeFDA-approved patient labeling (Patient Product Information).

All risks and benefits of HAEGARDA should be discussed with the patient/caregiver before prescribing or administering it to the patient.

Inform Patients/caregivers To Immediately Report The Following To Their Physician: 

  • Signs and symptoms of allergic hypersensitivity reactions, such as hives, tightness of the chest, difficulty breathing, wheezing, hypotension and/or anaphylaxis experienced during or after injection of HAEGARDA[seeWarnings and Precautions (5.1)].
  • Signs and symptoms of a thromboembolic event, including pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body[seeWarnings and Precautions (5.2)].

Inform All Patients/caregivers: 

  • HAEGARDA is indicated for HAE prophylaxis and should not be used for the treatment of acute HAE attacks. Patients/caregivers should be counselled regarding the appropriate course of action if breakthrough HAE attacks occur while on HAEGARDA, including:
    • Individualized rescue treatment for acute HAE attacks.
    • Situations in which to seek immediate medical attention, such as acute laryngeal HAE attacks.
  • Patients/caregivers must ensure an adequate supply of HAEGARDA when traveling.
  • Because HAEGARDA is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent[seeWarnings and Precautions (5.3)andDescription (11)].Inform patients of the risks and benefits of HAEGARDA before prescribing or administering it to the patient.
  • Patients with known risk factors for thromboembolic events are at an increased risk for these events[seeWarnings and Precautions (5.2)].
  • Ensure that the patient/caregiver has access to and has received training in the administration of subcutaneous epinephrine and/or other appropriate supportive therapy for the treatment of any acute anaphylactic or severe hypersensitivity reaction[seeWarnings and Precautions (5.1)].

Advise Female Patients: 

Self-administration- Ensure that the patient/caregiver receives clear instructions and training on S.C. administration in the home or other appropriate setting and has demonstrated the ability to perform S.C. injection.

  • The patient (or caregiver) has the necessary dexterity and comprehension to be trained to self-administer.
  • Instruct patients/caregivers to record the lot number from the HAEGARDA vial label every time they use HAEGARDA.

The attached HAEGARDA "Patient Product Information (PPI)" contains more detailed instructions for patients/caregivers who will be self-administering HAEGARDA.



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