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Berinert Warnings and Precautions

In some cases, using Berinert may lead to serious and even life-threatening complications, including dangerous allergic reactions. To avoid these and other problems, your healthcare provider will follow certain precautions for using Berinert safely, including warnings for people who have a history of a stroke or women who are pregnant or nursing.

 

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to receiving Berinert® (C1 esterase inhibitor) if you have:
   
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings for Berinert

Some warnings and precautions to be aware of prior to using this medication include the following:
 
  • It is possible to have a severe, life-threatening allergic reaction to this medication. Symptoms of an allergic reaction may be similar to the symptoms of a hereditary angioedema (HAE) attack -- the condition Berinert is used to treat. Talk to your healthcare provider about ways to tell the two apart. Stop using the medication and seek immediate medical attention if you develop signs of an allergic reaction during or after your injection, including:
    • A rash
    • Hives
    • Wheezing
    • Difficulty breathing
    • Chest tightness
    • Swelling of the face, throat, or tongue
    • Dizziness or faintness
    • A rapid heartbeat
    • A bluish tinge to the lips, gums, or skin.
 
  • Berinert has been reported to increase the risk for blood clots and strokes. Seek immediate medical attention if you develop signs of a stroke or blood clot, such as:
    • Chest pain or pressure
    • Pain, warmth, or swelling in one or both legs
    • Abdominal (stomach) pain or swelling
    • Sudden weakness or numbness, especially on one side of the body
    • A sudden severe headache
    • Changes in speech or vision
    • Confusion
    • Shortness of breath.
 
  • Berinert is made from human blood and, therefore, theoretically may contain infectious agents, such as viruses or the agent that may cause Creutzfeldt-Jakob disease (CJD), a rare brain disease.
 
  • If you self-inject Berinert to treat a laryngeal (voice box) attack, you should seek immediate medical attention after using the medication. Laryngeal attacks can be life-threatening.
 
  • Make sure to let your healthcare provider know if you use Berinert to treat an abdominal (stomach) attack. Several other medical problems can cause similar symptoms, and your healthcare provider may want to exclude these other possible causes.
 
  • Talk to your healthcare provider before traveling. You will need to plan to bring enough Berinert for treatment while you are away.
 
  • You should not self-inject this medication unless your healthcare provider has taught how to use it and you understand the instructions. Also, do not begin to give yourself a dose if your attack has progressed to the point where you cannot successfully prepare the medication or inject yourself with it. Instead, seek immediate medical attention. 
   
  • Berinert is a pregnancy Category C medication, which means it may not be safe for use during pregnancy, although the full risks are currently unknown (see Berinert and Pregnancy).
 
  • It is unknown whether Berinert passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Berinert and Breastfeeding).
 

Berinert Medication Information

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