"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
TPN is an intravenous"...
C1 Esterase Inhibitor (Human) Freeze-Dried Powder for Reconstitution
This leaflet summarizes important information about Berinert. Please read it carefully before using Berinert and each time you get a refill. There may be new information provided. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Berinert. If you have any questions after reading this, ask your healthcare provider.
What is Berinert?
Berinert is an injectable medicine used to treat swelling and/or painful attacks in adults and adolescents with hereditary angioedema (HAE). HAE is caused by the poor functioning or lack of a protein called C1 that is present in your blood and helps control inflammation (swelling) and parts of the immune system. Berinert contains C1 esterase inhibitor, a protein that helps control C1.
Who should not use Berinert?
You should not use Berinert if you have experienced life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product.
What should I tell my healthcare provider before Berinert is given?
Tell your healthcare provider about all of your medical conditions, including if you:
- Are pregnant or planning to become pregnant. It is not known if Berinert can harm your unborn baby.
- Are breastfeeding or plan to breastfeed. It is not known if Berinert passes into your milk and if it can harm your baby.
- Have a history of blood clotting problems. Blood clots (thrombosis) have occurred in patients receiving large amounts of Berinert. Very high doses of C1 esterase inhibitor could increase the risk of blood clots.
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.
How is Berinert given?
Your healthcare provider will infuse Berinert into your vein (intravenous injection). Before infusing, he or she must dissolve the Berinert powder using the sterile water provided. Your healthcare provider will prescribe the dose that you should be given.
What are the possible side effects of Berinert?
Allergic reactions may occur with Berinert. Call your healthcare provider or the emergency department right away if you have any of the following symptoms after using Berinert:
- difficulty breathing
- chest tightness
- turning blue (look at lips and gums)
- fast heartbeat
- swelling of the face
Signs of a blood clot include:
- new onset of swelling and pain in the limbs or abdomen
- new onset of chest pain
- shortness of breath
- loss of sensation or control of muscles/muscle weakness on one side of the body
- altered consciousness, vision, or speech.
In clinical studies, the most severe side effect reported in subjects who received Berinert was an increase in the severity of pain associated with HAE.
Other side effects patients experienced during clinical research studies include:
- subsequent HAE attack
- abdominal pain
- muscle spasms
Because Berinert is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, and, theoretically, the Creutzfeldt-Jakob (CJD) agent.
These are not all the possible side effects of Berinert.
Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 1-800-FDA-1088.
What else should I know about Berinert?
Medicines are sometimes prescribed for purposes other than those listed here. Do not use Berinert for a condition for which it is not prescribed. Do not share Berinert with other people, even if they have the same symptoms that you have.
This leaflet summarizes the most important information about Berinert. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about Berinert that was written for healthcare professionals. Talk to your healthcare provider before traveling.
This Patient Package Insert has been approved by the US Food and Drug Administration.
Last reviewed on RxList: 9/15/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Berinert Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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