Berinert

Berinert is a prescription medication used to treat several different types of angioedema attacks in adults and adolescents with hereditary angioedema (HAE). Berinert belongs to a class of medications called plasma-derived serine proteinase inhibitors. These work to treat angioedema attacks by reducing the permeability of certain small blood vessels.

This medication is available in an injectable form to be given directly into a vein and is typically given at the time of recognition of symptoms of an angioedema attack.

Common side effects of Berinert include nausea, headache, and abdominal pain.

Berinert can also cause dizziness. Do not drive or operate heavy machinery until you know how Berinert affects you.

Berinert is a prescription medication used to treat acute facial, abdominal, and/or laryngeal angioedema attacks in adults and adolescents with hereditary angioedema (HAE).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Berinert to treat acute facial, abdominal, and/or laryngeal angioedema attacks in adults and adolescents with hereditary angioedema (HAE) is 20 International Units (IU) per kilogram of body weight injected into a vein (intravenously) at the time of recognition of symptoms of an angioedema attack.

Serious side effects have been reported with Berinert including the following:

Serious allergic reactions. The signs and symptoms of serious allergic reactions may include the appearance of hives, skin redness, itching, tightness of the chest, and/or wheezing experienced during or after injection of Berinert. If you experience any of these symptoms, discontinue use immediately and seek emergency medical attention.

Blood clots. Serious blood clots have been reported in patients taking the recommended doses of Berinert. Risk factors may include presence of a permanent catheter, prior history of blood clots, heart disease, use of oral contraceptives, morbid obesity, and immobility. Benefits of Berinert should be weighed against the risks of blood clots in people with underlying risk factors. Consult with your physician about the risks for developing serious blood clots before beginning treatment with Berinert.

Transmission of infectious agents. Because Berinert is made from human blood products, it may carry a risk of transmitting infectious agents including viruses like HIV. Consult with your physician about this risk before beginning treatment with Berinert.

Berinert can also cause dizziness. Do not drive or operate heavy machinery until you know how Berinert affects you.

Do not take Berinert if you are allergic to Berinert or to any of its ingredients.

Serious side effects have been reported with Berinert. See the “Berinert Precautions” section.

Common side effects of Berinert include the following:

• muscle spasms
• diarrhea
• dizziness
• injection site pain
• rash
• headache
• abdominal pain
• nausea

This is not a complete list of Berinert side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• alteplase
• anistreplase
• bazedoxifene
• chlorotrianisene
• conjugated estrogens
• danazol
• darbepoetin alfa
• dehydroepiandrosterone
• desogestrel
• dienestrol
• dienogest
• diethylstilbestrol
• drospirenone
• epoetin alfa
• epoetin beta-methoxy polyethylene glycol
• esterified estrogens
• estradiol
• estrone
• estropipate
• ethinyl estradiol
• fluoxymesterone
• lenalidomide
• mestranol
• methyltestosterone
• nandrolone
• ospemifene
• oxandrolone
• oxymetholone
• peginesatide
• pomalidomide
• quinestrol
• raloxifene
• reteplase
• stanozolol
• streptokinase
• tamoxifen
• tenecteplase
• testolactone
• testosterone
• thalidomide
• toremifene
• urokinase

This is not a complete list of Berinert drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Berinert falls into category C. There are no well-controlled studies that have been done in pregnant women. Berinert should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Berinert crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Berinert.