Berinert Generic Name: C1 Esterase Inhibitor
(Human) (C1 ES-ter-ase in-HIB-i-ter)Brand Name:
Berinert is used for:
Treating stomach or facial attacks in certain patients with hereditary angioedema (HAE). It may also be used for other conditions as determined by your doctor.
Berinert is a C1 esterase inhibitor (human). It works by regulating the clotting and inflammatory reactions that can lead to local tissue swelling (angioedema).
Do NOT use Berinert if:
- you are allergic to any ingredient in Berinert or have had a severe allergic reaction (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness) to Berinert or another C1 esterase inhibitor
Contact your doctor or health care provider right away if any of these apply to you.
Before using Berinert :
Some medical conditions may interact with Berinert . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of blood clots in your veins or lungs (eg, deep vein thrombosis, pulmonary embolism)
Some MEDICINES MAY INTERACT with Berinert . However, no specific interactions with Berinert are known at this time.
Ask your health care provider if Berinert may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Berinert :
Use Berinert as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Berinert . Talk to your pharmacist if you have questions about this information.
- Berinert is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Berinert at home, a health care provider will teach you how to use it. Be sure you understand how to use Berinert . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Do not use Berinert if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- This product must be used within 8 hours after mixing.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Berinert , contact your doctor right away.
Ask your health care provider any questions you may have about how to use Berinert .
Important safety information:
- Berinert may contain albumin, which comes from human blood. There is a very rare risk of getting a viral disease or a central nervous system disease called Creutzfeldt-Jakob disease from products with albumin. No cases of these problems have been found in patients who have used Berinert .
- Tell your doctor or dentist that you take Berinert before you receive any medical or dental care, emergency care, or surgery.
- Berinert should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Berinert can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Berinert while you are pregnant. It is not known if Berinert is found in breast milk. If you are or will be breast-feeding while you use Berinert , check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Berinert :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; headache; mild injection-site pain or redness; muscle spasms; nausea, stomach pain, or vomiting.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bluish color of the lips and gums; calf pain, swelling, or redness; changes in consciousness, speech, or vision; chest pain; dark urine; fainting; fast heartbeat; fatigue; fever or chills; loss of muscle control or muscle weakness on one side of the body; numbness or tingling; severe nausea or stomach pain; severe or persistent headache; severe or persistent injection-site pain or redness; shortness of breath or trouble breathing; swelling or pain in the arms, legs, or stomach; weakness; wheezing; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include calf pain, swelling, or redness; shortness of breath or trouble breathing.Proper storage of Berinert :
Berinert is usually handled and stored by a health care provider. If you are using Berinert at home, store Berinert as directed by your pharmacist or health care provide. Keep Berinert out of the reach of children and away from pets.
- If you have any questions about Berinert , please talk with your doctor, pharmacist, or other health care provider.
- Berinert is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Berinert . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Berinert Prescribing Information (FDA)
- Berinert Consumer Overview
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