Generic Name: c1 esterase inhibitor (human) (C1 ES-ter-ase in-HIB-i-ter)
Brand Name: Berinert
Berinert is used for:
Treating stomach, facial, or laryngeal attacks of hereditary angioedema (HAE) in teenagers and adults.
Berinert is a C1 esterase inhibitor (human). It works by helping to control inflammation and parts of the immune system. This helps to prevent the swelling and/or painful attacks that occur with HAE.
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 or clotting problems, such as 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.
- At the first symptoms of an attack, immediately mix Berinert. If you are unable to mix or use Berinert yourself, seek immediate medical attention.
- This product must be used within 8 hours after mixing. Do not refrigerate or freeze after mixing.
- After using Berinert for a laryngeal attack, go to the nearest hospital emergency room immediately. You may need further medical attention.
- Contact your doctor right away after using Berinert for a stomach attack.
- Take the used container of Berinert with you when you visit the hospital or doctor for an attack.
- 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.
- Record the lot number from the vial of Berinert in your treatment diary or log book with the date and time every time you use Berinert.
- 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 is made 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.
- There have been reports of blood clots (eg, in your veins or lungs) in patients using Berinert. Tell your doctor if you have a history of blood clotting problems. Contact your doctor right away if you develop symptoms of a blood clot (eg, changes in consciousness, speech, or vision; one-sided weakness or loss of muscle control; severe or persistent headache; chest pain; shortness of breath; pain, numbness, or swelling in your arms, legs, or stomach) while you are using Berinert. Talk with your doctor for more information.
- Talk with your doctor before you travel while you are using Berinert. Be sure to take along enough of Berinert for your treatment while you are traveling.
- 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Bad taste in mouth.
Severe allergic reactions (rash; hives; itching; difficulty breathing or shortness of breath; tightness in the chest; fast heartbeat; severe dizziness or light-headedness; fainting; swelling of the mouth, face, lips, or tongue; blue gums or lips; wheezing; unusual hoarseness); fatigue; fever or chills; injection-site pain or redness; severe nausea or stomach pain; weakness.
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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include changes in consciousness, speech, or vision; chest pain; one-sided weakness or loss of muscle control; pain, numbness, or swelling in your arms, legs, or stomach; severe or persistent headache; shortness of breath.Proper storage of Berinert:
Store Berinert between 36 and 77 degrees F (2 and 25 degrees C). Do not freeze. Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use after the expiration date. 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.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Berinert or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Berinert. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Berinert. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Berinert.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.