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.

• CSL Behring GmbH

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.

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.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Berinert, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Berinert, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Berinert or to any of its ingredients
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• have a history of blood clots
• use contraceptive medications
• are overweight or obese
• are immobile
• have heart disease

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

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.

Take Berinert exactly as prescribed.

• Berinert comes 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
• Do not attempt to self-administer Berinert unless you have been taught how by your healthcare provider
• After self-administering Berinert for an acute laryngeal HAE attack, immediately seek medical attention in an appropriate healthcare facility
• Contact your healthcare provider after treating suspected abdominal HAE attacks to help rule out the possibility that another potentially serious medical cause may be responsible for your symptoms
• Call your healthcare provider right away if swelling is not controlled after using Berinert
• Bring Berinert with you when you visit a healthcare provider or facility for an acute HAE attack
• Talk to your healthcare provider before traveling to make sure you have an adequate supply of Berinert

You should always follow the specific instructions given by your healthcare provider. The steps listed below are general guidelines for using Berinert. If you are unsure of the steps, please call your healthcare provider or pharmacist before using.

Preparation

• Each Berinert vial contains 500 IU of C1 esterase inhibitor as a lyophilized concentrate for reconstitution with 10 mL of Sterile Water for Injection, USP provided
• Check the expiration date on the product vial label; do not use beyond the expiration date
• Use either the Mix2Vial transfer set provided with Berinert or a commercially available double-ended needle and vented filter spike
• Prepare and administer using aseptic techniques
• After reconstitution and prior to administration, inspect Berinert. The reconstituted solution should be colorless, clear, and free from visible particles. Do not use if the solution is cloudy, discolored, or contains particulates.

Reconstitution 

The procedures below are provided as general guidelines for the reconstitution of Berinert.

1. Ensure that the Berinert vial and diluent vial are at room temperature.

2. Place the Berinert vial, diluent vial and Mix2Vial transfer set on a flat surface.Remove the flip caps from the Berinert and diluent vials. Wipe the vial stoppers with the alcohol swab provided. Allow to dry prior to opening the Mix2Vial transfer set package.

3. Open the Mix2Vial transfer set package by peeling away the lid. Leave the Mix2Vial transfer set in the clear package.

4. Place the diluent vial on a flat surface and hold the vial tightly. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial.

5. Carefully remove the clear package from the Mix2Vial transfer set. Make sure that you pull up only the clear package, and not the Mix2Vial transfer set.

6. With the Berinert vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the Berinert vial. The diluent will automatically transfer into the Berinert vial.

7. With the diluent and Berinert vial still attached to the Mix2Vial transfer set, gently swirl the Berinert vial to ensure that the Berinert is fully dissolved. Do not shake the vial.

8. With one hand, grasp the Berinert-side of the Mix2Vial transfer set and with the other hand grasp the blue diluent-side of the Mix2Vial transfer set and unscrew the set into two pieces Carefully look at reconstituted solution in each vial of Berinert. It should be colorless, clear, and free from visible particles. Do not use the vial if the liquid looks cloudy, contains particles, or has changed color. Do not use if the expiration date on the label has expired

9. Draw air into an empty, sterile syringe. Use a silicone-free syringe. While the Berinert vial is upright, screw the syringe to the Mix2Vial transfer set. Inject air into the Berinert vial. While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly.

10.  Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe from the Mix2Vial transfer set. Attach the syringe to a suitable intravenous administration set.
11.  If patient is to receive more than one vial, pool the contents of multiple vials into one syringe. A new unused Mix2Vial transfer set should be used for each Berinert vial.
12.  Do not refrigerate after reconstitution. When reconstitution is carried out using aseptic technique, administration may begin within 8 hours, provided the solution has been stored at up to 25°C (77°F). Do not refrigerate or freeze the reconstituted solution. Only store the reconstituted product in the vial.

Self-Administration

Your healthcare provider will teach you how to safely administer Berinert. It is important that Berinert is injected directly into a visible vein. Do not inject into surrounding tissues or into an artery. Once you learn how to self-administer, follow the instructions provided below.

1. Wash hands. Thoroughly wash and dry your hands. If you have been told to wear gloves when preparing your infusion, put the gloves on.

2. Assemble supplies. Gather the Berinert syringe, the following disposable supplies (not provided with Berinert), and other items (sharps or other container, treatment diary or log book): 

   • Standard butterfly catheter infusion set (IV administration set with winged adapter and needle)
   • Sterile syringe (Use a silicone-free syringe).
   • Tourniquet
   • Sterile gauze and tape, or transparent dressing
   • Bandage (adhesive dressing)
   • Gloves (if recommended by your healthcare provider)
   • Alcohol wipe for cleaning the skin
3. Clean surface. Thoroughly clean a table or other flat surface using one or more of the alcohol wipes. 
4. Prime the infusion set as instructed by your healthcare provider: To prime (fill) the infusion tubing, connect the syringe filled with Berinert to the infusion set tubing and gently push on the syringe plunger to fill the tubing with Berinert.
5. Prepare the infusion site. Apply a tourniquet above the site of the infusion. Prepare the infusion site by wiping the skin well with an alcohol swab and allow it to dry.
6. Infusion. As instructed by your healthcare provider: Insert the butterfly needle of the infusion set tubing into your vein. If necessary, use sterile gauze and tape or transparent dressing to hold the needle in place. To make sure that the needle is in a vein, gently pull back on the syringe plunger and check to see if blood is in the tubing. If there is blood present, then the needle is in a vein. If there is no blood present, remove the needle and repeat this step using a new needle, new administration tubing, and a different injection site. Remove the tourniquet. Inject the Berinert solution slowly at a rate of approximately 4 mL per minute.
7. Clean up. After infusing the entire amount of Berinert, remove the infusion set and cover the infusion site with a bandage, holding pressure on the site for a few minutes. Dispose of all unused solution, the empty vials, and the used needles and syringe in an appropriate container used for throwing away waste that might hurt others if not handled properly.
8. Record treatment. Record the lot number from the Berinert vial label in your treatment diary or log book with the date and time of infusion every time you use Berinert.

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.

If you take too much Berinert, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Berinert is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• store at temperatures of 2-25°C (36-77°F), Berinert is stable for the period indicated by the expiration date on the carton and vial label (up to 30 months)
• keep Berinert in its original carton until ready to use
• do not freeze
• protect from light
• keep this medication and all other medications away from children