Berinert

Name: Berinert

How supplied

Dosage Forms And Strengths

  • Berinert is available in a single-use vial that contains 500 IU of C1 esterase inhibitor as a lyophilized concentrate.
  • Each vial must be reconstituted with 10 mL of Sterile Water for Injection, USP provided.
  • Berinert is supplied in a single-use vial.
  • 500 IU vial of Berinert for reconstitution with 10 mL of Sterile Water for Injection, USP.
  • The components used in the packaging for Berinert are latex-free.

Each product presentation includes a package insert and the following components:

Presentation Carton NDC
Number		 Components
500 IU 63833-825-02
  • Berinert in a single-use vial [NDC 63833-835-01]
  • 10 mL vial of Sterile Water for Injection, USP [NDC
    63833-765-15]
  • Mix2Vial filter transfer set
  • Alcohol swab

Storage And Handling

  • When stored 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.

Manufactured by: CSL Behring GmbH, 35041 Marburg, Germany. Distributed by: CSL Behring LLC, Kankakee, IL 60901 USA. Revised:: May 2015

Warnings

Included as part of the PRECAUTIONS section.

Uses of Berinert

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.

Side Effects of Berinert

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.

Berinert Food Interactions

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.

Berinert and Lactation

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.

What is complement C1 esterase inhibitor?

Complement C1 esterase inhibitor is a man-made form of a protein that occurs naturally in the blood stream and helps control swelling in the body. People with a condition called hereditary angioedema do not have enough of this protein. Hereditary angioedema can cause attacks of swelling and symptoms such as stomach problems or trouble breathing.

Complement C1 esterase inhibitor is used in people with hereditary angioedema. The Berinert brand of this medicine is used to treat attacks of angioedema. The Cinryze brand is used to prevent attacks of angioedema.

Complement C1 esterase inhibitor may also be used for purposes not listed in this medication guide.

Precautions While Using Berinert

It is very important that your doctor check the progress of you or your child at regular visits to make sure that the medicine is working properly. Blood tests may be needed to check for unwanted effects.

HAE attacks are life-threatening and require immediate medical attention. Check with your doctor right away, or go to an emergency room as soon as possible, even if you feel better after using this medicine.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Call your doctor or nurse right away if you or your child have a rash, itching, hives, hoarseness, chest tightness, lightheadedness, dizziness or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you or your child have swelling and pain in your arms, legs, or stomach, chest pain, shortness of breath, loss of sensation, confusion, or problems with muscle control or speech.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

What are some other side effects of Berinert?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Headache.
  • Bad taste in your mouth.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Berinert Dosage and Administration

For Intravenous Use Only.

Administer Berinert at a dose of 20 units per kg body weight by intravenous injection.

Berinert is provided as a freeze-dried powder for reconstitution with the diluent (sterile water) provided. Store the vial in the original carton in order to protect from light. Do not freeze.

Preparation and Handling

  • Check the expiration date on the product vial label. Do not use beyond the expiration date.
  • Use aseptic technique when preparing and administering Berinert (see Reconstitution and Administration [2.2]).
  • After reconstitution and prior to administration, inspect Berinert visually for particulate matter and discoloration. The reconstituted solution should be colorless, clear, and free from visible particles. Do not use if the solution is cloudy, discolored, or contains particulates.
  • The Berinert vial is for single use only. Berinert contains no preservative. Any product that has been reconstituted should be used promptly. The reconstituted solution must be used within 8 hours. Discard partially used vials.
  • Do not freeze the reconstituted solution.

Reconstitution and Administration

Each Berinert kit consists of one carton containing one single-use vial of Berinert, one 10 mL vial of diluent (sterile water), one Mix2Vial™ transfer set, and one alcohol swab.

Use either the Mix2Vial transfer set provided with Berinert (see How Supplied [16.1]) or a commercially available double-ended needle and vented filter spike.

Reconstitution

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

1. Ensure that the Berinert vial and diluent vial are at room temperature. Use aseptic technique during the reconstitution procedure.
2. Place the Berinert vial, diluent vial and Mix2Vial transfer set on a flat surface.
3. Remove the flip caps from the Berinert and diluent vials. Treat the vial stoppers with the alcohol swab provided and allow to dry prior to opening the Mix2Vial transfer set package.
4. Open the Mix2Vial transfer set package by peeling away the lid (Fig. 1). Leave the Mix2Vial transfer set in the clear package.
Fig. 1
5. Place the diluent vial on a flat surface and hold the vial tightly. Grip the Mix2Vial transfer set together with the clear package and snap the blue end of the Mix2Vial transfer set onto the diluent vial stopper at a 90° angle (Fig. 2).
Fig. 2
6. 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 (Fig. 3).
Fig. 3
7. With the Berinert vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and snap the transparent adapter onto the Berinert vial stopper at a 90° angle (Fig. 4). The diluent will automatically transfer into the Berinert vial.
Fig. 4
8. 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 (Fig. 5). Do not shake the vial.
Fig. 5
9. 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. (Fig. 6).
Fig. 6
10. Draw air into an empty, sterile 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. (Fig. 7).
Fig. 7
11. 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 (Fig. 8). Attach the syringe to a suitable intravenous (IV) administration set.
Fig. 8
12. If the same patient is to receive more than one vial, the contents of multiple vials may be pooled in a single administration device (eg, syringe). A new unused Mix2Vial transfer set should be used for each Berinert vial.
13. 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.

Administration

Do not mix Berinert with other medicinal products and administer by a separate infusion line.

Use aseptic technique when administering Berinert.

Administer Berinert by slow intravenous injection at a rate of approximately 4 mL per minute.

Contraindications

Berinert is contraindicated in individuals who have experienced life-threatening hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations.

What is complement c1 esterase inhibitor (berinert, cinryze)?

Complement C1 esterase inhibitor is a man-made form of a protein that occurs naturally in the blood stream and helps control inflammation in the body. In people with hereditary angioedema, complement C1 esterase inhibitor does not function properly or occurs in low levels.

Complement C1 esterase inhibitor is used in people with hereditary angioedema. The Berinert brand of this medication is used to treat attacks of angioedema. The Cinryze brand is used to prevent attacks of angioedema.

Complement C1 esterase inhibitor may also be used for purposes not listed in this medication guide.

What happens if i miss a dose (berinert, cinryze)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What is Berinert?

Berinert (complement C1 esterase inhibitor) is a man-made form of a protein that occurs naturally in the blood stream and helps control inflammation in the body. In people with hereditary angioedema, complement C1 esterase inhibitor does not function properly or occurs in low levels. Hereditary angioedema can cause attacks of swelling and symptoms such as stomach problems or trouble breathing.

Complement C1 esterase inhibitor is used in people with hereditary angioedema. Berinert is used to treat attacks of angioedema. The Cinryze brand of complement C1 esterase inhibitor is used to prevent attacks of angioedema.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include sudden headache, numbness, weakness, or problems with your speech, vision, or balance.

Berinert side effects

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction to Berinert: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any other serious side effect, such as:

  • new or worsening pain;

  • sudden numbness or weakness, especially on one side of the body;

  • sudden severe headache, confusion, problems with vision, speech, or balance;

  • stomach pain or swelling;

  • chest pain, sudden cough, rapid breathing, fast heart rate; or

  • pain, swelling, warmth, or redness in one or both legs.

Common Berinert side effects may include:

  • nausea, diarrhea;

  • altered sense of taste;

  • rash; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

C1 esterase inhibitor (human) Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy.

FDA pregnancy category: C Use only if clearly needed and benefit outweighs potential risk.

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