July 30, 2016
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Berinert

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Berinert




PATIENT INFORMATION

BERINERT
(BEAR-I-nert)
C1 Esterase Inhibitor (Human) Freeze-Dried Powder for Reconstitution

This leaflet summarizes important information about BERINERT. Please read it carefully before using BERINERT and each time you get a refill. There may be new information provided. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about BERINERT. If you have any questions after reading this, ask your healthcare provider.

Do not attempt to self-administer unless you have been taught how by your healthcare provider.

What is BERINERT?

BERINERT is an injectable medicine used to treat swelling and/or painful attacks in adults and adolescents with Hereditary Angioedema (HAE). HAE is caused by the poor functioning or lack of a protein called C1 that is present in your blood and helps control inflammation (swelling) and parts of the immune system. BERINERT contains C1 esterase inhibitor, a protein that helps control C1.

Who should not use BERINERT?

You should not use BERINERT if you have experienced life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product.

What should I tell my healthcare provider before using BERINERT?

Tell your healthcare provider about all of your medical conditions, including if you:

  • Are pregnant or planning to become pregnant. It is not known if BERINERT can harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if BERINERT passes into your milk and if it can harm your baby.
  • Have a history of blood clotting problems. Blood clots have occurred in patients receiving BERINERT. Very high doses of C1 esterase inhibitor could increase the risk of blood clots. Tell your healthcare provider if you have a history of heart or blood vessel disease, stroke, blood clots, or have thick blood, an indwelling catheter/access device in one of your veins, or have been immobile for some time. These things may increase your risk of having a blood clot after using BERINERT. Also, tell your healthcare provider what drugs you are using, as some drugs, such as birth control pills or certain androgens, may increase your risk of developing a blood clot.

Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.

What are the possible side effects of BERINERT?

Allergic reactions may occur with BERINERT. Call your healthcare provider or seek emergency support services right away if you have any of the following symptoms after using BERINERT:

  • wheezing
  • difficulty breathing
  • chest tightness
  • turning blue (look at lips and gums)
  • fast heartbeat
  • swelling of the face
  • faintness
  • rash
  • hives

Signs of a blood clot include:

  • pain and/or swelling of an arm or leg with warmth over the affected area
  • discoloration of an arm or leg
  • unexplained shortness of breath
  • chest pain or discomfort that worsens on deep breathing
  • unexplained rapid pulse
  • numbness or weakness on one side of the body

In clinical studies, the most serious adverse reaction reported in subjects who received BERINERT was an increase in the severity of pain associated with HAE.

In clinical studies, the most common adverse reaction reported among subjects who received BERINERT in the placebo-controlled clinical trial was dysgeusia (bad taste in mouth).

Because BERINERT is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, and, theoretically, the Creutzfeldt-Jakob (CJD) agent.

These are not all the possible side effects of BERINERT.

Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 1-800-FDA-1088.

How should I store BERINERT?

  • Keep BERINERT in its original carton to protect from light until ready to use.
  • 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.
  • Do not freeze.

What else should I know about BERINERT?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use BERINERT for a condition for which it is not prescribed. Do not share BERINERT with other people, even if they have the same symptoms that you have.

This leaflet summarizes the most important information about BERINERT. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about BERINERT that was written for healthcare professionals. For more information, go to www.BERINERT.com or call 1-877-236-4423.

What are the symptoms of a facial, abdominal or laryngeal Hereditary Angioedema (HAE) attack?

Early HAE symptoms appear anywhere from minutes to one to two days before the attack worsens. HAE attacks can last hours to several days, and range in severity. Itching is not a typical feature of HAE attacks.

Facial attacks — These attacks can occur in areas around the eyes and mouth, and result from local edema of tissue beneath the skin (subcutaneous).

Abdominal attacks — These attacks appear as pain (colic), nausea, vomiting, and/or diarrhea. These symptoms result from the swelling of walls of the gastrointestinal tract.

Laryngeal attacks — Swelling of the voice box (laryngeal edema) can occur by itself, or with swelling of the lips, tongue, uvula (the piece of mouth tissue that hangs down from the top of the mouth over the back of the tongue), and soft palate (the soft tissue at the back of the mouth). Removing a tooth and oral surgery can trigger a laryngeal attack. Laryngeal swelling can develop in minutes or hours.

Many HAE attacks involve only one location of the body at a time, although combination attacks, such as cutaneous attacks that spread to involve the larynx (the voice box), can occur.

What other diseases or symptoms could resemble a HAE attack?

Some abdominal-related causes that can appear as an HAE attack include:

Other symptoms that can appear as an HAE attack include:

  • Allergic reactions (eg, insect bites and rash)

What should I know about self-administration?

  • At the first symptoms of an attack, you should immediately prepare the prescribed dose of BERINERT for self-administration.
  • You should not start self-administration if the attack (regardless of type) has progressed to a point where you are unable to successfully dissolve BERINERT or to administer BERINERT.

Instructions for Use

  • Do not attempt to self-administer unless you have been taught how by your healthcare provider.
  • See the step-by-step instructions for injecting BERINERT at the end of this leaflet. 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 contact your healthcare provider or pharmacist before using.
  • Your healthcare provider will prescribe the dose that you should administer, which is based on your body weight.
  • After self-administering BERINERT for an acute laryngeal HAE attack, immediately seek medical attention in an appropriate healthcare facility after treatment with BERINERT.
  • Contact your healthcare provider after treating suspected abdominal HAE attacks to help exclude 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/ facility for an acute HAE attack.
  • Talk to your healthcare provider before traveling to make sure you have an adequate supply of BERINERT.

Reconstitution and Administration

  • 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.

3. 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.

4. Open the Mix2Vial transfer set package by peeling away the lid (Figure 1). Leave the Mix2Vial transfer set in the clear package.

Figure 1

peel away the lid - Illustration

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 push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial (Figure 2).

Figure 2

push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial - Illustration

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 (Figure 3).

Figure 3

Carefully remove the clear package from the Mix2Vial transfer set -  Illustration

7. 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 (Figure 4). The diluents will automatically transfer into the Berinert vial.

Figure 4

Push the plastic spike of the transparent adapter firmly through the center of the stopper of the Berinert vial - Illustration

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 (Figure 5). Do not shake the vial.

Figure 5

Gently swirl the Berinert vial - Illustration

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 (Figure 6).

Figure 6

Unscrew the set into two pieces - Illustration

10. 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.

11. 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 (Figure 7).

Figure 7

Draw the concentrate into the syringe - Illustration

12. 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 (Figure 8). Attach the syringe to a suitable intravenous administration set.

Figure 8

Unscrew the syringe from the Mix2Vial transfer set - Illustration

13. 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.

14. 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 (Intravenous Infusion)

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.

Step 1: 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

Step 2: Wash hands

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

Step 3: Clean surface

Thoroughly clean a table or other flat surface using one or more of the alcohol wipes.

Step 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 (Figure 9).

Figure 9

Prime the infusion tubing - Illustration

Step 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 (Figure 10).

Figure 10

Apply a tourniquet - Illustration

Step 6: Infusion

As instructed by your healthcare provider:

  • Insert the butterfly needle of the infusion set tubing into your vein (Figure 11).
  • 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 (Figure 12). 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 (Figure 13).

Figure 11

Insert the butterfly needle of the infusion set tubing into your vein - Illustration

Figure 12

Check to see if blood is in the tubing - Illustration

Figure 13

Rate of injection - Illustration

Step 7: Clean up

  • After infusing the entire amount of BERINERT, remove the infusion set (Figure 14) and cover the infusion site with a bandage (Figure 15), 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.

Figure 14

Remove the infusion set - Illustration

Figure 15

Cover the infusion site with a bandage - Illustration

Step 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.

This Patient Package Insert has been approved by the US Food and Drug Administration.

Last reviewed on RxList: 6/16/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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