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Berinert® Important Safety Information

Berinert®

500/Berinert® 1500, commonly referred to as Berinert® (C1 Esterase Inhibitor, Human)

Berinert® 500 is a lyophilised powder 500 IU/vial, reconstituted with 10 mL of diluent. Berinert® 1500 is a lyophilised powder 1500 IU/vial, reconstituted with 3 mL of diluent.

This is a summary and will not tell you everything about Berinert®. Contact your doctor or pharmacist if you have any questions about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

Berinert® is used:

For the treatment of acute facial, abdominal and laryngeal hereditary angioedema (HAE) attacks of moderate and severe intensity in pediatric and adult patients.

What are the symptoms of a Hereditary Angioedema attack (HAE)?

Hereditary angioedema (HAE) is a hereditary disorder where a naturally occurring blood protein called C1 esterase inhibitor (C1-INH) is present in low level or not functioning properly.

This lack of functional C1-INH leads to spontaneous episodes of edema (swelling) of various regions of the body. The factors which trigger these swelling episodes are not well known. However, surgery / dental procedures were reported as being susceptible of triggering such swellings.

In addition to the pain and general discomfort brought on by these episodes, the consequences can be fatal if the swelling occurs in the throat area.

HAE attacks most often affect three locations of the body:

  • The skin (called cutaneous attacks).
  • The gastrointestinal tract (stomach and intestines; called gastrointestinal attacks).
  • The upper airway (called laryngeal (voice box) attacks).

Early symptoms (called the prodromal stage) may include sudden mood changes, rash, irritability, aggressiveness, anxiety, extreme fatigue or a tingling sensation of the skin where the swelling will begin. Sometimes, early HAE symptoms appear anywhere from minutes to one to two days before the start of an attack. HAE attacks can last hours to several days, and range in severity from inconvenient skin (cutaneous) swelling to life-threatening laryngeal swelling (edema).

Cutaneous attacks — These attacks can occur on the face, hands, arms, legs, genitals and buttocks. The symptoms result from local edema of tissue beneath the skin (subcutaneous) in these areas.

Gastrointestinal attacks — These attacks appear as pain (colic), nausea, vomiting and/or diarrhea. These signs and 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 roof of the mouth). Removing a tooth or other oral surgery or dental procedures 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 symptoms could resemble a HAE attack?

Other causes that can appear as an HAE attack include:

  • Appendicitis.
  • Heartburn.
  • General gastric distress.
  • Morning sickness during pregnancy.
  • May include other symptoms.

What Berinert® does:

Berinert® is a concentrate of C1-INH and its administration during a swelling episode or prior to a surgery has been shown to alleviate or prevent the swelling by increasing the levels of functional C1-INH in the body.

What should I know about self-administration?

  • At the first signs of an acute attack you should immediately administer your prescribed dose of Berinert®.
  • If you are unable to start your self-administration of Berinert® please proceed to the Emergency or other designated place provided by your healthcare provider in order to get assistance with the administration of your product.

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 administrating Berinert® provided in this consumer information (Instructions for administration section). 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.
  • Follow the instructions from your healthcare provider if swelling is not controlled after using Berinert®.
  • Your healthcare provider will prescribe the dose that you should take.
  • When travelling bring an adequate supply of Berinert® for treatment.

When it should not be used:

Berinert® should not be used if you had previous severe allergic or body reactions to C1-INH products used to treat HAE or any components of Berinert®.

What the medicinal ingredient is:

Berinert® is a concentrate of the naturally occurring C1 esterase inhibitor found in human blood.

What the important nonmedicinal ingredients are:

Glycine, sodium chloride and sodium citrate.

For a full listing of nonmedicinal ingredients see Part 1 of the Product Monograph.

What dosage forms it comes in:

The Berinert® 500 package contains one single-use vial containing 500 IU of lyophilized human C1 esterase inhibitor (C1-INH), one 10 mL vial of Sterile Water for Injection (Diluent), one Mix2Vial® filter transfer set and an inner carton. The inner carton contains one syringe and one infusion set.

The Berinert® 1500 package contains one single-use vial containing 1500 IU of lyophilized human C1 esterase inhibitor (C1-INH), one 3 mL vial of Sterile Water for Injection (Diluent), one Mix2Vial® filter transfer set and an inner carton. The inner carton contains one syringe and one infusion set.

The components used in the packaging for Berinert® are latex-free.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Products made from human plasma may contain infectious agents such as viruses and the agent responsible for the variant Creutzfeldt-Jakob disease (vCJD).

 

Thromboembolic events have been reported with the use of Berinert® at the recommended dose following treatment of HAE attacks.

The development of thrombosis has been reported in association with Berinert® when used (off-label) and at higher than labelled doses (greater than 90 IU/kg body weight) in newborns and young children with congenital heart anomalies during or after cardiac surgery under extracorporeal circulation.

BEFORE you use Berinert® talk to your doctor or pharmacist if:

  • You have any special heart conditions.
  • You have experienced severe allergic reactions or other reactions with products used to treat your HAE condition or if you have experienced allergic reactions to this drug or its ingredients or components of the container.
  • You are pregnant or if you are breastfeeding.

INTERACTIONS WITH THIS MEDICATION

To date, no relevant interactions are known.

PROPER USE OF THIS MEDICATION

Usual dose:

The dose of Berinert® for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) of moderate to severe intensity is 20 IU per kg body weight administered by intravenous injection.

Instructions for administration:

It is recommended that Berinert® 500 be administered by slow intravenous injection at a rate of 4 mL/minute.

It is recommended that Berinert® 1500 be administered as a slow intravenous injection.

Berinert® should not be mixed with other medicinal products and should be administered by a separate infusion line.

Follow the steps below and use aseptic technique to administer Berinert®. 

A. PREPARATION:

Prepare the vials/Mix2Vial® and infusion supplies:

Ensure that the diluent and product vials are at room temperature. Prepare syringes (use the syringe provided with the product), infusion sets and other supplies for the infusion.

B. RECONSTITUTION: Follow these steps to reconstitute Berinert®: 

C. 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.

Step 1: Assemble supplies

  • Gather the Berinert® syringe, Mix2Vial® and other supplies as recommended by your healthcare provider as well as your treatment diary/log book.

Step 2: Clean surface

  • Thoroughly clean a table or other flat surface using an alcohol wipe.

Step 3: Prepare the infusion site

  • Apply a tourniquet on the arm above the site of the injection.
  • Prepare the injection site by wiping the skin well with an alcohol swab.

Step 4: Infusion

As instructed by your healthcare provider:

  • Remove the air from the tubing.
  • Insert the butterfly needle of the infusion set into your vein.
  • Remove the tourniquet.
  • If necessary, use sterile gauze and tape or transparent dressing to hold the needle in place.
  • Inject the Berinert® 500 solution slowly at a rate of approximately 4 mL per minute or inject the Berinert® 1500 solution as a slow intravenous injection.

Step 5: Clean up

  • After infusing Berinert®, remove the infusion set and cover the infusion site with a bandage.
  • Dispose of all unused solution, the empty vials, and the used needles and syringe in an appropriate container.

Step 6: Record treatment

  • Record the lot number from the Berinert® vial label in your treatment diary/log book with all other pertinent information instructed by your healthcare provider.

Do not refrigerate after reconstitution. To ensure product sterility, reconstitute and administer Berinert® using aseptic techniques. Berinert® contains no preservatives, the reconstituted product should be administered immediately. Do not freeze the Berinert® solution.

The reconstituted solution for Berinert 500® should be colourless and clear. The reconstituted solution for Berinert 1500® should be colourless, clear to slightly opalescent. Inspect Berinert® visually for particulate matter and discolouration prior to administration. Do not use if the solution is cloudy or contains particulates.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

 

HOW TO STORE IT

Store Berinert® in the refrigerator or at room temperature (at 2°C to 30°C). Do not use the product after the expiration date.

Keep Berinert® in its original carton until ready to use. Do not freeze. Protect from light.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Please see table “Side Effects, How Often they Happen and What to do About Them”.

Side effects*: How often they happen and what to do about them

Symptom Only if severe talk to your healthcare professional In all cases talk to your healthcare professional Stop taking and call your healthcare professional
Very rare Allergic-anaphylactic reactions x
Very common to common Headache x
Abdominal pain† x
Nausea† x
Muscle spasms x
Pain x
Diarrhea† x
Vomiting† x
Back pain x
HAE x
Peripheral edema Abdominal distention x
Upper respiratory tract infection x
Dysgeusia x
Uncommon to rare Anxiety x
Increased blood pressure x
Increased body temperature x
Cough x
Dysphagia x
Ear pain x
Eructation x
Puncture site reaction x
Pyrexia x
Retching x
Rhinorrhoea x
Throat irritation x
Toothache x
Nasopharyngitis x
Upper abdominal pain x
Biliary colic x
Bronchitis x
Cystitis x
Facial edema x
Haematuria x
Haemorrhoidal haemorrhage x
Influenza x
Joint swelling x
Lip swelling x
Pharyngolaryngeal pain x
Tendonitis x
Renal pain x

* Reported in a key clinical study, related or not related to Berinert®.

† Symptoms were considered to be related to the underlying disease. Any increase in intensity or new occurrence of these symptoms after study medication administration was considered to be an adverse event.

These are not all the possible side effects. If you experience any side effects not listed here, contact your healthcare professional.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free to 1-866-234-2345;
  • Complete a Canada Vigilance Reporting Form and:
  • Fax toll-free to 1-866-678-6789, or
  • Mail to:
    Canada Vigilance Program
    Health Canada
    Postal Locator 1908C
    Ottawa, Ontario
    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the Management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.


We recommend that CSL Behring Canada be copied when reporting suspected side effects, at the following address: 
AdverseReporting@CSLBehring.com
For customer service inquiries during business hours, please call 613-232-2386.
For urgent inquiries and after-hours services, please call 514-219-7560.

MORE INFORMATION

This information plus the full Product Monograph, prepared for health professionals, can be obtained at: https://www.cslbehring.ca
Date of Approval: February 14, 2020

Berinert® is manufactured by CSL Behring AG and distributed by CSL Behring Canada Inc.
Berinert® is a registered trademark of CSL Behring AG. 
Mix2Vial® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Biotherapies for Life® is a registered trademark of CSL Behring LLC.