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Berinert

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Berinert

Berinert Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Berinert C1 esterase inhibitor (human) freeze-dried powder is a C-1 esterase inhibitor indicated for the treatment of acute abdominal or facial swelling attacks of hereditary angioedema (HAE) in adult and adolescent patients. Generic Berinert is termed C-1 esterase inhibitor and is available in other countries. Side effects can include HAE attack, headache, abdominal pain, nausea, muscle spasms, general pain, diarrhea, and vomiting. Allergic reactions may occur with Berinert.

Berinert is for intravenous use only; each vial contains 500 units of C-1 esterase. Berinert is administered at a dose of 20 units per kg body weight by intravenous injection. The most serious adverse reaction reported with Berinert was an increase in the severity of pain associated with HAE.

Patients should inform their doctors if they are pregnant or planning to become pregnant. It is not known if Berinert can harm unborn babies. Patients should also inform their doctors if they are breastfeeding or if they plan to breastfeed. It is not known if Berinert passes into breast milk.

Safety and efficacy of Berinert in children (ages 0 through 12) have not been established; only a very small number of children over age 12 have been given this drug so there is no complete data on the safety and effectiveness in pediatric patients.

Our Berinert Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Berinert in Detail - Patient Information: Side Effects

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: 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.

Less serious side effects may include:

  • nausea, vomiting, stomach pain;
  • altered sense of taste;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • mild itching or rash; or
  • mild 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.

Read the entire detailed patient monograph for Berinert ([C1 Esterase Inhibitor (Human)] Freeze-dried powder) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Berinert FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most serious adverse reaction reported in subjects enrolled in clinical studies who received Berinert was an increase in the severity of pain associated with HAE. The most common adverse reactions that have been reported in greater than 4% of the subjects who received Berinert in clinical studies were subsequent HAE attack, headache, abdominal pain, nausea, muscle spasms, pain, diarrhea and vomiting.

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Placebo-controlled Clinical Study

In the placebo-controlled clinical study, referred to as the randomized clinical trial (RCT) (see Clinical Studies), 124 subjects experiencing an acute moderate to severe abdominal or facial HAE attack were treated with Berinert (either a 10 unit per kg body weight or a 20 unit per kg body weight dose), or placebo (physiological saline solution).

The treatment-emergent serious adverse reactions/events that occurred in 5 subjects in the RCT were laryngeal edema, facial attack with laryngeal edema, swelling (shoulder and chest), exacerbation of hereditary angioedema, and laryngospasm.

Table 1: Adverse Reactions* Occurring up to 4 hours After Initial Infusion in More Than 4% of Subjects, Irrespective of Causality†

Adverse Reactions Number (%) of Subjects Reporting Adverse Reactions Berinert 20 units/kg
(n = 43)
Number (%) of Subjects Reporting Adverse Reactions Placebo Group
(n = 42)
Nausea† 3 (7%) 5 (11.9%)
Dysgeusia 2 (4.7%) 0 (0)
Abdominal Pain† 2 (4.7%) 3 (7.1%)
Vomiting† 1 (2.3%) 3 (7.1%)
Diarrhea† 0 (0) 4 (9.5%)
Headache 0 (0) 2 (4.8%)
* The study protocol specified that adverse events that began within 72 hours of blinded study medication administration were to be classified as at least possibly related to study medication (ie, adverse reactions).
† The following abdominal symptoms were identified in the protocol as associated with HAE abdominal attacks: abdominal pain, bloating, cramps, nausea, vomiting, and diarrhea.

Table 2: Adverse Reactions* Occurring in More Than 4% of Subjects up to 72 hours After Infusion of Initial or Rescue Medication† by Intent-to- Treat, Irrespective of Causality

Adverse Reactions Number (%) of Subjects Reporting Adverse Reactions†‡ Berinert 20 units/kg
(n = 43)
Number (%) of Subjects Reporting Adverse Reactions†‡ Placebo Group
( n = 42)
Nausea 3 (7%) 11 (26.2%)
Headache 3 (7%) 5 (11.9%)
Abdominal Pain 3 (7%) 5 (11.9%)
Dysgeusia 2 (4.7%) 1 (2.4%)
Vomiting 1 (2.3%) 7 (16.7%)
Pain 1 (2.3%) 4 (9.5%)
Muscle spasms 1 (2.3%) 4 (9.5%)
Diarrhea 0 (0) 8 (19%)
Back pain 0 (0) 2 (4.8%)
Facial pain 0 (0) 2 (4.8%)
* The study protocol specified that adverse events that began within 72 hours of blinded study medication administration were to be classified as at least possibly related to study medication (ie, adverse reactions).
† If a subject experienced no relief or insufficient relief of symptoms within 4 hours after infusion, investigators had the option to administer a blinded second infusion (“rescue” treatment) of Berinert (20 units/kg for the placebo group or 10 units/kg for the 10 units/kg group), or placebo (for the 20 units/kg group).
‡ Adverse reactions following either initial treatment and/or blinded “rescue” treatment. Because more subjects in the placebo randomization group than in the Berinert randomization group received rescue treatment, the median observation period in this analysis for subjects randomized to placebo was slightly longer than for subjects randomized to receive Berinert.

Table 3 lists the adverse events that occurred in more than 4% of the subjects 7 to 9 days after the end of a Berinert infusion, irrespective of causality.

Table 3: Adverse Events Occurring in More Than 4% of Subjects* Receiving Berinert at Either 10 Units/kg or 20 units/kg 7 to 9 Days after Infusion, Irrespective of Causality

Adverse Events Number (%) of Subjects Reporting Adverse Events
(n=108)
Hereditary angioedema 12 (11.1%)
Headache 12 (11.1%)
Abdominal pain† 7 (6.5%)
Nausea† 7 (6.5%)
Muscle spasms 6 (5.6%)
Pain 6 (5.6%)
Diarrhea† 5 (4.6%)
Vomiting† 5 (4.6%)
* Includes subjects in the placebo group who received Berinert 20 units/kg as rescue study medication.
† These symptoms were identified in the protocol as 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.

Subjects were tested at baseline and after 3 months for possible exposure to Parvovirus B19, hepatitis B, hepatitis C, and HIV-1 and HIV-2. No subject who underwent testing evidenced seroconversion or treatment-emergent positive polymerase chain reaction testing for these pathogens.

Extension Study

In an interim safety analysis, of the ongoing open-label extension study, 56 subjects with 559 acute moderate to severe abdominal, facial, peripheral and/or laryngeal attacks received a 20 unit/kg body weight dose of Berinert (see Clinical Studies). This study provides additional safety data in subjects who received multiple infusions of the product for sequential HAE attacks (one infusion per attack).

Table 4 lists the adverse events that occurred in this interim safety analysis of the ongoing open-label extension study in more than 4% of subjects up to 72 hours or 9 days after the end of a Berinert infusion, irrespective of causality.

Table 4: Incidence of Adverse Events by Descending Frequency Occurring in More Than 4% of Subjects Receiving Berinert up to 72 Hours or 9 Days After Infusion, Irrespective of Causality

Adverse Events Number (%) of Subjects Reporting Adverse Events up to 72 hours
(n=56)
Number (%) of Subjects Reporting Adverse Events up to 9 Days
(n=56)
Headache 3 (5.4%) 4 (7.1%)
Abdominal pain 3 (5.4%) 3 (5.4%)
Hereditary angioedema 2 (3.6%) 4 (7.1%)
Nasopharyngitis 2 (3.6%) 3 (5.4%)

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

Adverse reactions reported in Europe since 1979 in patients receiving Berinert for treatment of HAE include hypersensitivity/anaphylactic reactions, a few suspected cases of viral transmission, including cases of acute hepatitis C, injection-site pain, injection-site redness, chills, and fever.

The following adverse reactions, identified by system organ class, have been attributed to Berinert during post-approval use outside the US.

  • Immune System Disorder: Hypersensitivity/anaphylactic reactions, and shock
  • General/Body as a Whole: Pain on injection, redness at injection site, chills, and fever

Read the entire FDA prescribing information for Berinert ([C1 Esterase Inhibitor (Human)] Freeze-dried powder) »

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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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