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Ruconest

Last reviewed on RxList: 4/14/2016
Ruconest Side Effects Center

Last reviewed on RxList 4/11/2016

Ruconest (C1 esterase inhibitor [recombinant]) Intravenous Injection is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Common side effects of Ruconest include:

  •  headache
  • nausea
  • diarrhea
  • sneezing
  • skin burning sensation or rash
  • back pain
  • changes in taste, and
  • spinning sensation (vertigo)

The recommended dose of Ruconest is 50 IU per kg with a maximum of 4200 IU to be administered as a slow intravenous injection over approximately 5 minutes. Ruconest may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Ruconest should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Ruconest (C1 esterase inhibitor [recombinant]) Intravenous Injection 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.

Ruconest Professional Information

SIDE EFFECTS

The serious adverse reaction in clinical studies of RUCONEST was anaphylaxis.

The most common adverse reactions ( ≥ 2%) reported in all clinical trials were headache, nausea, and diarrhea.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the 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 clinical practice.

The RUCONEST clinical development program evaluated a combined total of 940 administrations in 236 subjects (symptomatic and nonsymptomatic). In clinical studies, a total of 205 symptomatic HAE patients received treatment with RUCONEST for a combined total of 650 acute angioedema attacks. Among these HAE patients, 83 were treated for a single HAE attack and 122 were treated for multiple attacks.

Three randomized, placebo-controlled clinical trials (RCTs) were conducted in which 137 patients experiencing acute HAE attacks received RUCONEST (either an initial 50 IU/kg or 100 IU/kg body weight dose) or placebo (saline solution).

Table 2 shows all adverse reactions (ARs) in the RCTs, compared with the placebo group.

Table 2 : Adverse reactions occurring in ≥ 2% of subjects in the three RCT studies

MedDRA Preferred Term RUCONEST 100 IU/kg
(N=29) n (%)
RUCONEST 50IU/kg*
(N=66) n (%)
Placebo**
(N=47) n (%)
Total number of patients with adverse reactions 4 (14%) 6 (9%) 13 (28%)
Headache 3 (10%) 0 2 (4%)
Sneezing 0 1 (2%) 0
Angioedema 1 (3%) 0 0
Erythema marginatum 0 1 (2%) 0
Skin burning sensation 0 1 (2%) 0
Back pain 0 2 (3%) 0
C-reactive protein increased 0 1 (2%) 0
Fibrin D-dimer increased 0 1 (2%) 0
Vertigo 1 (3%) 0 0
Procedural headache 0 1 (2%) 0
Lipoma 0 1 (2%) 0
* Includes 5 patients who received an additional 50 IU/kg dose
MedDRA: Medical Dictionary for Regulatory Activities, version 15.0.
** Events only occurring in placebo patients are not listed

Integrated RCT And Open-Label Extension (OLE) Studies

In a total of seven RCT and OLE studies, 205 patients experiencing acute HAE attacks were treated with RUCONEST for a total of 650 HAE attacks. Included in this population were 124 patients who were treated at the 50 IU/kg dosage strength for one or more attacks.

Table 3 shows adverse reactions in ≥ 2% of patients in any RUCONEST group for the integrated dataset combining all seven RCT and OLE studies in patients experiencing acute HAE attacks.

Table 3 : Adverse reactions in the seven RCT and OLE studies occurring ≥ 2% of RUCONEST-treated patients (all doses), irrespective of Causality

MedDRA Preferred Term All RUCONEST doses*
N=205 n (%)
Headache 19 (9%)
Nausea 5 (2%)
Diarrhea 5 (2%)
* RUCONEST doses: doses up to 100 IU/kg
MedDRA: Medical Dictionary for Regulatory Activities, version 15.0.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. Pre- and post-exposure samples from 205 HAE patients treated for 650 acute attacks with RUCONEST were tested for the antibodies against plasma-derived C1INH or rhC1INH and for antibodies against host-related impurities (HRI). Testing was performed prior to and after treatment of a first attack and subsequent repeated attacks at 7, 22 or 28, and 90 days after RUCONEST treatment.

Prior to the first exposure to RUCONEST, the frequency of anti-C1INH antibodies varied from 1.2% to 1.6% of samples. After the first exposure, the frequency of anti-C1INH antibodies varied from 0.6% to1.0% of samples tested. After repeated exposures, the frequency of anti-C1INH antibodies varied from 0.5 to 2.2% of samples tested. The frequency of anti-HRI antibodies was 1.0% in pre-exposure samples, and after the first exposure varied from 3.5% to 4.6%. After repeated exposure, the frequency of anti-HRI antibodies varied from 5.7% to 17% of samples. At least 10% of subjects formed a specific antibody response to RUCONEST after five treated HAE attacks. No anti-C1INH neutralizing antibodies were detected. Observed anti-C1INH and anti-HRI antibodies were not associated with adverse clinical findings.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to RUCONEST with the incidence of antibodies to other products may be misleading.

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 in HAE patients receiving RUCONEST include abdominal pain and rash.

Read the entire FDA prescribing information for Ruconest (C1 Esterase Inhibitor [Recombinant] Intravenous Injection)

Related Resources for Ruconest

© Ruconest Patient Information is supplied by Cerner Multum, Inc. and Ruconest Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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