Medical Editor: John P. Cunha, DO, FACOEP
What Is Ruconest?
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).
What Are Side Effects of Ruconest?
Ruconest may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- chest tightness,
- fast heartbeats,
- lightheadedness,
- wheezing,
- blue lips or gums,
- sudden numbness or weakness (on one side of the body),
- pain, swelling, warmth, or redness in an arm or leg,
- sudden severe headache,
- confusion,
- problems with vision, speech, or balance,
- chest pain while taking deep breaths, and
- fast heart rate
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Ruconest include:
- headache
- nausea
- diarrhea
- sneezing
- skin burning sensation or rash
- back pain
- changes in taste, and
- spinning sensation (vertigo)
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Ruconest
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.
What Drugs, Substances, or Supplements Interact with Ruconest?
Ruconest may interact with other drugs. Tell your doctor all medications and supplements you use.
Ruconest During Pregnancy and Breastfeeding
During pregnancy, Ruconest should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
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.
Get emergency medical help if you have signs of an allergic reaction: hives; chest tightness, fast heartbeats, feeling light-headed; wheezing or difficult breathing, blue lips or gums; or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- sudden numbness or weakness on one side of the body;
- pain, swelling, warmth, or redness in an arm or leg;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- chest pain while taking deep breaths; or
- fast heart rate.
Common side effects may include:
- unusual or unpleasant taste in your mouth;
- headache, dizziness;
- nausea, vomiting;
- pain, bruising, itching, swelling, bleeding, warmth, or a hard lump where the medicine was injected;
- stuffy nose, sore throat;
- rash; or
- fever.
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.
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 non-symptomatic). 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 U/kg or 100 U/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 U/kg (N=29) n (%) | RUCONEST 50 U/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 U/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 U/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 U/kg | |
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% to 1.0% 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.
Read the entire FDA prescribing information for Ruconest (C1 Esterase Inhibitor [Recombinant] Intravenous Injection)
© 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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