nausea . The safety and efficacy of Ruconest in children less than 2 years old have not been established. When an attack occurred, the patients were given one of two doses of Ruconest (50 or 100 units/kg) or placebo (a dummy treatment). Do not mix Ruconest with other medicinal products. . A Randomized, Double Blind, Placebo Controlled, Cross-Over, Proof-of-Concept Study to Evaluate the Benefit of RUCONEST (C1 Esterase Inhibitor [Recombinant]) in Improving Neurological Symptoms in Post-SARS-CoV-2 Infection: Actual Study Start Date : December 30, 2020: Estimated Primary Completion Date : January 2022: Estimated Study Completion Date : There were no adverse findings in a safety pharmacology study in dogs and a local tolerance study in rabbits. Once you have withdrawn your dose, turn the vial right side up and place on a flat surface. Pharmaceutical form: Powder for solution for injection. Do not exceed 4200 U per dose. Immunogenicity 2.51 mi. See prescribing information for directions for use. Among patients who achieved relief within 4 hours, there were 4 (27%) patients in the placebo group who had a relapse of their symptoms within 24 hours as compared with 1 (3%) in the Ruconest group. Step 7: Remove syringe from package and withdraw sterile water for injection from the diluent vial. He has since worked as a journalist and science writer, covering topics from rare diseases to the intersection between environmental science and social justice. Step 9: Swirl the vial to mix. Generic Name. Insert the butterfly needle of the infusion set into your vein (insert as flat to skin surface as possible). Pharming Group has committed to building a new manufacturing facility in the Netherlands to expand production of Ruconest (conestat alfa), its treatment for acute attacks of hereditary angioedema(HAE). HAE patients have low levels of endogenous or functional C1INH. Ruconest (C1 esterase inhibitor, recombinant) is a prescription injection for acute attacks of hereditary angioedema. Generic name: c1 esterase inhibitor recombinant Ruconest is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Do not use if the solution is cloudy, colored, or contains particulates. Use sterile gauze and tape or transparent dressing to hold the needle in place. Drug class: Hereditary angioedema agents. A VAS decrease of > 20 mm compared with baseline with persistence of the improvement at two consecutive time points was considered the onset of relief in Studies 2 and 3. Discard partially used vials after treatment. Swirl the vial slowly to mix and avoid foaming. 3 W Garden St No anti-C1INH neutralizing antibodies were detected. STN: BL 125495 Non-US patients receiving Ruconest had a median time to beginning of relief of 90 minutes [95% CI: (63, 120); n=22] and non-US patients receiving placebo had a median time to beginning of relief of 334 minutes [95% CI: (150, -); n=15]. Ruconest comes as a powder that is dissolved in sterile water and is slowly injected into a vein (intravenous injection). Also tell your healthcare provider if you are pregnant, breastfeeding, or planning to do so. Manufacturer: Pharming Group N,V, Available Country: United Kingdom . If there is no blood, remove the needle and repeat this step using a new needle, new administration tubing, and a different injection site. There may be new information provided. Ruconest (conestat alfa) is a member of the hereditary angioedema agents drug class and is commonly used for Hereditary Angioedema. References 1. The hazard ratio for time to the beginning of relief of symptoms in this subpopulation was 1.20 [95% CI: 0.48 to 3.01] for patient receiving Ruconest as compared with patient receiving placebo. None of the subgroup confidence intervals were adjusted for multiplicity. Most patients would like a cure for their HAE and a life free from attacks. How Ruconest works. Pharmacol Rev. The safety and efficacy of Ruconest were evaluated in 17 adolescent patients (13-17 years of age) treated for 52 HAE attacks. Step 5: Now, place a 2nd adapter over a Ruconest vial and press down until it snaps into place. IB/0033 B.II.b.3.a - Change in the manufacturing process of the finished or intermediate product - Minor change It is concluded that preclinical toxicology data for daily doses up to 40 times the proposed human dose of Ruconest (50 U/kg) do not indicate a safety concern for the use of Ruconest in humans. Get medical help right away if you have any of these side effects: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness / fainting, pain . ruconest and/or its suppliers make no representations about the suitability, reliability, availability, timeliness, and accuracy of the information, software, products, services and related graphics contained on the ruconest web site for any purpose. Access to the information and documents contained on the following websites may be illegal in certain jurisdictions, and only certain categories of persons may be authorized to access such information and documents. December 21, 2020. Product protected by U.S. patent Nos. The NDC Code 71274-350-02 is assigned to a package of 1 vial, single-use in 1 carton > 1 injection, powder, for solution in 1 vial, single-use (71274-350-01) of Ruconest, a human prescription drug labeled by Pharming Healthcare Inc.. Noah, a 13-year old student with HAE, will help you learn the step-by-step instructions on preparing and administering Ruconest. Manufacturer: Pharming. Conestat alfa is produced by "recombinant DNA technology", meaning it is . Administer Ruconest by a separate infusion line. You can ask your healthcare provider or pharmacist for information about Ruconest that was written for healthcare professionals. Brand Names. Gently pull back on the syringe plunger and check to see if blood is in the tubing. Following administration of Ruconest (50 U/kg) in asymptomatic HAE patients ( Table 5), the mean Cmax was 1.2 U/mL, and the elimination half-life was approximately 2.5 hours. For more information, please see the full Prescribing Information including the Patient Product Information. The procedures below are provided as general guidelines for the reconstitution and administration of RUCONEST. Use only if clearly needed. Cover the injection site with a bandage, holding pressure on the site for a few minutes. Background. If there is blood present, then the needle is in a vein. "Acute" means. The drug has to be administered at the onset of angioedema attack symptoms. sudden severe headache, slurred speech, problems with vision or balance; or. There will still be some diluent left in the vial. Patients ranged in age from 17 to 71 years of age: 53% were female and 47% were male; and 100% were Caucasian. If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please inform your healthcare provider or pharmacist. Because animal reproduction studies are not always predictive of human response, Ruconest should only be used during pregnancy if clearly needed. Manufacturing Plant. Remove the package from the adapter connected to one of the Ruconest vials. Caliezi C, Wuillemin WA, Zeerleder S, Redondo M, Eisele B, Hack CE. Sterile Water for Injection (diluent), 14mL per vial of Ruconest to be reconstituted. Thoroughly clean a table or other flat surface using one or more of the antiseptic wipes. After reconstitution and prior to administration, inspect the Ruconest vials visually for particulate matter and discoloration. Ruconest is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Health Conditions Ruconest is a medicine used to treat attacks of hereditary angioedema in adults and adolescents. No plausible biological explanations for the regional or gender subgroup effects were found. Product protected by U.S patent Nos. The proportion of patients who received Ruconest as rescue medication was greater in patients randomized to placebo (13 of 31 patients; 42%) than in patients randomized to Ruconest (5 of 44 patients; 11%). Supportive evidence of effectiveness is provided by two double-blind, randomized, placebo-controlled studies (Studies 2 and 3). For women receiving Ruconest, the median time to beginning of relief was 113 minutes [95% CI: (63, 151); n=28], and for women receiving placebo, the median time to beginning of relief was 105 minutes [95% CI: (60, 334); n=19]. HAE is caused by a shortage of a protein called C1 esterase inhibitor, that is present in your blood and helps control inflammation (swelling) and parts of the immune system. Manufacturer: Salix Pharmaceuticals, Inc. Ensure that the RUCONEST vial and diluent vial are at room temperature. Regulation of these systems is performed through the formation of complexes between the protease and the inhibitor, resulting in inactivation of both and consumption of the C1INH. Ruconest is a brand (trade) name for a man-made form of a protein called C1 esterase inhibitor, that naturally occurs in our plasma. The product's dosage form is injection, powder, for solution and is administered via intravenous form. Hold both wings of the butterfly between the thumb and the index finger with the obliquely cut (slanted) opening of the butterfly needle pointing upward. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. Because hypersensitivity reactions may have symptoms similar to HAE attacks, treatment methods should be carefully considered. In the OLE phase of Study 1, patients were treated with open-label Ruconest 50 U/kg for repeated attacks of HAE. Your healthcare provider will teach you how to safely administer Ruconest. Indication: An official website of the United States government, : These are not all the possible side effects of RUCONEST. In the OLE phase of Study 1, 5/170 (3%) attacks received a second dose of Ruconest 50 U/kg. The pharmacokinetics of Ruconest was evaluated in a study of 12 asymptomatic HAE patients (dose ranged from 6.25 U/kg to 100 U/kg). Patients ranged in age from 17 to 66 years of age; 74% were female and 26% were male; and 92% were Caucasian. The impact of the nontherapeutic proteins identified has not yet been evaluated. In clinical studies, a total of 205 symptomatic HAE patients received treatment with Ruconest for a combined total of 650 acute angioedema attacks. Call your healthcare provider or the emergency department immediately if you have any of the following symptoms after receiving Ruconest: In clinical studies, the most severe side effect reported in a person who received Ruconest was a severe allergic reaction in a subject who was allergic to rabbits. There is no intention to register any Shares referred to herein in the United States or to make a public offering of the Shares in the United States. Composition: One vial contains 2100 Units of conestat alfa, corresponding to 2100 U/14 ml after reconstitution, or a concentration of 150 U/ml. Hereditary angioedema (HAE) is a swelling condition caused by poorly functioning or low levels of C1 esterase inhibitor. Pharming Americas B.V. In the European Union, Ruconest has been approved for this . The clinical studies included an insufficient number of patients in this age group to determine if they respond differently from younger patients. Ruconest has a very high purity profile but is not identical to the human C1-INH protein. The hazard ratio for men receiving Ruconest versus placebo was 3.94 [95% CI: 1.23 to 12.68]. It was originally designated an orphan medicine on 11 May 2001. STN: BL 125495. Additional findings from other Phase 2 trials (NCT02247739; NCT00851409) showed that Ruconest was safe and effective when used as a short-term prophylactic (preventive) therapy to prevent HAE attacks in adults and adolescents.. Seventy-five (75) adults and adolescent patients were randomized (3:2) to receive Ruconest 50 U/kg (N = 44) or placebo (N = 31). Figure 1. One possible explanation is a larger-than-expected placebo response among US women. 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. It does not provide medical advice, diagnosis or treatment. It is not known if Ruconest can harm your unborn baby. * Includes 5 patients who received an additional 50 U/kg dose Shelf life: 48 months when stored at 36F - 77F (2C - 25C). No treatment-related SAEs or hypersensitivity reactions were reported 1. The primary endpoint in both studies was disease severity on the seven-point WHO ordinal scale on Day Seven. 1995 Mar;73(3):466-71. RUCONEST is distributed in Argentina, Colombia, Costa Rica, the Dominican Republic, Panama, and Venezuela by Cytobioteck, in South Korea by HyupJin Corporation and in Israel by Kamada. Do not mix or administer Ruconest with other medicinal products or solutions. Wipe the vial stoppers with the antiseptic wipes provided and allow to dry for 30 seconds. Pharming holds a minority stake in BioConnection. Each vial contains 2100 U of rhC1INH. Advise patients to notify their physician if they are breastfeeding or plan to breastfeed. fever. What is Ruconest used for and how does it work? Construction will begin in mid-2021. DOSAGE AND ADMINISTRATION For intravenous use after reconstitution only. Add to Pricing Basket. RUCONEST is indicated for treatment of acute HAE attacks in children 2 years with HAE due to C1-INH deficiency 2**. MedDRA: Medical Dictionary for Regulatory Activities, version 15.0. Active ingredient: conestat alfa. Ruconest was studied in two main studies involving a total of 73 patients with hereditary angioedema caused by low levels of C1 esterase inhibitor protein. Blood Coagul Fibrinolysis. Ruconest side effects. Ruconest is available as a lyophilized powder for reconstitution for injection in a single-use 25 mL glass vial. by All persons residing outside of the Netherlands who wish to have access to the documents contained on this website should first ensure that they are not subject to local laws or regulations that prohibit or restrict their right to access this website, or require registration or approval for any acquisition of securities by them. Findings of the study, "Treatment of Hereditary Angioedema Attacks with Icatibant and Recombinant C1 Inhibitor During Pregnancy," were published in the Journal of Clinical Immunology. If the attack symptoms persist, an additional (second) dose can be administered at the recommended dose level. Forty-four patients who completed the RCT phase were enrolled into the OLE phase where they were treated for a total of 170 attacks. It is not known if Ruconest is excreted in human milk. Ruconest is an injectable medicine that is used to treat acute angioedema attacks in adult and adolescent patients with Hereditary Angioedema (HAE). DrugBank Accession Number. ** Events only occurring in placebo patients are not listed. These defects are considered to be a chance finding, but a Ruconest-related effect cannot be excluded. If using a syringe with vial adapter, use a new vial adapter for each vial of Ruconest and diluent. Ruconest C1 ESTERASE INHIBITOR, RECOMBINANT (C1 ES ter ase in HIB i ter, ree kom bi nant) helps to treat angioedema attacks. Ruconest (rhC1INH) is a recombinant human C1 inhibitor (C1INH) by Pharming, approved to treat acute attacks of hereditary angioedema, a rare condition that results from dysfunctional or low levels of C1INH in the blood. previously received Ruconest to be tested fo r the presence of IgE antibodies against rabbit epithelium (dander) prior to initiation of Ruconest or for such testing to be repeated periodically in previously tested patients. Marketing Authorisation Holder and Manufacturer Pharming Group N.V. Darwinweg 24 Closed. If the same patient is to receive more than one vial, the contents of multiple vials may be pooled into a single administration device (i.e., syringe). In this phase, the median time to beginning of relief of symptoms was 75 minutes (95% CI: 64, 90), consistent with the results of the RCT phase of the study ( Table 6). It contains the active substance conestat alfa. 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