C1 Esterase Inhibitor Recombinant (Ruconest)

Trade Name : Ruconest

Tjoapack Netherlands BV

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Strength 2100 U/1

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of C1 Esterase Inhibitor Recombinant (Ruconest) which is also known as Ruconest and Manufactured by Tjoapack Netherlands BV. It is available in strength of 2100 U/1 per ml. Read more

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No data

RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Limitation of Use: u00a0Effectiveness was not established in HAE patients with laryngeal attacks.
RUCONEST is a C1 esterase inhibitor [recombinant] indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). (n n n n n n )n nn n nn
Limitation of Use: Effectiveness was not established in HAE patients with laryngeal attacks.

For intravenous use after reconstitution only.
For Intravenous Use Only.
u2022Reconstitute each vial (2100 U) by adding 14u00a0mL sterile Water for Injection per vial to obtain a solution of 150 U per mL. (n n n n n n )u2022Administer the reconstituted solution at room temperature as a slow intravenous injection over approximately 5 minutes. (n n n n n n )u2022Appropriately trained patients may self-administer upon recognition of an HAE attack. (n n n n n n )n nn n nn
Recommended dose of RUCONEST for an acute attack
If the attack symptoms persist, an additional (second) dose can be administered at the recommended dose level.u00a0 Do not exceed 4200 U per dose. u00a0No more than two doses should be administered within a 24 hour period.

2100 U Lyophilized powder for reconstitution for injection in a single-use vial. (n n n n n n )n nn n nn

No data

Known or suspected allergy to rabbits and rabbit-derived products.n
History of immediate hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor preparations. (n n n n n n )n n n n n n

No data

Hypersensitivity reactions, including anaphylaxis may occur. Should symptoms occur, discontinue RUCONEST and administer appropriate treatment. (n n n n n n )n n n n n n
Serious arterial and venous thromboembolic (TE) events have been reported at the recommended dose of plasma derived C1 esterase inhibitor products in patients with risk factors. Monitor patients with known risk factors for TE events during and after RUCONEST administration. (n n n n n n )n n n n n n

The serious adverse reaction in clinical studies of RUCONEST was anaphylaxis.
The most common adverse reactions (u2265 2%) reported in all clinical trials were headache, nausea, and diarrhea.
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 650u00a0acute 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).
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.
Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity.u00a0 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).u00a0 Testing was performed prior to and after treatment of a first attack and subsequent repeated attacks at 7, 22 or 28, and 90u00a0days 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.u00a0 After the first exposure, the frequency of anti-C1INH antibodies varied from 0.6% to 1.0% of samples tested.u00a0 After repeated exposures, the frequency of anti-C1INH antibodies varied from 0.5 to 2.2% of samples tested.u00a0 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. u00a0No anti-C1INH neutralizing antibodies were detected. Observed anti-C1INH and anti-HRI antibodies were not associated with adverse clinical findings.u00a0
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.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals, Inc. at 1-800-508-0024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The serious adverse reaction reported in clinical trials was anaphylactic reaction. (n n n n n n )n n n n n n
The common adverse reactions (u2265 2%) reported in clinical trials were headache, nausea, and diarrhea. (n n n n n n )n n n n n n

Pregnancy: Limited animal data. No human data. Use only if clearly needed. (n n n n n n )n nn n nn

RUCONEST is a recombinant analogue of human complement component 1 esterase inhibitor for intravenous injection. RUCONEST is purified from the milk of transgenic rabbits, and supplied as a sterile, preservative-free, white/off-white lyophilized powder for reconstitution for injection. One U of rhC1INH activity is defined as the equivalent of C1 esterase inhibiting activity present in 1 mL of pooled normal plasma.
RUCONEST is a soluble, single-chain glycoprotein containing 478 amino acids, with a molecular mass of 68 kDa, of which approximately 22% comprises oligosaccharide structures. The primary and secondary structures of the molecule and target protease selectivity are consistent with those of plasma-derived C1 esterase inhibitor.
Each vial of RUCONEST contains 2100 U of rhC1INH, 937 mg of sucrose, 83.3 mg of sodium citrate dihydrate and 1.0 mg of citric acid monohydrate. After reconstitution with 14 mL of sterile Water for Injection, each vial of RUCONEST contains 150 U of rhC1INH per 1 mL in a 20 mM sodium citrate buffer with a pH of 6.8. RUCONEST does not contain preservatives and each vial is for single use only.
RUCONEST is purified from the milk of transgenic rabbits. The rabbits are maintained in a closed colony that is controlled and routinely monitored for specific pathogens. The skimmed milk is screened for adventitious contaminants prior to further manufacture. The manufacturing process has been validated to demonstrate adequate capacity for removal and/or inactivation of viruses (n n n n n n ).u00a0 RUCONEST contains less than 0.002% of host-related impurities.n nn n nn

No data

No data

The safety and efficacy of RUCONEST for treatment of acute angioedema attacks in patients with HAE was established in Study 1, a double-blind, randomized, placebo-controlled trial (RCT) which included an open-label extension (OLE) phase; and supported by the results of 2 additional RCTs and 2 additional OLE studies.
Randomized, Controlled Trials
The safety and efficacy of RUCONEST in the treatment of acute attacks in patients with hereditary angioedema were demonstrated in a placebo-controlled, double-blind, randomized study (Study 1).u00a0 Supportive evidence of effectiveness is provided by two double-blind, randomized, placebo-controlled studies (Studies 2 and 3). Evidence for the efficacy of repeat treatment of HAE attacks is provided from the open-label extensions (OLE) of each of the three randomized studies.
Study 1 was a randomized, double-blind, placebo-controlled trial that included an open-label extension (OLE) phase to assess the efficacy and safety of RUCONEST 50 U/kg in the treatment of acute attacks in patients with HAE. Seventy-five (75) adults and adolescent patients were randomized (3:2) to receive RUCONEST 50 U/kg (N = 44) or placebo (Nu00a0= 31). Patients ranged in age from 17 to 69 years of age; 63% were female and 37% were male; 96% were Caucasian.
The primary efficacy endpoint was the time to beginning of relief of symptoms, assessed using patient-reported responses to two questions from a Treatment Effect Questionnaire (TEQ).u00a0 The TEQ required patients to assess the severity of their attack symptoms at each affected anatomic location, using a seven-point scale (u201cmuch worseu201d to u201cmuch betteru201d [TEQ Question 1]), and whether their symptoms had begun to decrease notably since receiving the study medication (u201cyesu201d or u201cnou201d [TEQ Question 2]). u00a0To achieve the primary endpoint, a patient had to have a positive response to both questions along with persistence of improvement at the next assessment time (i.e., the same or better response).u00a0
Rescue treatment with RUCONEST was available for patients who did not experience the beginning of relief at 4 hours after study drug administration, or earlier to patients who experienced life-threatening oropharyngeal-laryngeal angioedema symptoms. u00a0If a patient received a medication which could have impacted the efficacy evaluation or open-label RUCONEST as rescue medication, prior to achieving beginning of relief of symptoms, the time to beginning of relief of symptoms was censored at the last assessed time prior to medication use.
In the RCT phase, the median time to beginning of relief of symptoms was statistically significantly shorter in patients treated with RUCONEST 50 U/kg compared with patients treated with placebo as assessed by the TEQ; (n n n n n n , Figure 1).n nn n nn
Figure 1. Kaplan-Meier Plot of Time to Beginning of Relief of Symptoms (Study 1, RCT Phase)
Arrayn- Array
Among several planned subgroup analyses, descriptive statistics showedu00a0 that in US patients a median time to beginning of relief of symptoms with persistence at the primary attack location (based on TEQ) was 98 minutes [95% CI:(45, 240); n=22] for those receiving RUCONEST and 90 minutes [95% CI: (50, -); n=16] for those receiving placebo. 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.u00a0 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]. The hazard ratio for the non-US subgroup was 4.82 [95%u00a0CI:u00a01.58 to 14.72] for patients receiving RUCONEST compared to placebo.
Examination of gender subgroups suggested a larger treatment effect in men than women.u00a0 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].u00a0 The hazard ratio for women receiving RUCONEST versus placebo was 1.22 [95% CI: 0.60 to 2.48].u00a0 For men receiving RUCONEST, the median time to beginning of relief was 75 minutes [95% CI: (45, 210); n=16], and for men receiving placebo, the median time to beginning of relief was 480 minutes [95% CI: (150, -) n=12].u00a0 The hazard ratio for men receiving RUCONEST versus placebo was 3.94 [95% CI: 1.23 to 12.68].
No plausible biological explanations for the regional or gender subgroup effects were found.u00a0 One possible explanation is a larger-than-expected placebo response among US women.u00a0 None of the subgroup confidence intervals were adjusted for multiplicity.
Because almost all of the patients were Caucasian and were between 18 and 65 years of age, race and age subgroup analyses were not considered meaningful.
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.u00a0 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%).
The efficacy of RUCONEST 50 U/kg for different anatomical locations of HAE attacks is summarized in n n n n n n .n nn n nn
In the OLE phase of Study 1, patients were treated with open-label RUCONEST 50 U/kg for repeated attacks of HAE. Forty-four patients who completed the RCT phase were enrolled into the OLE phase where they were treated for a total of 170 attacks. In this phase, the median time to beginning of relief of symptoms was 75 minutes (95% CI:u00a0 64, 90), consistent with the results of the RCT phase of the study (n n n n n n ). Results were also comparable across attacks, suggesting that the efficacy of RUCONEST 50 U/kg was maintained over repeated attacks of HAE. In the OLE phase of Study 1, 5/170 (3%) attacks received a second dose of RUCONEST 50 U/kg.n nn n nn
In Study 2 (North American RCT), patients were randomized to receive a single administration of either RUCONEST 50u00a0U/kg (N=12), RUCONEST 100 U/kg (N=13) or placebo (N=13). Patients ranged in age from 17 to 66 years of age; 74% were female and 26% were male; and 92% were Caucasian.
In Study 3 (European RCT), patients were randomized to receive a single administration of either RUCONEST 100u00a0U/kg (N=16) or placebo (N=16). Patients ranged in age from 17 to 71 years of age: 53% were female and 47% were male; and 100% were Caucasian.
Patients scored their symptoms using a visual analog scale (VAS) ranging from 0-100 mm.u00a0 A VAS decrease of n n n n n n 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.n nn n nn
In both Study 2 and 3, the efficacy of RUCONEST in the treatment of acute angioedema attacks was demonstrated by significantly shorter times to beginning of relief of symptoms based on the VAS (Figure 2).
Figure 2. Mean VAS scores over time with 95% Confidence Intervals (Study 2 and 3, RCT Phase)
In open-label extension studies of Study 2 and 3, 119 patients were treated with RUCONEST for a total of 362 acute angioedema attacks.u00a0 As observed in Study 1, the efficacy of RUCONEST was maintained for repeat attacks.

No data

No data

Advise the patient to read the FDA-Approved patient labeling (Product Information and Instructions for Use).
Patients being treated with RUCONEST should receive the following information and instructions. This information is intended to aid the patient in the safe and effective use of RUCONEST.
u2022Advise female patients to notify their physician if they are pregnant or intend to become pregnant during the treatment of acute attacks of HAE with RUCONEST.u2022Advise patients to notify their physician if they are breastfeeding or plan to breastfeed.u2022Inform patients of the risks and benefits of RUCONEST before prescribing or administering it to the patient.
Advise patients to immediately report :
u2022Signs and symptoms of allergic hypersensitivity reactions, such as hives, urticaria, tightness of the chest, wheezing, hypotension and/or anaphylaxis experienced during or after injection of RUCONEST (
see WARNINGS AND PRECAUTIONS/Hypersensitivity [ n n n n ]n n nn
).
Manufactured by:n n n n n nPharming Technologies B.V.n n n n n nDarwinweg 24n n n n n nNL-2333 CR Leidenn n n n n nThe Netherlandsn n n n n nRUCONEST u00ae is a registered trademark of Pharming Group N.V.n n nn
Distributed by:n n n n n nSantarus, Inc., a wholly owned subsidiary of Salix Pharmaceuticals, Inc.n n n n n nRaleigh, NC 27615n n nn
Product protected by the following U.S patent Nos. 7,067,713.
Please see www.salix.com for patent information.
US License No. 2012
REV FEB 2015n n n n n nVENART-307-1n n n n n n60002124-02n n nn

RUCONEST u00ae (ROO-Ko-nest)
( C1 esterase inhibitor [recombinant])
Lyophilized powder for reconstitution for injection in a single-use vial
This leaflet summarizes important information about RUCONEST. Please read it carefully each time before using RUCONEST. There may be new information provided. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about RUCONEST. If you have any questions after reading this, ask your healthcare provider.
What is RUCONEST?
RUCONEST is an injectable medicine that is used to treat acute angioedema attacks in adult and adolescent patients with Hereditary Angioedema (HAE). 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. A shortage of C1 esterase inhibitor can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms. RUCONEST contains C1 esterase inhibitor.
Who should not use RUCONEST?
You should not use RUCONEST if you have a known or suspected allergy (hypersensitivity) to rabbits or rabbit-derived products.
You should not use RUCONEST if you have experienced life-threatening immediate hypersensitivity reactions, including anaphylaxis, to RUCONEST or to any other C1 esterase inhibitor product.
RUCONEST is not indicated for use in children under the age of 13 years.
What should I tell my healthcare provider before using RUCONEST?
Tell your healthcare provider about all of your medical conditions, including if you:
u2022have an
allergy to rabbits
since this can put you at high risk of a serious allergic reaction with RUCONEST. These allergy symptoms could include runny nose, itchy nose, sneezing, coughing, wheezing, difficulty breathing or watery eyes when you are near rabbits.u2022are pregnant or planning to become pregnant. It is not known if RUCONEST can harm your unborn baby.u2022are breastfeeding or plan to breastfeed. It is not known if RUCONEST passes to your milk and if it can harm your baby.
Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.
How is RUCONEST given?
RUCONEST will be slowly injected into your vein (intravenous injection). Before injection, the RUCONEST powder must be dissolved using sterile Water for Injection. The dose will be determined based on your weight.
Most of the time a single dose of RUCONEST is enough to treat an attack, but a second dose may be needed.
What are the possible side effects of RUCONEST?
Like all medicines, RUCONEST can cause side effects, although not everybody gets them.
Allergic reactions may occur with RUCONEST. Call your healthcare provider or the emergency department immediately if you have any of the following symptoms after receiving RUCONEST:
u2022wheezingu2022difficulty breathingu2022chest tightnessu2022turning blue (look at lips and gums)u2022fast heartbeatu2022swellingu2022faintnessu2022rashu2022hives
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.
Other side effects patients experienced during clinical research studies include:
u2022headacheu2022nauseau2022diarrhea
These are not all the possible side effects of RUCONEST.
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. You can also report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or contact Salix Pharmaceuticals, Inc. at 1u2011800-508-0024.
You can ask your healthcare provider for information about RUCONEST that is written for healthcare providers.
General Information about RUCONEST
Do not use RUCONEST for a condition for which it is not prescribed.
If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about RUCONEST that was written for healthcare professionals.
For more information go to n n n n or call 1-800-508-0024.n n nn
DOSAGE VERIFICATION
Discuss this section with your healthcare provider to ensure that the correct dose of RUCONEST is administered.
u2022The dose of RUCONEST and volume (mL) of reconstituted solution to be administered is based on body weight shown in the chart below.
No more than 2 vials may be combined for a single dose.
This Patient Package Insert has been approved by the US Food and Drug Administration.
Manufactured by:n n n n n nPharming Technologies B.V.n n n n n nDarwinweg 24n n n n n nNL-2333 CR Leidenn n n n n nThe Netherlandsn n n n n nRUCONEST u00ae is a registered trademark of Pharming Group N.V.n n nn
Distributed by:n n n n n nSantarus, Inc., a wholly owned subsidiary of Salix Pharmaceuticals, Inc.n n n n n nRaleigh, NC 27615n n nn
Product protected by the following U.S patent Nos. 7,067,713.
Please see www.salix.com for patent information.
US License No. 2012
REV FEB 2015n n n n n nVENART-307-1n n nn

RUCONESTu00ae
C1 esterase inhibitor (recombinant)
2100 U
NDC 68012-350-01
For intravenous use only.
For single patient use.
See prescribing informationn n nfor directions for use.n
Rx only

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C1 Esterase Inhibitor Recombinant (Ruconest)

Trade Name : Ruconest

INJECTION, POWDER, FOR SOLUTION

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C1 Esterase Inhibitor Recombinant (Ruconest)

Trade Name : Ruconest

INJECTION, POWDER, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

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