Explore Science-Based Management of Hereditary Angioedema


Watch Dr. Michael Manning share an overview of

  • Complex pathways leading to hereditary angioedema (HAE) attacks
  • Challenges of treating HAE
  • Efficacy and safety of an acute treatment: RUCONEST® (C1 esterase inhibitor [recombinant])1
Michael Manning, MD Board Certified Allergist and Immunologist

Explore Science-Based Management of Hereditary Angioedema


Watch Dr. Michael Manning share an overview of

  • Complex pathways leading to hereditary angioedema (HAE) attacks
  • Challenges of treating HAE
  • Efficacy and safety of an acute treatment: RUCONEST® (C1 esterase inhibitor [recombinant])1
Michael Manning, MD Board Certified Allergist and Immunologist

Explore Science-Based Management of Hereditary Angioedema


Watch Dr. Michael Manning share an overview of

  • Complex pathways leading to hereditary angioedema (HAE) attacks
  • Challenges of treating HAE
  • Efficacy and safety of an acute treatment: RUCONEST® (C1 esterase inhibitor [recombinant])1

Delve into the science and HAE challenges


Abbreviation: HAE-nl-C1INH, HAE with normal C1 inhibitor.


Examine the science of C1-INH to help inform treatment decisions

In 2019, Pharming partnered with a world authority on the pathogenesis and treatment of hereditary angioedema (HAE) to develop a visualization of the interconnectedness of the complement, contact activation, and fibrinolysis systems and how their interworkings lead to the symptomology experienced in HAE attacks.

Use this visualization to explore the role of C1 esterase inhibitor (C1-INH) in HAE attacks and potential HAE treatment challenges.

Redosing may prevent your patients from getting back to things that matter.

85% of patients surveyed were confident self-injecting RUCONEST (n=601). reference number 7 *
*

According to a review of redosing and self-administration rates from the research literature.2

Redosing may prevent your patients from getting back to things that matter.

85% of patients surveyed were confident self-injecting RUCONEST (n=601). reference number 7 *
*

According to a review of redosing and self-administration rates from the research literature.2


Insights from patients’ own experiences

In June 2020, Pharming launched an app for all patients with HAE, regardless of treatment. The app allows patients to track information about their attacks.

As of June 2021, 124 patients with HAE had logged 1,114 attacks in the app.3*

  • Almost half (46%) of logged attacks were identified by patients as severe3*
  • Half (50%) of all swells reported were in the stomach/abdomen3*
Are your patients giving you the full picture?

Better dialogue with patients may be needed to ensure they have the right acute therapy.

Explore self-reported patient data3*

Headache, nausea, diarrhea.
Headache, nausea, diarrhea.

Patients also reported experiencing swells in other body locations.*


*

Data self-reported by patients in the HAE & Me app from June 2020 through June 2021. Patients self-reported swell severity on a scale of 1 to 10, with severe defined as ≥6. On average, patients reported 1.2 swell locations per attack.

RUCONEST Can Get Your Patients Back to Things That Matter

Headache, nausea, diarrhea.

One dose of RUCONEST 50 U/kg (max 4200 U) offered relief from hereditary angioedema (HAE) attacks in clinical trials (n=44)1*:

•  89% of 44 patients in the double-blind study

•  97% of 170 attacks in the open-label extension phase

*

In the randomized controlled trial, the primary efficacy endpoint was time to beginning of relief of symptoms. Median time to beginning of relief was 90 minutes with RUCONEST 50 U/kg (n=44) vs 152 minutes with placebo (n=31).1

RUCONEST Can Get Your Patients Back to Things That Matter

Headache, nausea, diarrhea.

One dose of RUCONEST 50 U/kg (max 4200 U) offered relief from hereditary angioedema (HAE) attacks in clinical trials (n=44)1*:

•  89% of 44 patients in the double-blind study

•  97% of 170 attacks in the open-label extension phase

*

In the randomized controlled trial, the primary efficacy endpoint was time to beginning of relief of symptoms. Median time to beginning of relief was 90 minutes with RUCONEST 50 U/kg (n=44) vs 152 minutes with placebo (n=31).1

Headache, nausea, diarrhea.
Headache, nausea, diarrhea.

In a post hoc analysis of 2 clinical trials, patients treated for an acute attack with RUCONEST remained symptom-free for at least 3 days in 93% of attacks.4

*

Based on a post hoc analysis of pooled data from the randomized controlled trial and open-label extension phases of 2 studies involving 127 patients aged ≥13 years treated with RUCONEST 50 U/kg (max 4200 U) for acute attacks of HAE. Data for 72 hours available for 68 of 127 patients.4

Well-established tolerability profile1

In 7 clinical trials (RCT and OLE), the most common adverse events in patients treated with RUCONEST (incidence ≥2%, N=205, dose: 50-100 U/kg*) were1

Headache, nausea, diarrhea.

In clinical trials, a single patient experienced anaphylaxis, a serious adverse reaction. The patient was a healthy volunteer who did not report their known rabbit allergy.5

*

124 patients were treated with 50 U/kg; the rest included doses up to 100 U/kg.1

Abbreviations: RCT, randomized controlled trial; OLE, open-label extension.


There's more to explore

There's more to explore

Did you know there’s an app designed to enhance the encounters you have with your patients with hereditary angioedema (HAE)?

Watch the video demo.

There's more to explore

There's more to explore

Did you know there’s an app designed to enhance the encounters you have with your patients with hereditary angioedema (HAE)?

Most Patients Find Relief With Just One Dose

Choose a treatment for your patients with hereditary angioedema (HAE) that has been shown to deliver predictable results with just one dose.1

RUCONEST treats HAE attacks with a 5-minute IV injection that patients can confidently self-administer after receiving educational support—for as long and as often as needed—from RUCONEST Patient Advocate (RPA) clinical educators who specialize in RUCONEST and HAE.1,3

85% of patients surveyed were confident self-injecting RUCONEST (n=601). reference number 7 *
*

Data from 601 patients using RUCONEST showed that approximately 85% of patients trained to self-inject felt somewhat confident, mostly confident, or extremely confident on a 5-point Likert scale in terms of their ability to self-infuse.7

RUCONEST is the only recombinant C1 esterase inhibitor (C1-INH) indicated for the treatment of HAE attacks in adults and adolescents.1 Thanks to its extensive support program, tools, and well-established tolerability profile, you can feel confident prescribing RUCONEST for your patients.1

85% of patients surveyed were confident self-injecting RUCONEST (n=601). reference number 7 *
*

Data from 601 patients using RUCONEST showed that approximately 85% of patients trained to self-inject felt somewhat confident, mostly confident, or extremely confident on a 5-point Likert scale in terms of their ability to self-infuse.3

Vein finders are available on loan

Vein finders are available on loan through RUCONEST SOLUTIONS to eligible RUCONEST patients for as long as needed.

They are designed to help find veins, improve first-stick success, and rotate injection sites to help keep veins healthy.6

85% of patients surveyed were confident self-injecting RUCONEST (n=601). reference number 7 *

Watch and see how straightforward finding a vein can be.

Address HAE Attacks With a Portable Therapy

RUCONEST is a recombinant C1 esterase inhibitor (C1-INH) that treats acute hereditary angioedema (HAE) attacks in adult and adolescent patients. Offer your patients sustained relief in just one dose.1,2

After appropriate screening and education, patients can confidently address acute HAE attacks.1,7 RUCONEST does not require refrigeration, so patients can bring their treatment wherever they go.1 And at the first sign of attack, patients can self-administer a dose of RUCONEST intravenously in just 5 minutes (after reconstitution).1 Most patients in clinical trials achieved symptom relief with just one dose.1*

Address HAE attacks with a portable therapy

RUCONEST is a recombinant C1 esterase inhibitor (C1-INH) that treats acute hereditary angioedema (HAE) attacks in adult and adolescent patients. Offer your patients sustained relief in just one dose.1,4

After appropriate screening and education, patients can confidently address acute HAE attacks.1,3 RUCONEST does not require refrigeration, so patients can bring their treatment wherever they go.1 And at the first sign of attack, patients can self-administer a dose of RUCONEST intravenously in just 5 minutes (after reconstitution).1 Most patients in clinical trials achieved symptom relief with just one dose.1*

*

89% in the double-blind phase and 97% in the open-label extension phase of clinical study (n=44; 170 attacks).

Raise levels of functional C1-INH into normal range in patients1,7

People with type 1 or 2 hereditary angioedema (HAE) have low levels of endogenous or functional C1 esterase inhibitor (C1-INH). Supplementing the low or defective C1-INH modulates vascular permeability by preventing the overproduction of bradykinin.5,8

RUCONEST, a recombinant C1-INH, was predicted to raise functional C1-INH levels to normal in ≥94% of patients.7

85% of patients surveyed were confident self-injecting RUCONEST (n=601). reference number 7 *

N=294 administrations in 133 subjects. LLN=0.7 U/mL. HAE baseline=~0.176 U/mL.

Abbreviations: HAE, hereditary angioedema; LLN, lower limit of normal.

Robust Patient Support

RUCONEST SOLUTIONS offers individualized support for patients. So you can trust that when you prescribe RUCONEST for your patients, they have access to services to help them get started with therapy and receive support along the way.

Robust Patient Support

RUCONEST SOLUTIONS offers individualized support for patients. So you can trust that when you prescribe RUCONEST for your patients, they have access to services to help them get started with therapy and receive support along the way.

Personalized solutions

Patients will be assigned a case manager to help determine insurance coverage, identify gaps, and coordinate financial support.

RUCONEST SOLUTIONS will identify eligibility for the

RUCONEST StarterRx Program

RUCONEST Bridge to Therapy Program

RUCONEST Patient Savings Program

RUCONEST Patient Assistance Program

Additionally, patients will learn about hereditary angioedema (HAE) and additional resources that may be available.

Individualized education

Living with HAE can feel complicated for patients. To help, patients receive training at home from a team of RUCONEST Patient Advocate (RPA) clinical educators who identify and support their needs for as long and as often as needed. A RUCONEST Patient Advocate does not offer medical/treatment advice or replace discussions with a healthcare provider.

There’s More to Explore

Did you know there’s an app designed to improve the encounters you have with your patients with hereditary angioedema (HAE)?

Watch the HAE and Me app demo video.

Features of the HAE & Me app include

Reminders to support medication adherence

Symptom trackers

Attack logs

Shareable reports

Resources for you

From dosing calculators to templates for letters of medical necessity, we are here to help. And if you can’t find what you need, simply send us a request.

Address the root cause of HAE breakthrough attacks

Learn about the benefits of RUCONEST being plasma-free1

Visit our video resources

Indications and Usage

RUCONEST® (C1 esterase inhibitor [recombinant]) is indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Effectiveness in clinical studies was not established in HAE patients with laryngeal attacks.

Important Safety Information

RUCONEST is contraindicated in patients with a history of allergy to rabbits or rabbit-derived products and for patients with a history of life-threatening immediate hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor (C1-INH) preparations.

Monitor patients for early signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and/or anaphylaxis). If symptoms occur, discontinue RUCONEST and administer appropriate treatment.

Serious arterial and venous thromboembolic (TE) events have been reported with plasma-derived C1-INH products. Risk factors may include the presence of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, and immobility. Monitor patients with known risk factors for TE events during and after RUCONEST administration.

Appropriately trained patients may self-administer RUCONEST upon recognition of an HAE attack. Advise patients to seek medical attention if progress of any attack makes them unable to properly prepare or administer a dose of RUCONEST. No more than 2 doses should be administered within a 24-hour period.

The serious adverse reaction reported in clinical trials was anaphylaxis. The most common adverse reactions (incidence 2%) were headache, nausea, and diarrhea.

Before prescribing RUCONEST, please read the full Prescribing Information including the Patient Product Information.

REFERENCES: 1. Ruconest. Package insert. Pharming Healthcare Inc; 2020. 2. Bernstein JA, Tyson C, Relan A, Adams P, Magar R. Modeling cost-effectiveness of on-demand treatment for hereditary angioedema attacks. J Manag Care Spec Pharm. 2020;26(2):203-210. doi:10.18553/jmcp.2019.19217 3. Data on file, Pharming Healthcare Inc. 4. Bernstein JA, Relan A, Harper JR, Riedl M. Sustained response of recombinant human C1 esterase inhibitor for acute treatment of hereditary angioedema attacks. Ann Allergy Asthma Immunol. 2017;118(4):452-455. 5. Moldovan D, Bernstein JA, Cicardi M. Recombinant replacement therapy for hereditary angioedema due to C1 inhibitor deficiency. Immunotherapy. 2015;7(7):739-752. 6. AccuVein: the new AccuVein AV500. Published 2019. Accessed August 9, 2021. https://www.accuvein.com/inf/ 7. Farrell C, Hayes S, Relan A, van Amersfoort ES, Pijpstra R, Hack CE. Population pharmacokinetics of recombinant human C1 inhibitor in patients with hereditary angioedema. Br J Clin Pharmacol. 2013;76(6):897-907. 8. Kaplan AP, Joseph K. Pathogenesis of hereditary angioedema: the role of the bradykinin-forming cascade. Immunol Allergy Clin N Am. 2017;37(3):513-525.

Indications and Usage

RUCONEST® (C1 esterase inhibitor [recombinant]) is indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE). Effectiveness in clinical studies was not established in HAE patients with laryngeal attacks.

Important Safety Information

RUCONEST is contraindicated in patients with a history of allergy to rabbits or rabbit-derived products and for patients with a history of life-threatening immediate hypersensitivity reactions, including anaphylaxis, to C1 esterase inhibitor (C1-INH) preparations.

Monitor patients for early signs of allergic or hypersensitivity reactions (including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and/or anaphylaxis). If symptoms occur, discontinue RUCONEST and administer appropriate treatment.

Serious arterial and venous thromboembolic (TE) events have been reported with plasma-derived C1-INH products. Risk factors may include the presence of an indwelling venous catheter/access device, prior history of thrombosis, underlying atherosclerosis, use of oral contraceptives or certain androgens, morbid obesity, and immobility. Monitor patients with known risk factors for TE events during and after RUCONEST administration.

Appropriately trained patients may self-administer RUCONEST upon recognition of an HAE attack. Advise patients to seek medical attention if progress of any attack makes them unable to properly prepare or administer a dose of RUCONEST. No more than 2 doses should be administered within a 24-hour period.

The serious adverse reaction reported in clinical trials was anaphylaxis. The most common adverse reactions (incidence 2%) were headache, nausea, and diarrhea.

Before prescribing RUCONEST, please read the full Prescribing Information including the Patient Product Information.