Ruconest Prescribing & Dosing Schedule

Q: 1. Is RUCONEST safe to use during pregnancy?

There are no adequate and well-controlled studies of RUCONEST in pregnant women. Limited postmarketing data suggest no adverse effects in pregnant women treated with RUCONEST. A retrospective case collection study involving 14 pregnant women who received RUCONEST did not report adverse events related to RUCONEST treatment, and all women delivered healthy babies. However, the data's ability to definitively establish absence of risk is limited due to the study's small sample size and non-randomized design.

Q: 2. What do we know about RUCONEST use during lactation?

There is no available data on the presence of RUCONEST in human milk, its effects on breastfed infants, or its impact on milk production. When considering the use of RUCONEST, the developmental and health benefits of breastfeeding should be balanced with the mother's clinical need, while also assessing potential adverse effects on the breastfed child from RUCONEST or the maternal condition.

Q: 3. Has RUCONEST been tested in pediatric patients?

Yes, the safety and efficacy of RUCONEST were evaluated in 17 adolescent patients aged 13-17 years who were treated for HAE attacks. Some adverse reactions were observed in these patients, with the most common being abdominal pain, headache, and oropharyngeal pain. However, no serious adverse reactions were reported.

Q: 4. Is RUCONEST suitable for use in geriatric patients?

Clinical studies of RUCONEST included seven patients older than 65 years, but the number of patients in this age group was insufficient to determine whether they respond differently from younger patients.

Dosage & Administration Drug label Prior authorization Pharmacy Financial assistance Patient education People also ask

Ruconest(C1 esterase inhibitor (recombinant))

RUCONEST 2100 UNT Injection

NO BOXED WARNING

Dosage & Administration

For Intravenous Use Only.

•Reconstitute each vial (2100 U) by adding 14 mL sterile Water for Injection per vial to obtain a solution of 150 U per mL. ( 2.3)•Administer the reconstituted solution at room temperature as a slow intravenous injection over approximately 5 minutes. ( 2.3)•Appropriately trained patients may self-administer upon recognition of an HAE attack. ( 2.3)

Recommended dose of RUCONEST for an acute attack

Body weight	RUCONEST Dose for Intravenous Injection	Volume (mL) of Reconstituted Solution (150 U/mL) to be Administered
< 84 kg	50 U per kg	Body weight in kg divided by 3
≥ 84 kg	4200 U (2 vials)	28 mL

If the attack symptoms persist, an additional (second) dose can be administered at the recommended dose level. Do not exceed 4200 U per dose. No more than two doses should be administered within a 24 hour period.

drug label

Ruconest Prescribing Information

Report Adverse Event

prior authorization

Ruconest Prior Authorization Resources

Most recent state uniform prior authorization forms

Verified: Jun 26, 2024Arizona - Uniform Prior Authorization Form

Verified: Jun 26, 2024Colorado - Uniform Prior Authorization Form

Verified: Jun 26, 2024Hawaii - Uniform Prior Authorization Form

Verified: Jul 26, 2024Illinois - Uniform Prior Authorization Form

Verified: Jun 26, 2024Indiana - Uniform Prior Authorization Form

Verified: Jun 26, 2024Louisiana - Uniform Prior Authorization Form

Verified: Jun 26, 2024Minnesota - Uniform Prior Authorization Form

Verified: Jun 26, 2024New Hampshire - Uniform Prior Authorization Form

Verified: Jun 26, 2024New Mexico - Uniform Prior Authorization Form

Verified: Jun 26, 2024Oregon - Uniform Prior Authorization Form

Verified: Jun 26, 2024Texas - Uniform Prior Authorization Form

Verified: Jul 07, 2024Washington - Uniform Prior Authorization Form

Verified: Jul 07, 2024Wisconsin - Uniform Prior Authorization Form

Letter of Medical Necessity - English

Letter of Medical Necessity - Spanish

Benefits investigation

Ruconest Enrollment Form

Ruconest Enrollment Form - Spanish

pharmacy

Ruconest Preferred Pharmacy

Pharmacy List [mentioned at the top of form]

financial assistance

Ruconest Financial Assistance Options

Copay savings program

Ruconest Enrollment Form

Ruconest Enrollment Form - Spanish

Enroll in Patient Savings Program

Learn More

Overview

Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)

Patient benefit

A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max

Patient eligibility

Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance

How to sign up

Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form

Bridge program

Ruconest Enrollment Form

Ruconest Enrollment Form - Spanish

Starter Rx - Bridge Program

Learn More

Overview

Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)

Patient benefit

100% free (outside of insurance)

Patient eligibility

HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries

How to sign up

Typically HCP assisted enrollment (via form)

Foundation programs

Ruconest Enrollment Form

Ruconest Enrollment Form - Spanish

Patient Assistance Program

Learn More

Overview

Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned

Patient benefit

Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and copays) until the grant is exhausted

Patient eligibility

Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.

How to sign up

Patients submit proof of out-of-pocket drug costs to charities for reimbursement

patient education

Ruconest Patient Education

Getting started on Ruconest

Instructions For Use: Hereditary Angioedema

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Instructions For Use (Spanish): Hereditary Angioedema

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

To share resource; ask patient to:

1.Pull out phone

2.Open camera

3.Scan QR code with camera

4.Tap link

Patient toolkit

About Ruconest

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Patient Resources: Videos

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Reimbursement Form [To seek reimbursement for out-of-pocket medical and travel expenses pertaining to Ruconest]

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Patient Brochure

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Doctor Discussion Guide

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Doctor Discussion Guide - Spanish

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Other resources

HAE and Me App

ASK PATIENT TO:
Open Camera on Phone
Scan QR Code & Tap Link

Ruconest FAQs

1. Is RUCONEST safe to use during pregnancy?There are no adequate and well-controlled studies of RUCONEST in pregnant women. Limited postmarketing data suggest no adverse effects in pregnant women treated with RUCONEST. A retrospective case collection study involving 14 pregnant women who received RUCONEST did not report adverse events related to RUCONEST treatment, and all women delivered healthy babies. However, the data's ability to definitively establish absence of risk is limited due to the study's small sample size and non-randomized design.

2. What do we know about RUCONEST use during lactation?There is no available data on the presence of RUCONEST in human milk, its effects on breastfed infants, or its impact on milk production. When considering the use of RUCONEST, the developmental and health benefits of breastfeeding should be balanced with the mother's clinical need, while also assessing potential adverse effects on the breastfed child from RUCONEST or the maternal condition.

3. Has RUCONEST been tested in pediatric patients?Yes, the safety and efficacy of RUCONEST were evaluated in 17 adolescent patients aged 13-17 years who were treated for HAE attacks. Some adverse reactions were observed in these patients, with the most common being abdominal pain, headache, and oropharyngeal pain. However, no serious adverse reactions were reported.

4. Is RUCONEST suitable for use in geriatric patients?Clinical studies of RUCONEST included seven patients older than 65 years, but the number of patients in this age group was insufficient to determine whether they respond differently from younger patients.

FAQ Data Source

Dosage & Administration

Dosage & Administration

drug label

Ruconest Prescribing Information

prior authorization

Ruconest Prior Authorization Resources

Most recent state uniform prior authorization forms

Benefits investigation

pharmacy

Ruconest Preferred Pharmacy

financial assistance

Ruconest Financial Assistance Options

Copay savings program

Bridge program

Foundation programs

patient education

Ruconest Patient Education

Getting started on Ruconest

Patient toolkit

Other resources

people also ask

Ruconest FAQs