Haegarda Prescribing & Dosing Schedule

Q: 1. Is it safe to use HAEGARDA during pregnancy?

There are no prospective clinical data from HAEGARDA use in pregnant women. However, limited retrospective data suggest that C1-INH treatment during pregnancy did not lead to adverse events. The estimated background risk of birth defects and miscarriage in the general U.S. population is 2-4% and 15-20%, respectively.

Q: 2. What is known about HAEGARDA use during lactation?

There is no information available about the presence of HAEGARDA in human milk, its impact on breastfed infants, or its effects on milk production. The decision to breastfeed should consider the benefits of breastfeeding and the mother's clinical need for HAEGARDA, while also evaluating potential adverse effects on the breastfed infant.

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

Yes, the safety and effectiveness of HAEGARDA were evaluated in a subgroup of patients aged 8 to <17 years in clinical trials, and the results were consistent with overall study results.

Dosage & Administration

For subcutaneous use after reconstitution only.

* Administer 60 International Units per kg body weight twice weekly (every 3 or 4 days).
* Reconstitute HAEGARDA prior to use using Sterile Water for Injection, USP.
* Use a silicone-free syringe for reconstitution and administration.
* Administer at room temperature within 8 hours after reconstitution.

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Haegarda Prescribing Information

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Haegarda Prior Authorization Resources

Most recent state uniform prior authorization forms

Verified: Sep 24, 2024Arizona - Uniform Prior Authorization Form

Verified: Sep 24, 2024Colorado - Uniform Prior Authorization Form

Verified: Sep 24, 2024Hawaii - Uniform Prior Authorization Form

Verified: Sep 24, 2024Illinois - Uniform Prior Authorization Form

Verified: Sep 24, 2024Indiana - Uniform Prior Authorization Form

Verified: Sep 24, 2024Louisiana - Uniform Prior Authorization Form

Verified: Sep 24, 2024Minnesota - Uniform Prior Authorization Form

Verified: Sep 24, 2024New Hampshire - Uniform Prior Authorization Form

Verified: Sep 24, 2024New Mexico - Uniform Prior Authorization Form

Verified: Sep 24, 2024Oregon - Uniform Prior Authorization Form

Verified: Sep 24, 2024Texas - Uniform Prior Authorization Form

Verified: Oct 05, 2024Washington - Uniform Prior Authorization Form

Verified: Oct 05, 2024Wisconsin - Uniform Prior Authorization Form

Coverage Authorization Appeals

Formulary Exception Letter

Complete Letter of Medical Necessity

Prior Authorization Checklist

Benefits investigation

Haegarda Prescription Referral Form

Haegarda Financial Assistance Options

Copay savings program

Haegarda Prescription Referral Form

Enroll in Patient Savings Program

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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

Haegarda Quickstart Program

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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)

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Haegarda Patient Education

Getting started on Haegarda

Instructions For Use: Hereditary Angioedema (HAE)

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Patient toolkit

About Haegarda

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Patient Stories

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Women and Hereditary Angioedema Brochure

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Managing HAE Checklist

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Doctor Discussion Guide

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Haegarda Compliance Brochure

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Helpful Tips for Safe Travel

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Travel Medical Letter

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Haegarda FAQs

1. Is it safe to use HAEGARDA during pregnancy?

2. What is known about HAEGARDA use during lactation?

3. Has HAEGARDA been tested in pediatric patients?

4. Is HAEGARDA suitable for use in geriatric patients?

Clinical studies of HAEGARDA did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently from younger subjects. However, reported clinical experience has not identified differences in responses between the elderly and younger patients. Dosing for elderly patients should be cautious and typically start at the lower end of the dosing range, considering factors like decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapies.

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