SEE COMMONLY ASKED QUESTIONS AND HELPFUL ANSWERS ABOUT HAEGARDA.
Who can take HAEGARDA?
HAEGARDA, the only subcutaneous injectable C1-INH for the prevention of HAE attacks, is approved for use in adults and patients 6 years of age and older. You should not use HAEGARDA if you have experienced life-threatening immediate hypersensitivity reactions, including anaphylaxis, to HAEGARDA.
Can my child take HAEGARDA?
HAEGARDA is approved for patients age 6 years and over. The safety and effectiveness of HAEGARDA were evaluated in a subgroup of nine patients 8 to <17 years of age, in the randomized, double-blind, placebo-controlled, crossover, routine prophylaxis trial (Study 1) and the randomized, open-label, active treatment-controlled study (Study 2). Results of subgroup analysis by age were consistent with overall study results.
Talk to your doctor about how HAEGARDA may be an effective and safe therapy for your child.
Where can I find instructions for self-administering HAEGARDA?
In addition to instructions your doctor gives you and the instructions in the Patient Product Information that comes with each shipment of your medication, the HAEGARDA Welcome Kit includes a flip chart–style booklet with step-by-step instructions for self-administering HAEGARDA. You'll also find a USB drive with an instructional video within the kit. You can learn how to self-administer HAEGARDA from a HAEGARDA nurse.
Do I still need my on-demand rescue medication?
Yes. HAEGARDA can significantly reduce the number of HAE attacks you experience, but you should always be prepared with rescue medication in case of any breakthrough attacks.
How quickly does HAEGARDA work?
HAEGARDA starts raising your C1-INH levels right away, after your first dose. It may take 3 to 4 doses of HAEGARDA (or a couple of weeks) for your C1-INH levels to stabilize. While your levels are being stabilized, it is important to work with your doctor. Always be prepared with on-demand therapy in case of any breakthrough attacks.
How do I determine the correct dose? What if my weight changes?
Your doctor will calculate and prescribe a dose that’s right for you based on your body weight. Talk to your doctor about changes in weight that may affect your dose.
What should I do if I miss a dose?
Call your doctor if you miss a dose. Remember you should always have your rescue medication with you.
How should I store HAEGARDA?
Even though HAEGARDA is delivered in a refrigerated package, it does not need to be refrigerated after delivery and can be stored up to 30°C (86°F). Keep it in the original carton to protect it from light until ready for use, and do not freeze. HAEGARDA can be used up to 8 hours after reconstitution. Store reconstituted solution at room temperature and in the original vial. Do not refrigerate.
Can I travel with HAEGARDA?
Yes. Because it can be self-administered and does not need to be refrigerated, you can take HAEGARDA with you wherever you go. HAEGARDA can be stored up to 30°C (86°F). Keep it in the original carton to protect it from light until ready for use, and do not freeze. HAEGARDA can be used up to 8 hours after reconstitution. Store reconstituted solution at room temperature and in the original vial. The HAEGARDA Welcome Kit includes a few items to make traveling even easier, such as a travel bag for your medication, travel tips, a medical travel card, and medical letters. When traveling by plane, always carry medication with you on board.
What are the most common side effects of HAEGARDA?
The most common side effects of HAEGARDA are injection-site reactions (pain, redness, swelling), hypersensitivity (itching and rash), nasopharyngitis (runny or stuffy nose), and dizziness. Because HAEGARDA is injected under the skin, local reactions are common and expected. These are not all the possible side effects of HAEGARDA. Tell your doctor about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 1-800-FDA-1088.
How is HAEGARDA made?
HAEGARDA is made from human plasma that is collected and screened from carefully selected plasma donors. It goes through an advanced purification process that includes thorough testing for viruses, pasteurization (heat treatment for 10 hours), and virus nanofiltration. With 65 years of experience developing products with human plasma, CSL Behring is a global leader in the plasma protein industry. We have developed and own all collection, manufacturing, and distribution systems for HAEGARDA, maintaining high quality and safety standards.
How does HAEGARDA work?
HAEGARDA treats the root cause of HAE: missing or nonfunctioning C1 inhibitor (C1-INH), a key protein in your body that controls swelling. HAEGARDA adds functional C1-INH to your body. And because of its dosing and subcutaneous delivery, HAEGARDA helps your C1-INH levels stay high enough to reduce the risk of an HAE attack from happening in the first place.
Can I take other medications while on HAEGARDA?
It is important to speak to your doctor about any medications you take, including over-the-counter and herbal supplements.
Is there someone I can call if I have more questions about HAEGARDA?
Yes! HAEGARDA ConnectSM can assist you with your HAEGARDA treatment by coordinating care and helping answer insurance questions, as well as providing financial support and educational resources. Whenever you have questions about HAEGARDA or need support living with HAE, call HAEGARDA Connect at 1-844-HAEGARDA (1-844-423-4273), from 8 AM to 8 PM ET.
What if I forget how to mix or inject the product?
CSL Behring offers self-administration training through HAEGARDA ConnectSM. A HAEGARDA nurse will teach you, parents, and/or caregivers online or in person how to prepare the medicine and self-administer it correctly. To speak with someone from HAEGARDA ConnectSM call 1-844-HAEGARDA (1-844-423-4273). Or visit https://www.haegarda.com/support-resources for more information.
You can also find helpful information about mixing and injecting HAEGARDA in the Gather, Give, and Go Brochure or the Patient Product Information that comes with each shipment of your medication.
For additional resources, including self-administration training, please visit https://www.haegarda.com/support-resources.
How can I connect with other people taking HAEGARDA?
The HAEGARDA Advocate Program lets you communicate with people who have personal experience living with HAE and understand what you’re going through. They can offer you encouragement, assistance, and advice, as well as share their experiences with HAEGARDA.*
*Advocates are not healthcare providers or medical experts and are compensated for their participation. For medical questions you should contact your physician.
How do I know if my insurance will cover HAEGARDA?
Through HAEGARDA ConnectSM, you will be assigned a dedicated Case Manager who will work with your insurance provider to determine your coverage and guide you through all of the available financial assistance options.
Is HAEGARDA available at my local pharmacy, or only through specialty pharmacies?
HAEGARDA is only available through specialty pharmacies. Your doctor will fill out a HAEGARDA Prescription & Service Request Form, and send it to HAEGARDA ConnectSM, where we will conduct an insurance benefit investigation, share information with you about financial support programs, and ultimately have HAEGARDA shipped directly to you through a specialty pharmacy.
How is HAEGARDA administered?
HAEGARDA is a treatment you can administer yourself after proper training. It is an injection given just under the skin twice a week (every 3 to 4 days) as prescribed by your doctor. You can learn how to self-administer HAEGARDA from a nurse. Your HAEGARDA nurse will teach you how to prepare the medicine and how to safely and correctly self-administer it. Once you’ve been trained, you will have access to additional support from your nurse. This training program is provided through HAEGARDA ConnectSM at no cost to you.