Your first 90 days
Your first 90 days on Andembry for hereditary angioedema (HAE)
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Andembry has no safety program forms, no required blood tests and no dose build-up beyond a first-day loading dose. The first injections wait on a referral form, an insurance approval, a pharmacy delivery and injection training. After that the routine is one refrigerated autoinjector a month. This page lays out those weeks from the FDA label, CSL Behring's own Andembry pages and one insurer's written rules.
What has to happen before the first bottle ships
Andembry has no REMS, so the first dose waits on the referral form, a prior authorization, a pharmacy delivery and injection training. These are the 6 things in the way, in order.
The referral form
CSL Behring's prescriber site asks the office to complete a referral form and send it to ANDEMBRY Connect.
- The office can use the electronic form or fax it.
- ANDEMBRY Connect confirms receipt and may ask for more documents the insurer requests.HCP enrollment page
Three calls to answer
CSL Behring asks you to answer 3 calls.
- ANDEMBRY Connect calls from 1-844-423-4273, and the specialty pharmacy calls from 1-855-393-3656 to schedule the shipment.
- A training nurse calls from 1-941-556-8515 if you choose nurse training.ANDEMBRY Connect
The insurance approval
Plans such as Cigna require prior authorization.
- Cigna asks for lab results showing HAE type I or type II and an allergist, immunologist or HAE specialist.Cigna policy
A QuickStart supply at no cost
ANDEMBRY Connect says the QuickStart Program ships a 1-month supply at no cost.
- Eligible patients can continue and receive up to 2 months.
- CSL Behring says the supply may be extended during the insurance approval process.ANDEMBRY Connect
Injection training
ANDEMBRY Connect offers injection training and product support through its nursing team.
- A nurse calls to schedule the training if you choose to be trained by a nurse.ANDEMBRY Connect
A medicine list for your care team
The Patient Information asks you to tell your provider about every medicine, vitamin and herbal supplement.
- The label says no dedicated drug interaction studies have been done in humans.FDA label
The days that matter
Counted from the first-day loading dose, with one dose a month after it and one carton for each dose. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Referral form, then the insurance check
The office sends the referral form to ANDEMBRY Connect online or by fax.
- ANDEMBRY Connect confirms receipt and may ask the office for documents the insurer requests.
- No source sets how long approval takes.
Three calls
Your case manager helps coordinate the QuickStart request, and the specialty pharmacy calls to schedule the shipment.
- A nurse calls too if you choose nurse training.
Delivery and injection training
The autoinjectors go into the refrigerator in their original cartons.
- The label says a healthcare provider should train you or your caregiver before the first injection.
Loading dose
The label's first-day dose is 400mg, given as two 200mg injections under the skin.
- The instructions say to take each autoinjector out of the refrigerator 30 minutes before use.
Refills, one carton a month
Each carton holds one single-dose autoinjector, so each monthly dose is one carton.
- The label does not set how many cartons a pharmacy ships at once.
First monthly dose, then every month
The maintenance dose is 200mg, one autoinjector, once a month.
- On a monthly schedule, the next doses fall around days 61 and 91.
Refills, number 2
First monthly dose, number 2
Refills, number 3
Three months in
By now the label schedule has covered the loading dose and 2 monthly doses.
- In the 6-month main trial, 62% of people on Andembry had no attacks, against 0% on placebo.
First monthly dose, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Andembry label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated June 30, 2025, read from the FDA's label database today. FDA label
- June 2025
The FDA first approved Andembry on June 16th to prevent HAE attacks in adults and children 12 and older. The approval letter names a 200mg prefilled autoinjector and a 200mg prefilled syringe.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- The dose
The first-day loading dose is 400mg, given as two 200mg injections.
- After that the dose is 200mg once a month.
- The label gives one dose for adults and children 12 and older.FDA label
- Who gives the shot
Andembry is meant for self-injection or injection by a caregiver, after training by a healthcare provider.
- The instructions say children should inject under the supervision of an adult.FDA label
- Where the shot goes
The instructions say to inject into the thigh or the belly, staying 1 inch (2cm) away from the belly button.
- A caregiver can also use the upper arm.
- The instructions say to change the spot with each injection.FDA label
- How the autoinjector works
The injection may take up to 15 seconds.
- The instructions say to keep pressing until the yellow plunger fills the window and 5 seconds have passed after the second click.
- They also say never to put the clear cap back on, because this could start the injection.FDA label
- If a dose is missed
The label says to give a missed dose as soon as possible.
- It gives no further detail, so the prescriber decides how the doses after it are timed.FDA label
- It prevents attacks, it does not treat one
The label approves Andembry only to prevent HAE attacks.
- In the main trial, everyone could use on-demand medicine to treat attacks.
- The allergist decides which on-demand medicine you keep on hand.FDA label
- Clotting tests can read high
Andembry can lengthen the aPTT blood clotting test because of how the test works.
- In the main trial, none of the longer clotting times came with bleeding.
- The prescriber can explain what this means for any clotting test you need.FDA label
- Storage
Keep autoinjectors in the refrigerator at 36°F to 46°F (2°C to 8°C), in the original carton to block light.
- Do not freeze or shake them.
- The instructions say not to use an autoinjector that was frozen, even if it has thawed.FDA label
- Warming before the shot
Take the autoinjector out 30 minutes before injecting.
- The instructions say not to warm it in a microwave, in hot water or in direct sunlight.
- Once it reaches room temperature, it does not go back in the refrigerator.FDA label
- Dropped or damaged autoinjectors
The instructions say not to use an autoinjector that was dropped on a hard surface, looks damaged, is leaking or has expired.
- The medicine should be brownish-yellow to yellow, without particles.
- Air bubbles are normal.FDA label
- Needles and sharps
Put each used autoinjector in a sharps container after the injection, and never reuse it.
- The clear cap goes in the sharps container too.
- The instructions describe a heavy-duty plastic container with a tight lid if you do not have an FDA-cleared one.FDA label
- Pregnancy and breastfeeding
There are no data on Andembry in pregnant women.
- The label says antibodies like it cross the placenta during the third trimester.
- It is not known whether it passes into breast milk.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
A dose that may not have gone in
The instructions say to contact your healthcare provider right away if you think you did not get the full dose.
- A full dose means the yellow plunger filled the window and stopped moving.FDA label
Reactions where the shot went in
Redness, itchiness and bruising at the injection site are among the most common side effects.
- Across the main trial and a longer open-label study, 14% of 164 people reported injection site reactions.FDA label
Other common side effects
Stomach pain and a runny or stuffy nose, sneezing and watery eyes were the other common side effects.
- In the main trial, nasopharyngitis occurred in 21% on Andembry against 12% on placebo.
- The Patient Information says to tell your provider about any side effect that bothers you or does not go away.FDA label
Attacks that keep coming
In the 6-month main trial, the monthly attack rate on Andembry was 89% lower than on placebo.
- No attacks at all were seen in 62% on Andembry, so breakthrough attacks can still happen.
- The allergist decides what they mean for the plan.FDA label
What CSL Behring says about rescue medicine
CSL Behring's Andembry patient site says attacks can still occur with all HAE medications.
- It says patients should always have a rescue medication.Andembry patient site
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- Prior authorization pending or deniedCigna asks for a functional C1-INH level under 50% of normal and a low C4 level, each with lab documentation. It also wants an allergist, immunologist or HAE specialist, and a patient aged 12 or older.Cigna policy
- Other medicines the plan wants tried firstFor employer plans, Cigna approves Andembry if the patient has tried both Haegarda and Takhzyro, or is already receiving Andembry. The policy lists this step in its table for employer plans.Cigna policy
- HAE with normal C1-INHCigna's policy says HAE with normal C1-INH, also called type III, does not meet its diagnosis requirement. That holds for first approvals and for renewals.Cigna policy
- Another preventive medicine at the same timeCigna lists Andembry used with other preventive HAE medicines, such as Cinryze, Haegarda, Orladeyo or Takhzyro, as not medically necessary. Medicines that treat an attack, or prevent one around a procedure, are allowed.Cigna policy
- A dose the plan will not coverCigna approves a one-time 400mg loading dose, then 200mg no more often than once a month. Other doses go to case-by-case review by a Cigna clinician.Cigna policy
- Paperwork the insurer asks forCSL Behring's checklist lists what major insurers most often ask for, including C4 and C1-INH lab results, attack history and earlier treatments. It says CSL Patient Services can help the office at 1-844-423-4273.CSL Behring PA checklist
- A copay you cannot payANDEMBRY Connect lists co-pay support for people with commercial insurance, subject to program terms. It says it shares resources that can help people with government insurance. It also describes help getting therapy, potentially at little to no cost.ANDEMBRY Connect
Cigna prior authorization policy, January 1, 2026
- Age 12 or older
- HAE type I or type II, with a functional C1-INH protein level under 50% of normal at baseline, with lab documentation
- A serum C4 level below normal at baseline, with lab documentation
- HAE with normal C1-INH, also called type III, does not meet the diagnosis requirement
- Prescribed by or in consultation with an allergist, immunologist or a physician who specializes in HAE
- For employer plans, a trial of both Haegarda and Takhzyro, unless the patient is already receiving Andembry
- A one-time 400mg loading dose, then 200mg no more often than once every month
- Not used together with another preventive HAE medicine such as Cinryze, Haegarda, Orladeyo or Takhzyro
Approval length. Approved a year at a time. Renewal asks for HAE type I or II and a favorable response, such as fewer, milder or shorter attacks.
This is a new policy that took effect January 1, 2026. It cites the June 2025 prescribing information, which is the current label. Its step through Haegarda and Takhzyro sits in the table for employer plans. Other plans set their own criteria. It is here as an example, not as a rule. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- A dedicated case manager for one-on-one support
- Injection training and product support from the ANDEMBRY Connect nursing team
- Co-pay support for people with commercial insurance, subject to the program's terms and conditions
- Insurance navigation for eligible patients, and resources that can help people with government insurance
- The QuickStart Program, a 1-month supply at no cost, with up to 2 months for eligible patients
- The ANDEMBRY Mentor Program, a chance to learn from someone with experience of HAE and of Andembry
- QuickStart for commercially and government-insured patients, according to CSL Behring's prescriber site HCP support page
- In-home nurse training for patients new to therapy, and nurse support by phone CSL Behring support programs
Details as the drugmaker publishes them. ANDEMBRY Connect
Five questions for the pharmacist or the support line
- How many autoinjectors come in the first shipment, since the first-day dose uses two?
- When will each monthly shipment arrive, and who do I call to schedule it?
- What do I do if a shipment arrives warm or frozen?
- Where can I get a sharps container for used autoinjectors?
- Which on-demand HAE medicine do I keep at home, and is that prescription current?
Questions people ask in the first weeks
How often is Andembry given?
Once a month, after a first-day loading dose. The label dose is 400mg on the first day, given as two 200mg injections, then 200mg once a month. The dose is the same for adults and children 12 and older.
Can I give Andembry myself?
Yes, the label says Andembry is meant for self-injection or injection by a caregiver, after training by a healthcare provider. The instructions say children should inject under the supervision of an adult. ANDEMBRY Connect offers injection training through its nursing team.
Does Andembry treat an HAE attack?
No, the label approves it only to prevent attacks. In the main trial, everyone could use on-demand medicine to treat attacks. The allergist or immunologist decides which on-demand medicine you keep on hand.
Do I need blood tests on Andembry?
No, the label sets no routine blood tests. Andembry can lengthen the aPTT clotting test because of how the test works. In the main trial, none of the longer clotting times came with bleeding.
How do I store Andembry?
In the refrigerator at 36°F to 46°F (2°C to 8°C), in the original carton, never frozen or shaken. Take it out 30 minutes before the injection. The instructions say not to put it back in the refrigerator after it reaches room temperature.
What if I miss a dose of Andembry?
The label says to give a missed dose as soon as possible. It gives no further detail, so the prescriber decides how the doses after it are timed.
Is there help paying for Andembry?
ANDEMBRY Connect lists co-pay support for people with commercial insurance, subject to program terms. It says it shares resources that can help people with government insurance. Its QuickStart Program ships a 1-month supply at no cost, with up to 2 months for eligible patients.
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Sources
- DailyMed - ANDEMBRY- garadacimab injection, solution (prescribing information revised 6/2025, Patient Information revised 06/2025, Instructions for Use approved 06/2025), CSL Behring LLC, via DailyMed, June 30, 2025.
- Approved Risk Evaluation and Mitigation Strategies (REMS), FDA, November 11, 2026.
- ANDEMBRY Connect - ANDEMBRY® (garadacimab-gxii), CSL Behring, November 11, 2026.
- ANDEMBRY® (garadacimab-gxii) | Breaking New Ground In HAE Protection, CSL Behring, November 11, 2026.
- Patient Enrollment - ANDEMBRY garadacimab, CSL Behring, November 11, 2026.
- Support - ANDEMBRY garadacimab, CSL Behring, November 11, 2026.
- Hereditary Angioedema (HAE) Prior Authorization Submission Checklist (USA-AND-0024-JUN25), CSL Behring, June 19, 2025.
- USA Support and Assistance | CSL, CSL, November 11, 2026.
- Hereditary Angioedema - Andembry, Drug Coverage Policy IP0755, Cigna, January 1, 2026.
- BLA 761367 approval letter, Andembry (garadacimab-gxii), FDA, June 16, 2025.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing allergist or immunologist. Found an error? Use the report link in the footer and it will be checked against the source.