Prescribing guide
Andembry (garadacimab-gxii)Loading and monthly dosing, ANDEMBRY Connect enrollment, aPTT interference and prior authorization criteria for hereditary angioedemaFor prescribers and their offices treating hereditary angioedema (HAE): what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS; referral form to ANDEMBRY Connect by electronic form or fax, prior authorization, specialty pharmacy shipment, and injection training before the first self-injection.
Example PA threshold
Cigna example: age 12 or older; HAE type I or II with functional C1-INH under 50% and low C4, both documented; allergist, immunologist or HAE specialist; employer plans step through Haegarda and Takhzyro; no concomitant preventive HAE therapy.
Monitoring
No scheduled lab monitoring in the label; aPTT may be prolonged by assay interference, and PT or INR rose in some patients, none with bleeding events; no warnings and precautions.
Support line
ANDEMBRY Connect, 1-844-423-4273, Monday to Friday 8 AM to 8 PM ET; referral fax 1-866-415-2162; co-pay support for commercial patients under program terms; QuickStart 1-month supply at no cost, up to 2 months for eligible patients.
Give your patient their plan
A one-page handout for starting Andembry, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/andembryBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| No REMS | The label sets no REMS, no boxed warning, no contraindications and no warnings and precautions, and Andembry does not appear on the FDA REMS list. | FDA REMS list |
| Referral form | Complete the referral form, by electronic form or on paper. CSL Behring recommends starting before the patient's visit in case the insurer asks for more information. | HCP enrollment page |
| PA checklist | CSL Behring's checklist covers what major payers most often require: ICD-10-CM D84.1, C4, C1-INH antigenic and functional levels below the lab's lower limit of normal, attack history, therapy history and a treatment plan. It is not specific to one plan. | CSL Behring PA checklist |
| Submission | Use the electronic form, or fax the completed form(s) to ANDEMBRY Connect at 1-866-415-2162. ANDEMBRY Connect confirms receipt and may contact the office for additional documents requested by the insurer. | HCP enrollment page |
| Office support | A dedicated case manager for each office, benefits verification and prior authorization support (if applicable), financial assistance under program terms, and injection training through the ANDEMBRY Connect nursing team. QuickStart is listed for commercially and government-insured patients. | HCP support page |
| QuickStart terms | A 1-month supply shipped at no cost; eligible patients can continue for up to 2 months, and supply may be extended during the insurance approval process. Patients may not seek insurance reimbursement for QuickStart product, and it may not count toward true out-of-pocket cost for a Part D enrollee. | ANDEMBRY Connect |
| Patient contact | CSL Behring asks patients to answer 3 calls: ANDEMBRY Connect (1-844-423-4273), the specialty pharmacy scheduling the shipment (1-855-393-3656), and the self-administration nurse (1-941-556-8515) if the patient chooses nurse training. | ANDEMBRY Connect |
| Injection training | Train the patient or caregiver in preparation and subcutaneous technique before treatment starts. The Instructions for Use say children should inject under the supervision of an adult. | FDA label |
Prior authorization criteria and what to document
One public policy as the example: Cigna, January 1, 2026. Approval 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Age | 12 years of age or older | Date of birth on the request | Cigna policy |
| Diagnosis | HAE type I or II, with functional C1-INH below 50% of normal at baseline, as defined by the laboratory reference values | C1-INH functional lab report with reference range [documentation required] | Cigna policy |
| C4 | Serum C4 below normal at baseline, as defined by the laboratory reference values | C4 lab report with reference range [documentation required] | Cigna policy |
| Exclusion | HAE with normal C1-INH (type III) does not satisfy the diagnosis requirement, at initial review or continuation | Lab results that show C1-INH deficiency | Cigna policy |
| Prescriber | Prescribed by or in consultation with an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders | Specialty on the request, or the consult note | Cigna policy |
| Preferred products | Employer plans: the patient has tried both Haegarda and Takhzyro (each requires prior authorization), or is currently receiving Andembry | Therapy history on the request | Cigna policy |
| Dosing | Loading dose of 400mg as a one-time subcutaneous injection, or maintenance of 200mg no more frequently than once every month | Regimen on the request; other doses reviewed case by case | Cigna policy |
| Combination | Concomitant long-term prophylaxis with other HAE preventives (Cinryze, Haegarda, Orladeyo, Takhzyro) is not medically necessary; on-demand and short-term procedural use is allowed | Medication list on the request | Cigna policy |
| Continuation | Diagnosis of HAE type I or II [documentation required] and, per the prescriber, a favorable response since starting Andembry, such as fewer, less severe or shorter attacks; approval for 1 year | Attack log against pre-prophylaxis baseline | Cigna policy |
| Reauthorization labs | CSL Behring's checklist says payers may request both current and pretreatment C4 and C1-INH labs for existing patients | Historic HAE-related labs | CSL Behring PA checklist |
Andembry dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1, loading dose | 400mg subcutaneously, given as two 200mg injections. | FDA label |
| Maintenance | 200mg subcutaneously every month. Same dose for adult and pediatric patients aged 12 years and older; not established under age 12. | FDA label |
| Presentations | 200mg/1.2mL single-dose prefilled autoinjector (carton NDC 63833-925-01) and 200mg/1.2mL (167mg/mL) single-dose prefilled syringe with needle safety device (carton NDC 63833-920-01), 1 per carton, per section 16. The DailyMed listing carries product data, carton labeling and Instructions for Use for the autoinjector only. | FDA label |
| Administration | For self-administration or caregiver administration after training. Remove from the refrigerator and allow to sit for 30 minutes at room temperature; inspect for particulate matter and discoloration. The solution is slightly opalescent to clear, brownish-yellow to yellow. | FDA label |
| Injection sites | Thigh or abdomen, staying 1 inch (2cm) from the navel. The upper arm can also be used if a caregiver administers the injection. | FDA label |
| Missed dose | Administer the dose as soon as possible. The label gives no further instruction on the timing of later doses. | FDA label |
| Pharmacokinetics | Tmax median 6 days (range 2 to 15); half-life 17.4 days; absolute bioavailability 39%. Exposure after the 400mg loading dose is 133% of steady-state exposure on 200mg monthly. FXIIa-mediated kallikrein activity was inhibited after the first dose. | FDA label |
| Specific populations | No clinically significant PK differences by age (12 to 73 years), sex, race, body weight (43 to 153kg, about 95 to 337 pounds) or mild to moderate renal impairment (eGFR 30 to under 90). Severe renal impairment is unstudied. | FDA label |
| Storage | 2°C to 8°C (36°F to 46°F) in the original carton to protect from light; do not freeze or shake. The Instructions for Use say not to return the autoinjector to the refrigerator after it reaches room temperature, and not to use one that has been frozen. | FDA label |
Monitoring the Andembry label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Routine labs | None specified | The label has no warnings and precautions and sets no scheduled laboratory monitoring | FDA label |
| Any time | Injection site reactions | 23 of 164 patients (14%) across VANGUARD and the open-label study: bruising, erythema, hematoma, pruritus, urticaria | FDA label |
| VANGUARD, 6 months | Common adverse reactions | Nasopharyngitis 21% against 12% on placebo; abdominal pain 8% against 0 | FDA label |
| Coagulation labs | aPTT | Above 1.4x ULN in 3 patients (8%) against 0 on placebo; assay interference from FXIIa inhibition; not associated with bleeding events | FDA label |
| Coagulation labs | PT or INR | Above 1.3x ULN in 6 patients (15%) against 1 (4%) on placebo; not associated with bleeding events | FDA label |
| Immunogenicity | Anti-drug antibodies | 1 of 39 (2.6%) in VANGUARD; no effect on PK, safety or clinical response | FDA label |
| Attack control | Monthly attack rate | VANGUARD: LS mean 0.22 against 2.07 on placebo, an 89.2% reduction (95% CI 75.6 to 95.2); 62% attack free over 6 months against 0% | FDA label |
| Renewal | Attack frequency, severity or duration | Cigna approves 1 year at a time; continuation needs a favorable response according to the prescriber | Cigna policy |
Andembry drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Other drugs | No dedicated drug interaction studies have been conducted in humans. | FDA label |
| aPTT assay | Andembry can prolong aPTT because aPTT reagents initiate intrinsic coagulation through FXII activation in the contact system, which garadacimab-gxii inhibits. | FDA label |
| On-demand HAE therapy | All VANGUARD patients were allowed on-demand medications for attacks; other prophylactic HAE medications were discontinued before study entry. | FDA label |
| Pregnancy | No human pregnancy data; monoclonal antibodies cross the placenta during the third trimester. No fetal harm in rabbits at about 100 times the MRHD exposure. | FDA label |
| Lactation | No data on presence in human or animal milk, effects on the breastfed infant or milk production. Maternal IgG is known to be present in human milk. | FDA label |
| Pediatric and geriatric use | Established from age 12, supported by 6 pediatric patients in VANGUARD (4 on Andembry). Six treated patients (9%) were 65 or older, with no overall differences in safety or effectiveness. | FDA label |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
Questions prescribers' offices ask about Andembry
What is the Andembry dose?
400mg subcutaneously on the first day, given as two 200mg injections, then 200mg every month, per the June 2025 label (section 2.1). The dose is the same for adult and pediatric patients aged 12 years and older; a missed dose is given as soon as possible.
Does Andembry have a REMS or required lab monitoring?
No. The June 2025 label has no REMS, no boxed warning, no contraindications, no warnings and precautions (sections 4 and 5 read "None") and no scheduled lab monitoring, and Andembry is not on the FDA REMS list. The most common adverse reactions, at 7% or more, were nasopharyngitis and abdominal pain.
Does Andembry affect coagulation tests?
Yes. Per the June 2025 label (sections 6.1 and 7.1), aPTT above 1.4x ULN occurred in 3 patients (8%) on Andembry against 0 on placebo in VANGUARD, because garadacimab-gxii inhibits the FXIIa that aPTT reagents rely on. PT or INR above 1.3x ULN occurred in 6 (15%) against 1 (4%); none was associated with bleeding events.
How do I enroll a patient in ANDEMBRY Connect?
Fax the completed referral form to ANDEMBRY Connect at 1-866-415-2162, or use the electronic form on the Andembry prescriber site. ANDEMBRY Connect confirms receipt and may ask for documents the insurer requests; the line is 1-844-423-4273, Monday to Friday, 8 AM to 8 PM ET. The QuickStart Program ships a 1-month supply at no cost.
What do insurers ask for to approve Andembry?
The Cigna policy shown here, effective January 1, 2026, asks for age 12 or older, HAE type I or II with functional C1-INH under 50% of normal and a low C4, both documented, and an allergist, immunologist or HAE specialist. Employer plans also require a trial of both Haegarda and Takhzyro unless the patient is already on Andembry. Approval is for 1 year; it cites the June 2025 label.
Free email alert
Get an email when the Andembry label changes
One email the day the FDA revises the Andembry prescribing information, with a summary of what changed. No trial alerts or newsletter, and you can stop anytime.
Label changes for Andembry only, usually a few a year and some years none. Stop anytime. We never share your email. Privacy policy
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, 2025-06-30.
- Approved Risk Evaluation and Mitigation Strategies (REMS), FDA, 2026-11-11.
- ANDEMBRY Connect - ANDEMBRY® (garadacimab-gxii), CSL Behring, 2026-11-11.
- ANDEMBRY® (garadacimab-gxii) | Breaking New Ground In HAE Protection, CSL Behring, 2026-11-11.
- Patient Enrollment - ANDEMBRY garadacimab, CSL Behring, 2026-11-11.
- Support - ANDEMBRY garadacimab, CSL Behring, 2026-11-11.
- Hereditary Angioedema (HAE) Prior Authorization Submission Checklist (USA-AND-0024-JUN25), CSL Behring, 2025-06-19.
- USA Support and Assistance | CSL, CSL, 2026-11-11.
- Hereditary Angioedema - Andembry, Drug Coverage Policy IP0755, Cigna, 2026-01-01.
- BLA 761367 approval letter, Andembry (garadacimab-gxii), FDA, 2025-06-16.
A reference drawn from the June 30, 2025 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 11, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.