Lanadelumab-flyo injection
Lanadelumab-flyo injection is a targeted antibody therapy used to prevent attacks of hereditary angioedema (HAE) in adults and children age 2 and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Lanadelumab-flyo injection: Patient Information Guide
A plain-language walkthrough of Lanadelumab-flyo injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Lanadelumab-flyo injection is approved as a preventive therapy for hereditary angioedema (HAE). Here is what the evidence supports:
- Takhzyro is indicated to prevent HAE attacks in adults and pediatric patients aged 2 years and older.
- HAE is a rare genetic condition (Types I and II) caused by deficiency or dysfunction of a protein called C1-inhibitor, leading to recurrent episodes of severe swelling.
- Takhzyro is a preventive (prophylactic) medication — it is taken on a regular injection schedule to reduce how often attacks occur, not to stop an attack once it starts.
⚙️How it works▾
In people with HAE, a blood protein called plasma kallikrein is not properly regulated. When it becomes overactive, it produces large amounts of bradykinin — a substance that causes blood vessel walls to become leaky, leading to the swelling and pain of an HAE attack. Takhzyro is a fully human monoclonal antibody that attaches directly to plasma kallikrein and blocks its activity, keeping bradykinin levels under control and significantly reducing attack frequency.
💊How it's taken▾
Takhzyro is given as a subcutaneous (under the skin) injection on a regular schedule. The frequency depends on age and how well the condition is controlled — some patients inject every 2 weeks, and others every 4 weeks. Adults and patients 12 and older may self-inject or have a caregiver do it after appropriate training. Children under 12 should receive injections from a healthcare provider or trained caregiver.
- Always follow the specific schedule your prescriber has recommended.
- If you're unsure about a missed or late dose, contact your prescriber or pharmacist rather than doubling up.
- Keep rescue medication available at all times in case of a breakthrough HAE attack.
🤒Side effects — in detail▾
The most common side effects with Takhzyro include:
- Injection site reactions — pain, redness, bruising, or swelling at the injection site
- Upper respiratory infections (colds)
- Headache
- Rash
- Dizziness
- Diarrhea
- Muscle aches (myalgia)
Serious but less common reactions include severe allergic (hypersensitivity) responses and liver enzyme elevations. Seek medical attention right away if you develop difficulty breathing, hives, facial swelling, or feel faint after an injection.
⚠️Warnings & precautions▾
- Allergic reactions: Hypersensitivity reactions have been reported. If you have a severe reaction — trouble breathing, hives, swelling of the face or throat — stop the injection and get emergency help immediately.
- Liver enzyme changes: Some patients developed temporary, asymptomatic elevations in liver enzymes (ALT and AST). Your doctor may monitor your liver during treatment. One patient stopped treatment due to this.
- Lab test interference: Takhzyro can cause a falsely elevated result on a blood clotting test called aPTT. This does not mean you have a bleeding problem, but it is important to tell any healthcare provider or lab that you are on Takhzyro before blood tests are drawn.
🔀What it interacts with▾
No dedicated formal drug interaction studies have been performed with Takhzyro. Based on available data:
- Common medications (pain relievers, antibiotics, antihistamines, anti-inflammatory drugs) — did not affect Takhzyro's clearance or distribution in the body.
- HAE rescue medications (C1-inhibitor products, icatibant, ecallantide) — did not meaningfully alter Takhzyro drug levels.
- aPTT blood clotting test — Takhzyro interferes with this lab assay and can produce an elevated result; always inform lab staff and providers you are taking it to avoid misinterpretation.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: There are no controlled human studies. Monoclonal antibodies like Takhzyro cross the placenta, especially in the third trimester. Discuss risks and benefits with your doctor if you are pregnant or planning to become pregnant.
- Breastfeeding: It is unknown whether Takhzyro passes into human breast milk. Discuss with your doctor whether to continue, pause, or stop breastfeeding.
- Children under 12: Takhzyro is approved for children as young as 2 years, but injections for this age group must be given by a healthcare provider or trained caregiver — not self-administered.
- Injection training: Patients or caregivers planning to inject at home must be trained by a healthcare professional before doing so independently.
- Kidney impairment: Mild to moderate kidney impairment does not appear to meaningfully affect how Takhzyro works in the body; no dose adjustment is recommended based on available data.
🚑If you take too much▾
There is no clinical experience with Takhzyro overdose. If you or someone else may have received too much, contact a healthcare provider or poison control center right away for guidance.
📡Pharmacodynamics — effects in the body▾
Takhzyro works by suppressing plasma kallikrein activity in a concentration-dependent way — the more drug present, the more kallikrein is blocked. This is measured by a drop in a blood marker called cleaved high-molecular-weight kininogen (cHMWK), which reflects less bradykinin being produced. Studies showed this effect across all studied age groups and dosing schedules. Takhzyro does not affect heart rhythm (it did not prolong the QT/QTc interval in testing).
🔬Pharmacokinetics — how your body processes it▾
After a subcutaneous injection, Takhzyro reaches its peak blood concentration within about 5 days. Its half-life — the time it takes for the body to clear half of the drug — is approximately 2 weeks, which is why it is dosed every 2 to 4 weeks. It takes roughly 70 days of regular dosing to reach stable, steady-state levels in the blood. Body weight influences how much drug is in the system (lighter patients have somewhat higher exposure), but this difference is not considered clinically significant and no dose adjustments are recommended based on weight, age, gender, or race alone.
📦How to store it▾
Store the prefilled syringes refrigerated at 36°F to 46°F (2°C to 8°C). Do not freeze. protect from light.
📄 Written from Lanadelumab-flyo injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Lanadelumab-flyo injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Takhzyro do — is it a treatment for HAE attacks or something else? ▾
How do I give myself this injection at home? ▾
What side effects should I expect, and when should I call my doctor? ▾
My child is 5 years old — is Takhzyro safe for them, and can I give the injection at home? ▾
I'm pregnant. Is it safe to keep taking Takhzyro? ▾
I heard Takhzyro can mess up blood test results — what does that mean for me? ▾
Is Lanadelumab-flyo injection available over the counter? ▾
When was Lanadelumab-flyo injection first available? ▾
Who makes Lanadelumab-flyo injection? ▾
💬 Answers drafted from Lanadelumab-flyo injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Lanadelumab-flyo injection comes
Lanadelumab-flyo injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Takhzyro is used to prevent hereditary angioedema (HAE) attacks in adults and pediatric patients 2 years of age and older.
- Takhzyro is given on a regular preventive schedule and is not used to treat an HAE attack that is already in progress.
- Takhzyro is injected subcutaneously (under the skin) into the abdomen, thigh, or upper arm.
- Takhzyro prefilled syringes should be removed from the refrigerator about 15 minutes before use to reach room temperature — do not shake or vigorously agitate the syringe.
- Takhzyro should be inspected before use — do not use it if the solution appears discolored or contains visible particles; it should look clear to slightly opalescent and colorless to slightly yellow.
- Takhzyro is for single use only — discard any remaining solution in the syringe after the injection.
📊 Lanadelumab-flyo injection across the U.S. market
How Lanadelumab-flyo injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Lanadelumab-flyo injection is used
A general measure of how commonly Lanadelumab-flyo injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Lanadelumab-flyo injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Lanadelumab-flyo injection prescribed? Of the 1,596 medications we measure, Lanadelumab-flyo injection ranks #1,149 by Medicaid prescriptions — more than 28% of them.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lanadelumab-flyo injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 4 listed Lanadelumab-flyo injection NDCs with Medicaid activity.
🔍 Compare Lanadelumab-flyo injection products
A representative set of FDA-listed product records for Lanadelumab-flyo injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 300 mg/2 mL | — | Rentschler Biopharma SE | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING | View NDC → |
| 150 mg/mL | Subcutaneous | Takeda Pharmaceuticals America, Inc. × 3 listings | BLA | View NDC → |
| 300 mg/2 mL | Subcutaneous | Takeda Pharmaceuticals America, Inc. × 7 listings | BLA | View NDC → |
Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Lanadelumab-flyo injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Lanadelumab-flyo injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Lanadelumab-flyo injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Lanadelumab-flyo injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Lanadelumab-flyo injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Lanadelumab-flyo injection belongs to the Plasma Kallikrein Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Takeda Pharmaceuticals America, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.