Exdensur

Exdensur is an FDA-registered drug product whose active ingredient is DEPEMOKIMAB. It is labelled by GlaxoSmithKline LLC taken by subcutaneous and marketed as a human prescription drug product. Identifiers on file: NDC 0173-0927, application BLA761458, label effective 20260610. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DEPEMOKIMAB are most often described in connection with: add maintenance, treatment severe, asthma characterized, eosinophilic phenotype, pediatric patients, aged years, older limitations, relief acute. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE EXDENSUR is indicated for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )] . EXDENSUR is an interleukin‑5 (IL‑5) antagonist, a monoclonal antibody (humanized immunoglobulin G1 [IgG1] kappa) indicated for add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. ( 1 ) Limitations of Use : Not for relief of acute bronchospasm or status asthmaticus. ( 1 )

2 DOSAGE AND ADMINISTRATION The recommended dosage is 100 mg administered once every 6 months by subcutaneous injection into the upper arm, thigh, or abdomen. ( 2.1 ) • EXDENSUR should be administered by a healthcare provider. ( 2.2 ) • See full prescribing information for preparation and administration instructions. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage is 100 mg once every 6 months administered by subcutaneous injection into the upper arm, thigh, or abdomen avoiding 2 inches (5 cm) around the navel [see Dosage and Administration ( 2.2 )] . Missed Dose(s) If a dose is missed, administer the missed dose as soon as possible and resume the once every 6‑month injection schedule from the date of when the missed dose was given. 2.2 Preparation and Administration Instructions for EXDENSUR • EXDENSUR is for subcutaneous use only. • EXDENSUR should be administered by a healthcare provider. • Do not use EXDENSUR prefilled syringe if the security seal on the carton has been broken or if it has been dropped or damaged. Preparation Instructions 1. Remove the prefilled syringe from the refrigerator. Holding the middle of the prefilled syringe, take it out from the tray and allow it to sit at room temperature for 30 minutes prior to injection. Do not warm EXDENSUR injection in any other way. Do not remove the needle cap until you are ready to inject. Do not use the syringe if it has been left out of the carton for more than 8 hours. 2. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. EXDENSUR should be colorless to yellow to brown, clear to opalescent in color. Do not use EXDENSUR if the product exhibits discoloration, cloudiness, or particulate matter. It is normal to see an air bubble. Do not expel the air bubble prior to administration. Do not shake the device. 3. Choose the injection site; administer EXDENSUR into upper arm, thigh, or abdomen, avoiding the 2 inches (5 cm) around the navel. Do not give injections into areas where the skin is tender, bruised, red, or hard. Administration Instructions Figure 1. EXDENSUR Prefilled Syringe Components 1. Pull Off the Gray Needle Cap Remove the gray needle cap from the syringe by pulling it straight off, away from the needle. Do not handle the syringe by the white plunger while removing the gray needle cap. Do not put the gray needle cap back onto the syringe. Inject within 5 minutes after removing the gray needle cap. 2. Position the Syringe at the Injection Site Use your free hand to gently pinch the skin around the cleaned injection site. Do not handle the syringe by the white plunger while inserting the needle into the pinched skin. Hold the middle of the syringe and insert the entire needle into the pinched skin at a 45 degree angle, as shown. 3. Start the Injection and Fully Press the White Plunger Slowly push down on the white plunger with your thumb to inject the full dose. Make sure the white plunger is pushed all the way down until the stopper reaches the bottom of the syringe and all of the medication is injected. 4. Slowly Lift Thumb After Injection Completes Slowly lift your thumb up. This will allow the white plunger to come up and the needle to automatically pull up (retract) into the needle guard. After removing the syringe from the injection site, release the pinched skin. 5. Throw Away Dispose of used syringe according to local health and safety laws. Figure 1 1. Pull Off the Gray Needle Cap 2. Position the Syringe at the Injection Site 3. Start the Injection and Fully Press the White Plunger 4. Slowly Lift Thumb After Injection Completes

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] . The most common adverse reactions (incidence ≥4%) are upper respiratory tract infection, allergic rhinitis, influenza, arthralgia, and pharyngitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of EXDENSUR was based on a pooled safety population from 2 replicate, randomized, double‑blind, parallel‑group, placebo‑controlled, multicenter clinical trials (SWIFT‑1 and SWIFT‑2) of 52 weeks duration. The 2 trials included 762 adult and pediatric patients 12 years of age and older with asthma, who received either EXDENSUR 100 mg or placebo administered subcutaneously once every 6 months in addition to their existing background medications for asthma [see Clinical Studies ( 14 )] . A total of 475 patients received 2 doses of EXDENSUR 100 mg in these trials. Adverse reactions with EXDENSUR with incidence of ≥4% are shown in Table 1 . Table 1. Adverse Reactions With EXDENSUR With an Incidence ≥4% and More Common Than Placebo in Patients With Asthma Adverse Reaction EXDENSUR (N = 501) n (%) Placebo (N = 261) n (%) Upper respiratory tract infection 46 (9) 20 (8) Allergic rhinitis 29 (6) 7 (3) Influenza 24 (5) 11 (4) Arthralgia 19 (4) 8 (3) Pharyngitis 18 (4) 3 (1) Specific Adverse Reactions Injection Site Reactions: In the pooled safety population (SWIFT‑1 and SWIFT‑2), in which EXDENSUR was administered by a healthcare provider, injection site reactions (e.g., erythema, swelling, and itching) occurred in 7 (1%) and 2 (<1%) patients receiving EXDENSUR and placebo, respectively.

3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Exdensur used for?
1 INDICATIONS AND USAGE EXDENSUR is indicated for the add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Limitations of Use EXDENSUR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )] . EXDENSUR is an interleukin‑5 (IL‑5) antagonist, a …

Who makes Exdensur?
GlaxoSmithKline LLC is the labeler of record for Exdensur.

What form does Exdensur come in?
administered by subcutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Exdensur prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Exdensur been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.