Exdensur Drug Information

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.

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. 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.

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.

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. 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.

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.

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. 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 s 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 patients receiving EXDENSUR and placebo, respectively.

Pregnancy Risk Summary Available data from clinical trials with EXDENSUR use in pregnant women are insufficient to identify a drug‑associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with asthma in pregnancy (see Clinical Considerations). Transport of endogenous immunoglobulin G (IgG) antibodies and monoclonal antibodies, such as depemokimab‑ulaa, across the placenta increases as pregnancy progresses and peaks during the third trimester.

The impact of the YTE modification on placental transfer is uncertain; however, the presence of the YTE modification may lead to prolonged and increased exposure of the infant exposed in utero, and the potential of clinical impact is unknown and should be considered. No treatment‑related effects on embryofetal or postnatal development have been shown in animal studies targeting interleukin‑5 (IL‑5) signaling pathways (see Data). The background risk of major birth defects and miscarriage for the indicated population(s) is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively. Pregnant women exposed to EXDENSUR, or their healthcare providers, should report EXDENSUR exposure by calling 1‑888‑825‑5249.

Clinical Considerations Disease ‑ Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother, and prematurity, low birth weight, and small for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Data Animal Data: Reproductive toxicology studies have not been conducted with depemokimab‑ulaa.

In animal studies targeting the IL‑5 signaling pathway with a related biologic product without the YTE modification, there were no developmental effects observed. Embryofetal development of IL‑5 deficient mice has been reported to be generally unaffected relative to wild‑type mice.

Pediatric Use Asthma The safety and effectiveness of EXDENSUR for add‑on maintenance treatment of severe asthma characterized by an eosinophilic phenotype have been established in pediatric patients aged 12 years and older. Use of EXDENSUR for this indication is supported by evidence from adequate and well‑controlled trials (SWIFT‑1 and SWIFT‑2) in adults and pediatric patients aged 12 years and older, and pharmacokinetic data in pediatric patients aged 12 years and older. Pharmacokinetic and pharmacodynamic data have demonstrated no clinically significant differences in systemic exposure of depemokimab‑ulaa and reduction in blood eosinophil counts in pediatric patients aged 12 years and older compared to that observed in adults following administration of the recommended dosage of EXDENSUR.

The safety of EXDENSUR in pediatric patients aged 12 years and older was generally similar to that of the adult population in SWIFT‑1 and SWIFT‑2. The safety and effectiveness of EXDENSUR have not been established in pediatric patients younger than 12 years of age.

If an overdosage occurs, the patient should be treated supportively with appropriate monitoring as necessary. Consider contacting the Poison Help line (1‑800‑222‑1222) or a medical toxicologist for additional overdose management recommendations.