Depemokimab

FDA Drug Information • Also known as: Exdensur

Brand Names: Exdensur
Route: SUBCUTANEOUS
Dosage Form: INJECTION, SOLUTION
Product Type: HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION Depemokimab‑ulaa is an interleukin‑5 (IL‑5) antagonist monoclonal antibody (humanized Immunoglobulin G1 [IgG1] kappa). Depemokimab‑ulaa is produced by recombinant DNA technology in Chinese hamster ovary cells. The estimated molecular weight of depemokimab‑ulaa is 149 kDa. EXDENSUR (depemokimab‑ulaa) injection is a sterile, preservative‑free, colorless, yellow to brown, clear to opalescent solution for subcutaneous (SC) use. EXDENSUR injection is supplied in a single‑dose, 1‑mL, prefilled pen with a fixed 29‑gauge, half‑inch needle or in a single‑dose, 1‑mL, prefilled syringe with a fixed 29‑gauge, half‑inch needle with a needle guard. Each 1 mL delivers 100 mg depemokimab‑ulaa, (8.43 mg) arginine HCl, (0.017 mg) edetate disodium, (1.41 mg) histidine, (2.29 mg) L‑histidine HCl monohydrate, (0.20 mg) polysorbate 80, (61.6 mg) trehalose, and Water for Injection with a pH of 6.0.

What Is Depemokimab 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 monoclonal antibody (humanized immunoglobulin G [IgG]1 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 )

Dosage and Administration

2 DOSAGE AND ADMINISTRATION The recommended dosage is 100 mg administered once every 6 months by subcutaneous (SC) 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 (SC) 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 (SC) use only.

EXDENSUR should be administered by a healthcare provider. Do not use EXDENSUR prefilled pen or syringe if the security seal on the carton has been broken. Do not use EXDENSUR prefilled pen or syringe if it has been dropped or damaged. Preparation Instructions 1. Remove the prefilled pen or prefilled syringe from the refrigerator. Holding the middle of the prefilled pen or 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 pen or 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 the injection 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 for Single ‑ Dose Prefilled Pen Figure 1. EXDENSUR Prefilled Pen Components 1. Pull Off the Clear Cap Remove the clear cap by pulling it straight off, away from the yellow needle guard. Do not press the yellow needle guard. Do not put the cap back on the pen. This could accidentally start the injection. Inject within 5 minutes after removing the clear cap. 2. Position the Pen at the Injection Site and Press Firmly to Start the Injection Place the yellow needle guard flat against the skin (at a 90 degree angle to the skin). Make sure you can see the inspection window. The yellow needle guard will slide up into the pen. You may hear a “click” that tells you the injection has started. Do not use the pen if the yellow needle guard does...

Side Effects (Adverse Reactions)

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.

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Pregnancy and Breastfeeding

8.1 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 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 [see Clinical Pharmacology ( 12.1 )] ; 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 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 2% to 4% and 15% to 20%, 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...

Overdosage

10 OVERDOSAGE 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.

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied EXDENSUR (depemokimab‑ulaa) injection is a sterile, preservative‑free, colorless, yellow to brown, clear to opalescent solution for subcutaneous (SC) use. The pens and syringes are not made with natural rubber latex. EXDENSUR injection is supplied as described in Table 4 . Table 4. EXDENSUR Injection Package Configuration Package Configuration Strength NDC 1 single‑dose, prefilled pen with attached 29‑gauge, half‑inch needle in a carton 100 mg/mL 0173‑0927‑31 1 single‑dose, prefilled syringe with attached 29‑gauge, half‑inch needle with needle guard in a carton 100 mg/mL 0173‑0927‑42 Storage and Handling Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. Do not freeze. Do not shake. Avoid exposure to heat. The prefilled pen and prefilled syringe can be removed from the refrigerator and kept in the unopened carton, protected from light for up to 7 days at room temperature up to 86°F (30°C). Discard if left out of the refrigerator for more than 7 days. The prefilled pen or prefilled syringe must be administered within 8 hours once removed from the carton. Discard if not administered within 8 hours.

About This Information

This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

What are side effects?

Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

What are drug interactions?

Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.