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Indicaciones

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 )

Advertencias y precauciones

Hypersensitivity reactions, including anaphylaxis, can occur after administration of EXDENSUR. If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy. ( 5.1 )
Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation of therapy with EXDENSUR. Reduce corticosteroid dose gradually, if appropriate. ( 5.3 )
Treat pre-existing helminth infections before initiating therapy with EXDENSUR. If patients become infected while receiving treatment with EXDENSUR and do not respond to anti‑helminth treatment, discontinue EXDENSUR until the parasitic infection resolves. ( 5.4 )

5.1Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, can occur following administration of EXDENSUR. If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy.

5.2Acute Asthma Symptoms or Deteriorating Disease

Indicaciones

( 1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. ( 1 )

Advertencias y precauciones

Hypersensitivity reactions, including anaphylaxis, can occur after administration of EXDENSUR. If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy. ( 5.1 )
Do not abruptly discontinue systemic or inhaled corticosteroids upon initiation of therapy with EXDENSUR. Reduce corticosteroid dose gradually, if appropriate. ( 5.3 )
Treat pre-existing helminth infections before initiating therapy with EXDENSUR. If patients become infected while receiving treatment with EXDENSUR and do not respond to anti‑helminth treatment, discontinue EXDENSUR until the parasitic infection resolves. ( 5.4 )

5.1Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, can occur following administration of EXDENSUR. If a hypersensitivity reaction occurs, discontinue EXDENSUR and initiate appropriate therapy.

5.2Acute Asthma Symptoms or Deteriorating Disease

Embarazo y lactancia

8.1Pregnancy 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 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 [see Nonclinical Toxicology ( 13 )] . Embryofetal development of IL‑5 deficient mice has been reported to be generally unaffected relative to wild‑type mice.

Reacciones adversas

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.

6.1Clinical 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.

Exdensur

Indicaciones

Contraindicaciones

Advertencias y precauciones

5.1Hypersensitivity Reactions

5.2Acute Asthma Symptoms or Deteriorating Disease

¿Dos medicamentos en una misma pregunta?

Exdensur

Indicaciones

Contraindicaciones

Advertencias y precauciones

5.1Hypersensitivity Reactions

5.2Acute Asthma Symptoms or Deteriorating Disease

¿Dos medicamentos en una misma pregunta?

5.3Risk Associated with Abrupt Reduction of Corticosteroid Dosage Reduction

5.4Parasitic (Helminth) Infection

Embarazo y lactancia

8.1Pregnancy Risk Summary

Reacciones adversas

6.1Clinical Trials Experience

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Presentaciones

Documentos

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