Indications & Safety Info
Indications
Important Safety Information
Indications
EXDENSUR is a prescription medicine for the add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older whose asthma is not controlled with their current medicines. EXDENSUR is not used to treat sudden breathing problems that occur with asthma.
Important Safety Information
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Acute and delayed systemic reactions, including hypersensitivity reactions (such as urticaria and pruritus), have occurred with EXDENSUR. These reactions generally occur within hours of administration, but some had a delayed onset (i.e., days). Clinical judgment must be used regarding re-administration if hypersensitivity reaction occurs.
Asthma-Related Adverse Events or Exacerbations
EXDENSUR must not be used to treat acute asthma symptoms or acute exacerbations. Asthma-related adverse events or exacerbations may occur during treatment with EXDENSUR. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with EXDENSUR.
Reduction of Maintenance Medication Dosage
Abrupt discontinuation of background medications (including systemic and inhaled corticosteroids) after initiation of EXDENSUR therapy is not recommended. Reductions in the dosages of background medications, if appropriate, must be gradual and performed under the supervision of a physician.
Parasitic (Helminth) Infection
Treat patients with pre-existing helminth infections before initiating therapy with EXDENSUR. If patients become infected while receiving EXDENSUR and do not respond to anti-helminth treatment, consider delaying EXDENSUR until the infection resolves.
ADVERSE REACTIONS
Most common adverse reactions (≥1%) in patients were pruritus, administration-related systemic reactions, and injection site reactions.
USE IN SPECIFIC POPULATIONS
The effect of EXDENSUR on human pregnancy is unknown. Monoclonal antibodies, such as depemokimab-ulaa, are expected to be transported across the placenta in a linear fashion as the pregnancy progresses. EXDENSUR should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus.
Please see accompanying full Prescribing Information for EXDENSUR.
