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Fasenra
Generic Name: Benralizumab
Drug Category: Monoclonal Antibody
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 12 years old for a maximum duration of 56 weeks.
| Approved Uses |
|
Indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. FASENRA is not indicated for treatment of other eosinophilic conditions. FASENRA should not be used to treat acute asthma symptoms or acute exacerbations. Do not use FASENRA to treat acute bronchospasm or status asthmaticus. FASENRA is for subcutaneous use only. Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have occurred following administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Eosinophils may be involved in the immunological response to some helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy. Benralizumab is a humanized monoclonal antibody (IgG1/κ-class), and immunoglobulin G (IgG) is present in human milk in small amounts. If benralizumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to benralizumab are unknown. |
| Off-label Uses |
|
• Use in patients under the age of 12. GoToSource • Chronic obstructive pulmonary disease. GoToSource • Humoral immune response to the seasonal influenza vaccination. GoToSource • Bronchial asthma, atopic dermatitis, eosinophilic esophagitis, hypereosinophilic syndrome and churg-strauss syndrome. GoToSource • Nasal polyposis. GoToSource |
| Adverse Events |
|
Worsening asthma. GoToSource Disseminated herpes zoster. GoToSource Arthralgia, hypersensitivity reactions (including rash and hives) and impaired immune response to helminth infections. GoToSource Nasopharyngitis, bronchitis, allergic rhinitis, pharyngitis and upper respiratory tract infection. GoToSource |
| Litigation |
|
No major injury lawsuits reported. |
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