A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Xolair Warnings, Precautions, Pregnancy, Nursing, Abuse - Omalizumab
Xolair Warnings, Precautions, Pregnancy, Nursing, Abuse - Omalizumab
WARNINGS
Malignancy
Malignant neoplasms were observed in 20 of 4127 (0.5%) Xolair-treated
patients compared with 5 of 2236 (0.2%) control patients in clinical studies
of asthma and other allergic disorders. The observed malignancies in Xolair-treated
patients were a variety of types, with breast, non-melanoma skin, prostate,
melanoma, and parotid occurring more than once, and five other types occurring
once each. The majority of patients were observed for less than 1 year. The
impact of longer exposure to Xolair or use in patients at higher risk for malignancy
(e.g., elderly, current smokers) is not known (see ADVERSE
REACTIONS: Malignancy).
Anaphylaxis
Anaphylaxis has occurred within 2 hours of the first or subsequent
administration of Xolair in 3 ( < 0.1%) patients
without other identifiable allergic triggers. These events included urticaria
and throat and/or tongue edema (see ADVERSE REACTIONS).
Patients should be observed after injection of Xolair, and medications for the
treatment of severe hypersensitivity reactions including anaphylaxis should
be available. If a severe hypersensitivity reaction to Xolair occurs, therapy
should be discontinued (see CONTRAINDICATIONS).
PRECAUTIONS
General
Xolair has not been shown to alleviate asthma exacerbations
acutely and should not be used for the treatment of acute bronchospasm or status
asthmaticus.
Corticosteroid Reduction
Systemic or inhaled corticosteroids should not be abruptly
discontinued upon initiation of Xolair therapy. Decreases in corticosteroids
should be performed under the direct supervision of a physician and may need
to be performed gradually.
INFORMATION FOR PATIENTS
Patients receiving Xolair should be told not to decrease the
dose of, or stop taking any other asthma medications unless otherwise instructed
by their physician. Patients should be told that they may not see immediate
improvement in their asthma after beginning Xolair therapy.
Laboratory Tests
Serum total IgE levels increase following administration of
Xolair due to formation of Xolair:IgE complexes (see CLINICAL
PHARMACOLOGY, DOSAGE AND ADMINISTRATION).
Elevated serum total IgE levels may persist for up to 1 year following discontinuation
of Xolair. Serum total IgE levels obtained less than 1 year following discontinuation
may not reflect steady state free IgE levels and should not be used to reassess
the dosing regimen.
top
