Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most commonly reported local adverse reactions were itching and swelling (>75%) and pain (>15%) within 7 days of administration.( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Nielsen Biosciences, Inc.
at (855) 855-1212 or Food and Drug Administration (FDA) at 1-800-332-1088 or www.vaers.hhs.gov .
( 6.3 ) 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a skin test antigen cannot be directly compared to rates in the clinical trials of another skin test antigen, and may not reflect the rates observed in practice.
As with any skin test antigen, there is the possibility that broad use of Spherusol ® could reveal adverse reactions not observed in clinical trials.
In a double-blinded placebo-controlled clinical trial conducted in areas of the U.S.
endemic for C.
immitis (Bakersfield, CA and Tucson, AZ), 54 adults (23-64 years of age) with a history of pulmonary coccidioidomycosis of at least 45 days duration, diagnosed by clinical findings, radiography and serological and/or mycological evidence of the disease, received a single dose of Spherusol ® concomitantly with two licensed skin test extracts (Candin ® and Trichophyton) and two controls (product diluent [thimerosal ≤0.0001%] and saline).
Each intradermal injection of 0.1 mL of reagent was given at pre-determined sites on the right and left forearms.
Solicited local adverse reactions and systemic adverse events occurring within 7 days after injection were recorded by study subjects via diary card.
These events were also recorded on case report forms (CRFs) by study personnel during clinical visits 48 hours and 7 days following injections.
5 WARNINGS AND PRECAUTIONS Acute hypersensitivity reactions and anaphylaxis have occurred following the administration of other skin test antigens and may occur in individuals following the administration of Spherusol ® .
( 5.1 ) Patients receiving beta-blocking drugs may be refractive to the usual dose of epinephrine in cases of hypersensitivity.
( 5.2 ) Any condition or agent that impairs or attenuates delayed type hypersensitivity reactions, including infections and use of immunosuppressive drugs, can potentially cause a false negative reaction to Spherusol ® .
( 5.3 ) 5.1 Prevention and Management of Acute Hypersensitivity Reactions Prior to administration, the healthcare provider should review the medical history for possible skin test sensitivity and previous skin test related adverse reactions to assess the risks and benefits.
Immediate hypersensitivity, to include severe systemic reactions, may occur following administration of skin test antigens.
Like all medications, Spherusol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: