Coccidioides immitis spherule
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
The expected response to Spherusol ® is a local area of inflammation at the site of the skin test. The reaction is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur, which may require treatment with local cold compresses and anti-inflammatory medication. ( 2.3 , 6.1 ) Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or cause death. Emergency measures and personnel trained in their use should be immediately available. Patients should be observed for at least 20 minutes following the administration of a skin test.
( 6.2 ) Spherusol ® should never be given intravenously. ( 5 ) To report SUSPECTED ADVERSE REACTIONS, contact Nielsen BioSciences, Inc. at (855) 855-1212 or MEDWATCH, Food and Drug Administration (FDA), 5600 Fishers Lane, Rockville, MD 20852-9782. Telephone: (800) 332-1088 or www.vaers.hhs.gov . ( 6.2 ) WARNING See full prescribing information for complete boxed warning The expected response to Spherusol ® is a local area of inflammation at the site of the skin test. The reaction is usually dime to quarter size reaching maximum diameter between 24 and 48 hours. Larger accelerated reactions can occur, which may require treatment with local cold compresses and anti-inflammatory medication.
( 2.3 , 6.1 ) Systemic reactions can occur with skin test antigens and in certain individuals these reactions may be life-threatening or cause death. Emergency measures and personnel trained in their use should be immediately available. Patients should be observed for at least 20 minutes following the administration of a skin test. ( 5.3 , 6.2 ) Spherusol ® should never be given intravenously. ( 5 ) To report SUSPECTED ADVERSE REACTIONS, contact Nielsen BioSciences, Inc. at (855) 855-1212 or MEDWATCH, Food and Drug Administration (FDA), 5600 Fishers Lane, Rockville, MD 20852-9782. Telephone: (800) 332-1088 or www.vaers.hhs.gov . ( 6.2 )
Skin Test Antigen
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation for Administration Spherusol ® is a clear, colorless sterile solution for intradermal administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exists, the skin test antigen should not be administered.
Administration: Spherusol ® is administered as a 0.1 mL dose by intradermal injection to the volar surface of the forearm using a tuberculin syringe (0.5 or 1.0 mL) and a ½ inch 26-27 gauge needle. The needle should be inserted bevel side up in the skin at a 15-20 degree angle. Intradermal injection of 0.1 mL Spherusol ® will result in a bleb 5-10 mm in diameter at the injection site.
Drug interactions
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- Coccidioides immitis spherule
Label text (3 paragraphs)
Corticosteroids and immunosuppressive agents may suppress the response to the skin test.( 7.1 )
7.1 Corticosteroids and Immunosuppressives Corticosteroids and Immunosuppressive agents may suppress the response to the skin test. Pharmacologic doses of corticosteroids may suppress the response to skin test antigens after two weeks of therapy. The mechanism of suppression is thought to involve a decrease in monocytes and lymphocytes, particularly T-cells. The normal DTH response usually returns to pre-treatment levels within several weeks after steroid therapy is discontinued. (5) The use of Spherusol ® has not been evaluated during or following the use of corticosteroids or immunosuppressive agents.
7.2 Antifungal Medications It is not known if concurrent treatment with antifungal medications interferes with delayed-type hypersensitivity responses to Spherusol ® in patients with a history of pulmonary coccidioidomycosis.
Contraindications
4 CONTRAINDICATIONS A severe allergic reaction (e.g., anaphylaxis) to Spherusol ® , or any component of Spherusol ® or other coccidioidin products is a contraindication to administration. Severe allergic reaction (e.g., anaphylaxis) to Spherusol ® , or any component of Spherusol ® or other coccidioidin products. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for coccidioides immitis spherule. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy The safety and effectiveness of Spherusol ® in pregnant women have not been established. Pregnancy Category C Animal reproduction studies have not been conducted with Spherusol ® . It is also not known whether Spherusol ® can cause fetal harm when administered to a pregnant woman or affect reproduction capacity. Spherusol ® should be given to a pregnant woman only if clearly needed.
Lactation
8.3 Nursing Mothers The safety and effectiveness of Spherusol ® in nursing women have not been established. It is not known whether Spherusol ® is excreted in human milk. However, because the potential exists for Spherusol ® to be excreted in human milk, caution should be exercised when administering Spherusol ® to a nursing woman.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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