药名：Spherusol(粗球孢子菌皮试抗原)
适应症：检测18至64岁有肺球孢子菌病史的患者粗球孢子菌感染后的迟发型超敏反应
公司：Allermed Laboratories
获批日期：7月29日
类型：生物药
Spherusol是皮试抗原，通过激发细胞免疫反应来检测有肺球孢子菌病史的患者粗球孢子菌感染后的迟发型超敏反应。FDA批准用于18至64岁的患者。
1 HIGHLIGHTS OF PRESCRIBING INFORMATION
2 These highlights do not include all the information needed to use Spherusol safely and effectively. See full prescribing information for Spherusol.
(R)
3 Spherusol
4 Coccidioides immitis Spherule Derived Skin Test Antigen
5 Solution for Intradermal Injection
6
7 Initial U.S. Approval:
8
9 --------------INDICATIONS AND USAGE-----------------
10 Spherusol is a skin test antigen indicated for the detection of delayed-type hypersensitivity to Coccidioides immitis in individuals with a history of pulmonary
11 coccidioidomycosis. Spherusol is approved for use in individuals 18-64 years of age.
12 ? The use of Spherusol to detect delayed-type hypersensitivity response in a general population with unknown exposure to C. immitis has not been evaluated.
13 ? Persons with acute or disseminated coccidioidomycosis may not develop a delayed-type hypersensitivity response to Spherusol.
14 ? Persons with immunodeficiency and a history of coccidioidomycosis may not develop a delayed-type hypersensitivity response to Spherusol. (1)
15
16 --------------DOSAGE AND ADMINISTRATION-------------
17 ? A single 0.1 mL intradermal injection. Induration at injection site to be evaluated 48 hours after administration. (2.1, 2.3)
18
19 ----------DOSAGE FORMS AND STRENGTHS------------
20 ? Multi-dose vial (1 mL) containing a solution of spherule-derived C. immitis antigen, 1.27 mcg per 0.1 mL. (3)
21
22 ----------------CONTRAINDICATIONS-------------------
23 ? Severe allergic reaction (e.g., anaphylaxis) to Spherusol, or any component of Spherusol or other coccidioidin products. (4)
24
25 -------------WARNINGS AND PRECAUTIONS--------------
26 ? Acute hypersensitivity reactions and anaphylaxis have occurred following the administration of other skin test antigens and may occur in individuals following the
27 administration of Spherusol. (5.1)
28 ? Patients receiving beta-blocking drugs may be refractive to the usual dose of epinephrine in cases of hypersensitivity. (5.2)
29 ? Any condition or agent that impairs or attenuates delayed-type hypersensitivity reactions, including infections and use of immunosuppressive drugs, can
30 potentially cause a false negative reaction to Spherusol. (5.3)
31
32 -----------------ADVERSE REACTIONS--------------------
33 ? The most commonly reported local adverse reactions were itching and swelling (>75%) and pain (>15%) within 7 days of administration. (6.1)
34 To report SUSPECTED ADVERSE REACTIONS, contact Allermed Laboratories, Inc. at (800) 221-2748 or adverse@allermed.com or Food and Drug
35 Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.
36 36
37 ---------------DRUG INTERACTIONS--------------------
38 ? Corticosteroids and immunosuppressive agents may suppress the response to the skin test. (7.1)
39
40 -----------USE IN SPECIFIC POPULATIONS-------------
41 ? The safety and effectiveness of Spherusol in pregnant and nursing women have not been established. (8.1, 8.3)
42
43 See section 17 for PATIENT COUNSELING INFORMATION
44 http://www.fda.gov/downloads/BiologicsBloodVaccines/Allergenics/UCM266806.pdf