Candin: Package Insert and Label Information (Page 2 of 2)

14.2 Response to CANDIN® in Adults with HIV Infection

Response to CANDIN® in Adults with HIV Infection: In one study (Table 2), the skin test responses of adults with HIV infection were compared to those of healthy control subjects (age range AIDS 22 — 65, HIV positive 20 — 45, Controls 25 — 69). When HIV-infected subjects were classified by the CDC’s 1993 revised classification system for HIV infection (5) , a significant difference was found between AIDS patients and normal controls in both mean induration (p = 0.01) and proportion with ≥ 5 mm response (p < 0.01). The responses in HIV-infected patients (without AIDS-indicating conditions or AIDS-indicating CD4 T-cell counts) were less than in normal subjects, but the differences were not statistically significant.

In a second study involving 20 male patients (age range 26 — 57) diagnosed with AIDS based on clinical criteria only, one subject responded to CANDIN®. In the same study 65% of the male control subjects had DTH reactions ≥ 5 mm to CANDIN® (Table 1, Study 2). The mean induration response at 48 hours for control subjects was 8.33 mm compared to 1.78 mm for the AIDS subject. AIDS vs. control p-values were < 0.01 mean induration and < 0.01 induration ≥ 5 mm.

Because HIV infection can modify the DTH response to tuberculin, it is advisable to skin test HIV-infected patients at high risk of tuberculosis with antigens in addition to tuberculin.(6) In a published study of DTH anergy, 479 subjects (334 males and 145 females) infected with HIV and being screened for tuberculosis were skin tested with several additional antigens, including CANDIN® supplied under IND to the investigators. Only 12% reacted to tuberculin (≥ 5 mm), 57% reacted to CANDIN® (≥ 3 mm) and 60% reacted to either tuberculin or CANDIN® or both. In this study, a 3 mm induration response to CANDIN® was considered positive. The authors concluded that in HIV-infected subjects, testing with other DTH antigens increases the accuracy of interpretation of negative tuberculin reactions.

Table 2. Cellular hypersensitivity response to CANDIN® in adults with AIDS, adults with HIV infection (no-AIDS-indicator conditions) and adult control subjects. Range and mean of CD4 T-cell count shown in the shaded area of the table.

Group Classifi- cation* n Zidovu- dine Use

CD4

Range

CD4

Mean

Mean Indur. (mm) n≥5 mm %
AIDS A3,B3,C 32 14 4-483 145 3.35(a) 9 28(b)
HIV Pos. A1,A2, B1,B2 28 13 201-1065 455 5.67 15 54
Control† —— 18 0 554-1876 869 8.03 14 78

* (reference 5)
(a) p = 0.01 compared to Control. (b) p < 0.01 compared to Control.† See Control Group in Table 1.

14.3 Response to CANDIN® in Adults with Cancer

In one study of 18 patients with lung cancer, CANDIN® elicited a positive induration response in five patients (28%). In a second series of 20 patients with metastatic cancer, no reactions ≥5 mm were observed (Table 3).

Table 3. Cellular Hypersensitivity Response to CANDIN® in adults with Cancer.

n

Age

Range

(years)

Number

reactions

≥ 5mm at

48 hours

Response
Study 1 18 52-75 5 28%
Study 2 20 47-81 0 0%

15 REFERENCES

  1. Middleton, E. Jr., Reed, C.E., Ellis, F.E., Adkinson, N.F., Jr., Yunginger, J.W., Busse, W.W., Allergy Principles and Practice, 5th Ed., Vol II, pp 685-687, Mosby, St. Louis, 1998.
  2. Bernstein, I.L., ed., Proceedings of the task force of guidelines for standardizing old and new technologies used for the diagnosis and treatment of allergy, J. Allergy Clin. Immunol., 82: 487-526, 1988.
  3. Paul, W.E., Fundamental Immunology, 3rd Ed., pp 75-76, Raven Press, New York, 1993.
  4. MacPhee, M.J., Gordon, J., Christou, N.V., Sanchez-Cantu, L., Rode, H.H., Cells recovered from human DTH reactions: phenotypic and functional analysis. Cellular Immunology, 151: 80-96, 1993.
  5. CDC, 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. Morbidity and Mortality Weekly Report. 41: No. RR17, December 18, 1992.
  6. Huebner, R.E., Schein, M.F., Hall, C.A., Barnes, S.A., Delayed-type hypersensitivity anergy in human immunodeficiency virus-infected persons screened for infection with Mycobacterium tuberculosis. Clin. Infect. Dis., 19: 26-32, 1994.
  7. Klotz, S.D., Sweeney, M.J., Dienst, S., Klotz, L.R., Moeller, R.K., Rosenberg, S., Systemic anaphylaxis immediately following delayed hypersensitivity skin tests. Ann. Allergy, 49: 142-144, 1982.

16 HOW SUPPLIED/STORAGE AND HANDLING

CANDIN® is supplied in a 1 mL multidose vial containing ten 0.1 mL doses.

Storage

Store between 2 — 8°C. Do not freeze.

17 PATIENT COUNSELING INFORMATION

Local reactions to CANDIN® can include redness, swelling, pruritus, excoriation and discoloration of the skin. These reactions usually subside within hours or days after administration of the skin test. In some patients, skin discoloration may persist for several weeks. Progression of the DTH reaction to vesiculation, necrosis and ulceration are possible. Patients should be informed that all foreign antigens have the remote possibility of causing Type I anaphylactic reactions that may require the administration of epinephrine and other drugs or emergency procedures and may be life threatening in some cases. Patients should report any serious adverse reactions to their health care provider.

*Sections or subsections omitted from the full prescribing information are not listed.

CA-C Circular Date of Issue: September 27, 2021

Nielsen BioSciences, Inc.
11125 Flintkote Avenue Suite G
San Diego, CA 92121
(855) 855-1212
www.nielsenbio.com

Candida albicans Skin Test Antigen
for Cellular Hypersensitivity
CANDIN®

Mfg. by Allermed Laboratories, Inc.San Diego, CA. 92111

NDC 59584-138-01 — Vial Label

vial-label
(click image for full-size original)

NDC 59584-138-01

Candida albicans Skin Test Antigen for Cellular Hypersensitivity

Candin®

Mfd. for Nielsen BioSciences, Inc.

San Diego CA 92121

Vol: 1mL (10 Tests)

Dose: 0.1mL Intradermally

See Package Insert

Store: 2-8°C Rx Only

Preservatives: 0.4% Phenol

Lot:

Exp:

NDC 59584-138-01 — Carton Label

carton-label
(click image for full-size original)

Candida albicans Skin Test Antigen

for Cellular Hypersensitivity

Candin®

Skin Test Strength

For use in assessing cell-mediated or delayed-type hypersensitivity to Candida albicans.

Mfd. for Nielsen BioSciences, Inc. U.S. License 1903

San Diego, CA 92121

Dose: 0.1 mL intradermally. See circular.

Contents: 1 mL multidose vial (ten tests).

Ingredients: Candida antigen in buffered saline with 0.03% albumin USP, 8 ppm polysorbate 80 and phenol 0.4% w/v as a preservative.

Rev. 08/21

Potency: Measured by delayed-type intradermal skin test in guinea pigs.

Storage: Store at 2-8° C (35-46° F). Do not freeze.

No U.S. Standard of Potency.

Rx only.

NDC 59584-138-01

CANDIN candida albicans skin test antigen injection, solution
Product Information
Product Type Item Code (Source) NDC:59584-138
Route of Administration INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CANDIDA ALBICANS (CANDIDA ALBICANS) CANDIDA ALBICANS 1 U in 0.1 mL
Inactive Ingredients
Ingredient Name Strength
ALBUMIN HUMAN 0.03 mg in 0.1 mL
SODIUM CHLORIDE 0.5 mg in 0.1 mL
SODIUM BICARBONATE 0.25 mg in 0.1 mL
POLYSORBATE 80 0.8 ug in 0.1 mL
PHENOL 0.4 mg in 0.1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59584-138-01 1 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103257 12/01/1995
Labeler — Nielsen BioSciences, Inc. (078835288)
Registrant — Nielsen BioSciences, Inc. (078835288)
Establishment
Name Address ID/FEI Operations
Allermed Laboratories, Inc. 073364531 manufacture
Establishment
Name Address ID/FEI Operations
Nielsen BioSciences, Inc. 078835288 manufacture

Revised: 10/2021 Nielsen BioSciences, Inc.

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