"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
As has been observed with other, unstandardized, antigens used for DTH skin testing (14), it is possible that some patients may have exquisite immediate hypersensitivity to CANDIN® (candida albicans) . In persons with bleeding tendency, bruising and non-specific induration may occur due to the trauma of the skin test.
Physicians using this product must have available the facilities and medications necessary to treat all potential local and systemic side effects that can occur from the injection of an antigenic substance Epinephrine (1:1,000) must be immediately available. The patient, or parent or guardian, should be questioned about previous reactions to this product or a similar product.
The antigen must be injected intradermally as superficially as possible, causing a distinct, sharply defined bleb at the skin test site. An unreliable reaction may result if the product is injected subcutaneously. It must not be given intravenously; care should be taken to avoid injection into a blood vessel.
A separate sterile syringe and needle should be used for each patient to prevent transmission of infectious agents. Needles should be disposed of properly and should not be recapped.
Delayed or cellular hypersensitivity reactions can be diminished or completely suppressed if the person has received corticosteroids (see DRUG INTERACTIONS).
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been conducted with CANDIN® (candida albicans) to determine its potential for carcinogenicity, mutagenicity or impairment of fertility.
Pregnancy Category C
Animal reproduction studies have not been conducted with CANDIN® (candida albicans) . It is also not known whether CANDIN® (candida albicans) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. CANDIN® (candida albicans) should be given to pregnant women only if clearly needed.
It is not known whether CANDIN® (candida albicans) is excreted in human milk. Because drugs may be excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
The safety and effectiveness of intradermally administered CANDIN® (candida albicans) have not been established in children.
Candin (candida albicans) 7 has not been adequately studied in geriatric patients. However, the DTH response to CANDIN® (candida albicans) may be diminished in geriatric patients, since the aging process is known to alter cell-mediated immunity (1).
1. Middleton, E. Jr., Ree d, C.E., Ellis, F.E., Adkinson, N.F., Jr., Yunginger, J.W., Busse, W.W., Allergy Principles and Practice, 4th Ed., Vol II, pp 963-982, Mosby, St. Louis, 1993.
14. Klotz, S.D., Sweeney, M .J., Diens t, S., Klotz, L.R., Moeller, R.K., Rosenberg, S., Systemic anaphylaxis immediately following delayed hypersensitivity skin tests. Ann. Allergy, 49: 142-144, 1982.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/28/2009
Additional Candin Information
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