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Theracys

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Theracys

TheraCys®
[BCG Live (Intravesical)]

WARNING

TheraCys®, BCG Live (Intravesical) contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled and disposed of as a biohazard material. (See PRECAUTIONS and DOSAGE AND ADMINISTRATION.)

BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in immunosuppressed patients receiving parenteral drugs that were prepared in areas in which BCG was prepared. BCG is capable of dissemination when administered by the intravesical route and serious infections, including fatal infections, have been reported in patients receiving Intravesical BCG. (See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS.)

DRUG DESCRIPTION

TheraCys, BCG Live (Intravesical) is a freeze-dried preparation made from the Connaught strain of Bacillus Calmette and Guérin, which is an attenuated strain of Mycobacterium bovis.

The BCG organisms in the product are grown on media containing potatoes, glycerine, asparagine, citric acid, potassium phosphate, magnesium sulfate, ferric ammonium citrate, calcium chloride, copper sulfate and zinc sulfate. Monosodium glutamate is added to the BCG organisms prior to freeze-drying.

Each vial of TheraCys (bcg live intravesical) contains 81 mg of freeze-dried BCG. Prior to use, each vial is reconstituted with the accompanying diluent (3 mL), which contains 0.85% w/v sodium chloride, 0.025% w/v polysorbate 80, 0.06% w/v sodium dihydrogen phosphate and 0.25% w/v disodium hydrogen phosphate. Neither the freeze-dried BCG nor the diluent contain preservative.

One dose of TheraCys (bcg live intravesical) consists of one 81mg vial of reconstituted material further diluted in 50 mL sterile, preservative-free saline.

The BCG organisms are viable upon reconstitution. In vitro potency is determined by an assay of the number of colonies grown on solid medium. The reconstituted product contains 10.5 8.7 x 108 colony-forming units (CFU) per vial when resuspended in the diluent provided.

What are the possible side effects of BCG (TheraCys, Tice BCG Vaccine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any side effects to your doctor. Some side effects may be serious, including:

  • fever, chills, cough, body aches, joint pain, weakness, vomiting, or other flu symptoms;
  • nausea, vomiting, stomach pain, jaundice (yellowing of your skin or eyes);
  • pain or burning when you urinate;
  • difficult urination;
  • more frequent or urgent urinating;
  • blood in your...

Read All Potential Side Effects and See Pictures of Theracys »

What are the precautions when taking bcg live (intravesical) (Theracys)?

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: immune system problems (e.g., HIV, certain cancers such as leukemia/lymphoma), radiation treatment, current infection/fever (e.g., bladder infection, active tuberculosis), injury/procedure in the bladder within the last 7 days (e.g., catheterization, biopsy, signs of bloody urine).

Before using this medication, tell your doctor or pharmacist...

Read All Potential Precautions of Theracys »

Last reviewed on RxList: 10/28/2008
This monograph has been modified to include the generic and brand name in many instances.

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