August 27, 2016
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Theracys

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Theracys

TheraCys®
[BCG Live (Intravesical)]




WARNING

RISK OF TRANSMISSION AND INFECTION

TheraCys®, BCG Live (Intravesical) contains live, attenuated mycobacteria. Because of the potential risk for transmission, prepare, handle, and dispose of TheraCys as a biohazard material.

BCG is capable of dissemination when administered by the intravesical route. Serious infections, including fatal infections, have been reported in patients receiving Intravesical BCG.

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 contains 81 mg of freeze-dried BCG. The freeze-dried BCG does not contain any preservative.

One dose of TheraCys consists of one 81mg vial of freeze-dried BCG reconstituted and diluted in 50 mL sterile, preservative-free saline.

The BCG organisms from the vial are viable. In vitro potency is determined by an assay of live BCG organisms based on the number of colonies observed when grown on solid medium. The reconstituted product contains 10.5 ± 8.7 x 108 colony-forming units (CFU) per vial.

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: 2/4/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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