Theracys

DRUG DESCRIPTION

TheraCys, BCG Live (Intravesical) is a freeze-dried preparation made from the Connaught strain of Bacillus Calmette and Gu?rin, 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...

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


Theracys Consumer (continued)

SIDE EFFECTS: Bladder irritation (e.g., difficult/painful/frequent/bloody urination), fever, or chills may occur. High/persistent fever may be a sign of an infection. Tell your doctor or pharmacist promptly if any of these effects occur, persist, or worsen. Your doctor may prescribe additional medications to help control these symptoms. Nausea, vomiting, loss of appetite, or diarrhea may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: muscle/joint pain, pain/swelling of the testes, unusual tiredness, fast/pounding heartbeat, shortness of breath, cough, vision changes, redness/swelling/pain in the eye, eye sensitivity to light, severe stomach/abdominal pain, yellowing skin/eyes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 your medical history, especially of: certain blood vessel disease (aneurysm), man-made medical devices/parts in the body (e.g., pacemakers, artificial joints, arterial grafts).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is recommended that women receiving this medication avoid pregnancy. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (e.g., condoms, birth control pills) while receiving this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Theracys Patient Information Including Side Effects

Brand Names: TheraCys, Tice BCG Vaccine

Generic Name: BCG (Pronunciation: bee cee jee)

  • What is BCG (Theracys)?
  • What are the possible side effects of BCG (Theracys)?
  • What is the most important information I should know about BCG (Theracys)?
  • What should I discuss with my health care provider before I receive BCG (Theracys)?
  • How is BCG given (Theracys)?
  • What happens if I miss a dose (Theracys)?
  • What happens if I overdose (Theracys)?
  • What should I avoid while receiving BCG (Theracys)?
  • What other drugs will affect BCG (Theracys)?
  • Where can I get more information?

What is BCG (Theracys)?

BCG (Bacillus Calmette and Gu?rin) is made using the organisms of a bacteria.

This medication is injected directly into the bladder, where it causes inflammation and increases certain white blood cells known as natural killer cells. These killer cells act to destroy invading cells such as tumor cells in the bladder.

BCG is used to treat bladder cancer that is localized (has not spread to other parts of the body).

BCG may also be used for other purposes not listed in this medication guide.

What are the possible side effects of BCG (Theracys)?

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 urine, lower back pain;
  • pain or swelling in your testicles;
  • easy bruising or bleeding;
  • eye pain, redness, watering, severe burning or itching; or
  • vision changes, increased sensitivity to light.

Less serious side effects may include:

  • mild nausea, stomach pain, or loss of appetite;
  • mild bladder or groin pain;
  • urine leakage or incontinence;
  • diarrhea, constipation;
  • headache;
  • mild skin rash;
  • dizziness, tired feeling; or
  • tissue particles in your urine (not blood).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about BCG (Theracys)?

You should not be treated with this medication if you are allergic to BCG, or if you have tuberculosis, a fever, a bladder infection, blood in your urine, or a weak immune system (caused by certain drugs or disease such as AIDS, leukemia, or lymphoma).

You should also not receive BCG if you have had a bladder biopsy, surgery, or catheter within the past 14 days.

Before you receive BCG, tell your doctor if you are allergic to latex rubber, or if you have myasthenia gravis, a pacemaker or other artificial heart device, an artificial joint or other prosthetic, or any type of infection (including HIV).

Also tell your doctor if you have ever had tuberculosis, bypass surgery, or an aneurysm (dilated blood vessel), or if you currently need to have an organ transplant (kidney, liver, heart, etc).

Your doctor may ask you to drink extra fluids for several hours after your BCG treatment to help flush out your bladder. Follow your doctor's instructions about the type and amount of liquids you should drink.

Call your doctor right away if you have a fever after receiving BCG, especially if the fever lasts for several hours or longer.

Antibiotics can make BCG less effective and should be avoided during your treatment with BCG. If you have an infection that must be treated with an antibiotic, you may need to stop receiving BCG for a short time. Follow your doctor's instructions and be sure to tell any other doctor who treats you that you are receiving BCG.

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