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TheraCys BCG (Generic Bacillus Calmette-Guerin (BCG) Vaccine)

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Why is this medication prescribed?

TheraCys BCG (Bacillus Calmette-Guérin) is a type of bacteria that is used as a vaccine to help prevent tuberculosis (TB) in high-risk individuals. However, it is also used as a treatment for certain types of bladder cancer, particularly superficial bladder cancer. When used for bladder cancer, TheraCys BCG works by stimulating the immune system to attack and destroy cancer cells in the bladder.

How should this medicine be used?

TheraCys BCG is typically administered directly into the bladder through a catheter in a medical setting, such as a doctor’s office, clinic, or hospital. The procedure is known as intravesical instillation. Here’s a general overview of how TheraCys BCG is used:

  • Preparation: Before administering TheraCys BCG, your healthcare provider will ensure that your bladder is empty. They may also perform a bladder washout to remove any remaining urine.
  • Administration: The healthcare provider will insert a catheter through the urethra into the bladder. Then, they will instill the TheraCys BCG solution directly into the bladder through the catheter. The solution is left in the bladder for a specific period, usually about 1-2 hours, to allow it to come into contact with the bladder wall.
  • Emptying the bladder: After the specified dwell time, the solution is drained from the bladder through the catheter, and the catheter is removed.
  • Post-procedure care: After the procedure, you may be instructed to drink plenty of fluids to help flush out any remaining BCG bacteria from the bladder. You may also be advised to avoid urinating for a certain period to maximize the contact time of the BCG solution with the bladder wall.
  • Repeat treatments: TheraCys BCG treatment for bladder cancer typically involves a series of weekly instillations for about 6 weeks, followed by a maintenance schedule of less frequent doses over a period of up to three years. The exact treatment schedule will be determined by your healthcare provider based on your individual condition and response to treatment.

It’s essential to follow your healthcare provider’s instructions carefully regarding the administration of TheraCys BCG and any post-procedure care to ensure the effectiveness of the treatment and minimize the risk of complications. Additionally, since TheraCys BCG is a live bacteria vaccine, special precautions should be taken to prevent its spread to others, particularly those with weakened immune systems. Your healthcare provider will provide detailed instructions on handling the medication safely.

Other uses for this medicine

Some of these off-label uses include:

  • Treatment of other types of cancer: TheraCys BCG has been investigated for its potential use in treating other types of cancer, such as melanoma, lung cancer, and certain types of lymphoma.
  • Treatment of non-muscle-invasive bladder cancer: Besides superficial bladder cancer, TheraCys BCG may also be used in the treatment of non-muscle-invasive bladder cancer that has not responded adequately to other forms of treatment.
  • Treatment of genital warts: TheraCys BCG has been explored as a potential treatment for genital warts caused by the human papillomavirus (HPV), particularly in cases where other treatments have failed.

What special precautions should I follow?

Regarding special precautions for TheraCys BCG, here are some important points to consider:

  • Infection control: Since TheraCys BCG contains live bacteria, special precautions are necessary to prevent the spread of the bacteria to others. This includes proper handling and disposal of waste materials, such as catheters and urine, to minimize the risk of contamination.
  • Immune compromise: TheraCys BCG should be used with caution in individuals with weakened immune systems, such as those with HIV/AIDS, autoimmune disorders, or receiving immunosuppressive therapy, as they may be at increased risk of developing serious infections from the live bacteria.
  • Side effects monitoring: Patients receiving TheraCys BCG should be monitored closely for potential side effects, which can include fever, chills, fatigue, bladder irritation, and blood in the urine. If any concerning symptoms occur, they should be reported to a healthcare provider promptly.
  • Allergy precautions: Individuals with a history of severe allergic reactions to TheraCys BCG or any of its components should avoid using this medication.
  • Pregnancy and breastfeeding: The safety of TheraCys BCG during pregnancy and breastfeeding has not been established, and its use in these populations should be carefully considered based on the potential risks and benefits.

As with any medication, it’s essential to follow your healthcare provider’s instructions carefully and discuss any concerns or questions you may have about TheraCys BCG treatment.

What special dietary instructions should I follow?

As for special dietary instructions, there are generally no specific dietary restrictions associated with TheraCys BCG treatment. However, it’s essential to maintain a healthy and balanced diet to support overall health and well-being, which can contribute to a better response to treatment and recovery.

What should I do if I forget a dose?

If you forget a dose of TheraCys BCG, it’s crucial to contact your healthcare provider or clinic as soon as possible for guidance. They can advise you on the appropriate course of action, which may include rescheduling the missed dose or adjusting your treatment schedule accordingly. It’s essential not to double up on doses without consulting a healthcare professional, as this can increase the risk of side effects or complications.

What side effects can this medication cause?

TheraCys BCG (Bacillus Calmette-Guérin) can cause various side effects, ranging from mild to severe. These side effects can occur during treatment or shortly after. Common side effects include:

  • Fever: Low-grade fever is common after BCG instillations and usually resolves within 24 to 48 hours.
  • Chills: Some people may experience chills or shivering after receiving TheraCys BCG.
  • Fatigue: Feeling tired or fatigued is a common side effect of BCG treatment.
  • Bladder irritation: TheraCys BCG can cause irritation to the bladder, leading to symptoms such as frequent urination, urgency, and discomfort or pain while urinating.
  • Hematuria: Blood in the urine (hematuria) is a common side effect of BCG treatment. This can occur after each instillation and usually resolves within a few days.
  • Urinary tract infections: BCG treatment can increase the risk of urinary tract infections, which may cause symptoms such as burning or pain during urination, increased frequency of urination, and urgency.

Less common but more severe side effects of TheraCys BCG may include:

  • Systemic infection: In rare cases, TheraCys BCG can cause systemic infections, which may manifest as high fever, severe chills, weakness, and other symptoms of infection.
  • Granulomatous prostatitis: In men, BCG treatment may lead to inflammation of the prostate gland, known as granulomatous prostatitis.
  • Pneumonitis: Rarely, BCG treatment can cause inflammation of the lungs (pneumonitis), which may present with symptoms such as cough, shortness of breath, and chest pain.
  • Septicemia: In severe cases, BCG treatment can lead to bloodstream infections (septicemia), which can be life-threatening if not promptly treated.

It’s essential to report any side effects or symptoms experienced during or after TheraCys BCG treatment to your healthcare provider promptly. They can provide guidance on managing side effects and determine if any further medical intervention is necessary.

What should I know about storage and disposal of this medication?

Storage and disposal of TheraCys BCG:

  • Storage: TheraCys BCG should be stored in a refrigerator at a temperature between 2°C to 8°C (36°F to 46°F). Do not freeze TheraCys BCG. Keep the vials in their original packaging and protect them from light.
  • Disposal: Unused TheraCys BCG and any waste materials, such as catheters used for administration, should be disposed of properly according to local regulations for handling biohazardous materials. Follow your healthcare provider’s instructions or consult your pharmacist for guidance on proper disposal.

In case of emergency/overdose

In the case of an emergency or overdose of TheraCys BCG, seek immediate medical attention. Overdose of TheraCys BCG can lead to severe adverse reactions, including systemic infection. Symptoms of overdose may include fever, chills, difficulty breathing, severe pain, or other signs of infection. Do not attempt to manage an overdose on your own.

What other information should I know?

  • TheraCys BCG is administered directly into the bladder through a catheter by a healthcare professional.
  • Prior to administration, patients should be screened for tuberculosis (TB) infection and treated if necessary, as TheraCys BCG can cause TB reactivation.
  • Patients should inform their healthcare provider about any history of immune system disorders or recent treatment with immunosuppressive medications.
  • Common side effects of TheraCys BCG include bladder irritation, urinary frequency, urgency, and discomfort during urination.
  • Serious adverse reactions such as systemic infection or BCG sepsis are rare but can occur, especially in patients with compromised immune systems.
  • Patients may be advised to drink plenty of fluids after receiving TheraCys BCG to help flush the bladder and minimize irritation.
  • Follow-up appointments with the healthcare provider are important to monitor for efficacy and detect any adverse reactions.

Always follow the instructions provided by your healthcare provider regarding the storage, administration, and disposal of TheraCys BCG, and seek medical help promptly if you experience any concerning symptoms.

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