Bcg-Medac
This medicine uses weakened bacteria to boost your immune system and treat bladder cancer, or to prevent it from coming back.
Form
jauhe ja liuotin suspensiota varten, virtsarakkoon
Active Ingredient
Bacillus Calmette Guerin bacteria, live, attenuated
Manufacturer
Medac Gesellschaft Für Klinische Spezialpräparate mbH
How to Use
Dosage
The content of one medicine vial is used for a single treatment directly into the bladder.
Method
A healthcare professional will put the medicine into your bladder using a thin tube (catheter). The medicine should stay in your bladder for 2 hours. Do not drink anything for 4 hours before treatment and 2 hours after.
Important
Only one dose from a single vial is given per treatment session. Treatments are usually given once a week.
Possible Side Effects
COMMON
- •Nausea.
- •Bladder inflammation (cystitis) and granulomas in the bladder, which may be part of the tumor destruction process.
- •Frequent urination with discomfort and pain (affects up to 90% of patients).
- •Asymptomatic inflammatory reactions in the prostate (granulomatous prostatitis).
- •Temporary body reactions to the medicine, such as a mild fever below 38.5 °C, flu-like symptoms (feeling sick, fever, chills), and general discomfort.
- •Feeling tired.
- •Fever above 38.5 °C.
- •Muscle pain.
- •Diarrhea.
- •Abdominal pain.
- •Difficulty holding urine (urinary incontinence).
RARE
- •Severe body-wide reaction or infection from the medicine, including blood poisoning (sepsis).
- •Low number of blood cells (cytopenia).
- •Anemia (low red blood cell count or hemoglobin in the blood).
- •Reiter's syndrome (joint inflammation with skin, eye, and urinary tract inflammation).
- •Lung inflammation (including miliary pneumonia) or inflammatory reactions (granulomas) in the lungs.
- •Liver inflammation (hepatitis).
- •Skin abscess (pus pocket on the skin).
- •Rash, joint inflammation (arthritis), or joint pain (arthralgia); these are often signs of an allergic reaction.
- •Urinary tract infection, or visible blood in urine (macroscopic hematuria).
- •Unusually small bladder (bladder retraction), weak urine flow (urinary tract narrowing), or bladder shrinkage.
- •Inflammation of a testicle (orchitis) or epididymitis.
- •Symptomatic inflammatory reaction in the prostate (granulomatous prostatitis).
- •Low blood pressure (hypotension).
- •Abnormal liver function test.
- •Blood vessel infection (e.g., infected bulging of a vein).
- •Kidney abscess (pus pocket in the kidney).
- •BCG infection of implants (like joint replacements or heart devices) and surrounding tissues.
- •Inflammation of lymph nodes in the neck or local lymph node infection.
- •Allergic reaction (hypersensitivity), such as swollen eyelids or cough.
- •Eye inflammation, including inflammation of blood vessels and retina, conjunctivitis ("pink eye"), or uveitis.
- •Abnormal connection between blood vessels (vascular fistula).
- •Vomiting, abnormal connection in the intestines (intestinal fistula), or inflammation of the abdominal lining (peritonitis).
- •Bacterial infection of bone and bone marrow (osteomyelitis), or bone marrow inflammation.
- •Abscess (pus pocket) in the psoas muscle (hip flexor muscle).
- •Testicle or epididymis inflammation that doesn't respond to tuberculosis medicines.
- •Infection of the tip of the penis.
- •Swelling in the arms or legs.
- •Inflammation of blood vessels (vasculitis), possibly in the brain.
- •Genital problems, such as vaginal pain.
- •Pain during sex (dyspareunia).
- •Severe immune reactions with fever, enlarged liver, lymph nodes and spleen, yellow skin (jaundice), and rash (hemophagocytic syndrome).
- •Kidney failure or inflammation of kidney tissue, heart ventricles, and pelvic area (pyelonephritis, nephritis).
- •Absence or low number of sperm in semen (azoospermia, oligospermia).
- •Elevated prostate-specific antigen (PSA, a lab test for the prostate).
Important Warnings
- Do not use if you are allergic to BCG bacteria or any other ingredients.
- Do not use if your immune system is weak or you have an immune deficiency (e.g., due to HIV, leukemia, cancer treatment, or certain medicines like corticosteroids).
- Do not use if you have active tuberculosis.
- Do not use if you have had radiation therapy to your bladder or nearby areas before.
- Do not use if you are pregnant, think you might be pregnant, or are breastfeeding.
Show 4 more warnings
- Do not use if you have had bladder surgery (like a TUR) or a bladder biopsy, or if your bladder was injured during catheter insertion in the last 2-3 weeks.
- Do not use if you have a hole in your bladder, visible blood in your urine, or an active urinary tract infection.
- Use a condom during sex for one week after BCG treatment to prevent spreading bacteria.
- Tell your doctor about all other medicines you are taking, especially antibiotics, tuberculosis medicines, antiseptics, and lubricants, as they can affect this treatment.