Tice strain bcg bladder instillation
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Bladder installation containing Bacillus Calmette Guerin bacteria TICE strain equivalent to 2 to 8 x 10 to the power of 8 colony forming units (12.5 mg)
Carcinoma in situ of bladder: Treatment
Prophylaxis of bladder cancer recurrences after transurethral resection
Treatment of primary or recurrent carcinoma in situ of bladder.
Prophylaxis of carcinoma in situ of bladder.
Prophylaxis of high grade/relapsing superficial papillary transitional cell (urothelial) stage Ta (grade 2 or 3) or T1 (grade 1, 2 or 3) after transurethral resection.
The content of one vial is required for one bladder instillation.
One instillation per week for 6 consecutive weeks.
One instillation per week, during 3 consecutive weeks at months 3, 6 and 12 after initiation.
The need for maintenance treatment every 6 months beyond the first year should be evaluated on tumour classification and clinical response.
For Intravesical Instillation.
The patient should not drink any fluid for a period of 4 hours prior to the instillation and for the 2 hours while the instillation remains in the bladder.
The bladder must be completely emptied before the instillation. The BCG instillation is introduced into the bladder by means of a catheter at low pressure. The BCG suspension should remain in the bladder for a period of 2 hours if possible. During this period the suspension should have sufficient contact with the entire mucosal surface of the bladder. Therefore the patient should be mobilised as much as possible. After 2 hours the patient should void the instillation in a sitting position.
Children under 18 years
History of systemic BCG infection
Immunosuppressive treatment including radiotherapy
Traumatic transurethral catheterisation in the previous 10 days
Urinary tract infection
Precautions and Warnings
Advise ability to drive/operate machinery may be affected by side effects
Do not administer & delay treatment by 10 days if catheterisation traumatic
Maintain adequate hydration during therapy
Prior to starting therapy rule out active tuberculosis
Product contains viable organisms - treat as infectious material
Delay treatment for 10-14 days after TUR or biopsy of bladder lesions
Determine patient's reactivity to tuberculin prior to administration
Advise patient to report incidences of fever
Interrupt therapy if urinary tract infection occurs
Withhold treatment until gross haematuria resolves
Male & female: Barrier contraception required until 1 week after treatment
Advise patients to avoid close contact with recent BCG vaccinees
BCG infection of aneurysms and prosthetic devices (including arterial grafts, cardiac devices, and artificial joints) have been reported following intravesicular administration of BCG. The risk of these ectopic BCG infections has not been determined, but is considered to be very small. The benefits of BCG therapy must carefully be weighed against the possibility of an ectopic BCG infection in patients with pre-existing arterial aneurysms or prosthetic devices of any kind.
Localised and irritative toxicities, often accompanied by malaise, fever and influenza-like symptoms, may occur. These usually occur within 4 hours after instillation, and may last for 24 to 48 hours. These often reflect hypersensitivity reactions and should be treated symptomatically. If fever above 39 degrees celsius occurs, and does not resolve within 12 hours despite antipyretic treatment, consider as systemic BCG-infection and initiate clinical confirmatory diagnostics and appropriate treatment.
Pregnancy and Lactation
BCG bladder instillation is contraindicated in pregnancy.
There are no adequate data from the use of BCG bladder instillation in pregnant women. Reproductive animal studies have not been performed.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
BCG bladder instillation is contraindicated in breastfeeding.
There are no adequate data from the excretion of these bacteria in breast milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Acute renal failure
Increase in prostate specific antigen (PSA)
Increases in hepatic enzymes
Urinary tract infections
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: March 2016
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 24th May 2018
Summary of Product Characteristics: OncoTICE. Merck Sharp and Dohme Limited. Revised March 2018
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