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Intravesical medications

uses
• NMIBC
• IC
Non-muscle invasive urothelial carcinoma of
the bladder
• ntravesical BCG is an immunotherapy using an attenuated live strain of Mycobacterium
bovis used as a therapy for and prophylaxis against, recurrent tumors in patients with
intermediate and high risk NMIBC .
• Intravesical Mitomycin is a cytotoxic antibiotic that inhibits DNA synthesis in bladder
cancer cells. It may be given immediately, post TURBT in absence of perforation. Sodium
bicarbonate, which raises the pH of serum and urine, may be used orally in combination
with Mitomycin to buffer urine pH to optimize therapy and decrease recurrence of
bladder tumors (Au, 2001).
• Valrubicin (Valstar) is an option for patients who are unfit to undergo cystectomy and
have disease that has not responded to BCG.
• Epirubicin, Gemcitabine, Doxorubicin, and Adriamycin are examples of other cytotoxic
agents that may be used as second line therapies for bladder cancer.
• Data for intravesical therapy for pure non-urothelial bladder cancer histologies
(adenocarcinoma, pure squamous cell carcinoma, small cell or neuroendocrine tumors) is
lacking
Intermediate BC
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High risk BC
• T1/Tis, with high grade/G3, or CIS
Interstitial cystitis


later
requirement
• Assessment of ability to retain solution for the desired dwell time.
Anticholinergics may be prescribed if patient complains of bladder
spasms
• Perform a urine analysis (UA) prior to instillation. If bacteriuria is
present on HPF or if > 5 WBCs is present on HPF and/or gross
hematuria is noted and the patient is symptomatic, defer instillation
and send for urine culture to include identification and sensitivity of
all organisms. Discuss findings with prescribing clinician. Consider
sending patient home on an antibiotic. Microscopic hematuria only or
isolated WBCs in an otherwise asymptomatic patient should not
preclude treatment.
Contraindications To Administration

 Within 7 to 14 days of bladder or prostatic surgery, including biopsy


 Within 7 to 14 days following traumatic catheterization
 Pregnant or lactating patients
 Active tuberculosis
 Immunosuppressed patients with congenital or acquired immune deficiency, whether due to concurrent
disease (e.g. AIDs, leukemia, lymphoma), cancer therapy (cytotoxic drugs, radiation) or immunosuppressive
therapy (e.g. corticosteroids, DMARDs). If these conditions are present, but treatment is still deemed
necessary, informed consent must be discussed by prescribing provider and documented in patient's record.
(Herr, 2013).
 Symptomatic urinary tract infection
 In the presence of febrile illness
 Patients on treatment with certain antibiotics that may interfere with effectiveness of BCG. Discuss with
prescribing or collaborating provider before administration.
Flouroquinolones should be used with caution as they may alter the therapeutic effects of BCG.
 Any previous allergies or adverse reactions to BCG.
Preparation Of Agent (BCG)
 the dose for the intravesical treatment of BCG is one vial suspended in 50 mL preservative free
saline
 BCG must be used within 2 hours of reconstitution. Unused solution is discarded as bio hazardous
waste after 2 hours.
 The preparation of BCG suspension must be done using aseptic technique. To avoid cross
contamination, parental drugs are not prepared in areas where BCG has been prepared.
 All equipment and supplies in contact with BCG are handled and disposed of as bio hazardous.
 The individual responsible for mixing the agent should wear chemotherapy gloves or double
gloves and take precautions to avoid contact of BCG to broken skin. If preparation cannot be
performed in a biocontainment hood, then a mask, face shield, and non-permeable gown should
be worn to avoid inhalation and inadvertent exposure to broken skin. (TICE product insert)
 Do not use a filter with BCG instillation..
 Avoid exposing BCG to direct sunlight.
• Side Effects Complications
• Dysuria Urinary Tract Infection
• Urgency Epididymitis/Orchitis
• Frequency Abscess formation
• Malaise Hematuria with clot retention
• Arthralgia/Flu-like symptoms Fever >101.3 degrees F (38.5°C)
• Low-grade Fever/chills Myelosuppression
• Skin Rash/eruptions Ureteral obstruction
• Anorexia Bladder contracture/necrosis
• Nausea/Vomiting BCG Sepsis
• Urinary Incontinence Neutropenia
• Bladder Spasms Tissue necrosis with extravasation
• Hematuria Pneumonitis
• Hepatitis
• Death
• Common side effects within 24 hours post procedure: blood in urine;
low grade fever (99-100 degrees F); tiredness; urinary frequency,
urgency, and burning with urination; and muscle or joint achiness.
You will be given prescriptions to address the urinary symptoms
(frequency, urgency, and burning on urination) if needed.
• If sexually active, wear a condom with intercourse throughout the
entire treatment course.
• Flush toilet twice after the first void
• Sit to void to avoid urine splashing. Do not use public toilets or void
outside
• BCG has no place in the treatment of low-grade urothelial neoplasms
except in the rare cases where chemotherapy is unable to reduce the
recurrence rate of the tumors
• Three days of 300 mg isoniazid (or isonicotinylhydrazide [INH]), once
daily at the occasion of the BCG instillation, could not reduce local or
systemic toxicity (vegt et al )
• two doses of 200 mg ofloxacin, which is a strong tuberculostatic
agent, given shortly after BCG instillation, reduced moderate-to-
severe side effects by 18.5%.(colombel et al ) but weak study
• one-third dose BCG was found as effective as a full dose in the
prevention of recurrence and progression. However, patients with
multifocal tumors fared better with the standard dose.(flores etal )
• similar efficacy of one-third dose versus full dose in high-grade and
high-risk tumors. while overall side effects were significantly less.
However, the number of patients who discontinued BCG for toxicity
and the severe complications were similar in both arms (Martinez et
al )
BCG cystitis
• dysuria, urgency, and hematuria are frequent in the first 2 days after
BCG instillation and do not need therapy
• When side effects remain for longer time or are really intolerable for
the patient, symptomatic treatment with spasmolytics,
anticholinergics, and analgesics are empirically advised. Don’t use
oxybutynin
• culture of the urine
• Anyhow, next instillation should be postponed with at least a week
General malaise and fever
• these frequent side effects resolve mostly within 48 hours
• Symptomatic antipyretics can be given when fever exceeds 38°C.
Fever >38.5°C for >2 days needs close monitoring of the patient
• While further diagnostic evaluation, prompt treatment with a
minimum of two or more tuberculostatic agents as (fluoroquinolones,
INH, rifampicin) is started
• The duration of this therapy is badly defined and depends on further
evolution of fever, malaise, and other findings at diagnostic
exploration
Local infections with BCG
• BCG can invade the prostate and the seminal vesicles up to the epididymis.
• These diseases require a triple tuberculostatic treatment. Often
fluoroquinolone is one arm of it. The duration varies from one study to
another from 3 to 6 months
• Orchiepididymectomy may be a rapid solution for a severely symptomatic
patient, but it does not replace the general tuberculostatic treatment that
should be continued(macleod et al)
• BCG balanitis or contact dermatitis has been described and can be handled
with local steroids.
• Granulomatous balanitis, however, can present with multiple
erythematous and painless nodules of the glans, which should be treated
with systemic triple tuberculostatic drug therapy
Systemic BCG infections
• require cessation of BCG
• systemic treatment with at least three tuberculostatic agents. The
duration of the treatment reported in the literature is variable from 3
months to 1 year, depending on the severity of the complication
treated.
• In case of septicemia and multiorgan failure, early high-dose
corticosteroids support is an essential part of the treatment as long as
symptoms persist. In these cases, it is also recommended to start as
many as four tuberculostatic agents in order to obtain rapid and
trustable response.(macleod et al )
Tuberculostatic agents
• INH,
• rifampicin,
• ethambutol,
• fluoroquinolones,
• clarithromycin,
• aminoglycosides,
• doxycycline
TB therapy
• Monotherapy is never indicated as resistance to one drug rapidly
appears.
• Triple drugs, and even four drugs in the severe cases, should be used.
• The drugs are given as a single daily dose, all together before
breakfast, on an empty stomach
• INH has a well-known liver toxicity 10-20%
• Rifampicin can add to the liver toxicity and has many interactions with
other drugs
• Ethambutol can provoke optical neuritis
•Thank you