Bacillus Calmette- Guerin -refractory carcinoma in situ

Adverse Reactions-

Any local  bladder pain  40%
Bladder  pain  5%
Dysuria  10%
Hematuria 10%
Urinary frequency  25%
Urinary urgency  20%

Known hypersensitivity to the components

Special Precautions/Warnings

Compromised bladder - evaluate the state of the bladder before the intravesical installation of the drug

Antiseptic technique- antiseptic technique must be used during administration of intrvesical valrubicin to avoid introducing contaminants into the urinary tract.

Irritable bladder symptoms- use valrubicin with caution in patients with severe bladder syndrome

Pregnancy- valrubicin may cause fetal harm to a pregnant woman.

Lactation- Women should discontinue breast feedng before initiation of therapy

Children- safety and efficacy in children not established

Indication-

Bacillus Calmette- Guerin -refractory carcinoma in situ

Dosage-
800mg adminstered intravesically once a week for 6 weeks.
Adminstration should be delayed at least 2 weeks after transurethal resection and or fuulgration

Storage  - unopened vial are stable until the date indicated on the package.
 Store under refrigerated conditions at 2 to 8C ( 36 to 46F ). Store incartons
Do not freeze

1.Inform patients that major toxicities are related to irritable syndrome that can occur during
   instillation, and retention of valrubicin and for limited period following voiding. . For the
   first 24 hours following administration red tinge urine is typical

2. Inform patients to report prolonged irritable bladder syndrome or prolonged passage of
    red colored urine, to their doctor.

3. Advice women of child bearing potential not to become pregn during treatment

4. Advice men to refrain from procreative activites while receiving therapy.

5. Advice all patients of reproductive age to use an effective contraception  method during
   the treatment period 

Pregnancy-
Valrubicin may cause fetal harm to a pregnant woman.

Lactation-
Women should discontue breast feedng before initiation of therapy

Children -
Safety and efficacy in children not established