No

Antineoplastic Agent, Antibiotic

Intravesical therapy of BCG-refractory carcinoma in situ of the urinary bladder

C

It is not known whether valrubicin is secreted in human milk. Because many drugs are secreted in milk, and the potential for serious adverse reactions exists, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Known hypersensitivity to anthracyclines, Cremophor® EL, or any component of this product; concurrent urinary tract infection or small bladder capacity (unable to tolerate a 75 mL instillation)

Complete response observed in only 1 of 5 patients, delay of cystectomy may lead to development of metastatic bladder cancer, which is lethal. If complete response is not observed after 3 months or disease recurs, cystectomy must be reconsidered. Do not administer if mucosal integrity of bladder has been compromised or bladder perforation is present. Following TURP, status of bladder mucosa should be evaluated prior to initiation of therapy. Administer under the supervision of a physician experienced in the use of intravesical chemotherapy. Aseptic technique must be used during administration. All patients of reproductive age should use an effective method of contraception during the treatment period. Irritable bladder symptoms may occur during instillation and retention. Caution in patients with severe irritable bladder symptoms. Do not clamp urinary catheter. Red-tinged urine is typical for the first 24 hours after instillation. Prolonged symptoms or discoloration should prompt contact with the physician.

>10%: Genitourinary: Frequency (61%), dysuria (56%), urgency (57%), bladder spasm (31%), hematuria (29%), bladder pain (28%), urinary incontinence (22%), cystitis (15%), urinary tract infection (15%)

1% to 10%:

Cardiovascular: Chest pain (2%), vasodilation (2%), peripheral edema (1%)

Central nervous system: Headache (4%), malaise (4%), dizziness (3%), fever (2%)

Dermatologic: Rash (3%)

Endocrine & metabolic: Hyperglycemia (1%)

Gastrointestinal: Abdominal pain (5%), nausea (5%), diarrhea (3%), vomiting (2%), flatulence (1%)

Genitourinary: Nocturia (7%), burning symptoms (5%), urinary retention (4%), urethral pain (3%), pelvic pain (1%), hematuria (microscopic) (3%)

Hematologic: Anemia (2%)

Neuromuscular & skeletal: Weakness (4%), back pain (3%), myalgia (1%)

Respiratory: Pneumonia (1%)

<1%: Tenesmus, pruritus, taste disturbance, skin irritation, decreased urine flow, urethritis

Inadvertent paravenous extravasation was not associated with skin ulceration or necrosis. Myelosuppression is possible following inadvertent systemic administration or following significant systemic absorption from intravesical instillation.

No specific drug interactions studies have been performed; the systemic exposure to valrubicin is negligible, and interactions are unlikely

Store unopened vials under refrigeration at 2°C to 8°C (36°F to 48°F); stable for 12 hours when diluted in 0.9% sodium chloride

Blocks function of DNA topoisomerase II; inhibits DNA synthesis, causes extensive chromosomal damage, and arrests cell development

Absorption: Well absorbed into bladder tissue, negligible systemic absorption. Trauma to mucosa may increase absorption, and perforation greatly increases absorption with significant systemic myelotoxicity.

Metabolism: Negligible after intravesical instillation and 2 hour retention

Elimination: In urine, when expelled from urinary bladder

Adults: Intravesical: 800 mg once weekly for 6 weeks

Dosing adjustment in hepatic impairment: No specific adjustment recommended

Cystoscopy, biopsy, and urine cytology every 3 months for recurrence or progression

May cause dizziness or drowsiness

None noted

No information available to require special precautions

No effects or complications reported

This medication will be instilled into your bladder through a catheter to be retained for as long as possible. Your urine will be red tinged for the next 24 hours; report promptly if this continues for a longer period. You may experience altered urination patterns (frequency, dysuria, or incontinence), some bladder pain, pain on urination, or pelvic pain; report if these persist. Diabetics should monitor glucose levels closely (may cause hyperglycemia). It is important that you maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience some dizziness or fatigue (use caution when driving or engaging in tasks requiring alertness until response to drug is known); or nausea, vomiting, or taste disturbance (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help). Report chest pain or palpitations; persistent dizziness; swelling of extremities; persistent nausea, vomiting, diarrhea, or abdominal pain; muscle weakness, pain, or tremors; unusual cough or difficulty breathing; or other adverse effects related to this medication. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Breast-feeding is not recommended.

Injection: 40 mg/mL, 200 mg/5 mL