valrubicin

High Alert

Intravesicular (bladder instillation) therapy of BCG-refractory carcinoma in situ of the urinary bladder in patients for whom surgery is inappropriate.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to anthracyclines or poloxyl castor oil;
Known alcohol intolerance;
Concurrent urinary tract infection;
Small bladder capacity (unable to tolerate 75-mL instillation);
Perforated bladder or conditions where the integrity of the bladder mucosa has been compromised;
Recent (within 2 wk) transurethral resection.
OB: Pregnancy and lactation;

Use Cautiously in:

Severe irritable bladder symptoms;
Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established.

Adv. Reactions/Side Effects ⬆ ⬇

CV: chest pain, vasodilation

Derm: rash

Endo: hyperglycemia

F and E: peripheral edema

GI: abdominal pain, diarrhea, flatulence, nausea, vomiting

GU: bladder spasm, cystitis, dysuria, hematuria, red urine, urinary frequency, urinary incontinence, urinary tract infection, urinary urgency, local burning, nocturia, urethral pain, urinary retention

Hemat: anemia

MS: back pain

Neuro: dizziness, headache, malaise, weakness

Resp: pneumonia

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

(Generic available)

Solution for instillation: 40 mg/mL (contains dehydrated alcohol and polyoxyl castor oil)

Route/Dosage ⬆ ⬇

Intravesicular(Adults ): 800 mg instilled into urinary bladder once weekly for 6 wk.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Interferes with DNA synthesis.

Therapeutic effects:

Decreased spread of bladder carcinoma.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: anthracyclines

Pharmacokinetics ⬆ ⬇

Absorption: Action is primarily local; systemic absorption is negligible.

Distribution: Penetrates bladder wall.

Metabolism/Excretion: Excreted by voiding of instillate.

Half-Life: Unknown.

Canadian Brand Names ⬆ ⬇

Time/Action Profile ⬆ ⬇

(antineoplastic effect)

ROUTE	ONSET	PEAK	DURATION
Intravesicular	rapid	unknown	period of instillation

Patient/Family Teaching ⬆ ⬇

Inform patient that complete responses from valrubicin occur in only 1 in 5 patients and that delaying cystectomy may lead to metastatic bladder cancer, which is fatal. Discuss the risks associated with both procedures and the increased risk the longer cystectomy is delayed.
Advise patient that major toxicities from valrubicin cause irritable bladder symptoms, which may occur during instillation and retention and for a limited period following voiding. Red-tinged urine is common for the first 24 hr following instillation. Instruct patient to report prolonged irritable bladder symptoms or prolonged passage of red-tinged urine to health care professional immediately.
Rep: May be teratogenic. Advise females of reproductive potential to use effective contraception during and for 6 mo after last dose and to avoid breastfeeding during and for 2 wk after last dose of valrubicin. Advise males with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose. May impair male fertility.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

53183- Sicor S.r.l.
- 53183-7202-
  - 53183-7202-1- 1 kg in 1 CARTON (53183-7202-1)

67979- Endo USA, Inc.
- 67979-001- Valstar
  - 67979-001-01- 4 VIAL in 1 CARTON (67979-001-01) / 5 mL in 1 VIAL

77391- Gemini PharmChem Mannheim GmbH
- 77391-005-
  - 77391-005-01- 50 g in 1 BOTTLE, GLASS (77391-005-01)

77391- Gemini PharmChem Mannheim GmbH
- 77391-005-
  - 77391-005-02- 100 g in 1 BOTTLE, GLASS (77391-005-02)

77391- Gemini PharmChem Mannheim GmbH
- 77391-005-
  77391-005-03- 250 g in 1 BOTTLE, GLASS (77391-005-03)

77391- Gemini PharmChem Mannheim GmbH
- 77391-005-
  77391-005-04- 500 g in 1 BOTTLE, GLASS (77391-005-04)

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Indications ⬇