"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Patients should be informed that VALSTAR (valrubicin) has been shown to induce complete response in only about 1 in 5 patients with BCG-refractory CIS, and that delaying cystectomy could lead to development of metastatic bladder cancer, which is lethal. The exact risk of developing metastatic bladder cancer from such a delay may be difficult to assess (See Clinical Trials) but increases the longer cystectomy is delayed in the presence of persisting CIS. If there is not a complete response of CIS to treatment after 3 months or if CIS recurs, cystectomy must be reconsidered.
VALSTAR (valrubicin) should not be administered to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised (see PRECAUTIONS and CLINICAL PHARMACOLOGY, Pharmacokinetics Figure 2).
In order to avoid possible dangerous systemic exposure to VALSTAR (valrubicin) for the patients undergoing transurethral resection of the bladder, the status of the bladder should be evaluated before the intravesical instillation of drug. In case of bladder perforation, the administration of VALSTAR (valrubicin) should be delayed until bladder integrity has been restored.
VALSTAR (valrubicin) should be administered under the supervision of a physician experienced in the use of intravesical cancer chemotherapeutic agents.
Irritable Bladder Symptoms: VALSTAR (valrubicin) should be used with caution in patients with severe irritable bladder symptoms. Bladder spasm and spontaneous discharge of the intravesical instillate may occur; clamping of the urinary catheter is not advised and, if performed, should be executed under medical supervision and with caution.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of VALSTAR (valrubicin) has not been evaluated, but the drug does cause damage to DNA in vitro. VALSTAR (valrubicin) was mutagenic in in vitro assays in Salmonella typhimurium and Escherichia coli. VALSTAR (valrubicin) was clastogenic in the chromosomal aberration assay in CHO cells. Studies of the effects of VALSTAR (valrubicin) on male or female fertility have not been done.
Pregnancy Category C. Valrubicin can cause fetal harm if a pregnant woman is exposed to the drug systemically. Such exposure could occur after perforation of the urinary bladder during valrubicin therapy. Daily intravenous doses of 12 mg/kg (about one sixth of the recommended human intravesical dose on a mg/m²basis) given to rats during fetal development caused fetal malformations. A dose of 24 mg/kg (about one third the recommended human intravesical dose on a mg/m²basis) caused numerous, severe alterations in the skull and skeleton of the developing fetuses. This dose also caused an increase in fetal resorptions and a decrease in viable fetuses. Thus, valrubicin is embryo-toxic and teratogenic. There are no preclinical studies of the effects of intra-vesical valrubicin on fetal development and no adequate and well controlled studies of valrubicin in pregnant women. If valrubicin is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women who might become pregnant should be advised to avoid doing so during therapy with VALSTAR (valrubicin) .
It is not known whether VALSTAR (valrubicin) is excreted in human milk. Nevertheless, the drug is highly lipophilic and any exposure of infants to VALSTAR (valrubicin) could pose serious health risks. Women should discontinue nursing before the initiation of VALSTAR (valrubicin) therapy.
Safety and effectiveness in pediatric patients have not been established.
Because carcinoma in situ of the bladder generally occurs in older individuals, 85% of the patients enrolled in the clinical studies of VALSTAR (valrubicin) were more than 60 years of age (49% of the patients were more than 70 years of age). In the primary efficacy studies, the mean age of the population was 69.5 years. There are no specific precautions regarding use of VALSTAR (valrubicin) in geriatric patients who are otherwise in good health.
Last reviewed on RxList: 11/24/2008
This monograph has been modified to include the generic and brand name in many instances.
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