VALSTAR (valrubicin)

There are 4 contraindications. Absolute contraindication.

Contraindication List
Lactation
Rupture of bladder
Small capacity bladder
Urinary tract infection

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Bladder hyperactivity
Bladder surgery
Pregnancy

There are 0 moderate contraindications.

There are 6 severe adverse reactions.

More Frequent	Less Frequent
None.	Chest pain Skin rash Vasodilation of blood vessels

Rare/Very Rare
Hyperglycemia Peripheral edema Pneumonia

There are 26 less severe adverse reactions.

More Frequent	Less Frequent
Bladder irritability Dysuria Hematuria Increased urinary frequency Urinary incontinence Urinary tract infection Urine discoloration	Abdominal pain with cramps Back pain Bladder pain Diarrhea Dizziness Fever Flatulence General weakness Headache disorder Malaise Nausea Nocturia Pelvic pain Urinary burning sensation Vomiting

Rare/Very Rare
Dysgeusia Myalgia Pruritus of skin Tenesmus

Although there are no adequate and controlled studies to date in humans, valrubicin has been shown to be embryotoxic and teratogenic in animal studies. Reproduction studies in rats using daily doses of valrubicin 12 mg/kg IV (about one-sixth the recommended human intravesical dose on a mg/m2 basis) administered during fetal development caused fetal malformations. Administration of valrubicin 24 mg/kg IV (about one-third the recommended human intravesical dose on a mg/m2 basis) to rats resulted in numerous, severe abnormalities in the skull and skeleton of the developing fetuses, an increase in fetal resorptions, and a decrease in viable fetuses.

Animal studies to evaluate the effects of intravesical valrubicin on fetal development have not been performed to date. Valrubicin can cause fetal harm if a pregnant woman is exposed to the drug systemically (as could occur in the case of bladder perforation during intravesical valrubicin therapy), and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. If the drug is used during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus.

Women of childbearing potential should be advised to avoid becoming pregnant during therapy with valrubicin. The manufacturer also states that men should refrain from engaging in procreative activities during therapy with valrubicin. All sexually active male and female patients of childbearing potential must use an effective method of contraception during valrubicin therapy.

It is not known whether valrubicin is distributed in milk. Because valrubicin is highly lipophilic, and because of the potential for serious adverse reactions to valrubicin in nursing infants, nursing should be discontinued before the initiation of and during valrubicin therapy.

No enhanced Geriatric Use information available for this drug.