Valstar (valrubicin)

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No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

Because systemic exposure to valrubicin is minimal following intravesical administration of the drug in patients with an intact bladder mucosa, the potential for drug interactions is low. The possibility of clinically important drug interactions must be considered in patients with systemic exposure to valrubicin (e.g., inadvertent systemic administration of the drug, bladder rupture or perforation in patients receiving intravesical therapy with the drug). Formal studies to evaluate drug interactions with valrubicin have not been performed to date.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Selected Immunosuppressive Agents/Live Vaccines; Live Bcg

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: A variety of disease modifying agents suppress the immune system. Immunocompromised patients may be at increased risk for uninhibited replication after administration of live, attenuated vaccines or intravesicular BCG. Immune response to vaccines may be decreased during periods of immunocompromise.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained and/or the vaccine may result in illness.(1) After instillation of intravesicular BCG, immunosuppression may interfere with local immune response, or increase the severity of mycobacterial infection following inadvertent systemic exposure.(2)

PREDISPOSING FACTORS: Immunosuppressive diseases (e.g. hematologic malignancies, HIV disease), treatments (e.g. radiation) and drugs may all increase the magnitude of immunodeficiency.

PATIENT MANAGEMENT: The Centers for Disease Control(CDC) Advisory Committee on Immunization Practices (ACIP) states that live-virus and live, attenuated vaccines should not be administered to patients who are immunocompromised. The magnitude of immunocompromise and associated risks should be determined by a physician.(1) For patients scheduled to receive chemotherapy, vaccination should ideally precede the initiation of chemotherapy by 14 days. Patients vaccinated while on immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated at least 3 months after discontinuation of therapy.(1) Patients who receive anti-B cell therapies should not receive live vaccines for at least 6 months after such therapies due to a prolonged duration of immunosuppression. An exception is the Zoster vaccine, which can be given at least 1 month after receipt of anti-B cell therapies.(1) The US manufacturer of abatacept states live vaccines should not be given during or for up to 3 months after discontinuation of abatacept.(2) The US manufacturer of live BCG for intravesicular treatment of bladder cancer states use is contraindicated in immunosuppressed patients.(3) The US manufacturer of daclizumab states live vaccines are not recommended during and for up to 4 months after discontinuation of treatment.(4) The US manufacturer of guselkumab states that live vaccines should be avoided during treatment with guselkumab.(5) The US manufacturer of inebilizumab-cdon states that live vaccines are not recommended during treatment and after discontinuation until B-cell repletion. Administer all live vaccinations at least 4 weeks prior to initiation of inebilizumab-cdon.(6) The US manufacturer of ocrelizumab states that live vaccines are not recommended during treatment and until B-cell repletion occurs after discontinuation of therapy. Administer all live vaccines at least 4 weeks prior to initiation of ocrelizumab.(7) The US manufacturer of ozanimod states that live vaccines should be avoided during and for up to 3 months after discontinuation of ozanimod.(8) The US manufacturer of siponimod states that live vaccines are not recommended during treatment and for up to 4 weeks after discontinuation of treatment.(9) The US manufacturer of ustekinumab states BCG vaccines should not be given in the year prior to, during, or the year after ustekinumab therapy.(10) The US manufacturer of satralizumab-mwge states that live vaccines are not recommended during treatment and should be administered at least four weeks prior to initiation of satralizumab-mwge.(11) The US manufacturer of ublituximab-xiiy states that live vaccines are not recommended during treatment and until B-cell recovery. Live vaccines should be administered at least 4 weeks prior to initiation of ublituximab-xiiy.(12) The US manufacturer of etrasimod states that live vaccines should be avoided during and for 5 weeks after treatment. Live vaccines should be administered at least 4 weeks prior to initiation of etrasimod.(13) The US manufacturer of emapalumab-lzsg states that live vaccines should not be administered to patients receiving emapalumab-lzsg and for at least 4 weeks after the last dose of emapalumab-lzsg. The safety of immunization with live vaccines during or following emapalumab-lzsg therapy has not been studied.(14) The US manufacturer of sibeprenlimab-szsi states live vaccines should not be given within 30 days prior to initiation or during treatment with sibeprenlimab-szsi.(15)

DISCUSSION: Killed or inactivated vaccines do not pose a danger to immunocompromised patients.(1) Patients with a history of leukemia who are in remission and have not received chemotherapy for at least 3 months are not considered to be immunocompromised.(1)

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

• Lactation
• Rupture of bladder
• Small capacity bladder
• Urinary tract infection

• Bladder hyperactivity
• Bladder surgery
• Pregnancy

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

Less Frequent

• Chest pain
• Skin rash
• Vasodilation of blood vessels

Rare or Very Rare

• Hyperglycemia
• Peripheral edema
• Pneumonia

More Frequent

• Bladder irritability
• Dysuria
• Hematuria
• Increased urinary frequency
• Urinary incontinence
• Urinary tract infection
• Urine discoloration

Less Frequent

• 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 or Very Rare

• Dysgeusia
• Myalgia
• Pruritus of skin
• Tenesmus

No enhanced messaging available.

No enhanced messaging available.

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 messaging available.