valrubicin (Rx)

Brand and Other Names:Valstar
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravesical solution

  • 40mg/mL
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Bladder Carcinoma

Indicated for intravesicular treatment of BCG-Refractory bladder carcinoma in situ

800 mg intravesical once weekly for 6 weeks; retain in bladder for 2 hours before voiding

Monitor q3month for recurrence/progression of CIS

Administration

Reconstitution: withdraw contents of 4 vials, each containing 200 mg in 5 mL (allowed to warm to room temp without heating), & dilute with 55 mL NS

Instill slowly via gravity flow through a urinary catheter (following sterile insertion)

Withdraw the catheter & allow patient to retain solution for 2 hours

After 2 hours, patient should void

Use caution when preparing, handling, and disposal

Not recommended

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Interactions

Interaction Checker

and valrubicin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Urinary frequency (61%)

            Urinary urgency (57%)

            Dysuria (56%)

            Bladder spasm (31%)

            Hematuria (29%)

            Bladder pain (28%)

            Urinary incontinence (22%)

            Cystitis (15%)

            UTI (15%)

            1-10%

            Abd pain (5%)

            Nausea (5%)

            Headache (4%)

            Malaise (4%)

            Urinary retention (4%)

            Back pain (3%)

            Dizziness (3%)

            Rash (3%)

            Diarrhea (3%)

            Anemia (2%)

            Chest pain (2%)

            Vomiting (2%)

            Vasodilation (2%)

            Pneumonia (1%)

            Asthenia (undefined)

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            Warnings

            Contraindications

            Hypersensitivity to valrubicin, anthracyclines or other ingredients

            Perforated bladder mucosa

            Active UTI

            Small bladder capacity; unable to tolerate a 75 mL instillation

            Cautions

            Complete response in only 20%

            Delaying cystectomy can lead to development of metastatic bladder cancer, which is lethal

            Not for administration to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised

            Evaluate status of bladder before intravesical instillation of therapy

            Use with caution in patients with severe irritable bladder symptoms

            Advise females of reproductive potential of potential risk to fetus and to use effective contraception

            Delay valrubicin therapy for 2 weeks after transurethral resection or fulguration

            Urine may be red-tinged for 24 hr post-instillation

            Was unavailable since 2002 due to manufacturing problems; reintroduced 2009

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if excreted in breast milk, do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Semisynthetic analog of doxorubicin; inhibits DNA topoisomerase II, which in turn inhibits DNA synthesis; causes extensive chromosomal damage and arrests cells at the G2 phase of the cell cycle; readilly penetrate cells but does not appear to intercalate DNA

            Pharmacokinetics

            Absorption: Negligible systemic absorption

            Metabolites: N-trifluoroacetyladriamycin, N-trifluoroacetyladriamycinol

            Excretion: Urine

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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