valrubicin (Rx)

Brand and Other Names:Valstar
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravesical solution

  • 40mg/mL

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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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (3)

              • palifermin

                palifermin increases toxicity of valrubicin by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • tofacitinib

                valrubicin, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, valrubicin. Either increases toxicity of the other by unknown mechanism. Avoid or Use Alternate Drug. Trastuzumab may cause cardiomyopathy. Incidence and severity was highest when used with anthracycline-containing chemotherapy regimens. If possible, avoid anthracycline-based therapy for 7 months after last trastuzumab/hyaluronidase dose. If anthracyclines are used, carefully monitor cardiac function.

              Monitor Closely (4)

              • cholera vaccine

                valrubicin, cholera vaccine. immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

              • dengue vaccine

                valrubicin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.

              • siponimod

                siponimod and valrubicin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                valrubicin decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              Minor (0)

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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; readily 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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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                valrubicin intravesical
                -
                40 mg/mL vial
                valrubicin intravesical
                -
                40 mg/mL vial
                Valstar intravesical
                -
                40 mg/mL vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                valrubicin intravesical

                VALRUBICIN - INTRAVESICAL

                (val-REWB-eh-sin)

                COMMON BRAND NAME(S): Valstar

                USES: Valrubicin is used to treat bladder cancer. The usual treatment for bladder cancer is surgery. However, if you and your doctor decide that the risk of surgery is greater than its benefit or that surgery may be delayed, this medication may be used as part of your treatment.This medication belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells.This medication may not cure your cancer. Delaying surgery could lead to a more serious illness (metastatic cancer). Discuss the risks and benefits of this medication with your doctor.

                HOW TO USE: This medication is given by placement into the bladder as directed by your doctor. Do not give by injection into a vein or muscle or under the skin. After this medication is placed through a tube (catheter), it is usually left in the bladder for 2 hours, then released by urinating. This drug is usually used once weekly for 6 weeks or as directed by your doctor.Drink plenty of fluids after each treatment with this medication unless otherwise directed by your doctor. Doing so helps clear it from your body and decrease side effects.

                SIDE EFFECTS: Bladder irritation, with symptoms such as pain, spasm, and frequent urge to urinate, usually occurs. This medication usually will cause your urine to turn a reddish color. This is a normal, harmless effect of the drug and should not be mistaken for blood in your urine. If any of these effects persist or worsen after 24 hours, contact your doctor right away.Infrequent side effects include nausea, abdominal/stomach pain, diarrhea, headache, weakness, dizziness, or back pain. If any of these effects persist or worsen, tell your doctor.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: bloody urine, signs of infection (e.g., fever, chills), unusual tiredness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing, severe dizziness.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: Before using valrubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyethylated castor oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: small bladder size or other bladder problems (e.g., perforation, incontinence), current urinary infection/symptoms of bladder irritation (including pain, spasm, frequent urge to urinate).This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Laboratory and/or medical tests (e.g., biopsy, cystoscopy, urine cytology) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor right away for a new dosing schedule. Do not double the dose to catch up.

                STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

                Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                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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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.