Valrubicin is a prescription medicine indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. MedsAcross supplies Valrubicin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
VALSTAR is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.
Source: US FDA prescribing information
Valrubicin is an anthracycline that affects a variety of interrelated biological functions, most of which involve nucleic acid metabolism. In cells, it inhibits the incorporation of nucleosides into nucleic acids, causes chromosomal damage, and arrests the cell cycle in G 2. Although valrubicin does not bind strongly to DNA, valrubicin metabolites interfere with the normal DNA breaking-resealing action of DNA topoisomerase II.
Source: US FDA prescribing information
For Intravesical Use Only. VALSTAR is recommended at a dose of 800 mg administered intravesically once a week for six weeks. Delay administration at least two weeks after transurethral resection and/or fulguration. Warm VALSTAR slowly to room temperature, but do not heat. Use caution when handling and preparing the solution of VALSTAR.
Source: US FDA prescribing information
VALSTAR is contraindicated in patients with: Perforated bladder Known hypersensitivity to anthracyclines or polyoxyl castor oil Active urinary tract infection Small bladder capacity and unable to tolerate a 75 mL instillation Perforated bladder or compromised bladder mucosa. Hypersensitivity to anthracyclines or polyoxyl castor oil. Concurrent urinary tract infections. Patients with a small bladder capacity unable to tolerate a 75 mL instillation.
Source: US FDA prescribing information
Delaying cystectomy can lead to development of metastatic bladder cancer, which is lethal. Do not administer VALSTAR to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. Evaluate the status of the bladder before the intravesical instillation of VALSTAR. Use with caution in patients with severe irritable bladder symptoms. Embryo-Fetal Toxicity: VALSTAR can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Source: US FDA prescribing information
The most frequently reported adverse reactions ( > 5%) after administration of VALSTAR are urinary frequency, dysuria, urinary urgency, bladder spasm, hematuria, bladder pain, urinary incontinence, cystitis, urinary tract infection, nocturia, local burning symptoms, abdominal pain, and nausea.
Source: US FDA prescribing information
No drug interaction studies were conducted.
Source: US FDA prescribing information
Store vials under refrigeration at 2°-8°C (36°-46°F) in the carton. DO NOT FREEZE.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Valrubicin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Valrubicin 200 mg/5 mL injectionIntravesical Cold chainGeneric name | — | US FDA | Available on request |
| Valstar 200 mg/5 mL injectionIntravesical Cold chain | Endo | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 25 September 1998 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Valrubicin in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Valrubicin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Valrubicin, including Valstar.
Yes. The US FDA first approved Valrubicin on 25 September 1998, according to Drugs@FDA.
At least one listed presentation of Valrubicin must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Valrubicin is classified under ATC code L01DB09 (Valrubicin).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.