"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Valrubicin (N-trifluoroacetyladriamycin-14-valerate), a semisynthetic analog of the anthra-cycline doxorubicin, is a cytotoxic agent with the chemical name, (2S-cis)-2-[1,2,3,4, 6,11-hexahydro-2,5,12-trihydroxy-7-methoxy-6,11-dioxo-4-[[2,3,6-trideoxy-3-[(trifluoroacetyl)amino]-α-L-lyxo-hexopyranosyl]oxyl]-2-naphthacenyl]-2-oxoethyl pentanoate. Valrubicin is an orange or orange-red powder that is highly lipophilic, soluble in methylene chloride, ethanol, methanol and acetone, and relatively insoluble in water. Its chemical formula is C34H36F3NO13 and its molecular weight is 723.65. The chemical structure is shown in FIGURE 1.
VALSTAR® (valrubicin) Sterile Solution for Intravesical Instillation is intended for intra-vesical administration in the urinary bladder. It is supplied as a nonaqueous solution that should be diluted before intravesical administration. Each vial of VALSTAR contains valrubicin at a concentration of 40 mg/mL in 50% polyoxyl castor oil/50% dehydrated alcohol, USP without preservatives or other additives. The solution is sterile and nonpyro-genic.
What are the possible side effects of valrubicin (Valstar)?
If you experience an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to valrubicin, seek emergency medical attention.
Other, less serious side effects may be more likely to occur. Continue taking valrubicin and talk to your doctor if you experience:
- bladder irritation (increased frequency of urination, painful urination, a very strong feeling of needing to urinate, blood in the urine);
- urinary incontinence;
- urinary tract infection;
- red colored urine for 24 hours following a...
What are the precautions when taking valrubicin (Valstar)?
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...
Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.
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