Valrubicin

What is Valrubicin?

• Valrubicin (Valstar) is an anthracycline topoisomerase inhibitor used to treat bladder carcinoma in situ that did not get better after treatment with bacillus Calmette-Guerin (BCG).
• It is used in patients who cannot have surgery right away to remove all or part of the bladder.

Valrubicin

What are the uses of this medicine?

• Valrubicin (Valstar) is approved to treat:

Bladder cancer:

• It is given directly into the bladder as a treatment for carcinoma in situ that does not respond to treatment with bacillus Calmette-Guérin (BCG).
• It is used in patients who cannot have surgery right away.

How does this medicine work?

• 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.

Who Should Not Use this medicine ?

This medicine cannot be used 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

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• It was approved as a therapy of bladder cancer in the United States 1998, was removed in 2002 because of manufacturing issues, but reintroduced in 2009.

How should this medicine be used?

Recommended dosage:

• 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.

Administration:

• Valrubicin comes as a solution (liquid) to be infused (injected slowly) through a catheter (small flexible plastic tube) into your bladder while you are lying down.
• Valrubicin solution is given by a doctor or a health care provider in a medical office, hospital, or clinic.
• It is usually given once a week for 6 weeks.
• You should keep the medication in your bladder for 2 hours or as long as possible.
• At the end of 2 hours you will empty your bladder.
• If any valrubicin solution leaks out of the bladder and gets on your skin, the area should be cleaned with soap and water.
• Spills on the floor should be cleaned with undiluted bleach.
• Drink plenty of fluids after receiving your treatment with valrubicin.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 200 mg/5 mL in single-use vials

This medicine is available in fallowing brand namesː

• VALSTAR

What side effects can this medication cause?

The most common side effects of this medicine include:

• urinary frequency
• dysuria
• urinary urgency
• bladder spasm
• hematuria
• bladder pain
• urinary incontinence
• cystitis
• urinary tract infection
• nocturia
• local burning symptoms
• abdominal pain
• nausea

What special precautions should I follow?

• Inform patients that VALSTAR has been shown to induce complete response in only about 1 in 5 patients. Delaying cystectomy can lead to development of metastatic bladder cancer, which is lethal.
• Evaluate the bladder before the intravesical instillation of drug and do not administer VALSTAR to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised.
• To avoid systemic exposure to VALSTAR for the patients undergoing TURB, evaluate the status of the bladder before the intravesical instillation of drug.
• Use VALSTAR with caution in patients with severe irritable bladder symptoms.
• Based on findings in animal studies and its mechanism of action, VALSTAR can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with VALSTAR and for 6 months following the final dose.
• Advise females not to breastfeed during treatment with VALSTAR and for 2 weeks after the last dose.
• Inform patients that for the first 24 hours following administration, red-tinged urine is typical.
• Instruct patients to maintain adequate hydration following VALSTAR treatment.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• irritable bladder
• If significant systemic exposure occurs following intravesical administration (e.g., in patients with bladder rupture/perforation) myelosuppression may occur.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on findings in animal studies and its mechanism of action, VALSTAR can cause fetal harm when administered to a pregnant females.
• There are no available data in pregnant females to inform the drug-associated risk.
• Advise females who are or might become pregnant of the potential risk to a fetus.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• VALRUBICIN

Inactive ingredients:

• ALCOHOL
• POLYOXYL 35 CASTOR OIL
• NITROGEN

Who manufactures and distributes this medicine?

Distributed by:

• Endo Pharmaceuticals Inc.
• Malvern, PA

Manufactured by:

• BSP Pharmaceuticals S.p.A
• Latina Scalo, Italy

• VALSTAR is a trademark of Endo Pharmaceuticals Inc.

What should I know about storage and disposal of this medication?

• Store vials under refrigeration at 2°-8°C (36°-46°F) in the carton.
• DO NOT FREEZE.

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• Dailymed label info on Valrubicin
• FDA Valrubicin