Valrubicin
What is Valrubicin?[edit | edit source]
- 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.
What are the uses of this medicine?[edit | edit source]
- 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?[edit | edit source]
- 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 ?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- Safety and effectiveness in pediatric patients have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
Active ingredient:
- VALRUBICIN
Inactive ingredients:
- ALCOHOL
- POLYOXYL 35 CASTOR OIL
- NITROGEN
Who manufactures and distributes this medicine?[edit | edit source]
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?[edit | edit source]
- Store vials under refrigeration at 2°-8°C (36°-46°F) in the carton.
- DO NOT FREEZE.
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