Valrubicin is a medication used in the treatment of certain types of cancer, specifically non-invasive bladder cancer (carcinoma in situ) that has not responded to other treatments. It is a synthetic analog of a naturally occurring compound called daunorubicin, which belongs to the anthracycline class of chemotherapy drugs.

Valstar (Valrubicin) is a chemotherapeutic drug that inhibits the cell cycle in the G phase. It is used in the treatment of BCG-refractory bladder carcinoma (intravesical) in situ of the urinary bladder when cystectomy would be associated with unacceptable morbidity or mortality.

Valstar (Valrubicin) dose in Adults

Note: Wait at least 2 weeks after having a procedure called transurethral resection or fulguration in your bladder before using Valrubicin. This gives your body time to heal before starting the Valrubicin treatment.

Valstar (Valrubicin) dose in the treatment of Bladder cancer:

• In the treatment of bladder cancer with Valrubicin, the usual dose is 800 milligrams.
• This dose is given once a week, and it's done by putting the medication directly into the bladder (intravesical).
• After putting the medicine in the bladder, it should be held there for 2 hours before being emptied out.
• This treatment is typically done for a total of 6 weeks.

Valstar (Valrubicin) dose in Childrens

Not studied in children.

Pregnancy Risk Factor C

• Animal studies have shown harmful effects on pregnancies when exposed to Valrubicin.
• If Valrubicin gets into the bloodstream (for example, due to a bladder perforation) during pregnancy, it can harm the fetus.
• Women who can become pregnant should avoid getting pregnant while receiving Valrubicin treatment.
• All patients who can have children should use a reliable form of birth control while undergoing Valrubicin treatment to prevent pregnancy.

Valrubicin use during breastfeeding:

• We don't know if Valrubicin passes into breast milk.
• Because Valrubicin could harm a nursing baby, breastfeeding should be stopped before starting Valrubicin treatment.

Valrubicin dose in kidney disease:

• The manufacturer's labeling does not recommend changing the Valrubicin dosage for people with kidney problems.
• This is because Valrubicin is not likely to be absorbed into the bloodstream in significant amounts, so it's less likely to affect the kidneys.
• Therefore, there's typically no need to adjust the dosage based on kidney function.

Valrubicin dose in liver disease:

• The manufacturer's labeling for Valrubicin does not suggest changing the dosage for individuals with liver impairment.
• This is mainly because Valrubicin is not highly absorbed into the bloodstream, which means it is less likely to affect the liver or require dosage adjustments based on liver function.

• However, dosage adjustment is unlikely due to low systemic absorption.

Common Side Effects of Valrubicin Include:

• Genitourinary:
  • Irritable Bladder
  • Urinary Frequency
  • Urinary Urgency
  • Dysuria
  • Bladder Spasm
  • Hematuria
  • Bladder Pain
  • Urinary Incontinence
  • Cystitis
  • Urinary Tract Infection
  • Red Urine Discoloration

Less Common Side Effects of Valstar (Valrubicin) Include:

• Cardiovascular:
  • Chest Pain
  • Vasodilatation
  • Peripheral Edema
• Central Nervous System:
  • Localized Burning
  • Headache
  • Malaise
  • Dizziness
• Dermatologic:
  • Skin Rash
• Endocrine & Metabolic:
  • Hyperglycemia
• Gastrointestinal:
  • Abdominal Pain
  • Nausea
  • Diarrhea
  • Vomiting
  • Flatulence
• Genitourinary:
  • Nocturia
  • Urinary Retention
  • Urethral Pain
  • Pelvic Pain
• Hematologic & Oncologic:
  • Anemia
• Neuromuscular & Skeletal:
  • Weakness
  • Back Pain
  • Myalgia
• Respiratory:
  • Pneumonia
• Miscellaneous:
  • Fever

Contraindication to Valrubicin (Valstar) Include:

• Allergic reaction to anthracycline drugs, polyoxyl castor oil, or any part of Valrubicin.
• A perforated (hole in) bladder.
• Having a urinary tract infection at the same time.
• If your bladder is too small to hold at least 75 milliliters of liquid during treatment.

Warnings and precautions

Bladder irritation

• Valrubicin can sometimes cause irritation in the bladder.
• Irritable bladder symptoms might happen while you're receiving Valrubicin and holding it in your bladder.
• If you already have severe irritable bladder symptoms, be cautious when using Valrubicin.
• If these symptoms last a long time or become worse, it's important to get in touch with your doctor.

Urine with a reddish hue

• When you use Valrubicin, your urine might turn red in the first 24 hours after the treatment.
• It's normal for your urine to have a red tint shortly after the Valrubicin treatment.
• However, if your urine stays discolored for a long time or if you're concerned, it's a good idea to contact your doctor.
• They can provide guidance and address any concerns you have.

Perforation of the bladder

• Make sure your bladder is healthy before starting Valrubicin treatment.
• If there's any damage to the lining of your bladder or if you have a bladder perforation (a hole), do not use Valrubicin.
• Wait until your bladder heals and its integrity is restored before considering Valrubicin treatment.

Bladder procedures

• Wait for at least 2 weeks after having procedures like transurethral resection or fulguration on your bladder before starting Valrubicin treatment.
• This delay allows your bladder to heal properly before beginning the therapy.

Monitor:

Cystoscopy:

• This is a procedure where a doctor looks inside your bladder with a thin, flexible tube.
• It's done every 3 months to check for any signs of the cancer coming back or getting worse.

Biopsy:

• During cystoscopy, if the doctor sees any suspicious areas in your bladder, they may take a small tissue sample (biopsy) to check for cancer.
• This is also done every 3 months to monitor your condition.

Urine Cytology:

• Your doctor will collect a urine sample and examine the cells in it under a microscope.
• This helps in detecting any abnormal cells that might indicate a recurrence or progression of bladder cancer.
• Urine cytology is also done every 3 months as part of the monitoring process.

These regular check-ups are essential to catch any potential issues early and ensure the most effective treatment if needed.

How to administer Valrubicin (Valstar)?

Preparing for the Procedure:

• Insert a urinary catheter.
• Empty the bladder completely before starting the instillation.

Instillation Process:

• Use gravity flow to slowly introduce 800 mg of Valrubicin in 75 mL of 0.9% sodium chloride injection into the bladder.
• After instillation, remove the catheter.

Retaining the Medication:

• Allow Valrubicin to stay inside the bladder for 2 hours.

Voiding:

• After the 2-hour retention, you can urinate to empty your bladder.

Tubing Material:

• Ensure that you use non-PVC tubing for administering Valrubicin due to the presence of polyoxyl castor oil in the medication.

Hydration:

• Make sure to drink enough fluids to stay well-hydrated following the treatment.

These instructions are essential to ensure the proper administration of Valrubicin and to minimize the risk of complications.

Mechanism of action of Valrubicin (Valstar):

• Valrubicin works by blocking the function of DNA topoisomerase II, which is a crucial enzyme involved in DNA processing.
• This blockage hinders the synthesis of DNA, leading to significant damage to the chromosomes and stopping the cell's growth during the G phase of its development.
• Unlike some other similar drugs, Valrubicin doesn't seem to fit itself between DNA strands.
• It can easily enter cells to perform its actions.

Absorption:

• Intravesical Use: Valrubicin is used inside the bladder, where it can penetrate into the bladder wall. There's very little absorption into the bloodstream, but this can vary depending on the condition of the bladder wall. If the bladder wall is injured or perforated (has a hole), more Valrubicin might get into the bloodstream, which can lead to systemic side effects like blood problems.

Metabolism:

• Intravesical Use: After Valrubicin is placed inside the bladder and left there for 2 hours, it doesn't go through much metabolism. This means it doesn't change into different substances inside the body during this time.

Excretion:

• Through Urine: When Valrubicin is removed from the bladder through urination after the 2-hour retention period, nearly all of it (98.6%) comes out in its original form. Only a very small amount (0.4%) might be found in the urine as a substance called N-trifluoroacetyladriamycin, which is related to Valrubicin.

International Brands of Valrubicin:

• Valstar
• Valtaxin

Brands in Pakistan Valstar (Valrubicin):

Not available.