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.

(Valrubicin) Valstar dose in Adults

Note: After transurethral resection and/or fulguration delay use for at least 2 weeks.

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

• Intravesical: 800 mg once a week (retain for 2 hours) for a total of 6 weeks

(Valrubicin) Valstar dose in Childrens

Not studied in children.

Pregnancy Risk Factor C

• Animal reproduction studies showed adverse effects.
• During human pregnancy systemic exposure (eg, with bladder perforation) may result in fetal harm.
• Women of childbearing age should avoid pregnancy during treatment.
• An effective method of contraception should be used in all patients of reproductive age should use during the treatment period.

Valrubicin use during breastfeeding:

• Valrubicin excretion in breast milk is not known.
• Breast-feeding should be discontinued prior to initiation of therapy as there is a potential for serious adverse reactions.

Valstar dose in kidney disease:

• No dosage adjustments have been provided in the manufacturer’s labeling.
• However, dosage adjustment is unlikely due to low systemic absorption

Valstar dose in liver disease:

No dosage adjustments have been provided in the manufacturer’s labeling.

• 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:

• Hypersensitivity reactions to polyoxyl or castor oil, anthracyclines or any component of this formulation.
• Perforated bladder. Concurrent urinary tract infection. Small bladder capacity. (Unable to tolerate 75 mL instillation).

Warnings and precautions

• Bladder irritation

  • Retention and instillation can cause symptoms of irritable bladder. 
  • Patients with severe symptoms of irritable bladder need to be cautious.
  • Contact your physician immediately if you experience prolonged symptoms.

• Urine with a reddish hue

  • It may occur within the first 24 hours of instillation. Contact your physician if you experience persistent discoloration.

• Perforation of the bladder

  • Before instillation, it is important to evaluate your bladder status.
  • If there is any compromise in the bladder's mucosal integrity or bladder perforation, do not give treatment. Wait until your bladder is fully restored.

• Bladder procedures

  • After transurethral surgery and/or fulguration, valrubicin therapy should be continued for at least two weeks.

Monitor:

• Cystoscopy, biopsy, and urine cytology should be done every 3 months for recurrence or progression of the disease.

How to administer Valrubicin (Valstar)?

• Only intravenous use should be permitted. 
• It should not be used intramuscularly or intravenous.

Instillation of intravenous bladder:

• The patient should be catheterized. Before you instill the drug, empty your bladder. 
• Slowly, by gravitational flow instill 800 mg/75mL (in 0.9% sodium saltide injection).
• The catheter should be removed. You should keep the drug in your bladder for at least 2 hours.
• Then, void it. Because of the polyoxyl oil component, administration through non-PVC tubing is recommended. 
• Following treatment, it is important to maintain adequate hydration.

Mechanism of action of Valrubicin (Valstar mechanism of action):

• DNA topoisomerase 2 is blocked. 
• Inhibiting DNA synthesis results in extensive chromosomal damage, and cell development is stopped (in the G phase).
• DNA is not intercalated, unlike other anthracyclines. It easily penetrates cells.

Absorption

• When Intravesical is used: It can penetrate the bladder wall. 
• It is dependent on the condition of the bladder wall.
• Systemic absorption is negligible. 
• It may be affected by trauma to the mucosa. 
• Systemic myelotoxicity can also occur if the bladder wall is perforated.

Metabolism

• After intravesical instillation, 2-hours retention in the bladder, and negligible in other cases.

Excretion:

• Urine (post-2 hour retention): 98.6% for intact drug; 0.4% for Ntrifluoroacetyladriamycin

International Brands of Valrubicin:

• Valstar
• Valtaxin

(Valrubicin) Valstar Brands in Pakistan:

No Brands Available in pakistan