Valrubicin

Valrubicin is a prescription medication used for the intravesicular treatment of BCG-Refractory bladder carcinoma in situ.

• Valrubicin is available under the following different brand names: Valstar.

Common side effects of Valrubicin include:

• bladder irritation (symptoms such as pain, spasm, frequent urge to urinate, and
• blood in the urine)
• urinary incontinence
• urinary tract infection
• nausea

Serious side effects of Valrubicin include:

• hives
• difficult breathing 
• swelling of the face, lips, tongue, or throat
• blood in your urine or painful urination lasting for longer than 24 hours
• pain or burning while urinating
• low white blood cell counts (about 1 week after a valrubicin injection) --fever, mouth sores, skin sores, sore throat, cough, trouble breathing

Rare side effects of Valrubicin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Intravesical solution

• 40 mg/mL

Bladder carcinoma

Adult dosage

• 800 mg intravesical once weekly for 6 weeks; retain in the bladder for 2 hours before voiding
• Monitor every 3 months for recurrence/progression of CIS

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Valrubicin has severe interactions with no other drugs.
• Valrubicin has serious interactions with the following drugs:
  • palifermin
  • tofacitinib
  • trastuzumab deruxtecan
• Valrubicin has moderate interactions with the following drugs:
  • cholera vaccine
  • dengue vaccine
  • siponimod
  • sipuleucel-T
• Valrubicin has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to valrubicin, anthracyclines, or other ingredients
• Perforated bladder mucosa
• Active UTI
• Small bladder capacity; unable to tolerate a 75 mL instillation

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Valrubicin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Valrubicin?”

Cautions

• Complete response achieved in only 20% of patients
• Delaying cystectomy can lead to the development of metastatic bladder cancer, which is lethal
• Do not administer to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised
• Evaluate the status of the bladder before intravesical instillation of therapy
• Use with caution in patients with severe irritable bladder symptoms
• Advise women of reproductive potential of potential risk to the fetus and to use effective contraception
• Delay valrubicin therapy for 2 weeks after transurethral resection or fulguration
• Urine may be red-tinged for 24 hours post-instillation
• Was unavailable since 2002 due to manufacturing problems; reintroduced in 2009

Pregnancy and Lactation

• Use with caution if the benefits outweigh the risks during pregnancy.
• Lactation
  • Not known if excreted in breast milk, so do not nurse