Valstar

DRUG DESCRIPTION

Valrubicin (N-trifluoroacetyladriamycin-14-valerate), a semisynthetic analog of the anthra-cycline doxorubicin, is a cytotoxic agent with the chemical name, (2S-cis)-2-[1,2,3,4, 6,11-hexahydro-2,5,12-trihydroxy-7-methoxy-6,11-dioxo-4-[[2,3,6-trideoxy-3-[(trifluoroacetyl)amino]-?-L-lyxo-hexopyranosyl]oxyl]-2-naphthacenyl]-2-oxoethyl pentanoate. Valrubicin is an orange or orange-red powder that is highly lipophilic, soluble in methylene chloride, ethanol, methanol and acetone, and relatively insoluble in water. Its chemical formula is C34H36F3NO13 and its molecular weight is 723.65. The chemical structure is shown in FIGURE 1.

FIGURE 1. Chemical Structure of Valrubicin
VALSTAR® (Valrubicin) Structural Formula Illustration

VALSTAR® (valrubicin) Sterile Solution for Intravesical Instillation is intended for intra-vesical administration in the urinary bladder. It is supplied as a nonaqueous solution that should be diluted before intravesical administration. Each vial of VALSTAR contains valrubicin at a concentration of 40 mg/mL in 50% polyoxyl castor oil/50% dehydrated alcohol, USP without preservatives or other additives. The solution is sterile and nonpyro-genic.

What are the possible side effects of valrubicin (Valstar)?

If you experience an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to valrubicin, seek emergency medical attention.

Other, less serious side effects may be more likely to occur. Continue taking valrubicin and talk to your doctor if you experience:

  • bladder irritation (increased frequency of urination, painful urination, a very strong feeling of needing to urinate, blood in the urine);
  • urinary incontinence;
  • urinary tract...

Read All Potential Side Effects and See Pictures of Valstar »

What are the precautions when taking valrubicin (Valstar)?

Before using valrubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyethylated castor oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: small bladder size or other bladder problems (e.g., perforation, incontinence), current urinary infection/symptoms of bladder irritation (including pain, spasm, frequent urge to urinate).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell...

Read All Potential Precautions of Valstar »


Valstar Consumer (continued)

SIDE EFFECTS: Bladder irritation, with symptoms such as pain, spasm, and frequent urge to urinate, usually occurs. This medication usually will cause your urine to turn a reddish color. This is a normal, harmless effect of the drug and should not be mistaken for blood in your urine. If any of these effects persist or worsen after 24 hours, contact your doctor immediately.

Infrequent side effects include nausea, abdominal/stomach pain, diarrhea, headache, weakness, dizziness, or back pain. If any of these effects persist or worsen, tell your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: bloody urine, signs of infection (e.g., fever, chills), unusual tiredness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), trouble breathing, severe dizziness.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using valrubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); or if you have any other allergies. This product may contain inactive ingredients (such as polyoxyethylated castor oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: small bladder size or other bladder problems (e.g., perforation, incontinence), current urinary infection/symptoms of bladder irritation (including pain, spasm, frequent urge to urinate).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Valstar Patient Information Including Side Effects

Brand Names: Valstar

Generic Name: valrubicin (Pronunciation: val ROO bi sin)

  • What is valrubicin (Valstar)?
  • What are the possible side effects of valrubicin (Valstar)?
  • What is the most important information I should know about valrubicin (Valstar)?
  • Who should not use valrubicin (Valstar)?
  • How should I use valrubicin (Valstar)?
  • What happens if I miss a dose (Valstar)?
  • What happens if I overdose (Valstar)?
  • What should I avoid while using valrubicin (Valstar)?
  • What other drugs will affect valrubicin (Valstar)?
  • Where can I get more information?

What is valrubicin (Valstar)?

Valrubicin is a cancer (antineoplastic) medication. Valrubicin interferes with the growth of cancer cells and slows their growth and spread in the body.

Valrubicin is used to treat bladder cancer.

Valrubicin may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of valrubicin (Valstar)?

If you experience an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to valrubicin, seek emergency medical attention.

Other, less serious side effects may be more likely to occur. Continue taking valrubicin and talk to your doctor if you experience:

  • bladder irritation (increased frequency of urination, painful urination, a very strong feeling of needing to urinate, blood in the urine);
  • urinary incontinence;
  • urinary tract infection;
  • red colored urine for 24 hours following a dose; or
  • nausea.

Talk to your doctor immediately if you have prolonged (longer than 24 hours after a dose) red-colored urine or prolonged bladder irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about valrubicin (Valstar)?

Valrubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of valrubicin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with valrubicin.

Related Drug Centers
  • Valstar


Related Drugs Index: