Generic name: valrubicin
Drug class: Antibiotics / antineoplastics
Medically reviewed by A Ras MD.
What is Valstar used for?
Valstar is a prescription medicine that is used to treat bladder cancer.
VALSTAR contains valrubicin (N-trifluoroacetyladriamycin-14-valerate), which is a semisynthetic analog of the anthracycline doxorubicin as a cytotoxic agent. The chemical name of valrubicin is (2 S– 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]-α-L- lyxo-hexopyranosyl]oxyl]-2-naphthacenyl]-2-oxoethylpentanoate. 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 C 34H 36F 3NO 13 and its molecular weight is 723.65. The chemical structure is shown in FIGURE 1.
VALSTAR is intended for intravesical administration in the urinary bladder. It is supplied as a nonaqueous solution that should be diluted before intravesical administration. Each vial of VALSTAR contains 200 mg valrubicin at a concentration of 40 mg/mL in 5 mL of 50% polyoxyl castor oil/50% dehydrated alcohol, USP without preservatives or other additives. The solution is sterile and nonpyrogenic.
Mechanism of Action
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.
Before taking Valstar, tell your doctor:
- If you are allergic to Valstar; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If you have any of these health problems: Small bladder, torn bladder or hole in the bladder, or a urinary tract infection (UTI).
- If you have had any of these in the past 14 days: A biopsy, a procedure called transurethral resection (TUR), or damage to the urinary tract after a catheter has been placed.
- If you are breast-feeding. Do not breast-feed while you take Valstar and for 2 weeks after your last dose.
This is not a list of all drugs or health problems that interact with this medicine.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Valstar with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Valstar?
- Tell all of your health care providers that you take Valstar. This includes your doctors, nurses, pharmacists, and dentists.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This medicine may lead to a complete response in about 1 in 5 people. Putting off having your bladder taken out may raise the chance of your cancer spreading. This can be deadly. Talk with your doctor to see if you need to think about having your bladder taken out.
- This medicine may affect being able to father a child. Talk with the doctor.
- If you are a man and have sex with a female who could get pregnant, protect her from pregnancy during treatment and for 3 months after your last dose.
- If you are a man and your sex partner gets pregnant while you take Valstar or within 3 months after your last dose, call your doctor right away.
- This medicine may cause harm to the unborn baby if you take it while you are pregnant.
- Use birth control that you can trust to prevent pregnancy while taking Valstar and for 6 months after stopping Valstar.
- If you get pregnant while taking Valstar or within 6 months after your last dose, call your doctor right away.
How is Valstar best taken?
Use Valstar as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given through a catheter into the bladder.
- You will need to try to keep Valstar in your bladder for up to 2 hours, but no longer than 2 hours. This medicine will come out when you pass urine.
- Drink plenty of liquids that do not have caffeine for several hours after getting Valstar unless told to drink less liquids by your doctor. This helps to get rid of the drug from your bladder.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are the side effects of Valstar that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Worse pain or burning when passing urine or if these effects will not go away.
- Not able to pass urine or change in how much urine is passed.
- Blood in the urine.
What are some other side effects of Valstar?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Bladder irritation.
- Passing urine more often.
- Pain when passing urine.
- Not able to control bladder.
- Stomach pain.
- Upset stomach.
- It is normal to have red-colored urine for 24 hours after you get Valstar. If you keep having bladder irritation or you keep passing red-colored urine, call your doctor right away.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out Valstar?
- If you need to store Valstar at home, talk with your doctor, nurse, or pharmacist about how to store it.
PACKAGE LABEL – PRINCIPLE DISPLAY PANEL – VIAL LABEL
PACKAGE LABEL – PRINCIPLE DISPLAY PANEL – CARTON – 4 VIALS