Valrubicin Intravesical
Valrubicin intravesical is a chemotherapy medicine placed directly into the bladder to treat a specific type of bladder cancer (BCG-refractory carcinoma in situ) when removing the bladder is too risky.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Valrubicin Intravesical: Patient Information Guide
A plain-language walkthrough of Valrubicin Intravesical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
What Valrubicin Intravesical is used for
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Valrubicin intravesical solution has one supported use:
- Treating BCG-refractory carcinoma in situ (CIS) of the bladder, given into the bladder, in people for whom immediate cystectomy (bladder removal) would carry unacceptable risk of complications or death.
How Valrubicin Intravesical works
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Valrubicin is an anthracycline chemotherapy. It disrupts how cells make nucleic acids (the building blocks of genetic material), damages chromosomes, and halts cells in the G2 phase of the cell cycle so they cannot divide.
Valrubicin itself doesn’t bind strongly to DNA. Its metabolites interfere with topoisomerase II, an enzyme that cuts and reseals DNA.
How Valrubicin Intravesical is taken (dosage)
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Valrubicin is given by a healthcare professional through a urinary catheter into the bladder. It is not given by mouth, vein, or muscle.
- Given about once a week for six weeks.
- Started at least two weeks after bladder tumor surgery or fulguration.
- Kept in the bladder for two hours, then you urinate.
- Some people can’t hold it the full two hours.
- Drink plenty of fluids afterward.
Staff wear protective gear and handle it like other cytotoxic drugs. Follow your prescriber’s instructions.
Valrubicin Intravesical side effects in detail
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Most side effects are local to the bladder. About 84% of people had them, usually during or shortly after treatment, and they cleared within 1 to 7 days.
- Urinary frequency, urgency, and burning
- Bladder spasms and bladder pain
- Blood in the urine
- Urinary incontinence, cystitis, nocturia
- Urinary tract infection
- Abdominal pain and nausea
- Less often: headache, weakness, diarrhea, rash, dizziness
Contact your doctor about signs of infection, heavy bleeding, or severe pain. Seek help for allergic reactions.
Valrubicin Intravesical warnings and precautions
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- Delayed surgery risk: Valrubicin fully clears the cancer in only about 1 in 5 people, and delaying cystectomy can allow lethal metastatic bladder cancer.
- Perforated bladder: Do not use if the bladder is perforated or the lining is compromised. Drug absorbed into the body caused severe low white blood cell counts in one patient.
- After bladder tumor surgery: Wait at least two weeks.
- Irritable bladder: Use caution if symptoms are severe.
- Pregnancy: It can cause fetal harm.
Valrubicin Intravesical interactions: what it interacts with
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Interaction information is limited.
- No drug interaction studies were done.
- The solution shouldn’t be mixed with other drugs, since compatibility data are lacking.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
Before taking Valrubicin Intravesical
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- Not for people with a perforated bladder or damaged bladder lining.
- Not for people with an active urinary tract infection.
- Not for people allergic to anthracyclines or polyoxyl castor oil.
- Not for people with a bladder too small for a 75 mL instillation.
- Pregnancy: can harm an unborn baby; use effective contraception during treatment and for 6 months after the last dose.
- Men: use effective contraception for 3 months after the last dose; fertility may be affected.
- Breastfeeding: avoid during treatment and for 2 weeks after.
- Children: safety and effectiveness not established.
- Older adults: no specific precautions for those otherwise in good health.
Valrubicin Intravesical overdose: if you take too much
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There is no known antidote. Overdose in the bladder would mainly cause irritable bladder symptoms. If the drug gets into the body, such as through a perforated bladder, low blood counts are possible, so blood counts are checked weekly for 3 weeks.
Pharmacodynamics: what Valrubicin Intravesical does in the body
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Valrubicin enters the bladder wall, where tissue levels exceeded those that killed 90% of cultured human bladder cells in lab tests. It stops cancer cells from dividing and damages their chromosomes.
Pharmacokinetics: how your body processes Valrubicin Intravesical
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Valrubicin penetrates the bladder wall, with little breakdown during the two-hour hold. Almost all of it (about 99%) leaves the body in urine when you void. Only tiny amounts reach the blood, but exposure rises if the bladder wall is damaged, for example soon after tumor surgery or with a perforation.
How to store Valrubicin Intravesical
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Store vials under refrigeration at 2°-8°C (36°-46°F) in the carton. DO NOT FREEZE.
📄 Written from Valrubicin Intravesical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Valrubicin Intravesical
24 supplements and herbal products have documented interactions with Valrubicin Intravesical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 14
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Valrubicin Intravesical: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Valrubicin Intravesical — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How will I get it?
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What side effects should I expect?
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When should I call my doctor?
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Is it safe in pregnancy or while breastfeeding?
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What if it doesn’t work?
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Is Valrubicin Intravesical available over the counter?
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When was Valrubicin Intravesical first available?
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💬 Answers drafted from Valrubicin Intravesical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 More about Valrubicin Intravesical on HelloPharmacist
💊 Valrubicin Intravesical forms and strengths (how it comes)
Valrubicin Intravesical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Oral solution
How this form is used
- Valrubicin Intravesical Solution is used for BCG-refractory carcinoma in situ of the bladder in people who cannot safely have immediate cystectomy.
- Valrubicin Intravesical Solution is for intravesical use only, never by vein or muscle.
- Valrubicin Intravesical Solution is given once a week for six weeks.
- Valrubicin Intravesical Solution stays in the bladder for two hours before you urinate.
- Valrubicin Intravesical Solution should start at least two weeks after bladder tumor surgery or fulguration.
📊 Valrubicin Intravesical on the U.S. market: products, makers and brands
How Valrubicin Intravesical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
🔍 Compare Valrubicin Intravesical products
A representative set of FDA-listed product records for Valrubicin Intravesical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Oral solution | ||||
| 40 mg/mL | Intravesical | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Valrubicin Intravesical NDCs →
📈 Valrubicin Intravesical side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Valrubicin Intravesical — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Valrubicin Intravesical in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ Valrubicin Intravesical FDA approval history
How Valrubicin Intravesical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Valrubicin Intravesical recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Valrubicin Intravesical supply and shortage status
Whether Valrubicin Intravesical is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Valrubicin Intravesical brand names
🏭 Who makes Valrubicin Intravesical: manufacturers and labelers
Valrubicin Intravesical drug class (RxNorm)
Valrubicin Intravesical belongs to the Anthracyclines and related substances class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Sources for this Valrubicin Intravesical page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Hikma Pharmaceuticals USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.