Valrubicin Intravesical Solution 40 mg/mL
Valrubicin Intravesical Solution · SOLUTION, CONCENTRATE · Hikma Pharmaceuticals USA Inc.
Valrubicin Intravesical Solution is a solution, concentrate containing valrubicin intravesical solution at 40 mg/mL, taken intravesical. Manufactured by Hikma Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Valrubicin Intravesical Solution
- Generic Name
- Valrubicin Intravesical Solution
- NDC Code (Product)
24201-101- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 40 mg/mL
- Dosage Form
- SOLUTION, CONCENTRATE
- Route
- INTRAVESICAL
- Marketing Status
- Application #
- ANDA206430
- Marketing Start
- 04/23/2019
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. • Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For Intravesical Use Only. ( 2.1 ) • Valrubicin intravesical solution is recommended at a dose of 800 mg administered intravesically once a week for six weeks. ( 2.1 ) • Delay administration at least two weeks after transurethral resection and/or fulguration. ( 2.1 ) • Warm valrubicin intravesical solution slowly to room temperature, but do not heat. ( 2.1 ) • Use caution when handling and preparing the solution of valrubicin intravesical solution. ( 2.2 ) 2.1 Recommended Dosing For Intravesical Use Only. Do NOT administer by intravenous or intramuscular routes. Valrubicin intravesical solution is recommended at a dose of 800 mg administered intravesically once a week for six weeks. Delay administration at least two weeks after transurethral resection and/or fulguration [see Warnings and Precautions ( 5.2 , 5.3 )]. 2.2 Preparation, Handling, and Administration Handle and dispose of valrubicin intravesical solution in a manner consistent with other cytotoxic drugs. 1 The use of goggles, gloves, and protective gowns is recommended during preparation and administration of the drug. Valrubicin intravesical solution contains polyoxyl castor oil, which has b…
Contraindications
4 CONTRAINDICATIONS Valrubicin intravesical solution is contraindicated in patients with: • Perforated bladder [see Warnings and Precautions ( 5.2 )] • Known hypersensitivity to anthracyclines or polyoxyl castor oil • Active urinary tract infection • Small bladder capacity and unable to tolerate a 75 mL instillation • Perforated bladder or compromised bladder mucosa ( 4 , 5.2 ) • Hypersensitivity to anthracyclines or polyoxyl castor oil. ( 4 ) • Concurrent urinary tract infections. ( 4 ) • Patients with a small bladder capacity unable to tolerate a 75 mL instillation. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS No drug interaction studies were conducted.
Adverse Reactions
6 ADVERSE REACTIONS The most frequently reported adverse reactions ( > 5%) after administration of valrubicin intravesical solution are urinary frequency, dysuria, urinary urgency, bladder spasm, hematuria, bladder pain, urinary incontinence, cystitis, urinary tract infection, nocturia, local burning symptoms, abdominal pain, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma at us.hikma@primevigilance.com or call 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of valrubicin intravesical solution was assessed in 230 patients with transitional cell carcinoma of the bladder, including 205 patients who received multiple weekly doses. One hundred seventy-nine of the 205 patients received the approved dose and schedule of 800 mg weekly for multiple weeks. Approximately 84% of patients who received intravesical valrubicin intravesical solution in cl…
Frequently Asked Questions
What is Valrubicin Intravesical Solution used for?
Valrubicin Intravesical Solution contains Valrubicin Intravesical Solution. It is a solution, concentrate taken intravesical. Consult your doctor for specific uses.
Is Valrubicin Intravesical Solution a controlled substance?
Valrubicin Intravesical Solution is not classified as a controlled substance by the DEA.
What is the generic name for Valrubicin Intravesical Solution?
The generic name for Valrubicin Intravesical Solution is Valrubicin Intravesical Solution. There are no other listed brand versions of Valrubicin Intravesical Solution.
What is the NDC code for Valrubicin Intravesical Solution 40 mg/mL?
The NDC (National Drug Code) for Valrubicin Intravesical Solution 40 mg/mL is 24201-101, listed by Hikma Pharmaceuticals USA Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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