solutions [grade:<4 C, warm vial in the hand until solution is clear (do not use vial if particulate still present). Dilute 800 mg (20 mL) with 55 mL NS (total volume of 75 mL). Use non-PVC containers (glass, polyolefin, or polypropylene) and administration sets to avoid leaching of DEHP plasticizers. Stable for 12 hours at room temperature when diluted in 0.9% sodium chloride. Do not mix with other drugs. Administration For intravesical use only; not for IV or IM use. Intravesicular bladder instillation: Insert urinary catheter, empty bladder prior to instillation, slowly by gravity flow, instill 800 mg/75 mL (in 0.9% sodium chloride injection), remove catheter. Retain in the bladder for 2 hours, then void. Administer through non-PVC tubing due to the polyoxyl castor oil component. Maintain adequate hydration following treatment. Storage Store intact vials at 2 C to 8 C (36 F to 48 F). Do not freeze. Solutions diluted in 0.9% sodium chloride are stable for 12 hours at room temperature. Drug Interactions There are no known significant interactions. Adverse Reactions In general, local adverse reactions occur during or shortly after instillation and resolve within 1 to 7 days.> 10%: Genitourinary: Irritable bladder (88%), urinary frequency (61%), urinary urgency (57%), dysuria (56%), bladder spasm (31%), hematuria (29%; microscopic: 3%; gross hematuria: 1%), bladder pain (28%), urinary incontinence (22%), cystitis (15%), urinary tract infection (15%), red urine discoloration 1% to 10%: Cardiovascular: Chest pain (3%), vasodilatation (2%), peripheral edema (1%) Central nervous system: Localized burning (5%), headache (4%), malaise (4%), dizziness (3%) Dermatologic: Skin rash (3%) Endocrine & metabolic: Hyperglycemia (1%) Gastrointestinal: Abdominal pain (5%), nausea (5%), diarrhea (3%), vomiting (2%), flatulence (1%) Genitourinary: Nocturia (7%), urinary retention (4%), urethral pain (3%), pelvic pain (1%) Hematologic & oncologic: Anemia (2%) Neuromuscular & skeletal: Weakness (4%), back pain (3%), myalgia (1%) Respiratory: Pneumonia (1%) Miscellaneous: Fever (2%) <1% (Limited to important or life-threatening): Ageusia, increased nonprotein nitrogen, pruritus, reduced urine flow, skin irritation (local), tenesmus, urethritis Warnings/Precautions Concerns related to adverse effects: Bladder irritation: Irritable bladder symptoms may occur during instillation and retention, and for a brief time after voiding. Use with caution in patients with severe irritable bladder symptoms;. Prolonged symptoms should prompt contact with the physician. Red-tinged urine: May occur in first 24 hours after instillation. Prolonged discoloration should prompt contact with the physician. Disease-related concerns: Bladder perforation: Evaluate bladder status prior to instillation. Do not administer if mucosal integrity of bladder has been compromised or bladder perforation is present; delay treatment until restoration of bladder integrity. Bladder procedures: Delay valrubicin therapy for at least 2 weeks after transurethral resection and/or fulguration. Other warnings/issues: Administration: Use aseptic technique to prevent urinary tract infection or traumatizing urinary mucosa. Although clamping of the urinary catheter after administration is not recommended, use caution and appropriate medical supervision if performed. Appropriate use: Delaying cystectomy for intravesical treatment may lead to metastatic bladder cancer; the risk for metastatic disease increases with delay duration; reconsider cystectomy for recurrence or if complete response to treatment does not occur within 3 months. Polyoxyl castor oil: Contains polyoxyl castor oil which may be associated with hypersensitivity reactions. Use is contraindicated in patients with hypersensitivity to polyoxyl castor oil. Monitoring Parameters Cystoscopy, biopsy, and urine cytology every 3 months for recurrence or progression Pregnancy Risk Factor C Pregnancy Considerations Adverse effects were observed in animal reproduction studies. Systemic exposure (eg, with bladder perforation) during human pregnancy may result in fetal harm. Women of childbearing potential should avoid becoming pregnant during treatment. All patients of reproductive age should use an effective method of contraception during the treatment period. Patient Education Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?) Patient may experience bladder irritation, polyuria, urinary incontinence, abdominal pain, nausea, or urine discoloration. Have patient report immediately to prescriber painful urination, hematuria, change in amount of urine passed, or urinary retention (HCAHPS). Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions. Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients. Next Interactions Print this page Add to My Med List More about valrubicin Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 0 Reviews Add your own review/rating Drug class: antibiotics/antineoplastics Consumer resources Valrubicin Valrubicin Intravesical (Advanced Reading) Professional resources Other brands: Valstar Related treatment guides Urinary Tract Tumors> ] Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Valrubicin Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Antibiotics / antineoplastics Related Drugs antibiotics / antineoplastics Adriamycin , doxorubicin , mitomycin , Doxil , Valstar , epirubicin Urinary Tract Tumors Valstar , bcg , TheraCys , Tice BCG , More... everybody
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