Valrubicin Intravesical Solution (Valrubicin Intravesical Solution)

Trade Name : Valrubicin Intravesical Solution

Leucadia Pharmaceuticals

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Strength 40 mg/mL

VALRUBICIN

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Valrubicin Intravesical Solution (Valrubicin Intravesical Solution) which is also known as Valrubicin Intravesical Solution and Manufactured by Leucadia Pharmaceuticals. It is available in strength of 40 mg/mL per ml. Read more

Valrubicin Intravesical Solution (Valrubicin Intravesical Solution) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma n n n (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality.n nn

Valrubicin intravesical solution is an anthracycline topoisomerase inhibitor indicated for intravesical therapy of BCG-refractory carcinoma n n n (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. (n n n )n n n

No data

For Intravesical Use Only.
Valrubicin intravesical solution is recommended at a dose ofu00a0 800 mg administered intravesically once a week for six weeks. (n n n )n n n
Delay administration at least two weeks after transurethral resection and/or fulguration. (n n n )n n n
Warm valrubicin intravesical solution slowly to room temperature, but do not heat. (n n n )n n n
Use caution when handling and preparing the solution of valrubicin intravesical solution. (n n n )n n n

200 mg/5 mL sterile, clear red, solution in single-use vials for intravesical instillation upon dilution.u00a0

Injection: 200 mg/5 mL in single-use vials u00a0(n n n )n n n

Valrubicin intravesical solution is contraindicated in patients with:

Perforated bladder or compromised bladder mucosa (n n n , n n n )n n n
Hypersensitivity to anthracyclines or polyoxyl castor oil. (n n n )n n n
Concurrent urinary tract infections. (n n n )n n n
Patients with a small bladder capacity unable to tolerate a 75 mL instillation. (n n n )n n n

No data

Delaying cystectomy canu00a0 lead to development of metastatic bladder cancer, which is lethal. (n n n )n n n
Do not administer valrubicin intravesical solution to patients with a perforated bladder or to those in whom the integrity of the bladder mucosa has been compromised. (n n n , n n n )n n n
Evaluate the status of the bladder before the intravesical instillation of valrubicin intravesical solution. (n n n )n n n
Use with caution in patients with severe irritable bladder symptoms. (n n n )n n n
Embryo-Fetal Toxicity: Valrubicin intravesical solution can cause fetal harm.u00a0 Advise females of reproductive potential of the potential risk to a fetus andu00a0 to use effective contraception. (n n n , n n n , n n n )n n n

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. u00a0One 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 clinical studies experienced local adverse reactions. The local adverse reactions associated with valrubicin intravesical solution usually occur during or shortly after instillation and resolve within 1 to 7 days after the instillate is removed from the bladder. Seven out of 143 patients (5%) who were scheduled to receive six doses of valrubicin intravesical solution failed to receive all of the planned doses because of the occurrence of local bladder symptoms.
TABLE 1 displays the frequency of the local adverse reactions at baseline and during treatment among 179 patients who received 800 mg doses of valrubicin intravesical solution in a multiple-cycle treatment regimen.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
TABLE 2 displays the adverse reactions other than local bladder symptoms that occurred in 1% or more of the 230 patients who received at least one dose of valrubicin intravesical solution in a clinical trial.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
Adverse reactions other than local reactions that occurred in less than 1% of the patients who received valrubicin intravesical solution intravesically in clinical trials are listed below.
u00a0u00a0u00a0u00a0Digestive System:
u00a0u00a0u00a0u00a0Metabolic and Nutritional:
u00a0u00a0u00a0u00a0Skin and Appendages:
u00a0u00a0u00a0u00a0Special Senses:
u00a0u00a0u00a0u00a0Urogenital System:
The most frequently reported adverse reactions (n n n 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. (n n n )n nn

No drug interaction studies were conducted.

No data

Lactation: Advise not to breastfeed. (n n n )n n n

There is no known antidote for overdoses of valrubicin intravesical solution. The primary anticipated complications of overdosage associated with intravesical administration would be consistent with irritable bladder symptoms.
Myelosuppression is possible if valrubicin intravesical solution is inadvertently administered systemically or if significant systemic exposure occurs following intravesical administration (e.g., in patients with bladder rupture/perforation).u00a0 Under such inadvertent exposures in the peritoneal cavity, the expected toxicities include leukopenia and neutropenia, beginning within 1 week of dose administration, with nadirs by the second week, and recovery generally by the third week. If valrubicin intravesical solution is administered when bladder rupture or perforation is suspected, weekly monitoring of complete blood counts should be performed for 3 weeks.

Valrubicin Intravesical Solution, USP 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 (2n n n -n n n )-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]-u03b1-L-n n n -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 Cn n n Hn n n Fn n n NOn n n and its molecular weight is 723.65. The chemical structure is shown in FIGURE 1.n nn
FIGURE 1. Chemical Structure of Valrubicin
Valrubicin Intravesical Solution, USP 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 ofu00a0Valrubicin Intravesical Solution, USP contains 200 mg valrubicin at a concentration of 40 mg/mL in 5 mL of 50% polyoxyl castor oil/50% v/v dehydrated alcohol, USP without preservatives or other additives. The solution is sterile and nonpyrogenic.

No data

The carcinogenic potential of valrubicin has not been evaluated.
In vitro, valrubicin was mutagenic in the bacterial reverse mutation (Ames) assayand clastogenic in the chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells.
Studies in animals evaluating the effects of valrubicin on male or female fertility have not been conducted.u00a0 Based on effects on male reproductive organs in general toxicology studies in dogs with intravesical instillation, valrubicin may impair fertility in male patients.u00a0 When instilled into the bladder of male dogs weekly for 6 weeks, valrubicin caused mild to moderate atrophy of the prostate with inflammation, diffuse decrease in acinar size, epithelial changes.u00a0 It also caused testicular degeneration, marked germ cell depletion, spermatid giant cells and karyomegaly.

Valrubicin intravesical solution was administered intravesically to a total of 230 patients with transitional cell carcinoma of the bladder, including 205 patients who received multiple weekly doses ranging from 200 to 900 mg. One hundred seventy-nine of the 205 patients received the approved dose and schedule of 800 mg weekly for multiple weeks. Patients receiving Valrubicin intravesical solution for refractory carcinoma in situ were monitored for disease recurrence or progression with cystoscopy, biopsy, and urine cytology every 3 months.
In the 90 study patients with BCG-refractory carcinoma n n n (CIS), 70% had received at least 2 courses of BCG and 30% had received one course of BCG and at least one additional course of treatment with another agent(s) - e.g., mitomycin, thiotepa, or interferon. Valrubicin intravesical solution was administered beginning at least two weeks after transurethral resection and/or fulguration.n nn
After intravesical administration of valrubicin intravesical solution, 16 patients (18%) had a complete response documented by bladder biopsies and cytology at 6 months following initiation of therapy. Median duration of response from start of treatment varied according to the method of analysis (13.5 months if measured to last bladder biopsy without tumor and 21 months if measured until time of documented recurrence). A retrospective analysis in the 16 patients with complete response to valrubicin intravesical solution demonstrated that time to recurrence of their disease after treatment with valrubicin intravesical solution was longer than time to recurrence after previous courses of intravesical therapy.
Of the 90 patients with BCG-refractory CIS, 11% (10 patients) developed metastatic or deeply-invasive bladder cancer during follow-up; four of these patients, none who underwent cystectomy, died with metastatic bladder cancer and six were found to have developed stage progression to deeply-invasive disease (T3), with lymph node involvement in one patient, at the time of cystectomy. It is uncertain to what extent the development of advanced bladder cancer in these patients was due to the delay in cystectomy required to receive treatment with valrubicin intravesical solution (3 months was the time of follow-up to determine response), as cystectomy was often delayed or was never performed despite failure of treatment with valrubicin intravesical solution. In the 10 patients documented to have invasive bladder cancer or metastatic disease, the delay between the time of treatment failure (when cystectomy should have been performed) and cystectomy or documentation of advanced bladder cancer was a median of 17.5 months.

No data

Valrubicin Intravesical Solution, USPu00a0is a sterile, clear red solution in polyoxyl castor oil/dehydrated alcohol, USP, containing 40 mg valrubicin per mL.u00a0Valrubicin Intravesical Solution, USP is available in single-use, clear glass vials, individually packaged in the following sizes:
NDCu00a024201-101-04 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 Carton of four 200 mg/5 mL single-use vials
Store vials under refrigeration at 2u00b0-8u00b0C (36u00b0-46u00b0F) in the carton. DO NOT FREEZE.
The container closure is not made with natural rubber latex.

Risk of Metastatic Bladder Cancer with Delayed Cystectomy
Local Adverse Reactions Before and During Treatment
Embryo-Fetal Toxicity
Lactation
Healthcare professionals can telephoneu00a0Leucadia Pharmaceuticals (1-877-411-9681) for information on this product.
Manufactured by:n n n The University of Iowa Pharmaceuticalsn n n Iowa City, Iowa 52242n nn
Manufactured for: n n n Leucadia Pharmaceuticalsn n n Carlsbad, CA 92011n nn
Rev. January 2019

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Valrubicin Intravesical Solution (Valrubicin Intravesical Solution)

Trade Name : Valrubicin Intravesical Solution

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Valrubicin Intravesical Solution (Valrubicin Intravesical Solution)

Trade Name : Valrubicin Intravesical Solution

SOLUTION, CONCENTRATE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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