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Vincristine Sulfate (Marqibo)

Trade Name : Marqibo

Talon Therapeutics, Inc.

KIT

Strength

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

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Vincristine Sulfate (Marqibo) which is also known as Marqibo and Manufactured by Talon Therapeutics, Inc.. It is available in strength of per ml. Read more

Vincristine Sulfate (Marqibo) 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

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Dosage and Administration ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a011/2016
  • WARNING
  • See full prescribing information for complete boxed warning
  • For Intravenous Use Only u2013 Fatal if Given by Other Routes ()
  • Death has occurred with intrathecal use
  • Marqibo (vinCRIStine sulfate LIPOSOME injection) has different dosage recommendations than vinCRIStine sulfate injection. Verify drug name and dose prior to preparation and administration to avoid overdosage.
  • Marqibo is indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified.
  • Marqibo is a vinca alkaloid indicated for the treatment of adult patients with Philadelphia chromosome-negative (Ph-) acute lymphoblastic leukemia (ALL) in second or greater relapse or whose disease has progressed following two or more anti-leukemia therapies. This indication is based on overall response rate. Clinical benefit such as improvement in overall survival has not been verified ().
  • For Intravenous Use Only. Fatal if Given by Other Routes.
  • Marqibo (vinCRIStine sulfate LIPOSOME injection) has different dosage recommendations than vincristine sulfate injection. Verify drug name and dose prior to preparation and administration to avoid overdosage.
  • Intravenous use only. Do not administer by any other route ()
  • Administer Marqibo at a dose of 2.25 mg/m intravenously over 1 hour once every 7 days ().
  • Marqibo is prepared from the components in the Marqibo Kit. Following the preparation procedure according to section , each single-dose vial of Marqibo (vinCRIStine sulfate LIPOSOME injection) contains 5 mg/31 mL (0.16 mg/mL) vincristine sulfate.
  • The final drug product is prepared on site from the components in the Marqibo Kit. After preparation, each single-dose vial of Marqibo (vinCRIStine sulfate LIPOSOME injection) contains 5 mg/31 mL (0.16 mg/mL) vincristine sulfate ().
  • Marqibo is contraindicated in patients with demyelinating conditions including Charcot-Marie-Tooth syndrome.
  • Marqibo is contraindicated in patients with hypersensitivity to vincristine sulfate or any of the other components of Marqibo (vinCRIStine sulfate LIPOSOME injection).
  • Marqibo is contraindicated for intrathecal administration.
  • No data
  • 2.2n- 5.3
  • 5.9n- 8.1
  • The following adverse reactions are also discussed in other sections of the labeling:
  • 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 clinical practice.
  • Most commonly reported adverse reactions (incidence u2265 30%) in clinical studies include constipation, nausea, pyrexia, fatigue, peripheral neuropathy, febrile neutropenia, diarrhea, anemia, decreased appetite, and insomnia ().
  • To report SUSPECTED ADVERSE REACTIONS, contact Talon Therapeutics at 1-888 292 9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No formal drug interaction studies have been conducted with Marqibo. Marqibo is expected to interact with drugs known to interact with non-liposomal vincristine sulfate.
  • Simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included non-liposomal vincristine sulfate have been reported to reduce blood levels of phenytoin and to increase seizure activity.
  • Marqibo is expected to interact with drugs known to interact with non-liposomal vincristine sulfate ().
  • Pediatric Use: The safety and effectiveness of Marqibo in pediatric patients has not been established ()
  • When Marqibo (vinCRIStine sulfate LIPOSOME injection) was administered at a dose of 2.4 mg/m, severe toxicities including motor neuropathy of Grade 3, grand mal seizure of Grade 4, and elevated aspartate aminotransferase and hyperbilirubinemia of Grade 4 were reported in 1 patient each. There is no known antidote for overdosage.
  • Marqibo (vinCRIStine sulfate LIPOSOME injection) is vincristine encapsulated in sphingomyelin/cholesterol liposomes for intravenous administration.
  • The active ingredient in Marqibo is vincristine sulfate. Vincristine sulfate is a vinca alkaloid isolated as a 1:1 sulfate salt from the periwinkle plant (). It is a hygroscopic, white to slightly yellowish crystalline powder that is soluble in water. It has a molecular weight of 923.04 (salt form) / 824.98 (base form) and a molecular formula of CHNO u2022 HSO. The chemical name for vincristine sulfate is 22-oxovincaleukoblastine and it has the following chemical structure:
  • Vincristine is encapsulated in a Sphingomyelin/Cholesterol liposome. The lipid components in the liposome are sphingomyelin and cholesterol at a molar ratio of approximately 60:40 (mol:mol).
  • After preparation, each vial of Marqibo contains 5 mg vincristine sulfate, 500 mg mannitol, 73.5 mg sphingomyelin, 29.5 mg cholesterol, 36 mg sodium citrate, 38 mg citric acid, 355 mg sodium phosphate, and 225 mg sodium chloride.
  • Marqibo (vinCRIStine sulfate LIPOSOME injection) appears as a white to off-white, translucent suspension, essentially free of visible foreign matter and aggregates, comprised of sphingomyelin/cholesterol liposomes, with an approximate liposome mean diameter of 100 nm. Greater than 95% of the drug is encapsulated in the liposomes.
  • The Marqibo Kit component vials for the preparation of Marqibo (vinCRIStine sulfate LIPOSOME injection) include:
  • No data
  • No data
  • Marqibo was studied in an international, open-label, multi-center, single-arm trial (Study 1). Eligible patients were 18 years of age or older with Philadelphia chromosome negative ALL in second or greater relapse or whose disease progressed after two or greater treatment lines of anti-leukemia therapy. Patients had to have achieved a complete remission (CR) to at least one prior anti-leukemia chemotherapy, defined by a leukemia-free interval of equal or more than 90 days. Patients were not eligible for immediate hematopoietic stem cell transplantation (HSCT) at the time of screening and enrollment.
  • Patients received intravenous Marqibo monotherapy at 2.25 mg/m over 60 minutes every 7 days. Concomitant corticosteroids were not permitted beyond Day 5.
  • The treated population included 65 patients who received at least 1 dose of Marqibo. All of the treated patients had received prior vincristine sulfate and 80% had evidence of residual neuropathy at study baseline. Among treated patients, 51% were male, 86% were white, 45% were under 30 years of age, 11% were age 65 or older, 48% had undergone prior HSCT, 51% had received 3 or more prior therapies, and 45% were refractory to their immediate prior therapy. Disease characteristics were 85% precursor B-cell ALL and 15% precursor T-cell ALL. In addition, 22 of 65 (34%) treated patients did not receive asparaginase products prior to enrollment. Efficacy results are shown in .
  • No data
  • The Marqibo Kit (NDC # 20536-322-01) contains:
  • Store the Marqibo Kit in the refrigerator at 2u00b0C to 8u00b0C u2013 Do Not Freeze
  • Physicians are advised to discuss the following with patients prior to treatment with Marqibo:
  • Manufactured for:
  • PRINCIPAL DISPLAY PANEL
  • Vial LabelNDC 20536-323-01VinCRIStine Sulfate Injection, USP5 mg/5 mL (1 mg/mL)for use only in the preparation of Marqibon Single Use Vial
  • Vial LabelNDC 20536-324-01Sphingomyelin-Cholesterol Liposome Injection103 mg/mLfor use only in the preparation of Marqibon Single Use Vial
  • Vial LabelNDC 20536-325-01Sodium Phosphate Injection355 mg/25 mL (14.2 mg/mL)for use only in the preparation of Marqibon Single Use Vial
  • Kit LabelNDC 20536-322-01Marqibo (vinCRIStine sulfate LIPOSOME injection)Marqibo Kit Contents:
  • Single Use Vials

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