"The U.S. Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), an uncommon form of ALL.
Precursor B-cell A"...
Adult ALL in Second or Greater Relapse
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.
DOSAGE AND ADMINISTRATION
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.
The recommended dose of Marqibo is 2.25 mg/m2 intravenously over 1 hour once every 7 days.
Marqibo is liposome-encapsulated vincristine.
Dose modifications: Peripheral Neuropathy
Marqibo is contraindicated in patients with demyelinating conditions including Charcot-Marie-Tooth syndrome [see CONTRAINDICATIONS]. Patients with preexisting severe neuropathy should be treated with Marqibo only after careful risk-benefit assessment [see WARNINGS AND PRECAUTIONS]. For dose or schedule modifications guidelines for patients who experience peripheral neuropathy, see Table 1.
Table 1: Recommended Dose
Modifications for Marqibo-related Peripheral Neuropathy
|Severity of Peripheral Neuropathy Signs and Symptomsa||Modification of Dose and Regimen|
|If the patient develops Grade 3 (severe symptoms; limiting self-care activities of daily living [ADL]b) or persistent Grade 2 (moderate symptoms; limiting instrumental ADLc) peripheral neuropathy:||Interrupt Marqibo. If the peripheral neuropathy remains at Grade 3 or 4, discontinue Marqibo.
If the peripheral neuropathy recovers to Grade 1 or 2, reduce the Marqibo dose to 2 mg/m².
|If the patient has persistent Grade 2 peripheral neuropathy after the first dose reduction to 2 mg/m²:||Interrupt Marqibo for up to 7 days. If the peripheral neuropathy increases to Grade 3 or 4, discontinue Marqibo.
If peripheral neuropathy recovers to Grade 1, reduce the Marqibo dose to 1.825 mg/m².
|If the patient has persistent Grade 2 peripheral neuropathy after the second dose reduction to 1.825 mg/m²:||Interrupt Marqibo for up to 7 days. If the peripheral neuropathy increases to Grade 3 or 4, discontinue Marqibo.
If the toxicity recovers to Grade 1, reduce the Marqibo dose to 1.5 mg/m².
|aGrading based on the National Cancer Institute (NCI) Common
Terminology Criteria for Adverse Events (CTCAE) v3.0.
bSelf-care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.
cInstrumental ADL: refers to preparing meals, shopping for groceries and clothes, using telephone, managing money, etc.
Preparation and Handling
Items Required by the Pharmacy to Prepare Marqibo
- Calibrated thermometera (0°C to 100°C)
- Calibrated electronic timera
- Sterile venting needle or other suitable device equipped with a sterile 0.2 micron filter
- 1 mL or 3 mL sterile syringe with needle, and
- 5 mL sterile syringe with needle.
a The manufacturer will provide the water bath, calibrated thermometer, and calibrated electronic timer to the medical facility at the initial order of Marqibo and will replace them every 2 years.
Preparation Instructions for Marqibo (vinCRIStine sulfate LIPOSOME injection), 5 mg/31 mL (0.16 mg/mL)
Procedures for handling and disposal of anticancer drugs should be followed [see REFERENCES].
Call [1 888 292 9617] if you have questions about the preparation of Marqibo. Marqibo takes approximately 60 to 90 minutes to prepare. The preparer should have dedicated uninterrupted time to prepare Marqibo due to the extensive monitoring of temperature and time required for the preparation.
Aseptic technique must be strictly observed since no preservative or bacteriostatic agent is present in Marqibo. The preparation steps of Marqibo that involve mixing the Sodium Phosphate Injection, Sphingomyelin/Cholesterol Liposome Injection, and VinCRIStine Sulfate Injection must be done in a biological safety cabinet or by established pharmacy safety procedures for the preparation of sterile injectable formulations and hazardous drugs. However, the preparation steps that involve placement of the vial in the water bath must be done outside of the sterile area.
Do not use with in-line filters. Do not mix with other drugs.
- Fill a water bath with water to a level of at least 8 cm (3.2 inches) measured from the bottom and maintain this minimum water level throughout the procedure. The water bath must remain outside of the sterile area.
- Place a calibrated thermometer in the water bath to monitor water temperature and leave it in the water bath until the procedure has been completed.
- Preheat water bath to 63°C to 67°C. Maintain this water temperature until completion of the procedure using the calibrated thermometer.
- Visually inspect each vial in the Marqibo Kit for particulate matter and discoloration prior to preparation, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.
- Remove all the caps on the vials and swab the vials with sterile alcohol pads.
- Vent the Sodium Phosphate Injection vial with a sterile venting needle equipped with a sterile 0.2 micron filter or other suitable venting device in the biological safety cabinet. Always position venting needle point well above liquid level before adding Sphingomyelin/Cholesterol Liposome Injection and VinCRIStine Sulfate Injection.
- Withdraw 1 mL of Sphingomyelin/Cholesterol Liposome Injection.
- Inject 1 mL of Sphingomyelin/Cholesterol Liposome Injection into the Sodium Phosphate Injection vial.
- Withdraw 5 mL of VinCRIStine Sulfate Injection.
- Inject 5 mL of VinCRIStine Sulfate Injection into the Sodium Phosphate Injection vial.
- Remove the venting needle and gently invert the Sodium Phosphate Injection vial 5 times to mix. DO NOT SHAKE.
- Fit Flotation Ring around the neck of the Sodium Phosphate Injection vial.
- Confirm that the water bath temperature is at 63°C to 67°C using the calibrated thermometer. Remove the Sodium Phosphate Injection vial containing VinCRIStine Sulfate Injection, Sphingomyelin/Cholesterol Liposome Injection, and Sodium Phosphate Injection from the biological safety cabinet and place into the water bath for 10 minutes using the calibrated electronic timer. Monitor the temperature to ensure the temperature is maintained at 63°C to 67°C.
- IMMEDIATELY after placing the Sodium Phosphate Injection vial into the water bath, record the constitution start time and water temperature on the Marqibo Overlabel.
- At the end of the 10 minutes, confirm that the water temperature is 63°C to 67°C using the calibrated thermometer. Remove the vial from the water bath (use tongs to prevent burns) and remove the Flotation Ring.
- Record the final constitution time and the water temperature on the Marqibo Overlabel.
- Dry the exterior of the Sodium Phosphate Injection vial with a clean paper towel, affix Marqibo (vinCRIStine sulfate LIPOSOME injection) Overlabel, and gently invert 5 times to mix. DO NOT SHAKE.
- Permit the constituted vial contents to equilibrate for at least 30 minutes to controlled room temperature (15°C to 30°C, 59°F to 86°F).
- Marqibo (vinCRIStine sulfate LIPOSOME injection) contains 5 mg/31 mL (0.16 mg/mL) vincristine sulfate. ONCE PREPARED, STORE AT CONTROLLED ROOM TEMPERATURE (15°C to 30°C, 59°F to 86°F) FOR NO MORE THAN 12 HOURS.
- Swab the top of the vial now containing Marqibo with a sterile alcohol pad and return the vial back into the biological safety cabinet.
- Calculate the patient's Marqibo dose based on the patient's actual body surface area (BSA) and remove the volume corresponding to the patient's Marqibo dose from an infusion bag containing 100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
- Inject the dose of Marqibo into the infusion bag to result in a final volume of 100 mL.
- Complete the information required on the Infusion Bag Label and apply to the infusion bag.
- Finish administration of the diluted product within 12 hours of the initiation of Marqibo preparation.
- Empty, clean, and dry the water bath after each use.
- Deviations in temperature, time, and preparation procedures may fail to ensure proper encapsulation of vincristine sulfate into the liposomes. In the event that the preparation deviates from the instructions in the above steps, the components of the kit should be discarded and a new kit should be used to prepare the dose.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if a precipitate or foreign matter is present.
Dosage Forms And Strengths
Marqibo is prepared from the components in the Marqibo Kit. Following the preparation procedure according to section 2.3.2, each single-dose vial of Marqibo (vinCRIStine sulfate LIPOSOME injection) contains 5 mg/31 mL (0.16 mg/mL) vincristine sulfate.
Storage And Handling
The Marqibo Kit (NDC # 20536-322-01) contains:
- Vial containing VinCRIStine Sulfate Injection, USP 5 mg/5 mL (1 mg/mL) – NDC # 20536-323-01
- Vial containing Sphingomyelin/Cholesterol Liposome Injection 103 mg/mL – NDC # 20536-324-01
- Vial containing Sodium Phosphate Injection 355 mg/25 mL (14.2 mg/mL) – NDC # 20536-325-01
- Flotation Ring
- Overlabel for Sodium Phosphate Injection vial containing constituted Marqibo (vinCRIStine sulfate LIPOSOME injection), 5 mg/31 mL (0.16 mg/mL)
- Infusion Bag Label
Store the Marqibo Kit in the refrigerator at 2°C to 8°C – Do Not Freeze
1. NIOSH Alert: Preventing occupational exposure to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. (2006) 63:1172-1193.
4. Polovich M, White JM, Kelleher LO (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.
Manufactured by: VinCRIStine Sulfate Injection, USP: Hospira Australia Pty Ltd Mulgrave, Victoria 3170 Australia. Sphingomyelin/Cholesterol Liposome Injection: Cangene Corporation Winnipeg, Manitoba R3T 5Y3 Canada. Sodium Phosphate Injection: Jubilant HollisterStier Spokane, WA 99207. Marqibo Kit for the Preparation of vinCRIStine sulfate LIPOSOME injection: Anderson Packaging, Inc Rockford, IL 61109. Distributed by: Talon Therapeutics, Inc. 400 Oyster Point Boulevard, Suite 200 South San Francisco, CA 94080. Issued August 2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/17/2012
Additional Marqibo Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.