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vincristine liposomal (Rx)Brand and Other Names:Marqibo

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravenous injection

  • 5mg/31mL (0.16mg/mL) final concentration following constitution
  • Supplied as a kit that also contains sphingomyelin/cholesterol liposome injection (73.5mg/29.5mg/vial)
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Acute Lymphoblastic Leukemia

Indicated for treating Philadelphia chromosome-negative acute lymphoblastic leukemia in adults with second or greater relapse or whose disease has progressed following 2 or more antileukemia therapies

2.25 mg/m² IV infusion over 1 hr q7days

Dosage Modifications

Only treat patients with preexisting severe neuropathy after careful risk-benefit assessment

Drug-related peripheral neuropathy

Grade 3 or persistent Grade 2: Interrupt therapy; discontinue if symptoms remain at Grade 3/4; reduce dose to 2 mg/m² after improvement to Grade 1/2

Persistent Grade 2 following first dose reduction: Interrupt therapy for up to 7 days; discontinue if symptoms worsen to Grade 3/4; reduce dose to 1.825 mg/m² after improvement to Grade 1

Persistent Grade 2 following dose reduction to 1.825 mg/m²: Interrupt therapy for up to 7 days; discontinue if symptoms worsen to Grade 3/4; reduce dose to 1.5 mg/m² after improvement to Grade 1

Safety and effectiveness not established

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Interactions

Interaction Checker

vincristine liposomal and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Blood and lymphatic system disorders (56.6%)

            Infections (39.8%)

            General disorders and administration site condition (37.3%)

            Neuropathy (32.5%)

            Febrile neutropenia (31.3%)

            Respiratory thoracic and mediastinal disorders (20.5%)

            Investigations (24.1%)

            Gastrointestinal disorders (25.3%)

            Neutropenia (18.1%)

            Peripheral sensory and motor neuropathy (16.7%)

            Anemia (16.9%)

            Thrombocytopenia (16.9%)

            Pyrexia (14.5%)

            Fatigue (12%)

            Psychiatric disorders (10.8%)

            Cardiac disorders (10.8%)

            1-10%

            Vascular disorders (9.6%)

            Abdominal pain (8.4%)

            Musculoskeletal and connective tissue disorders (8.4%)

            Pain (8.4%)

            Pneumonia (8.4)

            Increased aspartate aminotransferase (7.2%)

            Renal and urinary disorders (7.2%)

            Cardiac arrest (6%)

            Septic shock (6%)

            Hypotension (6%)

            Staphylococcal bacteremia (6%)

            Ileus, colonic pseudo-obstruction (6%)

            Respiratory distress (6%)

            Constipation (4.8%)

            Asthenia (4.8%)

            Respiratory failure (4.8%)

            Mental status changes (3.6%)

            Muscular weakness (1.2%)

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            Warnings

            Black Box Warnings

            For IV use only; other routes may result in fatalities

            Death has occurred with intrathecal administration

            Do not confuse liposomal injection with vincristine injection due to different dosage recommendations; verify drug name and dose prior to administration

            Contraindications

            Hypersensitivity

            Demyelinating conditions including Charcot-Marie-Tooth syndrome

            Intrathecal administration (see Black Box Warnings)

            Cautions

            IV use only (see Black Box Warnings)

            Only administer through secure and free-flowing venous access line; discontinue infusion immediately if extravasation is suspected consider local treatment measures

            Sensory and motor neuropathies common and cumulative; monitor for symptoms of neuropathy before and after treatment; risk greater with history of preexisting neuromuscular disorders or concomitant drugs with risk of neurological toxicity

            Orthostatic hypotension may occur

            Monitor due to risk of myelosuppression; consider dose modification/ reduction if Grade 3/4 neutropenia, thrombocytopenia, or anemia develops

            Tumor lysis syndrome

            Ileus, bowel obstruction, and colonic pseudo-obstruction; risk of constipation; institute prophylactic bowel regimen

            Severe fatigue; dose delay, reduction, or discontinuation may be necessary

            Fatal liver toxicity and elevated levels of aspartate aminotransferase; monitor hepatic function tests; reduce or interrupt therapy if necessary

            Teratogenic; women of childbearing potential should avoid becoming pregnant while being treated (see Pregnancy & Lactation)

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            Pregnancy & Lactation

            Pregnancy Category: D; fetal malformations (eg, decreased fetal weights, increased early resorptions and post-implantation losses) in animals reported at systemic exposures ~20-40% of those reported in humans at recommended doses; also decreased maternal body weight

            Lactation: Unknown if excreted in human milk; use caution, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Spingomyelin/cholesterol liposome-encapsulated formulation of vincristine; binds to tubulin and alters polymerization equilibrium, resulting in altered microtubule structure and function; prevents chromosome segregation and triggers metaphase arrest and inhibition of mitosis

            Absorption

            Bioavailability: 100%

            Peak plasma concentration: 1,220 ng/mL

            AUC: 14,566 hr•ng/mL

            Metabolism

            Metabolized by CYP3A4 isozymes

            Elimination

            Total body clearance: 347 mL/hr

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            Administration

            IV Preparation

            Follow proper procedures for handling and disposal of chemotherapy

            Preparation takes 60-90 minutes; preparer must have uninterrupted time due to the extensive monitoring of temperature and time required

            Observe aseptic technique strictly due to lack of preservative or bacteriostatic agents; prepare in a biological safety cabinet

            Do not use with in-line filters

            Do not mix with other drugs

            Mixing procedure

            • Fill 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; water bath must remain outside of the sterile area
            • Place calibrated thermometer in water bath to monitor water temperature and leave it in the water bath until procedure completed; preheat water bath to 63-67°C; maintain this water temperature until completion of the procedure
            • Visually inspect each vial in the kit for particulate matter and discoloration prior to preparation, whenever solution and container permit; do not use if precipitate or foreign matter observed
            • 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 injection
            • Withdraw 1 mL of sphingomyelin/cholesterol liposome Injection and inject this into the sodium phosphate injection vial
            • Withdraw 5 mL of vincristine sulfate injection (ie, 5 mg) and inject 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 10. Confirm that the water bath temperature is at 63-67°C using the calibrated thermometer; remove the sodium phosphate injection vial containing vincristine, sphingomyelin/cholesterol liposome, and sodium phosphate from the biological safety cabinet and place into the water bath for 10 minutes using the calibrated electronic timer
            • Monitor the water bath temperature to ensure it is maintained between 63-67°C
            • Immediately after placing the mixture vial into the water bath, record the constitution start time and water temperature on the vincristine liposomal overlabel
            • At the end of the 10 minutes, confirm that the water temperature is 63-67°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 vincristine liposomal overlabel

            Labeling

            • Dry the exterior of the constituted vial (ie, vincristine liposomal 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- 30°C, 59-86°F)
            • Final vincristine concentration is 5 mg/31 mL (0.16 mg/mL)
            • Once vincristine liposomal is prepared, may store at controlled room temperature (15-30°C, 59-86°F) not to exceed 12 hr
            • Swab the top of the vial now containing vincristine liposomal with a sterile alcohol pad and return the vial back into the biological safety cabinet
            • Calculate the dose based on the patient’s actual body surface area (BSA) and remove the volume corresponding to the dose from an infusion bag containing 100 mL of 5% dextrose injection or 0.9% NaCl injection Inject the vincristine liposomal dose 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
            • Complete administration of the diluted product within 12 hr of the initiation of vincristine liposomal 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

            IV Administration

            Infuse IV over 1 hr

            Storage

            Kit: Store in refrigerator at 2-8°C; do not freeze

            Constituted vial (ie, 5 mg/31 mL prepared vial): May store at controlled room temperature 15-30°C (59-86°F) for up to 12 hr in biological safety hood

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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