Marqibo

Marqibo is a prescription medication used to treat a certain type of acute lymphoblastic leukemia (ALL) which is a type of cancer of the white blood cells.

Marqibo belongs to a group of drugs called vinca alkaloids. It works by slowing or stopping the growth of cancer cells in your body.

This medication comes in a liposome injection and is given directly into a vein (IV) by a healthcare provider. It is usually given once a week.

Common side effects of Marqibo include constipation, nausea, plus weakness, numbness, and pain, usually in the hands and feet (peripheral neuropathy). Marqibo can cause drowsiness. Do not drive or operate heavy machinery until you know how Marqibo affects you. 

• Spectrum Pharmaceuticals, Inc.

Marqibo is for intravenous (into the vein) use only. Your doctor will choose the correct dosage for your situation and in most cases will give the injection in his or her office or clinic.

The recommended dose of Marqibo is 2.25 mg/m² intravenously over 1 hour once every 7 days.

Keep all scheduled appointments with your doctor as well as all laboratory appointments. This medicine may cause a decrease of blood cells. Your doctor may order tests before, during and after your treatment to monitor this side effect.

Drink lots of water while receiving Marqibo treatments, unless you are told not to, to help prevent constipation and dehydration.

Good diet and nutrition will be helpful, as well as eating foods that will help reduce the effects of diarrhea.

People on Marqibo may be at risk of infections, so avoiding crowds or other people with contagious illnesses may help. Always maintain good hygiene and wash hands often.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe constipation, severe cramps;

• pale skin, feeling light-headed or short of breath, rapid heart rate, feeling very weak or tired;

• numbness, tingling, or burning pain in your hands or feet;

• fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• lower back pain, blood in your urine, little or no urinating;

• tingly feeling around your mouth, muscle weakness, tightness, or contraction, overactive reflexes;

• fast or slow heart rate, weak pulse, confusion, fainting; or

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• diarrhea, constipation,

• nausea, loss of appetite; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• If you have an allergy to vincristine or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have Charcot-Marie-Tooth syndrome.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with Marqibo, like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with this medicine.
• If you are taking St. John's wort. Do not take St. John's wort with Marqibo. This medicine may not work as well.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Marqibo with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If you need to store Marqibo at home, talk with your doctor, nurse, or pharmacist about how to store it.

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.

Recommended Dosage

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 (4)]. Patients with preexisting severe neuropathy should be treated with Marqibo only after careful risk-benefit assessment [see Warnings and Precautions (5.3)]. 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 Symptoms*	Modification of Dose and Regimen
* Grading based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. † Self-care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. ‡ Instrumental ADL: refers to preparing meals, shopping for groceries and clothes, using telephone, managing money, etc.
If the patient develops Grade 3 (severe symptoms; limiting self-care activities of daily living [ADL]†) or persistent Grade 2 (moderate symptoms; limiting instrumental ADL‡) 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.

Preparation and Handling

  2.3.1 Items Required by the Pharmacy to Prepare Marqibo • Marqibo Kit • Water bath1 or block heater2 • Calibrated thermometer1 (0°C to 100°C) • Calibrated electronic timer1 • 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. • Tongs3 1 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. 2 The manufacturer will provide the block heater to the medical facility at the initial order of Marqibo. The block heater will be replaced every 5 years. 3 The manufacturer will provide tongs to the medical facility at the initial order of Marqibo.   2.3.2 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 (15)].

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.

Water bath process:

1. 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. 2. 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. 3. Preheat water bath to 63°C to 67°C. Maintain this water temperature until completion of the procedure using the calibrated thermometer. 4. 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. 5. Remove all the caps on the vials and swab the vials with sterile alcohol pads. 6. 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. 7. Withdraw 1 mL of Sphingomyelin/Cholesterol Liposome Injection. 8. Inject 1 mL of Sphingomyelin/Cholesterol Liposome Injection into the Sodium Phosphate Injection vial. 9. Withdraw 5 mL of VinCRIStine Sulfate Injection. 10. Inject 5 mL of VinCRIStine Sulfate Injection into the Sodium Phosphate Injection vial. 11. Remove the venting needle and gently invert the Sodium Phosphate Injection vial 5 times to mix. DO NOT SHAKE. 12. Fit Flotation Ring around the neck of the Sodium Phosphate Injection vial. 13. 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. 14. IMMEDIATELY after placing the Sodium Phosphate Injection vial into the water bath, record the constitution start time and water temperature on the Marqibo Overlabel. 15. At the end of the 10 minutes using the water bath, 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. 16. Record the final constitution time and the water temperature on the Marqibo Overlabel. 17. 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. 18. 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). 19. 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. 20. Swab the top of the vial now containing Marqibo with a sterile alcohol pad and return the vial back into the biological safety cabinet. 21. 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. 22. Inject the dose of Marqibo into the infusion bag to result in a final volume of 100 mL. 23. Complete the information required on the Infusion Bag Label and apply to the infusion bag. 24. Finish administration of the diluted product within 12 hours of the initiation of Marqibo preparation. 25. Empty, clean, and dry the water bath after each use. 26. 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.

Block heater process:

Note: Do NOT use water with the block heater preparation process.

Note: The flotation ring included with the Marqibo kit is not required for the block heater application.

1. Arrange the three heater blocks in the block heater such that the block holding the constitution vial is centered between the two other blank heater blocks. (See the illustration below.) 2. Place a calibrated thermometer in the block opening adjacent to the vial well to monitor the temperature. Leave the thermometer in the block opening until the procedure has been completed. 3. Turn on the block heater and set the controller to 75°C. Verify the block temperature by checking that the thermometer inserted in the block reads 75 ±2°C. Equilibrate the heating block at 75 ±2°C for 15 minutes. Maintain this block temperature until completion of the procedure using the calibrated thermometer. 4. 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. 5. Remove all the caps on the vials and swab the vials with sterile alcohol pads. 6. 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. 7. Withdraw 1 mL of Sphingomyelin/Cholesterol Liposome Injection. 8. Inject 1 mL of Sphingomyelin/Cholesterol Liposome Injection into the Sodium Phosphate Injection vial. 9. Withdraw 5 mL of VinCRIStine Sulfate Injection. 10. Inject 5 mL of VinCRIStine Sulfate Injection into the Sodium Phosphate Injection vial. 11. Remove the venting needle and gently invert the Sodium Phosphate Injection vial 5 times to mix. DO NOT SHAKE. 12. Confirm that the block heater temperature is at 73°C to 77°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 block heater for 18 minutes using the calibrated electronic timer. Monitor the temperature to ensure the temperature is maintained at 73°C to 77°C. 13. IMMEDIATELY after placing the Sodium Phosphate Injection vial into the block heater, record the constitution start time and block heater temperature on the Marqibo Overlabel. Use only the calibrated thermometer inserted in the block to monitor temperature. 14. At the end of the 18 minutes using the block heater, confirm that the block heater temperature is 73°C to 77°C using the calibrated thermometer. Remove the vial from the block heater (use tongs to prevent burns). 15. Record the final constitution time and the block heater temperature on the Marqibo Overlabel. 16. Affix Marqibo (vinCRIStine sulfate LIPOSOME injection) Overlabel, and gently invert 5 times to mix. DO NOT SHAKE. 17. 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). 18. 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. 19. Swab the top of the vial now containing Marqibo with a sterile alcohol pad and return the vial back into the biological safety cabinet. 20. 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. 21. Inject the dose of Marqibo into the infusion bag to result in a final volume of 100 mL. 22. Complete the information required on the Infusion Bag Label and apply to the infusion bag. 23. Finish administration of the diluted product within 12 hours of the initiation of Marqibo preparation. 24. 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity studies have been conducted with Marqibo or non-liposomal vincristine sulfate. Based on the mechanism of action and genotoxicity findings in nonclinical studies conducted with non-liposomal vincristine sulfate, Marqibo may be carcinogenic.

No genotoxicity studies have been conducted with Marqibo. Non-liposomal vincristine was genotoxic in some in vitro and in vivo studies.

The single- and repeat-dose animal toxicology study results indicate that Marqibo can impair male fertility, consistent with the literature on non-liposomal vincristine sulfate. Administration of vincristine liposome injection causes testicular degeneration and atrophy, and epididymal aspermia in rats.

Gonadal dysfunction has been reported in both male and female post-pubertal patients who received multi-agent chemotherapy including non-liposomal vincristine sulfate. The degree to which testicular or ovarian functions are affected is age-, dose-, and agent-dependent. Recovery may occur in some but not all patients.

Animal Toxicology and/or Pharmacology

In a repeat-dose comparative toxicology study in rats, vincristine sulfate liposome injection or non-liposomal vincristine sulfate was administered to animals intravenously once per week for 6 weeks. Clinical signs of toxicity consistent with neurotoxicity were greater with vincristine sulfate liposome injection than with non-liposomal vincristine sulfate at equal vincristine sulfate doses of 2 mg/m2/week and included uncoordinated movements, weakness, reduced muscle tone, and limited usage of the limbs. Neurological testing indicated drug-induced peripheral neurotoxicity with both drugs. Based on the histopathology examination after 6 weekly doses, vincristine sulfate liposome injection induced greater peripheral neurotoxicity (nerve fiber degeneration) and secondary skeletal muscle atrophy than the equal dose of non-liposomal vincristine sulfate. In a separate tissue distribution study in rats, administration of 2 mg/m2 of intravenous liposomal or non-liposomal vincristine sulfate showed greater accumulation of vincristine sulfate in sciatic and tibial nerves (as well as the lymph nodes, spleen, and bone marrow) of the animals following vincristine sulfate liposome injection.

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.

Applies to vincristine liposome: intravenous solution, intravenous suspension

Along with its needed effects, vincristine liposome (the active ingredient contained in Marqibo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking vincristine liposome:

More common

• Abdominal or stomach pain
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• change in consciousness
• change in muscle reflexes
• chest pain
• chills
• confusion
• cough
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• increased sensitivity to pain or touch
• low blood pressure or pulse
• lower back or side pain
• nerve pain
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• sensation of pins and needles
• severe constipation
• severe vomiting
• shortness of breath
• sneezing
• sore throat
• stabbing pain
• sweating
• tightness in the chest
• troubled breathing
• ulcers, sores, or white spots in the mouth
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Blue lips, fingernails, or skin
• irregular, fast or slow, or shallow breathing

Incidence not known

• Abdominal or stomach tenderness
• clay colored stools
• dark urine
• decreased appetite
• headache
• itching
• joint pain, stiffness, or swelling
• loss of appetite
• nausea and vomiting
• skin rash
• swelling of the feet or lower legs
• yellow eyes or skin

Some side effects of vincristine liposome may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Lack or loss of strength
• mental depression or anxiety
• muscle weakness
• nightmares or unusually vivid dreams

Incidence not known

• Redness, pain, or swelling at the injection site

Data not available.

Standard Dose: 1.4 mg/m2 IV over one minute, once. The drug is generally administered once a week.

However, doses from 0.4 to 1.4 mg/m2 IV have been used. Dosages of vincristine may depend upon the specific indication for its use, and whether other cytotoxic agents are coadministered. Subsequent doses may be determined by the clinical and hematologic response of the patient.

Maximum Dose = 2 mg

Standard Dose: 1.4 mg/m2 IV over one minute, once. The drug is generally administered once a week.

However, doses from 0.4 to 1.4 mg/m2 IV have been used. Dosages of vincristine may depend upon the specific indication for its use, and whether other cytotoxic agents are coadministered. Subsequent doses may be determined by the clinical and hematologic response of the patient.

Maximum Dose = 2 mg

Standard Dose: 1.4 mg/m2 IV over one minute, once. The drug is generally administered once a week.

However, doses from 0.4 to 1.4 mg/m2 IV have been used. Dosages of vincristine may depend upon the specific indication for its use, and whether other cytotoxic agents are coadministered. Subsequent doses may be determined by the clinical and hematologic response of the patient.

Maximum Dose = 2 mg

Standard Dose: 1.4 mg/m2 IV over one minute, once. The drug is generally administered once a week.

However, doses from 0.4 to 1.4 mg/m2 IV have been used. Dosages of vincristine may depend upon the specific indication for its use, and whether other cytotoxic agents are coadministered. Subsequent doses may be determined by the clinical and hematologic response of the patient.

Maximum Dose = 2 mg

The manufacturer recommends a 50% dose reduction for patients having a serum bilirubin value above 3 mg/100 mL. However, some clinicians recommend a 50% dose reduction for serum bilirubin values ranging from 1.5 to 3 mg/100 mL.

Because the dose-limiting side effect is neurotoxicity, clinical evaluation is necessary to detect the need for dosage reduction or discontinuation. Although vincristine is only mildly myelosuppressive, the manufacturer recommends a complete blood count before the administration of each dose. Serum uric acid levels should be determined frequently during the first three to four weeks, or appropriate measures should be taken to avoid uric acid nephropathy.

A routine prophylactic regimen against constipation may be considered. Other medications known to cause urinary retention (particularly in the elderly) should, if possible, be discontinued for the first few days following the administration of vincristine.

The drug should not be administered to patients while they are receiving radiation therapy through ports that include the liver.

If the drug is to be used in combination with L-asparaginase, vincristine should be administered 12 to 24 hours before L-asparaginase in order to minimize toxicity. The administration of L-asparaginase before vincristine may reduce the hepatic clearance of vincristine.

Clinical reports of both male and female patients who received vincristine as a part of multiple agent chemotherapy indicate that azoospermia and amenorrhea can occur in postpubertal patients. Recovery occurred in some of the patients many months after the chemotherapy had been completed. In studies of several animal species, the drug has induced teratogenesis or embryonic fatality at dosages which were nontoxic to the pregnant animals.

Vincristine has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of teratogenicity. When administered as a part of combination antineoplastic therapy, vincristine may produce gonadal dysfunction in men and women. There are no controlled data in human pregnancy. Vincristine should only be given during pregnancy when there are no alternatives and benefit outweighs risk. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving this medication.

LactMed Record Number

278

Last Revision Date

20150908

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Marqibo is used to treat acute lymphoblastic leukemia (ALL). This is a type of blood cancer.

Marqibo comes as an injectable solution kit. Your healthcare provider will mix the drug and give it to you intravenously (into your vein). You won’t inject this drug yourself.

Marqibo is a brand name for the drug vincristine liposome. It isn’t available as a generic drug.

The more common side effects of this drug can include constipation, nausea, fever, tiredness, and nerve pain. They can also include low white blood cell counts with fever, and low iron counts.

In some cases, Marqibo can cause serious side effects. These include fever, low blood pressure, trouble breathing, and sudden cardiac arrest.

IMPORTANT INFORMATION

• FDA warning See Details

• Nervous system side effects See Details

• Low blood cell counts See Details

• Tumor lysis syndrome (TLS) See Details

What is Marqibo?

This drug is a prescription drug. It comes as an injectable solution kit. Your healthcare provider will mix the drug and give it to you intravenously (into your vein). You won’t inject this drug yourself.

This drug is available as the brand-name drug Marqibo. It isn’t available as a generic drug.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications to treat your condition.

Why it's used

This drug is used to treat acute lymphoblastic leukemia (ALL).

See Details

How it works

This drug belongs to a class of drugs called vinca alkaloids.

See Details

More common side effects

The more common side effects of Marqibo include:

• Constipation

• Nausea

• Fever

• Tiredness

• Infections due to low white blood cells. Symptoms can include:

  • fever
  • cold symptoms that don’t go away, such as runny nose or sore throat
  • flu symptoms, such as cough, tiredness, and body aches
  • burning pain during urination
  • white patches in your mouth or throat

• Diarrhea

• Anemia due to low red blood cells. Symptoms can include:

  • pale skin
  • extreme tiredness
  • lightheadedness
  • fast heart rate

• Loss of appetite

• Trouble sleeping

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Fever

• Low blood pressure. Symptoms can include:

  • dizziness
  • lightheadedness

• Trouble breathing

• Sudden cardiac arrest. This means your heart stops beating.

• Tumor lysis syndrome. Symptoms can include:

  • nausea
  • shortness of breath
  • irregular heart rate
  • cloudy urine
  • tiredness

• Digestive system blockage. Symptoms can include:

  • bloating
  • constipation
  • stomach pain and cramps

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.