Medical Editor: John P. Cunha, DO, FACOEP
What Is Marqibo?
Marqibo (vinCRIStine sulfate liposome injection) 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.
What Are Side Effects of Marqibo?
Commonly, side effects of Marqibo include:
- constipation
- nausea
- fever
- low blood pressure
- fatigue
- numbness and tingling or pain in the extremities (peripheral neuropathy)
- low white blood cell count (neutropenia)
- diarrhea
- anemia
- decreased appetite, and
- nsomnia
Dosage for Marqibo
Marqibo is for intravenous use only and is administered at a dose of 2.25 mg/m2 intravenously over 1 hour once every 7 days.
What Drugs, Substances, or Supplements Interact with Marqibo?
Marqibo may interact with antifungal azole drugs, HIV drugs, phenytoin, and St. John's Wort. Tell your doctor all medications you use.
Marqibo During Pregnancy and Breastfeeding
Marqibo can cause fetal harm when administered to a pregnant woman. Patients should use effective contraception measures to prevent pregnancy during treatment with Marqibo. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Patients should not receive Marqibo while pregnant or breastfeeding.
Additional Information
Our Marqibo Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
QUESTION
What is leukemia? See AnswerGet 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, stomach pain, bloating;
- severe ongoing nausea, vomiting, or diarrhea;
- numbness, tingling, weakness, or burning pain in your hands or feet;
- severe tiredness;
- low blood cell counts--fever, chills, cough, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or
- signs of tumor cell breakdown--tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.
Common side effects may include:
- fever, low blood cell counts;
- tiredness;
- numbness, tingling;
- 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.
Read the entire detailed patient monograph for Marqibo (VinCRIStine Sulfate Liposome Injection)
SLIDESHOW
Signs of Cancer in Men: Could it Be Cancer? See SlideshowSIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- For Intravenous Use Only [see WARNINGS AND PRECAUTIONS]
- Extravasation Tissue Injury [see WARNINGS AND PRECAUTIONS]
- Neurologic Toxicity [see WARNINGS AND PRECAUTIONS]
- Myelosuppression [see WARNINGS AND PRECAUTIONS]
- Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
- Constipation and Bowel Obstruction [see WARNINGS AND PRECAUTIONS]
- Fatigue [see WARNINGS AND PRECAUTIONS]
- Hepatic Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
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.
Acute Lymphoblastic Leukemia
Relapsed or Refractory Philadelphia Chromosome Negative ALL
The safety of Marqibo was evaluated in a total of 83 adults in two trials: study 1 and study 2. Patients received Marqibo 2.25 mg/m2 once every seven days. Adverse reactions were observed in 100% of patients. The most common adverse reactions (>30%) were constipation (57%), nausea (52%), pyrexia (43%), fatigue (41%), peripheral neuropathy (39%), febrile neutropenia (38%), diarrhea (37%), anemia (34%), decreased appetite (33%), and insomnia (32%).
Adverse reactions of Grade 3 or greater were reported in 96% of patients. Adverse reactions of Grade 3 or greater and occurring in ≥ 5% of patients are summarized in Table 2.
Table 2. Most Commonly Reported (> 5%) Grade 3a a or Greater Adverse Reactions among 83 Patients Receiving the Clinical Dosing Regimen
| Adverse Reactions Grade ≥ 3 | Study 1 and 2 (N=83) n (%) |
| Blood and Lymphatic System Disorders | 47 (56.6) |
| Febrile Neutropenia | 26 (31.3) |
| Neutropenia | 15 (18.1) |
| Anemia | 14 (16.9) |
| Thrombocytopenia | 14 (16.9) |
| Infections | 33 (39.8) |
| Pneumonia | 7 (8.4) |
| Septic Shock | 5 (6.0) |
| Staphylococcal Bacteremia | 5 (6.0) |
| Neuropathyb | 27 (32.5) |
| Peripheral Sensory and Motor Neuropathy | 14 (16.7) |
| Constipation | 4 (4.8) |
| Ileus, Colonic Pseudo-Obstruction | 5 (6.0) |
| Asthenia | 4 (4.8) |
| Muscular Weakness | 1 (1.2) |
| Respiratory Thoracic and Mediastinal Disorders | 17 (20.5) |
| Respiratory Distress | 5 (6.0) |
| Respiratory Failure | 4 (4.8) |
| General Disorders and Administration Site Condition | 31 (37.3) |
| Pyrexia | 12 (14.5) |
| Fatigue | 10 (12.0) |
| Pain | 7 (8.4) |
| Gastrointestinal Disorders | 21 (25.3) |
| Abdominal Pain | 7 (8.4) |
| Investigations | 20 (24.1) |
| Aspartate Aminotransferase Increased | 6 (7.2) |
| Vascular Disorders | 8 (9.6) |
| Hypotension | 5 (6.0) |
| Psychiatric Disorders | 9 (10.8) |
| Mental Status Changes | 3 (3.6) |
| Cardiac Disorders | 9 (10.8) |
| Cardiac Arrest | 5 (6.0) |
| Renal and Urinary Disorders | 6 (7.2) |
| Musculoskeletal and Connective Tissue Disorders | 7 (8.4) |
| a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0. b Including neuropathy-associated adverse reactions. | |
A total of 76% of patients experienced serious adverse reactions during the studies. The most frequent serious adverse reactions included febrile neutropenia (20%), pyrexia (13%), hypotension (7%), respiratory distress (6%), and cardiac arrest (6%).
Twenty-eight percent of patients experienced adverse reactions leading to treatment discontinuation. The most frequent adverse reactions that caused treatment discontinuation were peripheral neuropathy (10%), leukemia-related (7%), and tumor lysis syndrome (2%).
Dose reduction, delay, or omission occurred in 53% of patients.
Adverse reactions related to neuropathy and leading to treatment discontinuation were decreased vibratory sense, facial palsy, hyporeflexia, constipation, asthenia, fatigue, and musculoskeletal pain, each reported in at least 1 patient.
Deaths occurred in 23% of patients in study 1. The non-leukemia related causes of deaths were brain infarct (1), intracerebral hemorrhage (2), liver failure (1), multi system organ failure (2), pneumonia and septic shock (3), respiratory failure (4), pulmonary hemorrhage (1), and sudden cardiac death (1).
Read the entire FDA prescribing information for Marqibo (VinCRIStine Sulfate Liposome Injection)
© Marqibo Patient Information is supplied by Cerner Multum, Inc. and Marqibo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.