Marqibo Side Effects Center

Last updated on RxList: 11/3/2022
Marqibo Side Effects Center

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?

Marqibo may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • severe constipation,
  • stomach pain,
  • bloating,
  • severe ongoing nausea,
  • vomiting,
  • diarrhea,
  • numbness, tingling, weakness, or burning pain in your hands or feet,
  • severe tiredness,
  • fever,
  • chills,
  • cough,
  • mouth sores,
  • skin sores,
  • easy bruising,
  • unusual bleeding,
  • pale skin,
  • cold hands and feet,
  • lightheadedness, and
  • shortness of breath

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Marqibo include:

  • fever,
  • low blood cell counts,
  • tiredness,
  • numbness,
  • tingling,
  • diarrhea,
  • constipation,
  • nausea,
  • loss of appetite, and
  • sleep problems (insomnia)

Tell the doctor if you have any side effect that bothers you or that does not go away.

Commonly, side effects of Marqibo include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

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 Answer
Marqibo Consumer Information

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, 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.

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Marqibo Professional Information

SIDE 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 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)
Neuropathb 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 discontinuationwere 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).

DRUG INTERACTIONS

Effects Of Other Drugs On Marqibo

Strong CYP3A Inhibitors

Concomitant use of strong CYP3A4 inhibitors may increase the concentrations of vincristine, which may increase the risk of adverse reactions. Avoid concomitant use of strong CYP3A inhibitors.

Strong CYP3A Inducers

Concomitant use of strong CYP3A4 inducers may decrease the concentrations of vincristine, which may decrease antitumor activity. Avoid concomitant use of strong CYP3A inducers.

P-glycoprotein Inhibitors And Inducers

Concomitant use of Marqibo with P-glycoprotein inhibitors or inducers may alter the pharmacokinetics or pharmacodynamics of vincristine. Avoid the concomitant use of P-gp inhibitors or inducers.

Effects Of Marqibo On Other Drugs

Phenytoin

Simultaneous oral or intravenous administration of phenytoin and chemotherapy combinations that included non-liposomal vincristine sulfate have been reported to reduce blood levels of phenytoin and to increase seizure activity.Monitor phenytoin blood levels and seizure activity as appropriate.

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.

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