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Mozobil

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Mozobil

Mozobil Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Mozobil (plerixafor injection) is used in people with non-Hodgkin's lymphoma or multiple myeloma. It is a hematopoietic stem cell mobilizer that helps bone marrow release stem cells into the bloodstream so they can be collected and transplanted back into the body. Common side effects include nausea, vomiting, diarrhea, constipation, dry mouth, numbness in or around the mouth, upset stomach, bloating, gas, tired feeling, trouble sleeping, headache, dizziness, joint or muscle pain, increased sweating, or itching, rash, or other irritation where the medication was injected.

The recommended dose of Mozobil is 0.24 mg/kg body weight by subcutaneous (SC) injection. There may be other drugs that can interact with Mozobil. Tell your doctor all medications and supplements you use. Mozobil can cause harm to a fetus or cause birth defects. Before you receive this drug, tell your doctor if you are pregnant. Use birth control, and tell your doctor if you become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Mozobil (plerixafor injection) Side Effects Drug 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Mozobil in Detail - Patient Information: Side Effects

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

Tell your caregivers at once if you have a serious side effect such as:

  • easy bruising or bleeding, unusual weakness;
  • feeling like you might pass out; or
  • pain in your upper stomach, spreading to your shoulder or back.

Less serious side effects may include:

  • nausea, vomiting;
  • diarrhea, constipation;
  • dry mouth, numbness in or around your mouth;
  • upset stomach, bloating, gas;
  • tired feeling, trouble sleeping;
  • headache, dizziness;
  • joint or muscle pain;
  • increased sweating; or
  • itching, rash, or other irritation where the medication was injected.

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 Mozobil (Plerixafor Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Mozobil FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trial 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 practice.

The most common adverse reactions ( ≥ 10%) reported in patients who received Mozobil in conjunction with G-CSF regardless of causality and more frequent with Mozobil than placebo during HSC mobilization and apheresis were diarrhea, nausea, fatigue, injection site reactions, headache, arthralgia, dizziness, and vomiting.

Safety data for Mozobil in combination with G-CSF were obtained from two randomized placebo-controlled studies (301 patients) and 10 uncontrolled studies (242 patients). Patients were primarily treated with Mozobil at daily doses of 0.24 mg/kg SC. Median exposure to Mozobil in these studies was 2 days (range 1 to 7 days).

In the two randomized studies in patients with NHL and MM, a total of 301 patients were treated in the Mozobil and G-CSF group and 292 patients were treated in the placebo and G-CSF group. Patients received daily morning doses of G-CSF 10 micrograms/kg for 4 days prior to the first dose of Mozobil 0.24 mg/kg SC or placebo and on each morning prior to apheresis. The adverse reactions that occurred in ≥ 5% of the patients who received Mozobil regardless of causality and were more frequent with Mozobil than placebo during HSC mobilization and apheresis are shown in Table 2.

Table 2: Adverse Reactions in ≥ 5% of Non-Hodgkin's Lymphoma and Multiple Myeloma Patients Receiving Mozobil® and More Frequent than Placebo During HSC Mobilization and Apheresis

  Percent of Patients (%)
Mozobil® and G-CSF
(n = 301)
Placebo and G-CSF
(n = 292)
All Gradesa Grade 3 Grade 4 All Grades Grade 3 Grade 4
Gastrointestinal disorders
  Diarrhea 37 < 1 0 17 0 0
  Nausea 34 1 0 22 0 0
  Vomiting 10 < 1 0 6 0 0
  Flatulence 7 0 0 3 0 0
General disorders and administration site conditions
  Injection site reactions 34 0 0 10 0 0
  Fatigue 27 0 0 25 0 0
Musculoskeletal and connective tissue disorders
  Arthralgia 13 0 0 12 0 0
Nervous system disorders
  Headache 22 < 1 0 21 1 0
  Dizziness 11 0 0 6 0 0
Psychiatric disorders
  Insomnia 7 0 0 5 0 0
aGrades based on criteria from the World Health Organization (WHO)

In the randomized studies, 34% of patients with NHL or MM had mild to moderate injection site reactions at the site of subcutaneous administration of Mozobil. These included erythema, hematoma, hemorrhage, induration, inflammation, irritation, pain, paresthesia, pruritus, rash, swelling, and urticaria.

Mild to moderate allergic reactions were observed in less than 1% of patients within approximately 30 min after Mozobil administration, including one or more of the following: urticaria (n = 2), periorbital swelling (n = 2), dyspnea (n = 1) or hypoxia (n = 1). Symptoms generally responded to treatments (e.g., antihistamines, corticosteroids, hydration or supplemental oxygen) or resolved spontaneously.

Vasovagal reactions, orthostatic hypotension, and/or syncope can occur following subcutaneous injections. In Mozobil oncology and healthy volunteer clinical studies, less than 1% of subjects experienced vasovagal reactions following subcutaneous administration of Mozobil doses ≤ 0.24 mg/kg. The majority of these events occurred within 1 hour of Mozobil administration. Because of the potential for these reactions, appropriate precautions should be taken.

Other adverse reactions in the randomized studies that occurred in < 5% of patients but were reported as related to Mozobil during HSC mobilization and apheresis included abdominal pain, hyperhidrosis, abdominal distention, dry mouth, erythema, stomach discomfort, malaise, hypoesthesia oral, constipation, dyspepsia, and musculoskeletal pain.

Hyperleukocytosis: In clinical trials, white blood cell counts of 100,000/mcL or greater were observed, on the day prior to or any day of apheresis, in 7% of patients receiving Mozobil and in 1% of patients receiving placebo. No complications or clinical symptoms of leukostasis were observed.

Post-marketing Experience

In addition to adverse reactions reported from clinical trials, the following adverse reactions have been reported from post-marketing experience with Mozobil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune System Disorders: Anaphylactic reactions, including anaphylactic shock

Read the entire FDA prescribing information for Mozobil (Plerixafor Injection) »

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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.


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