MOZOBIL SIDE EFFECTS
- Generic Name: plerixafor injection
- Brand Name: Mozobil
- Drug Class: Hematopoietic Stem Cell Mobilizers
SIDE EFFECTS
The following clinically significant adverse reactions are discussed elsewhere in the labeling:
- Anaphylactic shock and hypersensitivity reactions
- Potential for tumor cell mobilization in leukemia patients
- Increased circulating leukocytes and decreased platelet counts
- Potential for tumor cell mobilization
- Splenic enlargement
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 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 1.
Table 1: 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 |
| a Grades 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.
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been reported from postmarketing 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.
Blood and Lymphatic System: Splenomegaly and splenic rupture
Immune System Disorders: Anaphylactic reactions, including anaphylactic shock
Psychiatric Disorders: Abnormal dreams and nightmares
SRC: NLM .