Mozobil (Plerixafor Subcutaneous) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical Trial Experience

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

• Potential for tumor cell mobilization in leukemia patients [see  Warnings and Precautions]
• Increased circulating leukocytes and decreased platelet counts [see  Warnings and Precautions]
• Potential for splenic enlargement [see  Warnings and Precautions]

The most common adverse reactions (≥ 10%) reported in patients who received Mozobil in conjunction with G-CSF regardless of causality and were 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 placebo-controlled studies and 10 uncontrolled studies in 543 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. 

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.

Grades based on criteria from the World Health Organization (WHO)

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

^a

	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

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 systemic reactions were observed in less than 1% of patients approximately 30 min after Mozobil administration. Events included 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 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.

REPORTS OF SUSPECTED MOZOBIL SIDE EFFECTS / ADVERSE REACTIONS

Possible Mozobil side effects / adverse reactions in 68 year old male

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-10-03

Patient: 68 year old male

Reactions: Renal Tubular Necrosis, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Neupogen
    Dosage: 960 mug, qd
    Indication: Product Used FOR Unknown Indication
    End date: 2011-04-13

Mozobil
    Dosage: 20 mg, qd
    Start date: 2011-04-11
    End date: 2011-04-12

Stemgen
    Dosage: 1650 mg, qd
    Start date: 2011-04-11
    End date: 2011-04-12

Other drugs received by patient: Neupogen; Plerixafor

Possible Mozobil side effects / adverse reactions in 68 year old male

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-11-09

Patient: 68 year old male

Reactions: Renal Tubular Necrosis, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Mozobil
    Dosage: 20 mg, qd
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-11
    End date: 2011-04-12

Mozobil
    Dosage: unk

Neupogen
    Dosage: 960 mcg, qd
    Indication: Product Used FOR Unknown Indication
    End date: 2011-04-13

Stemgen
    Dosage: 1650 mg, qd
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-11
    End date: 2011-04-12

Other drugs received by patient: Neupogen

Possible Mozobil side effects / adverse reactions in 32 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-21

Patient: 32 year old male

Reactions: Vomiting, Syncope, Nausea, Inappropriate Antidiuretic Hormone Secretion, Hyponatraemia

Suspect drug(s):
Mozobil
    Dosage: unk
    Indication: Haematopoietic Stem Cell Mobilisation
    Start date: 2011-01-01
    End date: 2011-01-01

Mozobil
    Indication: Multiple Myeloma

Other drugs received by patient: Melphalan Hydrochloride; Cyclophosphamide; Neupogen; Cyclophosphamide; Neupogen