Mozobil Side Effects

Generic Name: plerixafor

Please note - some side effects for Mozobil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Mozobil - for the Consumer

Mozobil

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mozobil:

Diarrhea; dizziness; gas; headache; joint pain; nausea; pain, redness, swelling, or bruising at the injection site; stomach pain; tiredness; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Mozobil:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, eyelids, lips, or tongue) black, tarry, or bloody stools; fainting; severe or persistent dizziness; severe stomach or shoulder pain; shortness of breath; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Mozobil Side Effects - for the Professional

Mozobil

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 (5.1)]
• Increased circulating leukocytes and decreased platelet counts [see Warnings and Precautions (5.2)]
• Potential for splenic enlargement [see Warnings and Precautions (5.4)]

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. 

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.

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 Grades*	Grade 3	Grade 4	All Grades	Grade 3	Grade 4
*   Grades based on criteria from the World Health Organization (WHO)
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 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.

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects including diarrhea (37%), nausea (34%), vomiting (10%), flatulence (7%), abdominal pain, abdominal distention, dry mouth, stomach discomfort, oral hypoesthesia, constipation, and dyspepsia have been reported.

Local

Local side effects including injection site reactions (34%) have been reported. Mild to moderate injection site reactions at the site of subcutaneous administration of plerixafor have included erythema, hematoma, hemorrhage, induration, inflammation, irritation, pain, paresthesia, pruritus, rash, swelling, and urticaria.

General

General side effects including fatigue (27%) and malaise have been reported.

Nervous system

Nervous system side effects including headache (22%), dizziness (11%), and vasovagal reactions have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (13%) and musculoskeletal pain have been reported.

Psychiatric

Psychiatric side effects including insomnia (7%) have been reported.

Dermatologic

Dermatologic side effects including hyperhidrosis and erythema have been reported.

Respiratory

Respiratory side effects including a case of dyspnea and a case of hypoxia have been reported.

Ocular

Ocular side effects including periorbital swelling have been reported.

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