Mozobil works by helping your bone marrow release stem cells into your bloodstream so they can be collected and transplanted back into the body.

Mozobilis used in people with non-Hodgkin's lymphoma or multiple myeloma.

Mozobil may also be used for purposes not listed in this medication guide.

Do not receive Mozobil without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. You should not receive Mozobil if you are allergic to plerixafor, or if you have leukemia.

Before you receive this medicine, tell your doctor if you have kidney disease.

Mozobil is given as an injection in a hospital or clinic setting.

Before receiving Mozobil, you will be given another medication that will help your bone marrow produce stem cells and certain white blood cells that help support your immune system.

To be sure Mozobil is not causing harmful effects, your blood will need to be tested often

Before taking this medicine

You should not be treated with Mozobil if you are allergic to plerixafor, or if you have leukemia.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take Mozobil, tell your doctor if you have kidney disease.

Plerixafor may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using Mozobil and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

You may need to have a negative pregnancy test before starting this treatment.

You should not breastfeed while receiving this medication.

Mozobil is injected under the skin. A healthcare provider will give you this injection.

You will be watched closely for at least 30 minutes to make sure you do not have an allergic reaction.

Before receiving Mozobil, you will be given a medication called a granulocyte (GRAN-yoo-loe-site) colony stimulating factor (G-CSF). A G-CSF helps your body produce stem cells and white blood cells to help support your immune system.

Mozobil works together with the G-CSF by causing stem cells and granulocytes produced in the bone marrow to circulate into your bloodstream where they can be collected in blood drawn from your vein.

After your blood is drawn, it will be processed so that the needed stem cells and granulocytes can be separated from other unneeded parts of the blood. These stem cells and granulocytes will then be "transplanted" back into your body.

Your blood will need to be tested often during your treatment.

Usual Adult Dose for non-Hodgkin's Lymphoma:

Dosing Based on Actual Patient Body Weight:
-83 kg or Less:
20 mg fixed dose or 0.24 mg/kg subcutaneously once in the evening, approximately 11 hours prior to initiation of each apheresis

-Greater than 83 kg and Less than 160 kg:
0.24 mg/kg subcutaneously once in the evening, approximately 11 hours prior to initiation of each apheresis

Duration of Therapy: Up to 4 consecutive days

Maximum Dose: 40 mg/day

Comments:
-The drug volume to be administered should be calculated using the following equation: 0.012 x actual patient body weight (kg) = administration dose (mL)
-The dosing has been calculated based on actual patient body weight up to 175% of ideal body weight; dosing and treatment of patients weighing more than 175% of ideal body weight have not been investigated.
-Granulocyte-colony stimulating factor (G-CSF) 10 mcg/kg should be administered once daily in the morning for 4 consecutive days prior to the first dose of this drug and on each morning prior to apheresis.

Use: Indicated in combination with G-CSF to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma.

Usual Adult Dose for Multiple Myeloma:

Dosing Based on Actual Patient Body Weight:
-83 kg or Less:
20 mg fixed dose or 0.24 mg/kg subcutaneously once in the evening, approximately 11 hours prior to initiation of each apheresis

-Greater than 83 kg and Less than 160 kg:
0.24 mg/kg subcutaneously once in the evening, approximately 11 hours prior to initiation of each apheresis

Duration of Therapy: Up to 4 consecutive days

Maximum Dose: 40 mg/day

Comments:
-The drug volume to be administered should be calculated using the following equation: 0.012 x actual patient body weight (kg) = administration dose (mL)
-The dosing has been calculated based on actual patient body weight up to 175% of ideal body weight; dosing and treatment of patients weighing more than 175% of ideal body weight have not been investigated.
-Granulocyte-colony stimulating factor (G-CSF) 10 mcg/kg should be administered once daily in the morning for 4 consecutive days prior to the first dose of this drug and on each morning prior to apheresis.

Use: Indicated in combination with G-CSF to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma.

You should not be treated with Mozobil if you are allergic to plerixafor, or if you have leukemia.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take Mozobil, tell your doctor if you have kidney disease.

Plerixafor may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using Mozobil and for at least 1 week after your last dose. Tell your doctor if you become pregnant.

You may need to have a negative pregnancy test before starting this treatment.

You should not breastfeed while receiving this medication.

Because you will receive Mozobil in a clinical setting, you are not likely to miss a dose.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Overdose symptoms may include stomach discomfort, severe dizziness, or fainting.

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving Mozobil.

Get emergency medical help if you have signs of an allergic reaction to Mozobil: 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

• severe pain in your left upper stomach, spreading to your shoulder blade.

Common Mozobil side effects may include:

• irritation where the medication was injected;

• nausea, vomiting, diarrhea;

• headache, dizziness;

• tiredness; or

• joint pain.

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.