INDICATIONS AND USAGE（适应症）

Mozobil is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).

DOSAGE（服用剂量）

Begin treatment with Mozobil after the patient has received G-CSF once daily for 4 days. Administer Mozobil approximately 11 hours prior to initiation of each apheresis for up to 4 consecutive days.

The recommended dose of Mozobil by subcutaneous injection is based on body weight:

20 mg fixed dose or 0.24 mg/kg of body weight for patients weighing less than or equal to 83 kg.

0.24 mg/kg of body weight for patients weighing greater than 83 kg

Use the patient's actual body weight to calculate the volume of Mozobil to be administered. Each vial delivers 1.2 mL of 20 mg/mL solution, and the volume to be administered to patients should be calculated from the following equation:

0.012 × patient's actual body weight (in kg) = volume to be administered (in mL)

In clinical studies, Mozobil dose has been calculated based on actual body weight in patients up to 175% of ideal body weight. Mozobil dose and treatment of patients weighing more than 175% of ideal body weight have not been investigated.

Based on increasing exposure with increasing body weight, the Mozobil dose should not exceed 40 mg/day.

Vials should be inspected visually for particulate matter and discoloration prior to administration and should not be used if there is particulate matter or if the solution is discolored.

Recommended Concomitant Medications

Administer daily morning doses of G-CSF 10 micrograms/kg for 4 days prior to the first evening dose of Mozobil and on each day prior to apheresis.

ADVERSE REACTIONS（不良反应）

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

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/0ed08d2b-5051-46b2-aa37-1d6275bf9003/spl-doc?hl=Mozobil

mozobilinformation