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.

Renal Dose Adjustments

Moderate and Severe Renal Impairment (CrCl 50 mL/min or less):
Dosing Based on Actual Patient Body Weight:

• 83 kg or Less:

13 mg or 0.16 mg/kg subcutaneously once a day

• Greater than 83 kg and Less than 160 kg:

0.16 mg/kg subcutaneously once a day

Duration of Therapy: Up to 4 consecutive days

Maximum Dose: 27 mg/day

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to plerixafor; anaphylactic shock has occurred with use

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

• Hemodialysis: Insufficient data available to make dosage recommendation.
• Peritoneal dialysis: Data not available

Other Comments

Administration Advice:

• Subcutaneous injection to the abdomen was primarily used in clinical trials, but some patients received subcutaneous injections in the extremities.
• Prior to administration, each drug vial should be inspected visually and should not be used if there is particulate matter or if the solution is discolored.

Storage Requirements:

• Each drug vial is for single use only; any unused drug should be discarded.

Monitoring:

• Hematologic: White blood cell counts, platelet counts (during treatment and apheresis)
• Hypersensitivity/Immunologic: Signs/symptoms of hypersensitivity (during and after drug administration)

Patient Advice:

• This drug may cause side effects such as dizziness and fatigue that can affect your ability to perform certain activities; avoid driving and activities such as operating machinery until you know how this drug affects you.