Mozobil

MOZOBIL- plerixafor injection, solution
sanofi-aventis U.S. LLC

1 INDICATIONS AND USAGE

Mozobil is indicated in combination with filgrastim 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).

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage and Administration

Begin treatment with Mozobil after the patient has received filgrastim once daily for 4 days [see Dosage and Administration (2.2)]. 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. [see Clinical Pharmacology (12.3)]
  • 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 [see Clinical Pharmacology (12.3)].

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.

Discard unused portion.

2.2 Recommended Concomitant Medications

Administer daily morning doses of filgrastim 10 mcg/kg for 4 days prior to the first evening dose of Mozobil and on each day prior to apheresis [see Clinical Studies (14)].

2.3 Dose Modifications in Renal Impairment

In patients with moderate and severe renal impairment (estimated creatinine clearance (CLCR ) less than or equal to 50 mL/min), reduce the dose of Mozobil by one-third based on body weight category as shown in Table 1. If CLCR is less than or equal to 50 mL/min the dose should not exceed 27 mg/day, as the mg/kg-based dosage results in increased plerixafor exposure with increasing body weight [see Clinical Pharmacology (12.3)]. Similar systemic exposure is predicted if the dose is reduced by one-third in patients with moderate and severe renal impairment compared with subjects with normal renal function [see Clinical Pharmacology (12.3)].

Table 1: Recommended Dosage of Mozobil in Patients with Renal Impairment
Estimated Creatinine Clearance (mL/min) Dose
Body Weight less than or equal to 83 kg Body Weight greater than 83 kg and less than 160 kg
greater than 50 20 mg or 0.24 mg/kg once daily 0.24 mg/kg once daily (not to exceed 40 mg/day)
less than or equal to 50 13 mg or 0.16 mg/kg once daily 0.16 mg/kg once daily (not to exceed 27 mg/day)

The following (Cockcroft-Gault) formula may be used to estimate CLCR :

Males:
Creatinine clearance (mL/min) = weight (kg) × (140 – age in years)
72 × serum creatinine (mg/dL)

Females: Creatinine clearance (mL/min) = 0.85 × value calculated for males

There is insufficient information to make dosage recommendations in patients on hemodialysis.

3 DOSAGE FORMS AND STRENGTHS

Injection: 24 mg/1.2 mL (20 mg/mL) sterile, clear, colorless to pale-yellow solution in a single-dose vial.

4 CONTRAINDICATIONS

Mozobil is contraindicated in patients with a history of hypersensitivity to plerixafor [see Warnings and Precautions (5.1)]. Anaphylactic shock has occurred with use of Mozobil.

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylactic Shock and Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening with clinically significant hypotension and shock have occurred in patients receiving Mozobil [see Adverse Reactions (6.2)]. Observe patients for signs and symptoms of hypersensitivity during and after Mozobil administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer Mozobil when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

In clinical studies, mild or moderate allergic reactions occurred within approximately 30 minutes after Mozobil administration in less than 1% of patients [see Adverse Reactions (6.1)].

5.2 Tumor Cell Mobilization in Leukemia Patients

For the purpose of HSC mobilization, Mozobil may cause mobilization of leukemic cells and subsequent contamination of the apheresis product. Therefore, Mozobil is not intended for HSC mobilization and harvest in patients with leukemia.

5.3 Hematologic Effects

Leukocytosis

Administration of Mozobil in conjunction with filgrastim increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during Mozobil use [see Adverse Reactions (6.1)].

Thrombocytopenia

Thrombocytopenia has been observed in patients receiving Mozobil. Monitor platelet counts in all patients who receive Mozobil and then undergo apheresis.

5.4 Potential for Tumor Cell Mobilization

When Mozobil is used in combination with filgrastim for HSC mobilization‚ tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of potential reinfusion of tumor cells has not been well-studied.

5.5 Splenic Enlargement and Rupture

Higher absolute and relative spleen weights associated with extramedullary hematopoiesis were observed following prolonged (2 to 4 weeks) daily plerixafor SC administration in rats at doses approximately 4-fold higher than the recommended human dose based on body surface area. The effect of Mozobil on spleen size in patients was not specifically evaluated in clinical studies. Cases of splenic enlargement and/or rupture have been reported following the administration of Mozobil in conjunction with filgrastim. Evaluate individuals receiving Mozobil in combination with filgrastim who report left upper abdominal pain and/or scapular or shoulder pain for splenic integrity.

5.6 Embryo-Fetal Toxicity

Based on findings from animal reproduction studies, Mozobil can cause fetal harm when administered to a pregnant woman. Plerixafor administration to pregnant rats during organogenesis resulted in embryo-fetal mortality, structural abnormalities, and alterations to growth at exposures approximately 10 times the exposure at the recommended human dose.

Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use an effective form of contraception during treatment with Mozobil and for one week after the final dose [see Use in Specific Populations (8.1)].

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed elsewhere in the labeling:

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