Plerixafor

What is Plerixafor?

• Plerixafor (Mozobil) a hematopoietic stem cell mobilizer used to mobilize hematopoietic stem cells in cancer patients into the bloodstream.

What are the uses of this medicine?

• Plerixafor (Mozobil) is used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM).
• Plerixafor is given together with granulocyte-colony stimulating factor (G-CSF) to help move stem cells from the bone marrow to the blood. The stem cells can then be collected, stored, and given back to the patient. Plerixafor is a type of chemokine receptor antagonist.

How does this medicine work?

• Plerixafor is an inhibitor of the CXCR4 chemokine receptor and blocks binding of its cognate ligand, stromal cell-derived factor-1α (SDF-1α).
• SDF-1α and CXCR4 are recognized to play a role in the trafficking and homing of human hematopoietic stem cells (HSCs) to the marrow compartment. Once in the marrow, stem cell CXCR4 can act to help anchor these cells to the marrow matrix, either directly via SDF-1α or through the induction of other adhesion molecules.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• a history of hypersensitivity to plerixafor.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Mozobil.

Is this medicine FDA approved?

• It was approved by the U.S. Food and Drug Administration (FDA) for this indication on 15 December 2008.

How should this medicine be used?

Recommended dosage:

• Dose based on patient weight
• Less than or equal to 83 kg: 20 mg dose or select dose based on 0.24 mg/kg actual body weight.
• greater than 83 kg: select dose based on 0.24 mg/kg actual body weight.

• Initiate Mozobil treatment after the patient has received G-CSF once daily for 4 days.
• Repeat Mozobil dose up to 4 consecutive days.

Renal impairment:

• If creatinine clearance is ≤50 mL/min, decrease dose by one-third to 0.16 mg/kg.

Administration:

• Administer by subcutaneous injection approximately 11 hours prior to initiation of apheresis.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 24 mg/1.2 mL (20 mg/mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• Mozobil

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• nausea
• fatigue
• injection site reactions
• headache
• arthralgia
• dizziness
• vomiting

What special precautions should I follow?

• 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. Monitor patients during and after completion of Mozobil administration.
• 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.
• Administration of Mozobil in conjunction with G-CSF increases circulating leukocytes as well as HSC populations. Monitor white blood cell counts during Mozobil use.
• Thrombocytopenia has been observed in patients receiving Mozobil. Monitor platelet counts in all patients who receive Mozobil and then undergo apheresis.
• Cases of splenic enlargement and/or rupture have been reported following the administration of Mozobil in conjunction with growth factor G-CSF. Evaluate individuals receiving Mozobil in combination with G-CSF who report left upper abdominal pain and/or scapular or shoulder pain for splenic integrity.
• Mozobil can cause fetal harm when administered to a pregnant woman. 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• gastrointestinal disorders
• vasovagal reactions
• orthostatic hypotension
• syncope

Management of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• Limited available data with Mozobil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Mozobil have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• PLERIXAFOR

Inactive ingredients:

• SODIUM CHLORIDE
• HYDROCHLORIC ACID
• WATER
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

• Genzyme Corporation
• Cambridge, MA
• A SANOFI COMPANY

• Mozobil is a registered trademark of Genzyme Corporation.

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F).

• Dailymed label info on Plerixafor
• FDA Plerixafor

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