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Important Safety Information for Mozobil (plerixafor) injection

Mozobil is contraindicated in patients with a history of hypersensitivity to Mozobil.
Anaphylactic shock and serious hypersensitivity reactions, some of which have been life-threatening, have occurred in patients receiving Mozobil. Observe patients for signs and symptoms of hypersensitivity during and after Mozobil administration for at least 30 minutes and until clinically stable. Only administer Mozobil when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
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.
Mozobil in conjunction with filgrastim increases circulating leukocytes and HSC populations. White blood cell counts should be monitored during treatment.
Thrombocytopenia has been observed in patients receiving Mozobil. Platelet counts should be monitored in patients who receive Mozobil and then undergo apheresis.
In patients treated with Mozobil 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.
Postmarketing cases of splenic enlargement and/or rupture have been reported following the administration of Mozobil in conjunction with filgrastim. Individuals receiving Mozobil in combination with filgrastim who report left upper abdominal pain and/or scapular or shoulder pain should be evaluated for splenic integrity.
Mozobil can cause fetal harm when administered to a pregnant woman. Plerixafor is teratogenic in animals. 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.
There are no data on the presence of plerixafor in human milk, the effect on the breastfed child, or the effect on milk production. Because of the potential serious adverse reactions in the breastfed child, advise females that breastfeeding is not recommended during treatment with Mozobil and for one week after the final dose.
Males treated with Mozobil should use effective contraception during treatment and for one week after cessation of treatment.
The most common adverse reactions (=10%) during HSC mobilization and apheresis were: diarrhea (37%), nausea (34%), fatigue (27%), injection site reactions (34%), headache (22%), arthralgia (13%), dizziness (11%), and vomiting (10%). The majority of these adverse reactions were Grade 1 or 2.

Indication

MOZOBIL® (plerixafor) injection 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).