MOZOBIL

Generic Name/API: plerixafor

Manufacturer: Genzyme Corporation

Dosage Forms & Strength & Pack Size:
• Injection: 24 mg/1.2 mL (20 mg/mL) in a single-dose vial.

Storage:
Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

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).

Important Safety Information for Mozobil (plerixafor) injection

  • Severe, life-threatening allergic reactions (anaphylaxis) can happen in people who take Mozobil. Tell your doctor right away if you experience hives (itchy raised bumps), eye swelling, or trouble breathing.
  • Mozobil is not intended for hematopoietic stem cell transplantation (HSCT) mobilization and collection in patients with leukemia.
  • Mozobil in combination with filgrastim increases circulating white blood cells (WBCs). Your WBC counts will be monitored.
  • Thrombocytopenia (a decrease in the number of platelets circulating in the blood) has been observed in patients receiving Mozobil. Your platelet counts will be monitored.
  • Cancer cells may be released from the bone marrow and subsequently collected along with your stem cells during apheresis. The potential effects of infusing cancer cells during your transplant have not been well-studied.
  • Your spleen may be examined if you experience pain in the left upper stomach area or left shoulder area as these may be signs of an enlarged or burst (ruptured) spleen.
  • Mozobil can harm the unborn child when administered to a pregnant woman. Scientific studies have shown that Mozobil causes harm or death to unborn animals. If you are pregnant, your doctor should tell you about the potential risk to the fetus. If you are a female or male of reproductive potential you should use an effective form of contraception during treatment with Mozobil and for one week following cessation of treatment.
  • Breastfeeding is not recommended during treatment with Mozobil and for one week following cessation of treatment.
  • The most common adverse reactions (occurring in greater than or equal to 10% of patients) during HSC mobilization and apheresis were: diarrhea (37%), nausea (34%), tiredness (fatigue) (27%), injection site reactions (34%), headache (22%), pain in your joints (arthralgia) (13%), dizziness (11%), and vomiting (10%).
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