Important Safety Considerations
Leukine® is contraindicated in patients with excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥ 10%), in patients with known hypersensitivity to GM-CSF, yeast derived products or any component of Leukine, and for concomitant use with chemotherapy and radiotherapy. View additional Important Safety Information. View Indications.

Reimbursement Support Line

Genzyme offers product support services to help ensure patient and physician access to Leukine including product-related reimbursement questions. Reimbursement consultants can be reached at the Leukine® Direct reimbursement support line: 1-888-4RX-Leukine, (888.479.5385) between Monday and Friday from 9 a.m. to 7 p.m. ET.

LEUKINE DIRECT Program Reimbursement Services

LEUKINE DIRECT is a comprehensive reimbursement support program for LEUKINE, providing informational resources for reimbursement and access questions.

Reimbursement specialists at LEUKINE DIRECT are equipped with expertise in public and private healthcare insurance, and are available to assist should you encounter any LEUKINE reimbursement and access issues.

LEUKINE DIRECT reimbursement specialists can assist you with prior authorization requests, patient-specific benefit verifications, claims tracking, and claims denial and appeal support.

Customized service can be provided, via biweekly or monthly calls with an assigned LEUKINE DIRECT reimbursement specialist to review, monitor and assist with reimbursement issues or activity.

In addition, LEUKINE DIRECT offers a Patient Assistance Program for uninsured patients who meet established program criteria. Providers and patients must complete the LEUKINE DIRECT enrollment form and submit it to the program for review. Should your patient be eligible, he or she will receive product for their upcoming LEUKINE treatments at no charge for an eligibility period of six months. If you have a patient who may be eligible for the patient assistance program or have any questions regarding the enrollment process, please feel free to contact one of the LEUKINE DIRECT reimbursement specialists at 888.4RX.LEUKINE (888.479.5385), between Monday and Friday from 9 a.m. to 7 p.m. ET.

Indication

Leukine® is indicated for the following uses: (i) following induction chemotherapy in older adult patients with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery; (ii) for mobilization and following transplantation of autologous peripheral blood progenitor cells; (iii) for myeloid reconstitution after autologous or allogeneic bone marrow transplantation (BMT); (iv) for use in bone marrow transplantation failure or engraftment delay.

Important Safety Considerations

  • Leukine is contraindicated in patients with excessive leukemic myeloid blasts in bone marrow or peripheral blood (≥10%); in patients with known hypersensitivity to GM-CSF, yeast-derived products, or any component of Leukine; and for concomitant use with chemotherapy and radiotherapy.
  • Serious allergic or anaphylactic reactions have been reported with Leukine. If any serious allergic or anaphylactic reactions occur, Leukine therapy should be immediately discontinued and appropriate therapy initiated.
  • Liquid solutions containing benzyl alcohol (including liquid Leukine) or lyophilized Leukine reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates.
  • Leukine should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure, respiratory symptoms or disease; cardiac symptoms or disease; and renal or hepatic dysfunction.
  • Edema, capillary leak syndrome, pleural and/or pericardial effusion, sequestration of granulocytes in the pulmonary circulation, and dyspnea have been reported in patients after Leukine administration. Occasional transient supraventricular arrhythmia has been reported during Leukine administration. Leukine has induced the elevation of serum creatinine or bilirubin and hepatic enzymes in some patients. Monitoring of renal and hepatic function in patients with preexisting renal or hepatic dysfunction is recommended at least every other week during Leukine administration.
  • Adverse events occurring in >10% of patients receiving Leukine in controlled clinical trials and reported in a higher frequency than placebo were: in AML patients – (fever, skin reactions, metabolic disturbances, nausea, vomiting, weight-loss, edema, anorexia); in Autologous BMT patients – (asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder); and in Allogeneic BMT patients – (abdominal pain, chills, chest pain, diarrhea, nausea, vomiting, hematemesis, dysphagia, GI hemorrhage, pruritus, bone pain, arthralgia, eye hemorrhage, hypertension, tachycardia, bilirubinemia, hyperglycemia, increased creatinine, hypomagnesemia, edema, pharyngitis, epistaxis, dyspnea, insomnia, anxiety, high BUN, and high cholesterol).
  • If ANC > 20,000 cells/mm3 or if platelet counts > 500,000/mm3, LEUKINE administration should be interrupted or the dose reduced by half. Twice weekly monitoring of CBC with differential should be performed.
  • Leukine therapy should be discontinued if disease progression is detected during treatment.

Please see full Prescribing Information.

To report suspected adverse events, contact Genzyme Corporation at 1-888-4RX-LEUKINE or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.