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.

Side Effects

There are a few drug interactions and side effects that should be considered before taking Leukine® (sargramostim).

Drug Interactions

Drugs that can increase white blood cells (WBCs), such as lithium and corticosteroids, should be used with caution while receiving Leukine. Also, Leukine should not be used 24 hours before through 24 hours after any chemotherapy or radiation therapy. Interactions between Leukine and other drugs have not been fully evaluated.

Common Side Effects

Some patients who take Leukine may experience side effects, most of which are mild to moderate. Some common side effects include bone pain; a slight temperature elevation (usually less than 100.5°F or 38°C) for one to four hours after your injection; and swelling, redness, and/or discomfort at the injection site. You may also feel weak or tired, experience muscle aches, have diarrhea, experience stomach upset, or feel like you have the flu.

More About Bone Pain

Bone pain generally occurs in the areas of large marrow reserves, such as the sternum, pelvis, or long bones, and may be a result of expansion of the myeloid cell mass.

More About Temperature Elevation

A slight temperature elevation is caused by natural pyrogen stimulation in the body brought on by Leukine and can often be managed with acetaminophen administration.

More About Skin Reactions

Skin reactions may occur because cells of the immune system, such as macrophages, are drawn to the injection site.

Managing Side Effects

The following techniques may be used by the person administering your injection to help prevent, relieve, or manage some of the common side effects of Leukine treatment. Please consult with your healthcare team before taking any medications for fever or pain while you are receiving Leukine therapy.

For fever and/or bone pain, your healthcare provider may recommend pain relievers such as acetaminophen.

To minimize injection site discomfort, the person administering the injection should:

  • Allow Leukine to come to room temperature before injecting
  • Rotate injection sites from one injection to the next
  • Avoid rubbing the skin before or after injecting
  • Apply ice to the site for 1 minute before injecting
  • Inject Leukine slowly (over thirty to sixty seconds)

Serious Side Effects

During your treatment, some serious but rare side effects or symptoms may occur that might be due to Leukine, your illness, or other treatments you may be receiving. Call your doctor immediately if you:

  • Notice any signs of infection, which can include chills, sore throat, congestion, inflammation (warmth or redness) of an area of the body, or development of a fever as defined by your healthcare provider
  • Have trouble breathing; or experience wheezing, fainting, skin rash, or hives; or feel you are having an allergic reaction of any kind
  • Experience sudden weight gain or other signs of fluid build-up such as swollen legs or feet
  • Develop chest pain, chest discomfort, or a rapid or irregular pulse
  • Develop any other unexpected symptoms

Ask your healthcare provider when and how often he or she wants you to call.

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.