Clinical Dataneptuneweb2021-04-19T06:54:40-04:00

Multiple benefits with multilineage defense¹

After AML induction therapy

LEUKINE^® (sargramostim) significantly reduced the risk of serious and fatal infection vs placebo in a phase 3, multicenter, randomized, double-blind, placebo-controlled study of patients following induction therapy for AML (N=99)^1-3

Significantly decreased incidence of fatal infection^1-3

Significantly decreased incidence of fatal infection chart

Significantly decreased incidence of serious infection^1-3

Leukine

(P=0.02)

Placebo

After allogeneic and autologous BMT

Following allogeneic BMT, patients receiving LEUKINE^® (sargramostim) experienced a reduced incidence of infection vs placebo in a multicenter, randomized, placebo-controlled, double-blind study (N=109)¹

Significantly reduced incidence of infection¹

Incidence of infection (P<0.05)

57% LEUKINE (n=30/53) to 75% Placebeo (n=42/56)

Incidence of Grade 3 and 4 mucositis (P<0.05)

8% LEUKINE (n=4/53) to 29% Placebeo (n=16/56)

Incidence of bacteremia (P<0.05)

17% LEUKINE (n=9/53) to 34% Placebeo (n=19/56)

LEUKINE safety and efficacy were evaluated in 3 single-center, randomized, placebo-controlled, double-blind studies of 128 patients undergoing autologous BMT. Efficacy data reflect a subpopulation of patients with NHL or ALL (N=104)¹

Significantly reduced duration of infection, antibacterial therapy, and hospitalization¹

LEUKINE® (sargramostim) reduced the duration of infection by 75%

vs placebo (1 day vs 4 days, respectively; P<0.05)

4-day reduction

of antibacterial therapy with LEUKINE vs placebo
(21 days vs 25 days, respectively; P<0.05)

6-day reduction

in length of hospitalization with LEUKINE vs placebo
(25 days vs 31 days, respectively; P<0.05)

Delayed engraftment

LEUKINE^® (sargramostim) provided a median survival benefit vs historical controls in a study of patients experiencing delayed or failed engraftment after allogeneic or autologous BMT¹

Median survival benefit after
autologous BMT (N=85)¹

474 days with Leukine vs. 161 days historical controls

Median survival benefit after
allogeneic BMT (N=158)¹

97 days with Leukine vs. 35 days historical controls

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IMPORTANT SAFETY INFORMATION AND INDICATIONS

Contraindications

LEUKINE is contraindicated in patients with known hypersensitivity to human granulocyte-macrophage colony stimulating factor such as sargramostim (GM-CSF), yeast-derived products, or any component of LEUKINE.

Warnings and Precautions

Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy and institute medical management. Permanently discontinue LEUKINE in patients with serious allergic reactions.
LEUKINE can cause infusion-related reactions, including respiratory distress, hypoxia, flushing, hypotension, syncope and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease, as dose adjustment or discontinuation may be required.
Do not administer LEUKINE simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy.
Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported in patients after LEUKINE administration. LEUKINE should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure.
Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE administration, particularly in patients with a previous history of cardiac arrhythmia. Use LEUKINE with caution in patients with preexisting cardiac disease.
If ANC > 20,000 cells/mm³ or if WBC counts > 50,000/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.
Treatment with LEUKINE may induce neutralizing anti-drug antibodies. Use LEUKINE for the shortest duration required.
Liquid solutions containing benzyl alcohol (including LEUKINE Injection) or LEUKINE for Injection reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates and low birth weight infants.
Concomitant use of drugs that can potentiate the myeloproliferative effects of LEUKINE should be avoided.

Adverse Reactions

Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

In Autologous bone marrow transplantation (BMT) patients–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder
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 glucose, low albumin
In AML patients–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema

INDICATIONS AND USAGE

LEUKINE is a leukocyte growth factor indicated for the following uses:

LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.
LEUKINE is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin’s lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin’s lymphoma (HL).
LEUKINE is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors.
LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.

Please see full Prescribing Information for LEUKINE.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

Contraindications

LEUKINE is contraindicated in patients with known hypersensitivity to human granulocyte-macrophage colony stimulating factor such as sargramostim (GM-CSF), yeast-derived products, or any component of LEUKINE.

Warnings and Precautions

Serious hypersensitivity reactions, including anaphylactic reactions, have been reported with LEUKINE. If any serious allergic or anaphylactic reaction occurs, immediately discontinue LEUKINE therapy and institute medical management. Permanently discontinue LEUKINE in patients with serious allergic reactions.
LEUKINE can cause infusion-related reactions, including respiratory distress, hypoxia, flushing, hypotension, syncope and/or tachycardia. Observe closely during infusion, particularly in patients with preexisting lung disease, as dose adjustment or discontinuation may be required.
Do not administer LEUKINE simultaneously with or within 24 hours preceding cytotoxic chemotherapy or radiotherapy or within 24 hours following chemotherapy.
Edema, capillary leak syndrome, pleural and/or pericardial effusion have been reported in patients after LEUKINE administration. LEUKINE should be used with caution and monitored in patients with preexisting fluid retention, pulmonary infiltrates, or congestive heart failure.
Supraventricular arrhythmia has been reported in uncontrolled studies during LEUKINE administration, particularly in patients with a previous history of cardiac arrhythmia. Use LEUKINE with caution in patients with preexisting cardiac disease.
If ANC > 20,000 cells/mm³ or if WBC counts > 50,000/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.
Treatment with LEUKINE may induce neutralizing anti-drug antibodies. Use LEUKINE for the shortest duration required.
Liquid solutions containing benzyl alcohol (including LEUKINE Injection) or LEUKINE for Injection reconstituted with Bacteriostatic Water for Injection, USP (0.9% benzyl alcohol) should not be administered to neonates and low birth weight infants.
Concomitant use of drugs that can potentiate the myeloproliferative effects of LEUKINE should be avoided.

Adverse Reactions

Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

In Autologous bone marrow transplantation (BMT) patients–asthenia, malaise, diarrhea, rash, peripheral edema, urinary tract disorder
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 glucose, low albumin
In AML patients–fever, weight loss, nausea, vomiting, anorexia, skin reactions, metabolic laboratory abnormalities, edema

INDICATIONS AND USAGE

LEUKINE is a leukocyte growth factor indicated for the following uses:

LEUKINE is indicated to shorten time to neutrophil recovery and to reduce the incidence of severe, life-threatening, or fatal infections following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML).
LEUKINE is indicated in adult patients with cancer undergoing autologous hematopoietic stem cell transplantation for the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.
LEUKINE is indicated for the acceleration of myeloid reconstitution following autologous peripheral blood progenitor cell (PBPC) or bone marrow transplantation in adult and pediatric patients 2 years of age and older with non-Hodgkin’s lymphoma (NHL), acute lymphoblastic leukemia (ALL) and Hodgkin’s lymphoma (HL).
LEUKINE is indicated for the acceleration of myeloid reconstitution in adult and pediatric patients 2 years of age and older undergoing allogeneic bone marrow transplantation from HLA-matched related donors.
LEUKINE is indicated for the treatment of adult and pediatric patients 2 years and older who have undergone allogeneic or autologous bone marrow transplantation in whom neutrophil recovery is delayed or failed.

Please see full Prescribing Information for LEUKINE.

References: 1. Leukine [package insert]. Boston, MA: Partner Therapeutics, Inc.; 2018. 2. Rowe JM, Andersen JW, Mazza JJ, et al. Blood. 1995;86(2):457-462. 3. Rowe JM, Rubin A, Mazza JJ, et al. In: Hiddemann W, Büchner T, Wörmann B, et al, eds. Acute Leukemias V: Experimental Approaches and Management of Refractory Diseases. Berlin: Springer; 1996:178-184.