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Leukine Side Effects, and Drug Interactions - Sargramostim

Leukine Side Effects, and Drug Interactions - Sargramostim

SIDE EFFECTS

Autologous and Allogeneic Bone Marrow Transplantation

Leukine is generally well tolerated. In 3 placebo-controlled studies enrolling a total of 156 patients after autologous BMT or peripheral blood progenitor cell transplantation, events reported in at least 10% of patients who received IV Leukine or placebo were:  Percent of AuBMT Patients Reporting Events  

Events by Body System	Leukine (n=79)	Placebo (n=77)	Events by Body System	Leukine (n=79)	Placebo (n=77)
Body, General			Metabolic/Nutritional Disorder
Fever	95	96	Edema	34	35
Mucous membrane disorder	75	78	Peripheral edema	11	7
Asthenia	66	51	Respiratory System
Malaise	57	51	Dyspnea	28	31
Sepsis	11	14	Lung disorder	20	23
Digestive System			Hemic and Lymphatic System
Nausea	90	96	Blood dyscrasia	25	27
Diarrhea	89	82	Cardiovascular System
Vomiting	85	90	Hemorrhage	23	30
Anorexia	54	58	Urogenital System
GI disorder	37	47	Urinary tract disorder	14	13
GI hemorrhage	27	33	Kidney function abnormal	8	10
Stomatitis	24	29	Nervous System
Liver damage	13	14	CNS disorder	11	16
Skin and Appendages
Alopecia	73	74
Rash	44	38

No significant differences were observed between Leukine and placebo-treated patients in the type or frequency of laboratory abnormalities, including renal and hepatic parameters. In some patients with preexisting renal or hepatic dysfunction enrolled in uncontrolled clinical trials, administration of Leukine has induced elevation of serum creatinine or bilirubin and hepatic enzymes (see WARNINGS). In addition, there was no significant difference in relapse rate and 24 month survival between the Leukine and placebo-treated patients.

In the placebo-controlled trial of 109 patients after allogeneic BMT, events reported in at least 10% of patients who received IV Leukine or placebo were: Percent of Allogeneic BMT Patients Reporting Events  

Events by Body System	Leukine (n=53)	Placebo (n=56)	Events by Body System	Leukine (n=53)	Placebo (n=56)
Body, General			Metabolic/Nutritional Disorder
Fever	77	80	Bilirubinemia	30	27
Abdominal pain	38	23	Hyperglycemia	25	23
Headache	36	36	Peripheral edema	15	21
Chills	25	20	Increased creatinine	15	14
Pain	17	36	Hypomagnesemia	15	9
Asthenia	17	20	Increased SGPT	13	16
Chest pain	15	9	Edema	13	11
Back pain	9	18	Increased alk. phosphatase	8	14
Digestive System			Respiratory System
Diarrhea	81	66	Pharyngitis	23	13
Nausea	70	66	Epistaxis	17	16
Vomiting	70	57	Dyspnea	15	14
Stomatitis	62	63	Rhinitis	11	14
Anorexia	51	57	Hemic and Lymphatic System
Dyspepsia	17	20	Thrombocytopenia	19	34
Hematemesis	13	7	Leukopenia	17	29
Dysphagia	11	7	Petechia	6	11
GI hemorrhage	11	5	Agranulocytosis	6	11
Constipation	8	11	Urogenital System
Skin and Appendages			Hematuria	9	21
Rash	70	73	Nervous System
Alopecia	45	45	Paresthesia	11	13
Pruritis	23	13	Insomnia	11	9
Musculo-skeletal System			Anxiety	11	2
Bone pain	21	5	Laboratory Abnormalities*
Arthralgia	11	4	High glucose	41	49
Special Senses			Low albumin	27	36
Eye hemorrhage	11	0	High BUN	23	17
Cardiovascular System			Low calcium	2	7
Hypertension	34	32	High cholesterol	17	8
Tachycardia	11	9

* Grade 3 and 4 laboratory abnormalities only. Denominators may vary due to missing laboratory measurements.

There were no significant differences in the incidence or severity of GVHD, relapse rates and survival between the Leukine and placebo-treated patients.

Adverse events observed for the patients treated with Leukine (Sargramostim) in the historically controlled BMT failure study were similar to those reported in the placebo-controlled studies. In addition, headache (26%), pericardial effusion (25%), arthralgia (21%) and myalgia (18%) were also reported in patients treated with Leukine in the graft failure study.

In uncontrolled Phase I/II studies with Leukine in 215 patients, the most frequent adverse events were fever, asthenia, headache, bone pain, chills and myalgia. These systemic events were generally mild or moderate and were usually prevented or reversed by the administration of analgesics and antipyretics such as acetaminophen. In these uncontrolled trials, other infrequent events reported were dyspnea, peripheral edema, and rash.

Reports of events occurring with marketed Leukine include arrhythmia, fainting, eosinophilia, dizziness, hypotension, injection site reactions, pain (including abdominal, back, chest, and joint pain), tachycardia, thrombosis, and transient liver function abnormalities.

In patients with preexisting edema, capillary leak syndrome, pleural and/or pericardial effusion, administration of Leukine may aggravate fluid retention (see WARNINGS). Body weight and hydration status should be carefully monitored during Leukine administration.

Adverse events observed in pediatric patients in controlled studies were comparable to those observed in adult patients.

Acute Myelogenous Leukemia

Adverse events reported in at least 10% of patients who received Leukine or placebo were: Percent of AML Patients Reporting Event  

Events by Body System	Leukine (n=52)	Placebo (n=47)	Events by Body System	Leukine (n=52)	Placebo (n=47)
Body, General			Metabolic/Nutritional Disorder
Fever (no infection)	81	74	Metabolic	58	49
Infection	65	68	Edema	25	23
Weight loss	37	28	Respiratory System
Weight gain	8	21	Pulmonary	48	64
Chills	19	26	Hemic and Lymphatic System
Allergy	12	15	Coagulation	19	21
Sweats	6	13	Cardiovascular System
Digestive System			Hemorrhage	29	43
Nausea	58	55	Hypertension	25	32
Liver	77	83	Cardiac	23	32
Diarrhea	52	53	Hypotension	13	26
Vomiting	46	34	Urogenital System
Stomatitis	42	43	GU	50	57
Anorexia	13	11	Nervous System
Abdominal distention	4	13	Neuro-clinical	42	53
Skin and Appendages			Neuro-motor	25	26
Skin	77	45	Neuro-psych	15	26
Alopecia	37	51	Neuro-sensory	6	11

Nearly all patients reported leukopenia, thrombocytopenia and anemia. The frequency and type of adverse events observed following induction were similar between Leukine and placebo groups. The only significant difference in the rates of these adverse events was an increase in skin associated events in the Leukine group (p=0.002). No significant differences were observed in laboratory results, renal or hepatic toxicity. No significant differences were observed between the Leukine and placebo-treated patients for adverse events following consolidation. There was no significant difference in response rate or relapse rate.

In a historically controlled study of 86 patients with acute myelogenous leukemia (AML), the Leukine treated group exhibited an increased incidence of weight gain (p=0.007), low serum proteins and prolonged prothrombin time (p=0.02) when compared to the control group. Two Leukine treated patients had progressive increase in circulating monocytes and promonocytes and blasts in the marrow which reversed when Leukine was discontinued. The historical control group exhibited an increased incidence of cardiac events (p=0.018), liver function abnormalities (p=0.008), and neurocortical hemorrhagic events (p=0.025).¹⁵ 

DRUG INTERACTIONS

Interactions between Leukine and other drugs have not been fully evaluated. Drugs which may potentiate the myeloproliferative effects of Leukine, such as lithium and corticosteroids, should be used with caution.

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