Note: This document contains side effect information about sargramostim. Some dosage forms listed on this page may not apply to the brand name Leukine.

Applies to sargramostim: injection powder for solution.

Serious side effects of Leukine

Along with its needed effects, sargramostim (the active ingredient contained in Leukine) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sargramostim:

More common

• Black, tarry stools
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the eye
• bloody nose
• blurred vision
• body aches or pain
• bone pain
• chest pain or tightness
• cloudy urine
• cough
• decrease in urine output or decrease in urine-concentrating ability
• difficult or labored breathing
• drowsiness
• dry mouth
• dryness or soreness of the throat
• eye pain
• fast, pounding, or irregular heartbeat or pulse
• fever
• flushed, dry skin
• fruit-like breath odor
• hoarseness
• increased hunger
• increased thirst
• increased urination
• irregular heartbeat
• large amount of cholesterol in the blood
• loss of appetite
• mood or mental changes
• muscle spasms
• nausea
• rapid weight gain
• redness in whites of eyes
• stomach pain
• stuffy or runny nose
• sweating
• tender, swollen glands in the neck
• tingling of the hands or feet
• trouble with swallowing
• trembling
• twitching
• unusual tiredness or weakness
• unusual weight gain or loss
• voice changes
• vomiting
• vomiting of blood or material that looks like coffee grounds
• yellow eyes or skin

Incidence not known

• Chills
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• general feeling of illness
• headache
• pain in the chest, groin, or legs, especially the calves
• severe, sudden headache
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg

Other side effects of Leukine

Some side effects of sargramostim may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Diarrhea
• difficulty in moving
• fear or nervousness
• itching skin
• lack or loss of strength
• muscle pain or stiffness
• pain in the joints
• trouble sleeping

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest

For Healthcare Professionals

Applies to sargramostim: injectable powder for injection, injectable solution.

General

The type and frequency of adverse events following induction in patients with acute myelogenous leukemia (AML) were similar between those treated with this drug and those taking placebo.^[Ref]

Other

Very common (10% or more): Fever (up to 95%), mucous membrane disorder (75%), asthenia (up to 66%), malaise (57%), edema (up to 34%), chills (up to 25%), pain (17%), chest pain (15%), peripheral edema (up to 15%)^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 90%), diarrhea (up to 89%), vomiting (up to 85%), stomatitis (up to 62%), abdominal pain (38%), gastrointestinal disorder (37%), gastrointestinal hemorrhage (up to 27%), dyspepsia (17%), hematemesis (13%), dysphagia (11%)

Common (1% to 10%): Constipation, abdominal distention^[Ref]

Dermatologic

Very common (10% or more): Alopecia (up to 73%), rash (up to 70%), pruritus (23%)

Common (1% to 10%): Petechia, sweats^[Ref]

Immunologic

Very common (10% or more): Infection (65%), allergy (12%), sepsis (11%)

Common (1% to 10%): Neutralizing antibodies

Frequency not reported: Allergic reaction, anaphylactoid reaction^[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 54%), glucose high (41%), weight loss (37%), hyperglycemia (25%), cholesterol high (17%), hypomagnesemia (15%)

Common (1% to 10%): Calcium low, weight gain^[Ref]

Nervous system

Very common (10% or more): Headache (up to 36%), central nervous system disorder (11%), paresthesia (11%)

Frequency not reported: Dizziness

Postmarketing reports: Fainting^[Ref]

Cardiovascular

Very common (10% or more): Hypertension (34%), hemorrhage (up to 29%), pericardial effusion (25%), hypotension (13%), tachycardia (11%)

Postmarketing reports: Arrhythmia, thrombosis^[Ref]

Hepatic

Very common (10% or more): Bilirubinemia (30%), liver damage (13%), ALT increased (13%)

Common (1% to 10%): Alkaline phosphatase increased

Postmarketing reports: Transient liver function abnormalities^[Ref]

Respiratory

Very common (10% or more): Dyspnea (28%), pharyngitis (23%), lung disorder (20%), epistaxis (17%), dyspnea (15%), rhinitis (11%)^[Ref]

Hematologic

Very common (10% or more): Albumin low (27%), blood dyscrasia (25%), thrombocytopenia (19%), leukopenia (17%)

Common (1% to 10%): Agranulocytosis

Frequency not reported: Anemia, serum proteins low, prothrombin time prolonged, progressive increase in circulating monocytes and promonocytes and blasts in the marrow

Postmarketing reports: Eosinophilia^[Ref]

Renal

Very common (10% or more): BUN high (23%), creatinine increased (15%)

Common (1% to 10%): Kidney function abnormal^[Ref]

Musculoskeletal

Very common (10% or more): Bone pain (21%), arthralgia (up to 21%), myalgia (18%)

Common (1% to 10%): Back pain

Postmarketing reports: Joint pain^[Ref]

Genitourinary

Very common (10% or more): Urinary tract disorder (14%)

Common (1% to 10%): Hematuria^[Ref]

Psychiatric

Very common (10% or more): Insomnia (11%), anxiety (11%)^[Ref]

Ocular

Very common (10% or more): Eye hemorrhage (11%)^[Ref]

Local

Postmarketing reports: Injection site reactions^[Ref]