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

Applies to filgrastim: injection solution. Other dosage forms:

• solution

Serious side effects of Releuko

Along with its needed effects, filgrastim (the active ingredient contained in Releuko) 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 filgrastim:

More common

• Bleeding gums
• bleeding, blistering, burning, coldness, discoloration of the 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
• blood in the urine or stools
• bloody nose
• chills
• cough
• coughing up blood
• diarrhea
• difficult or labored breathing
• difficulty with swallowing
• dizziness
• facial swelling
• feeling of fullness
• fever
• headache
• increased menstrual flow or vaginal bleeding
• lower back or side pain
• nausea
• nosebleeds
• pain in the back, ribs, arms, or legs
• pain spreading to the left shoulder
• painful or difficult urination
• pale skin
• paralysis
• pinpoint red or purple spots on the skin
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• skin rash
• sore throat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• stomach pain
• tightness in the chest
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• Blurred vision
• chest pain
• nervousness
• pounding in the ears
• slow or fast heartbeat

Incidence not known

• Blisters on the skin
• blue lips, fingernails, or skin
• difficult or fast breathing
• sores on the skin
• swollen glands

Other side effects of Releuko

Some side effects of filgrastim 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

• Bone, joint, or muscle pain
• hair loss or thinning of the hair
• loss of appetite
• weight loss

Less common

• Cracked lips
• difficulty having a bowel movement
• swelling or inflammation of the mouth

For Healthcare Professionals

Applies to filgrastim: injectable solution.

Hematologic

Very common (10% or more): Decreased platelet counts (up to 97%), increase in white blood cell counts between 10 x 10(9)/L and 70 x 10(9)/L (up to 88%), decreased hemoglobin (up to 65%), mild to moderate decreases in hemoglobin (up to 59%), leukocytosis (up to 41%), thrombocytopenia (up to 38%), transient thrombocytopenia (up to 35%), palpable splenomegaly (up to 30%), splenomegaly (up to 30%), anemia (up to 10%)

Common (1% to 10%): Spleen disorder, splenic rupture/fatal splenic rupture

Uncommon (0.1% to 1%): Sickle cell anemia with crisis/sickle cell crisis

Rare (0.01% to 0.1%): Cytopenia

Postmarketing reports: Sickle cell disorders^[Ref]

Musculoskeletal

Very common (10% or more): Mild to moderate musculoskeletal symptoms (up to 44%), medullary bone pain (up to 38%), mild to moderate bone pain (up to 33%), bone pain (up to 30%), back pain (up to 15%), musculoskeletal pain (up to 14%), flank pain (up to 12%), myalgia (up to 12%)

Common (1% to 10%): Arthralgia, extremity pain, muscle spasms, osteoporosis, severe musculoskeletal pain

Uncommon (0.1% to 1%): Pseudogout/chondrocalcinosis pyrophosphate, rheumatoid arthritis exacerbation

Rare (0.01% to 0.1%): Decreased bone density

Frequency not reported: Musculoskeletal chest pain, neck pain^[Ref]

Other

Very common (10% or more): Pyrexia (up to 48%), fatigue (up to 20%), pain (up to 12%)

Common (1% to 10%): Asthenia, generalized weakness, malaise, mucosal inflammation, mucositis^[Ref]

Respiratory

Very common (10% or more): Epistaxis (up to 15%), cough (up to 14%), dyspnea (up to 13%)

Common (1% to 10%): Bronchitis, hemoptysis, sore throat, upper respiratory tract infection

Uncommon (0.1% to 1%): Acute respiratory distress syndrome (ARDS), hypoxia, interstitial lung disease, pulmonary edema, pulmonary hemorrhage, pulmonary infiltrates/lung infiltration, respiratory failure

Very rare (less than 0.01%): Pulmonary adverse events

Frequency not reported: Interstitial pneumonia, serious pulmonary adverse events

Postmarketing reports: Alveolar hemorrhage^[Ref]

Metabolic

Very common (10% or more): Spontaneously reversible elevations in lactate dehydrogenase (up to 56%), spontaneously reversible elevations in uric acid (up to 56%)

Common (1% to 10%): Anorexia, blood glucose decreased, blood lactate dehydrogenase increased, blood uric acid increased, decreased appetite, hyperuricemia

Uncommon (0.1% to 1%): Fluid volume disturbances^[Ref]

Hepatic

Very common (10% or more): Spontaneously reversible elevations in alkaline phosphatase (up to 56%), blood alkaline phosphatase increased (up to 11%)

Common (1% to 10%): Gamma glutamyltransferase increased, hepatomegaly

Uncommon (0.1% to 1%): AST increased^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 43%), abdominal pain (up to 12%)

Common (1% to 10%): Constipation, diarrhea, oral pain, oropharyngeal pain, pharyngolaryngeal pain, vomiting

Frequency not reported: Stomatitis^[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 14%), headache (up to 10%)

Common (1% to 10%): Hypoesthesia, paresthesia^[Ref]

Dermatologic

Very common (10% or more): Rash/skin rash (up to 14%)

Common (1% to 10%): Alopecia, cutaneous/leukocytoclastic vasculitis, erythema

Uncommon (0.1% to 1%): Acute febrile neutrophilic dermatosis/Sweet's syndrome, maculopapular rash, pre-existing skin disorder exacerbation, psoriasis exacerbation

Frequency not reported: Urticaria^[Ref]

Cardiovascular

Very common (10% or more): Chest pain (up to 13%)

Common (1% to 10%): Hypertension, hypotension, peripheral edema

Uncommon (0.1% to 1%): Capillary leak syndrome, veno-occlusive disease

Rare (0.01% to 0.1%): Aortitis, vascular disorder^[Ref]

Genitourinary

Common (1% to 10%): Dysuria, hematuria, urinary tract infection

Uncommon (0.1% to 1%): Proteinuria,

Rare (0.01% to 0.1%): Urine abnormality^[Ref]

Local

Common (1% to 10%): Injection site pain, injection site reaction, transfusion reaction^[Ref]

Immunologic

Common (1% to 10%): Antibody formation, sepsis

Uncommon (0.1% to 1%): Graft versus Host Disease (GvHD)/fatal GvHD^[Ref]

Hypersensitivity

Common (1% to 10%): Drug hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction, hypersensitivity/hypersensitivity reactions, severe allergic reaction

Very rare (less than 0.01%): Allergic reaction

Frequency not reported: Anaphylaxis, angioedema^[Ref]

Renal

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

Psychiatric

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

Oncologic

Frequency not reported: cytogenetic abnormalities, transformation to myelodysplastic syndromes (MDS), transformation to acute myeloid leukemia (AML)^[Ref]

Transformation to MDS/AML and cytogenetic abnormalities appeared to be confined to patients with congenital neutropenia. The cumulative risk in this population in the eighth year of treatment was predicted to be 16.5%, or approximately 2% per year.^[Ref]