Releuko Side Effects

Generic name: filgrastim

Medically reviewed by Drugs.com. Last updated on Oct 18, 2023.

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]