Nivestym Side Effects

Generic name: filgrastim

Medically reviewed by Drugs.com. Last updated on Sep 16, 2024.

Note: This document provides detailed information about Nivestym Side Effects associated with filgrastim. Some dosage forms listed on this page may not apply specifically to the brand name Nivestym.

Applies to filgrastim: injection solution.

Other dosage forms:

• solution

Serious side effects of Nivestym

Along with its needed effects, filgrastim (the active ingredient contained in Nivestym) 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 side effects

• 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 side effects

• 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 Nivestym

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 side effects

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

Less common side effects

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

For healthcare professionals

Applies to filgrastim: injectable solution.

Hematologic adverse events

• 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]

Frequently asked questions

• What are biosimilar drugs and how do they compare to biologics?
• What biosimilars have been approved in the United States?
• What is the difference between Nivestym and Neupogen?

Further information

Nivestym side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer