Medication Guide App

Neupogen Side Effects

Generic Name: filgrastim

Note: This page contains side effects data for the generic drug filgrastim. It is possible that some of the dosage forms included below may not apply to the brand name Neupogen.

It is possible that some side effects of Neupogen may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to filgrastim: injection injectable, injection solution

As well as its needed effects, filgrastim (the active ingredient contained in Neupogen) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking filgrastim, check with your doctor immediately:

More common
  • Abdominal or stomach pain
  • 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
  • cough
  • coughing up blood
  • diarrhea
  • difficult or labored breathing
  • difficulty with swallowing
  • dizziness
  • facial swelling
  • feeling of fullness
  • fever or chills
  • headache
  • increased menstrual flow or vaginal bleeding
  • lower back or side pain
  • nausea or vomiting
  • 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
  • tightness in the chest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Blurred vision
  • chest pain
  • nervousness
  • pounding in the ears
  • slow or fast heartbeats
Incidence not known
  • Blisters on the skin
  • blue lips, fingernails, or skin
  • difficult or fast breathing
  • sores on the skin

Some filgrastim side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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 (stool)
  • swelling or inflammation of the mouth

For Healthcare Professionals

Applies to filgrastim: injectable solution

General

Filgrastim generally has been well tolerated. Whole body symptoms have included neutropenic fever (13%), fatigue (11%), generalized weakness (4%), and unspecified pain (2%). Many patients receiving filgrastim (the active ingredient contained in Neupogen) have had serious underlying conditions requiring concurrent medications associated with high toxicity. It is sometimes difficult to discern true drug toxicity from disease activity.

Musculoskeletal

Musculoskeletal symptoms have been the most frequently reported adverse effects of filgrastim (the active ingredient contained in Neupogen) therapy. Bone pain has been reported in approximately 22% of patients. Reactivation of pseudogout occurred in a patient receiving chemotherapy. Postmarketing reports have included decreased bone density and osteoporosis in pediatric severe chronic neutropenia (SCN) patients receiving chronic treatment with filgrastim.

Bone pain associated with filgrastim usually has localized in the lower back, posterior iliac crests, and sternum. Bone pain primarily occurred at initiation of therapy due to a transient increases in white blood cell (WBC) count, 2 to 3 days before a rise in peripheral blood neutrophils, and occurred more frequently with higher dosages. Analgesics may be helpful; however, pain may resolve with continued therapy and generally resolves within a few hours following discontinuation of therapy.

Hematologic

A case report described an acute arterial thrombosis thought to be due to filgrastim-induced platelet aggregation.

Hematologic changes associated with filgrastim occasionally have included petechiae, thrombocytopenia, anemia, myelodysplasia, and myeloid leukemia. White blood cell (WBC) counts equal to or greater than 100,000/mm3, without evidence of adverse effects, have occurred in approximately 2% of patients undergoing myelosuppressive chemotherapy. Results from treatment of HIV-infected patients with filgrastim (in combination with highly active antiretroviral therapy) have shown increases in the concentration of CD4, CD8 and NK cells without changes in the virus load. Postmarketing reports have included sickle cell crisis.

Dermatologic

Sweet syndrome (acute febrile neutropenic dermatosis), characterized by fever, leukocytosis, neutrophilia, painful and red skin plaques, and histological verification of dermal invasion by mature granulocytes, has occurred during filgrastim (the active ingredient contained in Neupogen) therapy. In one case, a woman who was treated for chemotherapy-related neutropenia after 3 days of 5 mcg/kg filgrastim via subcutaneous injection noted painful red plaques in an arm area affected by postmastectomy lymphedema. Biopsy confirmed dermal granulocyte infiltration without vasculitis. Following filgrastim discontinuation, the lesions rapidly healed. The authors speculated that poor granulocyte clearance by damaged lymphatics promoted Sweet syndrome in this patient.

Dermatologic reactions associated with filgrastim have included alopecia (18%), generalized maculopapular rash (6%), reversible exacerbations of acne, and Sweet's syndrome (acute febrile neutrophilic dermatosis). Filgrastim administration has also been associated with rare exacerbations of psoriasis and vasculitis.

Hepatic

Hepatic effects associated with filgrastim (the active ingredient contained in Neupogen) have included transient increases in alkaline phosphatase and lactate dehydrogenase in 28% to 57% of patients.

Cardiovascular

Cardiovascular effects of transient hypotension has been reported with filgrastim (the active ingredient contained in Neupogen) administration, primarily associated with intravenous administration. Chest pain was reported by 5% of patients receiving filgrastim following myelosuppressive chemotherapy. Postmarketing reports have included cutaneous vasculitis.

Hypersensitivity

Hypersensitivity-type reactions, primarily associated with intravenous (IV) administration, have been reported. Symptoms have frequently involved at least two body systems, most often dermatologic (rash, urticaria, facial edema), respiratory (wheezing, dyspnea), or cardiovascular (hypotension, bradycardia). Anaphylaxis following a first dose of filgrastim (the active ingredient contained in Neupogen) has been reported.

Renal

An 18-year-old male undergoing peripheral blood stem cell transplantation for non-Hodgkin's lymphoma received 150 mcg/day of filgrastim (the active ingredient contained in Neupogen) on day 17 of chemotherapy. On day 5 of filgrastim administration the plasma creatinine rose from approximately 0.6 mg/dl to 1.8 mg/dL with accompanying increases in white blood cell (WBC) counts and lactic dehydrogenase (LDH) levels. A slight decrease in urine volume was noted. Discontinuation of filgrastim lead to rapid renal function recovery. Rechallenge at a reduced filgrastim dosage (75 mcg/day) failed to result in recurrence of renal deterioration. The authors suspected renal leukostasis during filgrastim therapy may have precipitated the adverse renal effects.

Rarely, renal adverse effects have occurred. A case report of reversible renal impairment with elevated serum creatinine levels has been reported.

Endocrine

Rarely, endocrine reactions, such as reversible clinical hypothyroidism, have been reported.

A case report describes a woman without a history of thyroid disease who received 10 mcg/kg filgrastim subcutaneously on days 3 through 13 of each cycle as adjunct to chemotherapy for breast cancer. Chemotherapy consisted of doxorubicin and cyclophosphamide. The patient developed symptoms of clinical hypothyroidism without thyrotropin receptor antibodies during the third cycle of filgrastim and required thyroid replacement for 2 months. Thyroid function returned to baseline status 10 weeks following discontinuation of filgrastim and chemotherapy drugs were continued without effect on thyroid function.

Local

Local reactions have included bruising and erythema at the injection site.

Metabolic

Metabolic changes have included reversible increases in uric acid concentrations in 28% to 57% of patients.

Oncologic

Oncologic effects may occur due to filgrastim (the active ingredient contained in Neupogen) effect as a growth factor with any myeloid tumor.

Gastrointestinal

Gastrointestinal symptoms of nausea and vomiting have been reported in 57% of patients who received filgrastim (the active ingredient contained in Neupogen) following myelosuppressive chemotherapy. Diarrhea (14%), mucositis (12%), anorexia (9%), constipation (5%), stomatitis (5%), and sore throat (4%) have been reported.

Respiratory

Respiratory symptoms of dyspnea (9%), cough (6%) and alveolar hemorrhage and hemoptysis have been reported. Postmarketing reports have included acute respiratory distress syndrome (ARDS).

Nervous system

Nervous system side effects have been characterized by headaches in 7% of patients.

Other

Postmarketing reports have included splenic rupture and splenomegaly.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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