Filgrastim Side Effects

Some side effects of filgrastim may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to filgrastim: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking filgrastim: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using filgrastim and call your doctor at once if you have a serious side effect such as:

• sudden or severe pain in your left upper stomach spreading up to your shoulder;

• rapid breathing or feeling short of breath; or

• signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness.

Less serious side effects of filgrastim may include:

• diarrhea, constipation;

• bone pain;

• muscle aches;

• hair loss;

• headache, tired feeling;

• mild skin rash; or

• itching, swelling, or redness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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 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 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.

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 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. Filgrastim administration has also been associated with rare exacerbations of psoriasis and vasculitis.

Hepatic

Hepatic effects associated with filgrastim 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 administration, primarily associated with intravenous administration. Chest pain was reported by 5% of patients receiving filgrastim following myelosuppressive chemotherapy.

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 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 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 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 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.

Nervous system

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

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