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Filgrastim Side Effects

Not all side effects for filgrastim may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to filgrastim: injection injectable, injection solution

In addition to its needed effects, some unwanted effects may be caused by filgrastim. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking filgrastim:

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 of the side effects that can occur with filgrastim may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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 have had serious underlying conditions requiring concurrent medications associated with high toxicity. It is sometimes difficult to discern true drug toxicity from disease activity.[Ref]

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.[Ref]

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.[Ref]

Hematologic

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

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.[Ref]

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.[Ref]

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.[Ref]

Hepatic

Hepatic effects associated with filgrastim have included transient increases in alkaline phosphatase and lactate dehydrogenase in 28% to 57% of patients.[Ref]

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. Postmarketing reports have included cutaneous vasculitis.[Ref]

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.[Ref]

Renal

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

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.[Ref]

Endocrine

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.[Ref]

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

Local

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

Metabolic

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

Oncologic

Oncologic effects may occur due to filgrastim effect as a growth factor with any myeloid tumor.[Ref]

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.[Ref]

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).[Ref]

Nervous system

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

Other

Postmarketing reports have included splenic rupture and splenomegaly.

References

1. Martinez C, UrbanoIspizua A, Marin P, Merino A, Rovira M, Carreras E, Montserrat E "Efficacy and toxicity of a high-dose G-CSF schedule for peripheral blood progenitor cell mobilization in healthy donors." Bone Marrow Transplant 24 (1999): 1273-8

2. Hollingshead LM, Goa KL "Recombinant granulocyte colony-stimulating factor (rG-CSF). A review of its pharmacological properties and prospective role in neutropenic conditions." Drugs 42 (1991): 300-30

3. Ballestrero A, Ferrando F, Garuti A, Basta P, Gonella R, Stura P, Mela GS, Sessarego M, Gobbi M, Patrone F "Comparative effects of three cytokine regimens after high-dose cyclophosphamide: Granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor (GM-CSF), and sequential interleukin-3 and GM-CSF." J Clin Oncol 17 (1999): 1296-303

4. "Product Information. Neupogen (filgrastim)." Amgen, Thousand Oaks, CA.

5. Balmer CM "Clinical use of biologic response modifiers in cancer treatment: an overview. Part II. Colony-stimulating factors and interleukin-2." DICP 25 (1991): 490-8

6. Rogers KM "Topics in clinical pharmacology: filgrastim, a myeloid colony stimulating factor." Am J Med Sci 303 (1992): 429-31

7. Shpall EJ, Wheeler CA, Turner SA, Yanovich S, Brown RA, Pecora AL, Shea TC, Mangan KF, Williams SF, LeMaistre CF, Long G "A randomized phase 3 study of peripheral blood progenitor cell mobilization with stem cell factor and filgrastim in high-risk breast cancer patients." Blood 93 (1999): 2491-501

8. Snowden JA, Biggs JC, Milliken ST, Fuller A, Staniforth D, Passuello F, Renwick J, Brooks PM "A randomised, blinded, placebo-controlled, dose escalation study of the tolerability and efficacy of filgrastim for haemopoietic stem cell mobilisation in patients with severe active rheumatoid arthritis." Bone Marrow Transplant 22 (1998): 1035-41

9. Momin F, Kraut M, Lattin P, Valdivieso M "Thrombocytopenia in patients receiving chemoradiotherapy and G-CSF for locally advanced non-small cell lung cancer (NSCLC) (meeting abstract)." Proc Annu Meet Am Soc Clin Oncol 11 (1992): a983

10. Wun T "The Felty syndrome and G-CSF-associated thrombocytopenia and severe anemia ." Ann Intern Med 118 (1993): 318-9

11. Salloum E, Stoessel KM, Cooper DL "Hyperleukocytosis and retinal hemorrhages after chemotherapy and filgrastim administration for peripheral blood progenitor cell mobilization." Bone Marrow Transplant 21 (1998): 835-7

12. Aladdin H, Ullum H, Nielsen SD, Espersen C, Mathiesen L, Katzenstein TL, Gerstoft J, Skinhoj P, Pedersen BK "Granulocyte colony-stimulating factor increases CD4(+) T cell counts of human immunodeficiency virus-infected patients receiving stable, highly active antiretroviral therapy: Results from a randomized, placebo-controlled trial." J Infec Dis 181 (2000): 1148-52

13. Kawachi Y, Watanabe A, Uchida T, Yoshizawa K, Kurooka N, Setsu K "Acute arterial thrombosis due to platelet aggregation in a patient receiving granulocyte colony-stimulating factor." Br J Haematol 94 (1996): 413-6

14. Garty BZ, Levy I, Nitzan M, Barak Y "Sweet syndrome associated with G-CSF treatment in a child with glycogen storage disease type Ib." Pediatrics 97 (1996): 401-3

15. Ostlere LS, Harris D, Prentice HG, Rustin MH "Widespread folliculitis induced by human granulocyte-colony- stimulating factor therapy ." Br J Dermatol 127 (1992): 193-4

16. Samlaska CP, Noyes DK "Localized cutaneous reactions to granulocyte colony-stimulating factor ." Arch Dermatol 129 (1993): 645-6

17. Prevostblank PL, Shwayder TA "Sweet's syndrome secondary to granulocyte colony-stimulating factor." J Am Acad Dermatol 35 (1996): 995-7

18. Petit T, Frances C, Marinho E, Herson S, Chosidow O "Lymphoedema-area-restricted sweet syndrome during g-CSF treatment." Lancet 347 (1996): 690

19. Ross HJ, Moy LA, Kaplan R, Figlin RA "Bullous pyoderma gangrenosum after granulocyte colony-stimulating factor treatment." Cancer 68 (1991): 441-3

20. Batelcopel L, Mommejamarin H, Oudard S, Chauvenet L, Pujadelauraine E, Coupier J, Bernadou A "Anaphylactic reaction after a first filgrastim (granulocyte-colony stimulating factor) injection." Eur J Cancer 31A (1995): 2428

21. Munoz RM, Gomez-Bellver MJ, Pulido AM, Cuevas JC "Probable hypersensitivity reaction to filgrastim." Am J Health Syst Pharm 53 (1996): 1607

22. Hirokawa M, Lee M, Motegi M, Miura AB "Reversible renal impairment during leukocytosis induced by g-CSF in non-hodgkin's lymphoma." Am J Hematol 51 (1996): 328-9

23. Deluis DA, Romero E "Reversible thyroid dysfunction with filgrastim." Lancet 348 (1996): 1595-6

24. Schrijvers D, Slootmaekers V, Dirix L, Vanoosterom A "Neurological disturbances due to filgrastim." Lancet 349 (1997): 402-3

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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