Neocyte Adverse Reactions

The most commonly reported adverse reactions are mild to moderate musculoskeletal pain occurring in more than 10% of patients. Generally, adverse reactions to filgrastim are mild and tolerable, and special treatment is not necessary. The symptoms will disappear after withdrawal.
Gastrointestinal Effects: Nausea, vomiting and abdominal pain are very common. Mucosal inflammation, constipation and diarrhea are common.
Cardiovascular Effects: Sickle cell crisis, sometimes fatal, has been reported (see Warnings). Transient hypotension and vascular disorders including veno-occlusive disease and volume disturbances have also been reported.
Hematologic Effects: Leukocytosis and thrombocytopenia were reported. Thrombocytopenia and anemia are very common in patients with SCN (see Precautions).
Hepatic Effects: Increased gamma-glutamyl transpeptidase and alkaline phosphatase are very common. Hepatomegaly is common in patients with SCN. Increase in aspartate aminotransferase has also been reported.
Central Nervous System Effects: Headache and anorexia are common.
Metabolic Effects: Increased lactate dehydrogenase and uric acid are very common. Decreased glucose and hyperuricemia are very common in patients with SCN. Pseudogout has also been reported in cancer patients.
Musculoskeletal Effects: Chest pain and musculoskeletal pain are common. Osteoporosis is common in patients with SCN. Bone pain and myalgia are very common in patients with SCN and HIV infection. Rheumatoid arthritis, arthritic symptoms exacerbation and arthralgia have also been reported.
Respiratory Effects: ARDS (see Precautions). Cough and pharyngolaryngeal pain are common. Pulmonary edema, interstitial pneumonia, pulmonary infiltrates, hemoptysis, pulmonary hemorrhage, dyspnea, and hypoxia have also been reported.
Dermatologic Effects: Alopecia and skin rash are common. Sweet's syndrome and cutaneous vasculitis are very rare but are common in patients with SCN. Epistaxis has also been reported.
Lymphatic System Effects: Rare cases of splenic rupture (see Warnings). Splenomegaly and other spleen disorders were also reported.
Hypersensitivity (see Precautions): Allergic reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnea, wheezing, tachycardia, and hypotension are very rare.
Genitourinary Effects: Urinary abnormalities (predominantly dysuria) have also been reported. Hematuria and proteinuria have also been reported.
Local Effects: Erythema, swelling or pruritus may occasionally occur at the site of injection. SC injection or infusion may result in minor bruising, inflammation or bleeding, and continuous IV infusion may result in inflammation at the site of administration.
Others: Fatigue and generalized weakness are common.