Peg-Alvograstim Adverse Reactions

Summary of the safety profile: Assessment of undesirable effects is based on the following frequency groupings: Very common: ≥1/10; common: ≥1/100, <1/10; uncommon: ≥1/1,000, <1/100; rare: ≥1/10,000, <1/1,000; very rare: <1/10,000; not known: cannot be estimated from the available data.
The most frequently reported adverse reactions were bone pain (very common ≥1/10) and musculoskeletal pain (very common ≥1/10). Bone pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics.
Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon ≥1/1000 to <1/100).
Serious allergic reactions, including anaphylaxis can occur in patients receiving pegfilgrastim (uncommon ≥1/1000 to <1/100) (see Precautions).
Splenomegaly, generally asymptomatic, is uncommon (≥1/1000 to <1/100) (see Precautions).
Splenic rupture including some fatal cases is uncommonly (≥1/1000 to <1/100) reported following administration of pegfilgrastim (see Precautions).
Uncommon (≥1/1000 to <1/100) pulmonary adverse effects including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported. Uncommonly (≥1/1000 to <1/100), cases have resulted in respiratory failure or Adult Respiratory Distress Syndrome (ARDS), which may be fatal (see Precautions).
Isolated cases of sickle cell crises have been reported in patients with sickle cell disease (uncommon ≥1/1000 to <1/100 in sickle cell patients) (see Precautions).
Tabulated summary of adverse reactions: The data listed as follows describe adverse reactions reported from clinical trials and spontaneous reporting.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. (See table.)

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Description of selected adverse reactions: Uncommon: (≥1/1000 to <1/100) cases of Sweet's syndrome have been reported, although in some cases underlying haematological malignancies may play a role.
Uncommon (≥1/1000 to <1/100) events of cutaneous vasculitis have been reported in patients treated with pegfilgrastim. The mechanism of vasculitis in patients receiving pegfilgrastim is unknown.
Injection site reactions, including injection site pain and injection site erythaema (common (≥1/100 to <1/10)) have occurred on initial or subsequent treatment with pegfilgrastim.
Uncommon (≥1/1000 to <1/100) cases of leukocytosis (White Blood Count (WBC) >100 x 10⁹/L) have been reported (see Precautions).
Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon (≥1/1000 to <1/100); reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon (≥1/1000 to <1/100) in patients receiving pegfilgrastim following cytotoxic chemotherapy.
Nausea and headaches were very commonly observed in patients receiving chemotherapy.
Uncommon (≥1/1000 to <1/100) elevations in liver function tests (LFTs) for ALT (alanine aminotransferase) or AST (aspartate aminotransferase), have been observed in patients after receiving pegfilgrastim following cytotoxic chemotherapy. These elevations are transient and return to baseline.
Common (≥1/100 to <1/10) cases of thrombocytopenia have been reported.