Peg-Alvograstim Special Precautions



MR Pharma




Mega Lifesciences
Full Prescribing Info
Special Precautions
Limited clinical data suggest a comparable effect on time to recovery of severe neutropenia for pegfilgrastim to filgrastim in patients with de novo acute myeloid leukaemia.
However, the long-term effects of pegfilgrastim have not been established in acute myeloid leukaemia; therefore, it should be used with caution in this patient population.
Granulocyte-colony stimulating factor can promote growth of myeloid cells in vitro and similar effects may be seen on some non-myeloid cells in vitro.
The safety and efficacy of pegfilgrastim have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia and in patients with secondary Acute Myeloid Leukaemia (AML); therefore, it should not be used in such patients. Particular care should be taken to distinguish the diagnosis of blast transformation of chronic myeloid leukaemia from acute myeloid leukaemia.
The safety and efficacy of pegfilgrastim administration in de novo AML patients aged <55 years with cytogenetics t(15;17) have not been established.
The safety and efficacy of pegfilgrastim have not been investigated in patients receiving high dose chemotherapy. Pegfilgrastim should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Rare: (0.1/10.000 <1/1.000) pulmonary adverse effects, in particular interstitial pneumonia, have been reported after G-CSF administration. Patients with a recent history of pulmonary infiltrates or pneumonia may be at higher risk (see Adverse Reactions).
The onset of pulmonary signs such as cough, fever and dyspnoea in association with radiological signs of pulmonary infiltrates and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Adult Respiratory Distress Syndrome (ARDS). In such circumstances pegfilgrastim should be discontinued at the discretion of the physician and the appropriate treatment given (see Adverse Reactions).
Common (≥1/100 to <1/10) but generally asymptomatic cases of splenomegaly and uncommon (=1/100 to <1/10) cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim (see Adverse Reactions). Therefore, spleen size should be carefully monitored (e.g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
Treatment with pegfilgrastim alone does not preclude thrombocytopenia and anaemia because full dose myelosuppressive chemotherapy is maintained on the prescribed schedule. Regular monitoring of platelet count and haematocrit is recommended. Special care should be taken when administering single or combination chemotherapeutic agents which are known to cause severe thrombocytopenia.
Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell disease (see Adverse Reactions). Therefore, physicians should exercise caution when administering pegfilgrastim in patients with sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of pegfilgrastim with splenic enlargement and vaso-occlusive crisis.
White blood cell (WBC) counts of 100 x 109/l or greater have been observed in less than 1% of patients receiving pegfilgrastim. No adverse events directly attributable to this degree of leukocytosis have been reported. Such elevation in white blood cells is transient, typically seen 24 to 48 hrs after administration and is consistent with the pharmacodynamic effects of pegfilgrastim. Consistent with the clinical effects of pegfilgrastim and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy. If leukocyte counts exceed 50 x 109/L after the expected nadir; pegfilgrastim should be discontinued immediately.
If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Pegfilgrastim should be permanently discontinued in patients who experience a serious allergic reaction (see Adverse Reactions).
The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
The needle cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions.
Increased haematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging findings. This should be considered when interpreting bone-imaging results.
Peg-Alvograstim contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Peg-Alvograstim contains less than 1 mmol (23 mg) sodium per 6 mg dose, i.e. essentially 'sodium-free'.
Effects on the ability to drive or use machines: No studies on the effects on the ability to drive and use machines have been performed with pegfilgrastim.
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