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Neupopeg is a brand name for Pegfilgrastim. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Verbatim from this product's EMA label. Tap a section to expand.
Neupopeg therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. One 6 mg dose (a single pre-filled syringe) of Neupopeg is recommended for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy.
Neupopeg is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy. Renal impairment: no dose change is recommended in patients with renal impairment, including those with end stage renal disease.
In randomised clinical studies in patients with malignancy receiving Neupopeg after cytotoxic chemotherapy, most adverse events were caused by the underlying malignancy or cytotoxic chemotherapy. The most frequently reported and very common study-drug related undesirable effect was bone pain Bone pain was generally of mild-to-moderate severity, transient and could be controlled in most patients with standard analgesics.
Medicinal product no longer authorisedAllergic-type reactions, including anaphylaxis, skin rash, urticaria, angioedema, dyspnoea, hypotension, injection site reactions, erythaema and flushing, occurring on initial or subsequent treatment have been reported with Neupopeg.
In some cases, symptoms have recurred with rechallenge, suggesting a causal relationship. 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.
Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were common (≥ 1/100 to < 1/10); reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were very common (≥ 1/10) in patients receiving Neupopeg following cytotoxic chemotherapy.
Nausea was observed in healthy volunteers and patients receiving chemotherapy. 4). Other commonly reported undesirable effects include pain, injection site pain; chest pain (non-cardiac); headache; arthralgia; myalgia; back, limb, musculo-skeletal and neck pain.
Rare (≥ 1/10,000 to < 1/1,000) pulmonary adverse effects including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported. 4) Rare (≥ 1/10,000 to < 1/1,000) cases of thrombocytopenia and leukocytosis have been reported.
Hypersensitivity to the active substance or to any of the excipients. 1). However, the long-term effects of Neupopeg 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 Neupopeg 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 Neupopeg administration in de novo AML patients aged < 55 years with cytogenetics t(15;17) have not been established.
The safety and efficacy of Neupopeg have not been investigated in patients receiving high dose chemotherapy. Rare (≥ 1/10,000 to < 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. 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 Neupopeg should be discontinued at the discretion of the physician and the appropriate treatment given. Common (≥ 1/100 to < 1/10) but generally asymptomatic cases of splenomegaly and very rare (< 1/10,000) cases of splenic rupture, including some fatal cases, have been reported following administration of pegfilgrastim.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Rare (≥ 1/10,000 to < 1/1,000) cases of Sweet’s syndrome have been reported, although in some cases underlying haematological malignancies may play a role. Very rare (< 1/10,000) events of cutaneous vasculitis have been reported in patients treated with Neupopeg.
The mechanism of vasculitis in patients receiving Neupopeg is unknown. Very rare (< 1/10,000) 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. 4).
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 Neupopeg 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. Neupopeg should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens. Sickle cell crises have been associated with the use of pegfilgrastim in patients with sickle cell disease.
Therefore, physicians should exercise caution when administering Neupopeg in patients with sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of Neupopeg with splenic enlargement and vaso-occlusive crisis.
White blood cell counts of 100 x 109/l or greater have been observed in less than 1% of patients receiving Neupopeg. 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 hours after administration and is consistent with the pharmacodynamic effects of Neupopeg.
The safety and efficacy of Neupopeg for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated. Medicinal product no longer authorisedThe 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. Neupopeg contains sorbitol.
Patients with rare hereditary problems of fructose intolerance should not take this medicine. e. essentially ‘sodium-free’.