Loading…
Ristempa 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 adult 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.
Ristempa therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. Medicinal product no longer authorised 3 Method of administration Ristempa is injected subcutaneously. The injections should be given into the thigh, abdomen or upper arm.
6. Paediatric population The safety and efficacy of Ristempa in children has not yet been established. 2 but no recommendation on a posology can be made Patients with renal impairment No dose change is recommended in patients with renal impairment, including those with end stage renal disease.
Summary of the safety profile The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common). 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 Ristempa (uncommon [≥ 1/1,000 to < 1/100]). 4). 4 and section “Description of selected adverse reactions” below.
Splenomegaly, generally asymptomatic, is uncommon. 4). Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported. 4). Medicinal product no longer authorised 7 Tabulated summary of adverse reactions The data in the table below describe adverse reactions reported from clinical trials and spontaneous reporting.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. MedDRA system organ class Adverse reactions Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Blood and lymphatic system disorders Thrombocytopenia1 Leukocytosis1 Sickle cell crisis2; Splenomegaly2; Splenic rupture2 Immune system disorders Hypersensitivity reactions; Anaphylaxis Metabolism and nutrition disorders Elevations in uric acid Nervous system disorders Headache1 Vascular disorders Capillary leak syndrome1 Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome2; Pulmonary adverse reactions (interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis) Gastrointestinal disorders Nausea1 Skin and subcutaneous tissue disorders Sweet’s syndrome (acute febrile dermatosis)1,2; Cutaneous vasculitis1,2 Musculoskeletal and connective tissue disorders Bone pain Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculo- skeletal pain, neck pain) General disorders and administrative site conditions Injection site pain1 Non-cardiac chest pain Injection site reactions2 Investigations Elevations in lactate dehydrogenase and alkaline phosphatase1; Transient elevations in LFT's for ALT or AST1Medicinal product no longer authorised 8 MedDRA system organ class Adverse reactions Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Renal and urinary disorders Glomerulonephritis2 1 See section “Description of selected adverse reactions” below.
1). However, the long-term effects of Ristempa 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 Ristempa 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 Ristempa administration in de novo AML patients aged 55 years with cytogenetics t(15;17) have not been established.
The safety and efficacy of Ristempa have not been investigated in patients receiving high dose chemotherapy. This medicinal product should not be used to increase the dose of cytotoxic chemotherapy beyond established dosage regimens.
Pulmonary adverse events Uncommon (≥1/1,000 to < 1/100) pulmonary adverse reactions, in particular interstitial pneumonia, have been reported after G-CSF administration. 8). 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 Acute Respiratory Distress Syndrome (ARDS).
Medicinal product no longer authorised 4 Glomerulonephritis Glomerulonephritis has been reported in patients receiving filgrastim and pegfilgrastim. Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of filgrastim and pegfilgrastim.
Urinalysis monitoring is recommended. Capillary leak syndrome Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and hemoconcentration.
Hypersensitivity to the active substance or to any of the excipients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Pegfilgrastim in European Union.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
2 This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical trials in adults. The frequency category was estimated from a statistical calculation based upon 1576 patients receiving Ristempa in nine randomized clinical trials.
Description of selected adverse reactions Uncommon cases of Sweet’s syndrome have been reported, although in some cases underlying haematological malignancies may play a role. Uncommon events of cutaneous vasculitis have been reported in patients treated with Ristempa.
The mechanism of vasculitis in patients receiving Ristempa is unknown. Injection site reactions, including injection site erythaema (uncommon (≥ 1/1000 to < 1/100)) as well as injection site pain (common events ≥ 1/100 to < 1/10) have occurred on initial or subsequent treatment with Ristempa.
4). Reversible, mild to moderate elevations in uric acid and alkaline phosphatase, with no associated clinical effects, were uncommon; reversible, mild to moderate elevations in lactate dehydrogenase, with no associated clinical effects, were uncommon in patients receiving Ristempa following cytotoxic chemotherapy.
Nausea and headaches were very commonly observed in patients receiving chemotherapy. Uncommon 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 cases of thrombocytopenia have been reported. Cases of capillary leak syndrome have been reported in the post marketing setting with granulocyte colony-stimulating factor use.
4). Paediatric population The experience in children is limited. A higher frequency of serious adverse reactions in younger children aged 0-5 years (92%) has been observed compared to older children aged 6-11 and 12-21 years respectively (80% and 67%) and adults.
2). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the […]
8). 8). g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain. Thrombocytopenia and anaemia Treatment with Ristempa 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. 8). Therefore, physicians should use caution when prescribing Ristempa in patients with sickle cell trait or sickle cell disease, should monitor appropriate clinical parameters and laboratory status and be attentive to the possible association of this medicine with splenic enlargement and vaso-occlusive crisis.
Leukocytosis White blood cell (WBC) counts of 100 x 109/l or greater have been observed in less than 1% of patients receiving Ristempa. 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 this medicine.
Consistent with the clinical effects 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, this medicine should be discontinued immediately.
Hypersensitivity Hypersensitivity, including anaphylactic reactions, occurring on initial or subsequent treatment have been reported in patients treated with Ristempa. Permanently discontinue Ristempa in patients with clinically significant hypersensitivity.
Do not administer Ristempa to patients with a history of hypersensitivity to pegfilgrastim or filgrastim. Medicinal product no longer authorised 5 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity.
Rates of generation of antibodies against pegfilgrastim is generally low. Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present. The safety and efficacy of Ristempa for the mobilisation of blood progenitor cells in patients or healthy donors has not been adequately evaluated.
The needle cap 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 […]