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Ryzneuta is a brand name for Efbemalenograstim Alfa. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 4.1 Therapeutic indication Ryzneuta is indicated for the 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.
Ryzneuta therapy should be initiated and supervised by physicians experienced in oncology and/or haematology. Posology One 20 mg dose (a single pre-filled syringe) of Ryzneuta is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
3 Special populations Renal impairment No dose change is recommended in patients with renal impairment, including those with end-stage renal disease. Paediatric population The safety and efficacy of Ryzneuta in children have not yet been established and no data are available.
Method of administration Ryzneuta is for subcutaneous use. It is provided in a pre-filled syringe for manual administration. The injections should be given into the thigh, abdomen, buttock or upper arm. 6.
Summary of the safety profile The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]). Back pain, arthralgia and pain in extremity were reported commonly (≥ 1/100 to < 1/10). Musculoskeletal pain was generally of mild to moderate severity, transient and could be controlled in most patients with standard analgesics.
Serious angioedema occurred on subsequent treatment with efbemalenograstim alfa (uncommon [ ≥ 1/1 000 to < 1/100]). Splenomegaly, generally asymptomatic, is uncommon. 4) 7 Uncommon pulmonary adverse reactions such as pulmonary oedema occurred on treatment with efbemalenograstim alfa.
Other pulmonary adverse reactions including interstitial pneumonia, pulmonary infiltrates and pulmonary fibrosis have been reported following administration of G-CSF. 4). 4). 4 and section “Description of selected adverse reactions” below.
Tabulated list of adverse reactions The safety of efbemalenograstim alfa has been evaluated based on the results from clinical trials.. Adverse reactions are divided into groups according to the MedDRA system organ class (SOC) and into frequency groups using the following convention: 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), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriouness. 8 Table 1. List of adverse reactions MedDRA system organ class Adverse reactions Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1 000 to < 1/100) Infections and infestations Herpes infection2 Blood and lymphatic system disorders Leukopenia, Neutropenia, Thrombocytopenia, Anaemia, Splenomegaly Metabolism and nutrition disorders Hyperglycaemia, Decreased appetite Nervous system disorders Headache1 Dizziness, Taste disorder2, Muscle spasticity, Peripheral neuropathy2, Somnolence Eye disorders Lacrimation increased Ear and labyrinth disorders Vertigo1 Cardiac disorders Tachycardia, Palpitations Vascular disorders Vasculitis, Hot flush Respiratory, thoracic and mediastinal disorders Pulmonary oedema, Epistaxis, Oropharyngeal pain, Cough, Dyspnoea, Nasal dryness Gastrointestinal disorders Nausea1, Diarrhoea1, Vomiting1 Stomatitis, Dry mouth, Dyspepsia, Abdominal pain, Dysphagia Skin and subcutaneous tissue disorders Alopecia, Urticaria1, Dermatitis allergic, Rash, Dermatitis, Erythema, Toxic skin eruption, Rash maculo- papular, Pruritus, Eczema, Dry skin, Skin disorder, Angioedema, Cold sweat, Night sweats, Onychalgia Musculoskeletal and connective tissue disorders Bone pain Back pain, Arthralgia, Pain in extremity Myalgia, Osteoarthropathy, Musculoskeletal discomfort, Neck pain General disorders and administration site conditions Asthenia1, Fatigue1, Pyrexia1 Injection site reactions2 , Peripheral swelling, Chills, Thirst Investigations White blood cell count increased1, Alanine aminotransferase increased1, Aspartate aminotransferase increased1 Neutrophil count increased, Blood creatinine increased, Gamma-glutamyltransferase increased, Weight increased The frequency category was estimated from a statistical calculation based upon 488 patients receiving Ryzneuta in four clinical trials.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered medicinal product should be clearly recorded. Malignant cell growth Granulocyte colony-stimulating factor (G-CSF) 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 efbemalenograstim alfa have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, or acute myeloid leukaemia. Therefore, it should not be used in such patients. The safety and efficacy of efbemalenograstim alfa 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 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).
8). g. filgrastim and pegfilgrastim). Generally, events of glomerulonephritis resolved after dose reduction or withdrawal of G-CSF. Urinalysis monitoring is recommended. Capillary leak syndrome Capillary leak syndrome has been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
8). Splenomegaly and splenic rupture Generally asymptomatic cases of splenomegaly have been reported after administration of efbemalenograstim alfa. 8). g. clinical examination, ultrasound). A diagnosis of splenic rupture should be considered in patients reporting left upper abdominal pain or shoulder tip pain.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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1 See section “Description of selected adverse reactions” below. 2 Includes multiple adverse reaction terms. Description of selected adverse reactions Nausea, vomiting, diarrhoea, asthenia, fatigue, pyrexia, vertigo and headaches were commonly observed in patients receiving chemotherapy.
9 One case of serious urticaria was reported after efbemalenograstim alfa treatment. White blood cell count increased was commonly reported after efbemalenograstim alfa treatment. 4). Increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST) have been commonly observed in patients after receiving efbemalenograstim alfa following cytotoxic chemotherapy.
These elevations are transient and return to baseline. 4). 4). Cases of capillary leak syndrome have been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. 4). 4). 4).
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows […]
Thrombocytopenia and anaemia Treatment with efbemalenograstim alfa 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 efbemalenograstim alfa in patients with sickle cell trait or sickle cell disease, clinical parameters and laboratory status should be monitored appropriately and attentively by the physician for the possible association of this medicinal product with splenic enlargement and vaso-occlusive crisis.
Leukocytosis White blood cell (WBC) counts of 100 × 109/L or greater have been observed in patients receiving G-CSF. No adverse events directly attributable to this degree of leukocytosis have been reported. Such elevation in white blood cells is transient, being typically seen 24 to 48 hours after administration and is consistent with the pharmacodynamic effects of this medicinal product.
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 × 109/L after the expected nadir, this medicinal product should be discontinued immediately.
Hypersensitivity Hypersensitivity, including serious allergic reactions, occurring on initial or subsequent treatment have been reported in patients treated with G-CSF. Efbemalenograstim alfa should be permanently discontinued in patients with clinically significant hypersensitivity.
Efbemalenograstim alfa should not be administered to patients with a history of hypersensitivity to efbemalenograstim alfa. Caution should be exercised if using efbemalenograstim alfa in patients with a history of serious allergic reactions to other G-CSF products as the risk of cross-reactivity cannot be excluded.
In such circumstances, efbemalenograstim alfa should be administered at the discretion of the physician with 5 the appropriate assessment of risks and benefits. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Stevens-Johnson syndrome Stevens-Johnson syndrome (SJS), which can be life-threatening or fatal, has been reported rarely in association with G-CSF treatment. If the patient has developed SJS with the use of efbemalenograstim alfa, treatment with efbemalenograstim alfa must not be restarted in this patient at any time.
Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Rates of generation of antibodies against efbemalenograstim alfa is generally low. Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Aortitis Aortitis has been reported after G-CSF administration in healthy subjects and in cancer patients. The symptoms experienced included fever, abdominal pain, malaise, back pain and increased inflammatory markers […]