Efbemalenograstim alfa interacts in the following cases:
Sickle cell crises have been associated with the use of G-CSF in patients with sickle cell trait or sickle cell disease. 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.
Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) have been observed following the use of some G-CSF (e.g. pegfilgrastim) in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Patients with breast and lung cancer should be monitored for signs and symptoms of MDS/AML.
Pulmonary adverse reactions, 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.
There are no data from the use of efbemalenograstim alfa in pregnant women. Although studies in animals have not shown reproductive toxicity, efbemalenograstim alfa is not recommended during pregnancy and in women of childbearing potential not using contraception.
There is insufficient information on the excretion of efbemalenograstim alfa in human milk; a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from efbemalenograstim alfa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Efbemalenograstim alfa did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 2.2 times higher than the recommended human dose (based on body surface area).
Efbemalenograstim alfa has no or negligible influence on the ability to drive and use machines.
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. Splenic rupture, including some fatal cases, has been reported following administration of G-CSF.
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. Cases of respiratory failure or ARDS have been reported following administration of G-CSF, which may be fatal).
Isolated cases of sickle cell crises have been associated with the use of G-CSF in patients with sickle cell trait or sickle cell disease.
Capillary leak syndrome, which can be life-threatening if treatment is delayed, has been reported in cancer patients undergoing chemotherapy following administration of G-CSFs; see section “Description of selected adverse reactions” below.
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.
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 efbemalenograstim alfa in four clinical trials.
1 See section “Description of selected adverse reactions” below.
2 Includes multiple adverse reaction terms.
Nausea, vomiting, diarrhoea, asthenia, fatigue, pyrexia, vertigo and headaches were commonly observed in patients receiving chemotherapy.
One case of serious urticaria was reported after efbemalenograstim alfa treatment.
White blood cell count increased was commonly reported after efbemalenograstim alfa treatment. Leukocytosis (white blood cell counts ˃100 × 109/L) have been reported following the administration of G-CSF.
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.
Certain adverse reactions have not yet been observed in efbemalenograstim alfa clinical studies, but are generally accepted as being attributable to G-CSF and derivatives:
An increased risk of MDS/AML has been observed in an epidemiological study following the use of some G-CSF in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer.
Hypersensitivity reactions have been reported after G-CSF administration.
Cases of capillary leak syndrome have been reported after G-CSF administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration. Capillary leak syndrome generally occurred in patients with advanced malignant disease, sepsis, taking multiple chemotherapy medicinal products or undergoing apheresis.
Aortitis may occur following the administration of G-CSF.
Stevens-Johnson syndrome, Sweet’s syndrome (acute febrile neutrophilic dermatosis) may occur following the administration of G-CSF.
Glomerulonephritis may occur following administration of G-CSF.
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