Although available data on efbemalenograstim alfa use in pregnant women are insufficient to establish whether there is a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to other human G-CSF products. These studies have not established an association of G-CSF product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes.L48852
In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats and
rabbits that received cumulative doses of efbemalenograstim alfa-vuxw approximately 2.6 and 0.7 times, respectively, the
recommended human dose (based on body surface area).L48852
Overdosage of efbemalenograstim alfa may result in leukocytosis and bone pain. In the event of an overdose, general supportive measures should be instituted, as necessary. Monitor the patient for adverse reactions.L48852
No carcinogenicity or mutagenesis studies have been conducted with efbemalenograstim alfa-vuxw.L48852
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).L48852
Efbemalenograstim alfa is a long-acting recombinant fusion protein of granulocyte-colony stimulating factor (G-CSF) due to the addition of the Fc portion of human IgG2, allowing for once-per-cycle administration.L48852,A262167 As endogenous G-CSF mediates the differentiation of hematopoietic stem cells into granulocytes and eventually neutrophils, the administration of recombinant G-CSF like efbemalenograstim alfa can stimulate the production of neutrophils and thus reducing the severity and duration of neutropenia.A33650,A262172
On November 22, 2023, efbemalenograstim alfa was approved by the FDA under the brand name Ryzneuta for the treatment of chemotherapy-induced neutropenia in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. This approval was contingent on positive results observed in two pivotal Phase 3 Studies GC-627-04 and GC-627-05 in the US and Europe respectively.L48887
Fitur visualisasi ini dikembangkan menggunakan pendekatan Graph Theory untuk memetakan hubungan polifarmasi dan molekuler. Entitas (Obat, Target, Gen) direpresentasikan sebagai Simpul (Nodes), sedangkan hubungan biologisnya sebagai Sisi (Edges).
drugbank-id dan name pada skema XML DrugBank.targets/target yang memuat polipeptida sasaran.gene-name dan varian snp-effects.Tata letak grafik menggunakan algoritma Force-Directed Graph (Barnes-Hut). Model fisika ini menerapkan gaya tolak-menolak antar simpul (Gravitasi: -3000) agar tidak tumpang tindih, serta gaya pegas (Spring: 0.04) pada garis penghubung untuk fleksibilitas interaksi.
| Cyclophosphamide | The risk or severity of pulmonary toxicity can be increased when Efbemalenograstim alfa is combined with Cyclophosphamide. |
| Topotecan | The risk or severity of neutropenia can be increased when Efbemalenograstim alfa is combined with Topotecan. |
| Vindesine | The risk or severity of peripheral neuropathy can be increased when Efbemalenograstim alfa is combined with Vindesine. |
| Vinorelbine | The risk or severity of peripheral neuropathy can be increased when Efbemalenograstim alfa is combined with Vinorelbine. |
| Vincristine | The risk or severity of peripheral neuropathy can be increased when Efbemalenograstim alfa is combined with Vincristine. |
| Vinblastine | The risk or severity of peripheral neuropathy can be increased when Efbemalenograstim alfa is combined with Vinblastine. |
| Vintafolide | The risk or severity of peripheral neuropathy can be increased when Efbemalenograstim alfa is combined with Vintafolide. |
| Vinflunine | The risk or severity of peripheral neuropathy can be increased when Efbemalenograstim alfa is combined with Vinflunine. |
| Vincamine | The risk or severity of peripheral neuropathy can be increased when Efbemalenograstim alfa is combined with Vincamine. |