Motixafortide, sold under the brand name Aphexda, is a medication used for the treatment of multiple myeloma.[1] Motixafortide is a hematopoietic stem cell mobilizer and a CXCR4 antagonist.[1] It is given by subcutaneous injection.[1]
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| Trade names | Aphexda |
| Other names | BL-8040 |
| AHFS/Drugs.com | Monograph |
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| Routes of administration | Subcutaneous |
| Drug class | Antineoplastic |
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| Formula | C97H144FN33O19S2 |
| Molar mass | 2159.55 g·mol−1 |
The most common side effects include injection site reactions, pruritus, flushing, and back pain.[3]
Motixafortide was approved for medical use in the United States in September 2023.[3][4][5]
Medical uses
editMotixafortide is indicated, in combination with filgrastim, a granulocyte-colony stimulating factor (G-CSF), to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in people with multiple myeloma.[1][3][4]
Adverse effects
editMotixafortide can cause injection site reactions, anaphylactic shock, and hypersensitivity reactions.[3] Tumor cell mobilization in people with leukemia, leukocytosis, potential for tumor cell mobilization, and embryo-fetal toxicity can also be caused by motixafortide.[3]
History
editThe US Food and Drug Administration (FDA) approved motixafortide based on evidence from the GENESIS study, a double-blind, placebo-controlled study, in which 122 participants with multiple myeloma, due to undergo autologous transplantation, were randomized 2:1 to receive motixafortide 1.25 mg/kg with granulocyte-colony stimulating factor (N=80) or placebo with granulocyte-colony stimulating factor (N=42) for mobilization of hematopoietic stem cells for collection and apheresis.[3] This one trial evaluated the benefit and side effects of motixafortide in participants.[3] The trial was conducted at 21 sites in five countries including Italy, Hungary, Germany, Spain, and the United States.[3] There were 78 participants included in the trial from the United States, and 44 participants included from sites outside of the United States.[3] The GENESIS trial was used to assess efficacy and safety.[3]
Society and culture
editNames
editMotixafortide is the international nonproprietary name.[6]
References
edit- ^ a b c d e "Aphexda- motixafortide injection, powder, lyophilized, for solution". DailyMed. 4 September 2023. Archived from the original on 14 September 2023. Retrieved 13 September 2023.
- ^ "Aphexda- motixafortide acetate injection, powder, lyophilized, for solution". DailyMed. 22 September 2023. Retrieved 6 October 2023.
- ^ a b c d e f g h i j "Drug Trials Snapshots: Aphexda". U.S. Food and Drug Administration (FDA). 11 March 2024. Retrieved 14 March 2024.
This article incorporates text from this source, which is in the public domain.
- ^ a b "Aphexda approval letter" (PDF). 8 September 2023. Archived from the original (PDF) on 14 September 2023. This article incorporates text from this source, which is in the public domain.
- ^ "BioLineRx Announces FDA Approval of Aphexda (motixafortide) in Combination with Filgrastim (G-CSF) to Mobilize Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Patients with Multiple Myeloma" (Press release). BioLineRx Ltd. 11 September 2023. Retrieved 13 September 2023 – via PR Newswire.
- ^ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 82". WHO Drug Information. 33 (3). hdl:10665/330879.
Further reading
edit- Crees ZD, Rettig MP, Jayasinghe RG, Stockerl-Goldstein K, Larson SM, Arpad I, et al. (April 2023). "Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial". Nature Medicine. 29 (4): 869–879. doi:10.1038/s41591-023-02273-z. PMC 10115633. PMID 37069359.
External links
edit- "Motixafortide (Code C88309)". NCI Thesaurus.
- Clinical trial number NCT03246529 for "A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF as Compared to Placebo and G-CSF for thE MobilizatioN of HematopoiEtic Stem Cells for Autologous TransplantatIon in SubjectS With MM (GENESIS)" at ClinicalTrials.gov
