Eptotermin Alpha
- Atc Codes:M05BC02
- CAS Codes:129805-33-0
- PHARMGKB ID:129805-33-0
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Dosage
- Special Considerations
Brand Names
Europe
Austria: Opgenra, Osigraft; Bulgaria: Opgenra, Osigraft; Czech Republic: Opgenra, Osigraft; Denmark: Osigraft; Estonia: Opgenra, Osigraft; Finland: Opgenra, Osigraft; France: Osigraft; Germany: Opgenra, Osigraft; Greece: Opgenra, Osigraft; Hungary: Osigraft; Ireland: Opgenra, Osigraft; Italy: Osigraft; Latvia: Opgenra, Osigraft; Lithuania: Opgenra, Osigraft; Luxembourg: Opgenra, Osigraft; Malta: Opgenra, Osigraft; Netherlands: Opgenra, Osigraft; Poland: Opgenra, Osigraft; Portugal: Opgenra, Osigraft; Romania: Opgenra, Osigraft; Slovakia: Opgenra, Osigraft; Slovenia: Opgenra, Osigraft; Spain: Osigraft; Sweden: Opgenra, Osigraft.
Drug combinations
Chemistry
Eptotermin Alpha: (C~683~H~1061~N~197~O~208~S~10~)~2~. Human recombinant bone morphogenetic protein 7 (hrBMP-7) or osteogenic protein-1 (OP-1) produced in Chinese hamster ovary (CHO) cell line. CAS-129805-33-0.
Pharmacologic Category
Bone Morphogenetic Proteins; Osteoinductive and Osteoconductive Medicinal Product; Growth Factor. (ATC-Code: M05BC02).
Mechanism of action
Eptotermin alpha initiates bone formation through the induction of cellular differentiation in mesenchymal cells, which are recruited to the implant site from bone marrow, periosteum and muscle. Once bound at the cell surface, the active substance induces a cascade of cellular events leading to the formation of chondroblasts and osteoblasts, which play a key role in the bone formation process.
Therapeutic use
Indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
Pregnancy and lactiation implications
Should not be used during pregnancy unless potential benefit justifies potential risks to fetus. Women of childbearing potential should be advised to use effective contraception for a period of at least 2 years after treatment and should inform their surgeon of the possibility of pregnancy prior to treatment. It is recommended that breast-feeding be discontinued following treatment.
Unlabeled use
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Autoimmune disease, including Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren’s syndrome and dermatomyositis/polymyositis. Active infection at the site of spinal fusion or history of recurring infections. Inadequate skin coverage and vascularity at the site of spinal fusion. Prior history of exposure to any bone morphogenetic protein (BMP) product. Active malignancy or when undergoing treatment for a malignancy. Contraindicated in children, adolescents and the skeletally immature.
Warnings and precautions
This medicinal product should be used by an appropriately qualified surgeon. Treatment requires a single surgery. Use of eptotermin alpha does not guarantee fusion; additional surgeries may be required. Any material dislodged from the fusion site can cause ectopic ossification in the surrounding tissues with potential complications. Immune response to eptotermin alpha should be considered (validated tests for the presence of antibodies in serum should be performed in cases where an immune-mediated undesirable effect is suspected, including cases where the medicinal product is ineffective). Intended only for single use in each patient (risk of developing autoimmunity towards the endogenous BMP proteins may exist upon re-administration). Its use outside the region of the lumbar spine cannot be recommended. Concomitant use with a synthetic bone void filler is not recommended.