Dibotermin alfa
Also known as: BMP-2, Dibotermin alfa, InFuse Bone Graft, OP‑1, recombinant human bone morphogenetic protein-2, rhBMP-2, rhBMP‑2
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Summary
Recombinant human BMP‑2 used as an osteoinductive agent to enhance bone healing in spinal fusion, tibial non‑unions, and oral/maxillofacial reconstruction.
Mechanism of Action
Binds BMP type I/II receptors, activates SMAD1/5/8 signaling, promotes osteoblast differentiation and bone matrix formation
Routes of Administration
Goals & Uses
- Tibial shaft fracture repairOrthopedic / TraumaHigh
- Alveolar ridge augmentationDental SurgeryModerate
- Tibial non‑union repairOrthopedic SurgeryHigh
- Sinus augmentation and alveolar ridge augmentationDental / Oral SurgeryModerate
- Cervical spinal fusionOrthopedic / SpineLow
- Posterolateral lumbar spinal fusionOrthopedic / SpineModerate
- Lumbar spinal fusion (ALIF)Orthopedic / SpineHigh
- Spinal fusionOrthopedic SurgeryHigh
Contraindications
- Active malignancy at implantation siteOncologyHigh
- Cervical spine implantationAnatomicalHigh
- Known hypersensitivity to BMP‑2 or carrier matrixAllergyHigh
- Skeletally immature patientsPediatricHigh
- Known or suspected malignancy at or near implant siteOncologicHigh
- Infection at surgical siteInfectionModerate
- Hypersensitivity to rhBMP-2 or bovine collagenAllergicHigh
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Active infection at implant siteInfectiousHigh
Adverse Effects
- Retrograde ejaculationReproductiveUncommon
- Swelling and seromaLocal/InflammatoryCommon
- Immunogenic reactionSystemicUncommon
- Ectopic bone formationMusculoskeletalCommon
- Implant failure / subsidenceMechanicalUncommon
- Cancer risk (potential)OncologicRare
- Osteolysis / radiolucencyMusculoskeletalCommon
- Inflammatory swelling/seromaLocalCommon
Drug Interactions
- Non‑steroidal anti‑inflammatory drugs (NSAIDs)Moderate
- NSAIDsLowMay increase renal risk in susceptible patients
- CorticosteroidsModerate
Population Constraints
- Pediatric patients (skeletally immature)AgeAbsolute
- Pediatric patientsAgeRelative
- Pregnant or lactating womenReproductiveRelative
- Patients with active or prior malignancyOncologicRelative
- Pregnant womenReproductiveAbsolute
- Patients with autoimmune or inflammatory conditionsImmunologicRelative
Regulatory Status
- European UnionApprovedApproved: Spinal fusion, Long‑bone fracture repairAuthorized under the name OP‑1; similar indication restrictions as US.
- United StatesApprovedApproved: Anterior lumbar interbody fusion, Open tibial shaft fracture non‑unionMarketed as Infuse Bone Graft; use limited to FDA‑cleared indications.
- United KingdomApprovedApproved: Single-level anterior lumbar interbody fusionApproved as InductOs; NICE has issued guidance on use with conditions including specialist oversight and informed consent regarding cancer risk uncertainty.
Approved in the US (Infuse Bone Graft) for specific lumbar spinal fusion and tibial fracture applications; EU approval for similar orthopedic indications. Use outside approved sites is off‑label.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Dibotermin alfa?
Recombinant human BMP‑2 used as an osteoinductive agent to enhance bone healing in spinal fusion, tibial non‑unions, and oral/maxillofacial reconstruction.
What is Dibotermin alfa used for?
Dibotermin alfa is educationally associated with: Tibial shaft fracture repair, Alveolar ridge augmentation, Tibial non‑union repair, Sinus augmentation and alveolar ridge augmentation, Cervical spinal fusion, Posterolateral lumbar spinal fusion, Lumbar spinal fusion (ALIF), Spinal fusion. Educational only — not medical advice.
How is Dibotermin alfa administered?
Recorded routes of administration: Implantation (local Surgical Implant), Intra‑osseous, Local Implantation.
What are the potential side effects of Dibotermin alfa?
Reported adverse effects include: Retrograde ejaculation, Swelling and seroma, Immunogenic reaction, Ectopic bone formation, Implant failure / subsidence, Cancer risk (potential), Osteolysis / radiolucency, Inflammatory swelling/seroma. This list is not exhaustive — consult a qualified clinician.
Who should avoid Dibotermin alfa?
Recorded contraindications: Active malignancy at implantation site, Cervical spine implantation, Known hypersensitivity to BMP‑2 or carrier matrix, Skeletally immature patients, Known or suspected malignancy at or near implant site, Infection at surgical site, Hypersensitivity to rhBMP-2 or bovine collagen, Pregnancy, Active infection at implant site. Consult a qualified clinician before use.