Dibotermin alfa

Recombinant Human Bone Morphogenetic Protein (rhBMP 2)Rx: PrescriptionCompound: Approved

Also known as: BMP-2, InFuse Bone Graft, recombinant human bone morphogenetic protein-2, rhBMP-2

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Dibotermin alfa (rhBMP-2) is a recombinant human bone morphogenetic protein-2 used to promote bone formation and spinal fusion. It is delivered on an absorbable collagen sponge (ACS) carrier and is approved for specific spinal fusion and tibial fracture indications. Concerns about off-label use and serious adverse events (ectopic bone formation, cancer risk signals, retrograde ejaculation) have led to significant regulatory scrutiny.

Mechanism of Action

Binds to BMP type I and type II serine/threonine kinase receptors on mesenchymal stem cells, activating SMAD signaling pathways that drive osteoblast differentiation, bone matrix formation, and angiogenesis, thereby inducing de novo bone formation (osteoinduction).

Routes of Administration

Implantation (local Surgical Implant)

Goals & Uses

  • Tibial shaft fracture repairOrthopedic / TraumaHigh
  • Sinus augmentation and alveolar ridge augmentationDental / Oral SurgeryModerate
  • Cervical spinal fusionOrthopedic / SpineLow
  • Posterolateral lumbar spinal fusionOrthopedic / SpineModerate
  • Lumbar spinal fusion (ALIF)Orthopedic / SpineHigh

Contraindications

  • Cervical spine implantationAnatomicalHigh
  • Skeletally immature patientsPediatricHigh
  • Known or suspected malignancy at or near implant siteOncologicHigh
  • 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
  • Ectopic bone formationMusculoskeletalCommon
  • Implant failure / subsidenceMechanicalUncommon
  • Cancer risk (potential)OncologicRare
  • Osteolysis / radiolucencyMusculoskeletalCommon

Drug Interactions

  • NSAIDsLowMay increase renal risk in susceptible patients
  • CorticosteroidsModerate

Population Constraints

  • Pediatric patients (skeletally immature)AgeAbsolute
  • Patients with active or prior malignancyOncologicRelative
  • Pregnant womenReproductiveAbsolute
  • Patients with autoimmune or inflammatory conditionsImmunologicRelative

Regulatory Status

  • European UnionApprovedApproved: Single-level anterior lumbar interbody fusion in skeletally mature patients with degenerative disc diseaseApproved by EMA as InductOs. Restricted to specific spinal fusion indication with mandatory patient registry in some member states.
  • United StatesApprovedApproved: Anterior lumbar interbody fusion (ALIF) at L4-S1 with LT-CAGE device, Acute open tibial shaft fractures treated with intramedullary nail fixation, Sinus augmentation and localized alveolar ridge augmentation for dental implantsApproved by FDA in 2002. Black box warning for cervical spine off-label use. FDA safety communications issued 2008 and 2011. Serious concerns about off-label promotion led to congressional investigations.
  • 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.

FDA approved in 2002 (InFuse Bone Graft). EMA approved for lumbar spinal fusion. FDA issued safety communications in 2008 and 2011 warning against cervical spine off-label use due to life-threatening swelling and compression injuries. Black box warning added for cervical spine use.

Evidence & Sources

No sources recorded yet.

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