GNH USA

Europe — EMA

Inductos

GNH USA supplies Inductos (Dibotermin alfa), a recombinant human bone morphogenetic protein for spinal fusion surgery and orthopedic bone repair.

Dibotermin Alfa

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What is Dibotermin Alfa?

Dibotermin alfa, the active ingredient in Inductos, is a recombinant human bone morphogenetic protein presented as an implant for implantation use. It promotes bone formation and is employed in spinal fusion surgery and orthopedic bone repair procedures in patients requiring enhanced osteogenesis.

GNH USA supplies Inductos as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and orthopedic surgery centres worldwide. The company adheres to stringent quality standards and provides regulatory support for global distribution. Clients benefit from reliable logistics, temperature‑controlled shipping where required, and responsive technical assistance.

What is Dibotermin Alfa used for?

Inductos (dibotermin alfa) is used in orthopedic and spinal procedures that rely on bone morphogenetic protein pathways to enhance bone healing. - Spinal fusion surgery: promotes successful vertebral fusion and reduces time to solid bone union. - Orthopedic bone repair: stimulates bone regeneration in complex fracture sites. - Long bone non‑union: supports bridging bone formation in difficult fracture non‑unions. - Cervical spine fusion: facilitates fusion of cervical vertebrae during stabilization procedures.

What are the side effects of Dibotermin Alfa?

Inductos may be associated with a range of adverse reactions following implantation.

Common Side Effects: - Local swelling at the implant site. - Post‑operative pain or discomfort. - Seroma formation around the device. - Mild inflammatory response. - Transient fever. - Ectopic bone formation near the implant.

Serious or Rare Side Effects: - Severe infection requiring surgical intervention. - Allergic or hypersensitivity reaction. - Neurological impairment due to ectopic bone encroachment. - Deep wound dehiscence. - Systemic inflammatory response syndrome. - Malignant transformation (extremely rare).

What precautions apply to Dibotermin Alfa?

Prior to using Inductos, clinicians should consider several safety measures. - Patient selection: evaluate for active infection at the intended implantation site. - Allergy assessment: confirm no known hypersensitivity to recombinant BMPs. - Implant site preparation: ensure adequate vascularity and stable fixation. - Monitoring: obtain serial radiographs to assess appropriate bone growth. - Contraindications: avoid in patients with known malignancy at the implantation area. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Dibotermin Alfa interact with?

Inductos may interact with other therapies that influence bone metabolism or wound healing.

Major Interactions (Avoid): - High‑dose systemic corticosteroids: may markedly suppress BMP‑induced bone formation. - Concurrent use of other osteogenic agents: risk of excessive ectopic bone growth.

Moderate Interactions (Monitor Closely): - Non‑steroidal anti‑inflammatory drugs (NSAIDs): can reduce osteogenic efficacy. - Anticoagulants: may increase peri‑operative bleeding risk. - Radiation therapy: may impair local bone healing response. - Chemotherapy agents: could diminish osteoblast activity. - Immunosuppressants: heightened infection susceptibility at the implant site.

Frequently asked questions

What is Inductos used for?+
Inductos is an implant that contains the recombinant protein dibotermin alfa. It is employed to enhance bone formation in patients undergoing spinal fusion surgery or requiring orthopedic bone repair, such as treatment of complex fractures or non‑unions.
How does dibotermin alfa work?+
Dibotermin alfa activates bone morphogenetic protein receptors on mesenchymal cells, triggering SMAD‑mediated signaling pathways. This cascade promotes the differentiation of progenitor cells into osteoblasts and stimulates the synthesis of bone matrix, leading to accelerated new bone formation at the implantation site.
What is the usual dose of Inductos?+
The specific dose and implant size of Inductos are determined by the operating surgeon based on the patient’s anatomy, the surgical indication, and the desired bone‑growth outcome. Prescribers select the appropriate amount according to clinical guidelines and individual case requirements.
Is Inductos safe during pregnancy or breastfeeding?+
Safety data for dibotermin alfa in pregnant or lactating individuals are limited. The product should only be used during pregnancy or breastfeeding if the potential benefits justify the potential risks, and the decision must be made by the treating physician.
How do I order Inductos from GNH USA?+
To request Inductos, submit an enquiry on the product page at gnh-usa.com specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and necessary import documentation.
How does Inductos compare with other bone morphogenetic protein products?+
Inductos delivers dibotermin alfa in a sterile implant format, offering controlled local release at the surgical site. Compared with other BMP products that may be supplied as powders or gels, the implant provides precise placement, reduced handling steps, and consistent dosing, which can simplify the operative workflow.
What are the storage and handling requirements for Inductos?+
Inductos must be stored at 2‑8 °C in a refrigerator. Keep the implant in its original packaging, protect it from light, and avoid freezing or shaking. If temperature excursions occur, follow the manufacturer’s stability guidelines before use.
How is Inductos administered to the patient?+
Inductos is implanted directly into the surgical site during the operative procedure. The surgeon positions the sterile implant within the bone defect or fusion area, ensuring stable fixation before closing the wound. No additional systemic administration is required.
What are the most serious risks to watch for?+
Serious risks associated with Inductos include severe infection at the implant site, allergic or hypersensitivity reactions, ectopic bone formation that may compress adjacent structures, and rare cases of malignant transformation. Prompt recognition and management of these events are essential.
Who should not use Inductos?+
Inductos is contraindicated in patients with known hypersensitivity to dibotermin alfa or any component of the implant, active infection at the intended implantation site, or a diagnosed malignancy in the area where the implant would be placed. Clinical judgment should guide use in other special populations.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Dibotermin Alfa
Route
Implantation
Manufacturer
Medtronic Biopharma B.V.
Origin
EU

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