Dr. Reddy’s Biologics is now presenting ACVYBRA®
(denosumab Dr. Reddy’s)

Denosumab is recommended by key German Guidelines and Medical societies8-11

GUIDELINE / SOURCE DENOSUMAB USE LIMITATIONS / NOTES
DVO Guideline Osteoporosis 20238
  • Postmenopausal women and men ≥50 with high fracture risk
  • Secondary/tertiary prevention
  • Individual risk benefit assessment
  • Bone density monitoring recommended
See full table

Denosumab is usually positioned in the 2nd line of therapy, but can be considered earlier8

THERAPY STAGE RECOMMENDED OPTION ROLE OF DENOSUMAB
First-line therapy Oral bisphosphonates (e.g., Alendronate) Denosumab not first-line, but considered when bisphosphonates are unsuitable
See full table

Denosumab is recommended by key Spanish guidelines and Medical societies12-14

CLINICAL ASPECT GUIDELINE-BASED RECOMMENDATION SOURCE
Indication Osteoporosis (postmenopausal, male), bone loss from cancer or corticosteroids SEIOMM Position Paper12
Patient Selection High fracture risk; prior fragility fractures, T-score < -2.5, or multiple risk factors SEIOMM12
Line of treatment Second+ line; bisphosphonates preferred unless contraindicated or poorly tolerated Euskadi Health Dept. Advisory14
Dosage 60 mg subcutaneously every 6 Months SEIOMM / Euskadi12,14
Supplementation Mandatory calcium and vitamin D SEIOMM12
Monitoring BMD assessments, fracture risk evaluation, renal function, and serum calcium SEIOMM12
Discontinuation Protocol Initiate bisphosphonate 6 Months after last dose to prevent rebound fractures Euskadi Health Dept14
Sequential Therapy Strongly recommended; plan transition before stopping Denosumab SEIOMM / Euskadi12,14
Special Considerations Avoid abrupt discontinuation; educate patients on adherence and follow-up SEIOMM / Euskadi12,14

BMD: Bone Mineral Density

Denosumab is recommended by key French guidelines and medical agencies15-17

CLINICAL ASPECT DENOSUMAB
Indication
  • Postmenopausal osteoporosis, high fracture risk15, 16
Treatment algorhythm
  • Bisphosphonates should be considered for the first line treatment.16
  • Denosumab is to be used after a bisphosphonate
Severe cases
(hip fracture; very low BMD; comorbidities, memory impairments; poor adherence; polypharmacy)
  • Parenterally administered drugs (zoledronic acid and denosumab) can be given preference16
Monitoring
  • Bone density checks; do not stop treatment without medical advice15
Risks
  • Patients receiving treatment for postmenopausal osteoporosis should be informed about the very low risk of osteonecrosis of the jaw and of atypical femoral fractures associated with bisphosphonates and denosumab16
ONJ Prevention
  • Dental check-up before treatment, avoid invasive dental procedures during treatment17
Discontinuation Protocol
  • Follow-up with bisphosphonates (oral/injectable) for 6-12 Months to prevent rebound loss15,16

BMD: Bone Mineral Density; ONJ: Osteonecrosis of the Jaw