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Forsteo Summary of Product Characteristics (SmPC)
Forsteo® (teriparatide): Use in Patients with Monoclonal Gammopathy of Undetermined Significance
Patients with MGUS are at risk for progression to multiple myeloma or related malignancies. Patients with skeletal malignancies or bone metastases should be excluded from treatment with Forsteo (contraindication).
Monoclonal
Gammopathy of Undetermined Significance
Monoclonal
gammopathy of undetermined significance (MGUS) has an approximately
1% per year risk for progression to multiple myeloma or related
malignancies.1
If a
patient has MGUS with a likelihood of progression to multiple
myeloma, the clinician may consider not prescribing teriparatide.
Risk
factors for a patient with MGUS to progress to multiple myeloma or
related malignancies include
1.
Kyle RA, Rajkumar SV. Monoclonal gammopathy of undetermined
significance and smouldering multiple myeloma: emphasis on risk
factors for progression. Br J Haematol. 2007;139(5):730-743.
http://dx.doi.org/10.1111/j.1365-2141.2007.06873.x
2.
Kyle RA, Therneau TM, Rajkumar SV, et al. Prevalence of monoclonal
gammopathy of undetermined significance. N Engl J Med.
2006;354(13):1362-1369. http://dx.doi.org/10.1056/NEJMoa054494
3.
Rajkumar SV, Kyle RA, Therneau TM, et al. Serum free light chain
ratio is an independent risk factor for progression in monoclonal
gammopathy of undetermined significance. Blood.
2005;106(3):812-817. http://dx.doi.org/10.1182/blood-2005-03-1038
Glossary
BMD
= bone mineral density
IgA
= immunoglobulin A
IgM
= immunoglobulin M
M =
monoclonal
MGUS
= monoclonal gammopathy of undetermined significance
Date of Last Review:March 03, 2020
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