Polymyalgia rheumatica

Active Ingredient: Sarilumab

Indication for Sarilumab

Population group: only adults (18 years old or older)
Therapeutic intent: Curative procedure

Sarilumab is indicated for the treatment of polymyalgia rheumatica (PMR) in adult patients who have had an inadequate response to corticosteroids or who experience a relapse during corticosteroid taper.

For this indication, competent medicine agencies globally authorize below treatments:

200 mg once every 2 weeks

For:

Dosage regimens

Subcutaneous, 200 milligrams sarilumab, once every 2 weeks.

Detailed description

The recommended dose of sarilumab is 200 mg once every 2 weeks administered as a subcutaneous injection, in combination with a tapering course of systemic corticosteroids, after which sarilumab can be continued as monotherapy.

Data are available in patients that were treated for up to 1 year. Therefore treatment beyond 52 weeks should be guided by disease activity, physician discretion, and patient choice.

Dose modification

Laboratory Abnormalities: Discontinue sarilumab in patients with PMR who develop the following laboratory abnormalities:

  • neutropenia (ANC below 1 × 109/L at the end of the dosing interval)
  • thrombocytopenia (platelet count below 100 × 103 μL)
  • AST or ALT elevations (3 times above the ULN)

Dosage modifications have not been studied in patients with PMR with these conditions. For treatment initiation criteria, refer to the posology for PMR.

Missed dose

If a dose of sarilumab is missed and it has been 3 days or less since the missed dose, the next dose should be administered as soon as possible. The subsequent dose should be administered at the regularly scheduled time. If it has been 4 days or more since the missed dose, the subsequent dose should be administered at the next regularly scheduled time, the dose should not be doubled.

Dosage considerations

Injection sites (abdomen, thigh and upper arm) should be rotated with each injection. Sarilumab should not be injected into skin that is tender, damaged, or has bruises or scars.

Active ingredient

Sarilumab

Sarilumab is a human monoclonal antibody (IgG1 subtype) that specifically binds to both soluble and membrane-bound IL-6 receptors (IL-6Rα), and inhibits IL-6-mediated signalling which involves ubiquitous signal-transducing glycoprotein 130 (gp130) and the Signal Transducer and Activator of Transcription-3 (STAT-3). In functional human cell-based assays, sarilumab was able to block the IL-6 signalling pathway, measured as STAT-3 inhibition, only in the presence of IL-6.

Read more about Sarilumab

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