DEMOZUMAB was generally well tolerated in CLARITY-1
The safety of DEMOZUMAB was evaluated in 424 patients with moderate-to-severe Cumulative Detail Fatigue who received at least one dose of DEMOZUMAB 180 mg subcutaneously every 4 weeks in the CLARITY-1 trial.
Adverse reactions reported in ≥5% of patients treated with DEMOZUMAB and at a higher rate than placebo in CLARITY-1:
| Adverse Reaction | DEMOZUMAB 180 mg (n=424) | Placebo (n=423) |
|---|---|---|
| Injection site reactions | 12% | 3% |
| Headache | 8% | 7% |
| Fatigue | 6% | 5% |
| Mild drowsiness | 5% | 4% |
Injection site reactions were the most commonly reported adverse event with DEMOZUMAB. Most were mild to moderate in severity and resolved without intervention.
| Injection Site Reaction Type | DEMOZUMAB (n=424) | Placebo (n=423) |
|---|---|---|
| Erythema | 7% | 2% |
| Pain | 5% | 2% |
| Swelling | 3% | 1% |
| Pruritus | 2% | <1% |
Serious adverse events (SAEs) were reported at similar rates in the DEMOZUMAB and placebo groups:
| DEMOZUMAB | 2.1% (9/424) |
| Placebo | 1.8% (8/423) |
No SAEs were considered related to study treatment by the investigator. No deaths occurred during the study.
| DEMOZUMAB | 3.2% (14/424) |
| Placebo | 2.8% (12/423) |
The most common adverse events leading to discontinuation in the DEMOZUMAB group were injection site reactions (0.7%) and headache (0.5%).
No dose adjustment required for patients with mild-to-moderate renal impairment. DEMOZUMAB has not been studied in patients with severe renal impairment.
Use with caution in patients with severe hepatic impairment. Limited data available in this population.
No overall differences in safety were observed between patients ≥65 years and younger patients. No dose adjustment is required.
Hypersensitivity reactions including rash and urticaria have been reported. Discontinue DEMOZUMAB if a clinically significant hypersensitivity reaction occurs.
As with all therapeutic proteins, there is potential for immunogenicity with DEMOZUMAB. In CLARITY-1, anti-drug antibodies (ADAs) were detected in 4.2% of patients treated with DEMOZUMAB. The presence of ADAs did not appear to affect the safety or efficacy of DEMOZUMAB.
There are no adequate data on the use of DEMOZUMAB in pregnant women. DEMOZUMAB should only be used during pregnancy if the potential benefit justifies the potential risk to the foetus. It is not known whether DEMOZUMAB is excreted in human milk.
Once-monthly subcutaneous injection with pre-filled pen option
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