Tepezza Side Effects
Generic name: teprotumumab
Drug class: Growth hormone receptor blockers
SIDE EFFECTS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Infusion Reactions [see WARNINGS AND PRECAUTIONS]
- Exacerbation of Preexisting Inflammatory Bowel Disease [see WARNINGS AND PRECAUTIONS]
- Hyperglycemia [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of TEPEZZA was evaluated in two randomized, double-masked, placebo-controlled clinical studies (Study 1 [NCT:01868997] and Study 2 [NCT:03298867]) consisting of 170 patients with Thyroid Eye Disease (84 received TEPEZZA and 86 received placebo). Patients were treated with TEPEZZA (10 mg/kg for first infusion and 20 mg/kg for the remaining 7 infusions) or placebo given as an intravenous infusion every 3 weeks for a total of 8 infusions. The majority of patients completed 8 infusions (89% of TEPEZZA patients and 93% of placebo patients).
The most common adverse reactions (≥5%) that occurred at greater incidence in the TEPEZZA group than in the control group during the treatment period of Studies 1 and 2 are summarized in Table 1. In addition, menstrual disorders (amenorrhea, metrorrhagia, dysmenorrhea) were reported in approximately 23% (5 of 22 patients) of menstruating women treated with TEPEZZA compared to 4% (1 of 25 patients) treated with placebo in the clinical trials.
Table 1. Adverse Reactions Occurring in 5% or More of Patients Treated with TEPEZZA and Greater Incidence than Placebo
| Adverse Reactions | TEPEZZA N=84 N (%) |
Placebo N=86 N (%) |
| Muscle spasms | 21 (25%) | 6 (7%) |
| Nausea | 14 (17%) | 8 (9%) |
| Alopecia | 11 (13%) | 7 (8%) |
| Diarrhea | 10 (12%) | 7 (8%) |
| Fatiguea | 10 (12%) | 6 (7%) |
| Hyperglycemiab | 8 (10%) | 1 (1%) |
| Hearing impairmentc | 8 (10%) | 0 |
| Dysgeusia | 7 (8%) | 0 |
| Headache | 7 (8%) | 6 (7%) |
| Dry skin | 7 (8%) | 0 |
| a Fatigue includes asthenia b Hyperglycemia includes blood glucose increase c Hearing impairment (includes deafness, eustachian tube dysfunction, hyperacusis, hypoacusis and autophony) |
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Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
In a placebo-controlled study with TEPEZZA, 1 of 42 patients treated with placebo had detectable levels of antidrug antibodies in serum. In the same study, none of the 41 patients treated with TEPEZZA had detectable levels of antidrug antibodies in serum.
SRC: NLM .