Understanding safety and side effects
AGAMREE® was generally well tolerated in a clinical study, but as with all medicines, side effects are possible. Before starting AGAMREE, ask your healthcare provider about the benefits and risks. Corticosteroids such as AGAMREE can affect hormone levels, raise blood sugar or blood pressure, increase the risk of infections, affect mood or sleep, weaken bones, and cause eye problems such as cataracts or glaucoma. Some symptoms, including signs of infection or stomach problems, may be harder to notice while taking AGAMREE.
The most common side effects with AGAMREE in the study included:
- Puffiness in the face (sometimes called a “cushingoid appearance”)
- Behavior problems, including abnormal behavior, aggression, agitation, anxiety, irritability, personality changes, sleep disorder, and repetitive movements (stereotypy)
- Vomiting
- Weight gain
- Low levels of vitamin D
These are not all the possible side effects of AGAMREE. Call your doctor for medical advice about side effects.
Switching to AGAMREE from prednisone
In a study where some boys switched from prednisone to AGAMREE 6 mg/kg once daily, certain side effects were reported less often:
Immune-related
side effects
In boys who switched from prednisone to AGAMREE:
when taking prednisone
Growth slowed in some boys
Growth slowed in some boys
Boys taking AGAMREE 6 mg/kg once daily began to grow at a normal rate, showing an increase in growth trajectories
Boys taking AGAMREE 6 mg/kg once daily began to grow at a normal rate, showing an increase in growth trajectories
Study limitation: These results should be interpreted with caution because this was a small study where boys switched from prednisone to AGAMREE and the observations were based on comparing the same patients in 2 different study periods, each conducted in a different way. These were not from a head-to-head study comparison with placebo or prednisone at 48 weeks.
Individual results may vary. You or your child may have a different experience with AGAMREE. Talk with your healthcare provider about what to expect with treatment.
At 30 months, results with AGAMREE were similar to those with traditional corticosteroids
This study followed boys with Duchenne between 4.5 and under 7.5 years old for 30 months. This was an open-label study, a type of clinical study where everyone involved (both the participants and the medical team) knew exactly what medicine was being given.
- AGAMREE group: Forty-six boys who had not taken corticosteroids before they were started on AGAMREE at 1 of 4 different doses in a 6-month study designed to find the most effective dose. In the AGAMREE group, 41 boys who completed the 6-month study went on to participate in a 24-month extension study, making their total time taking AGAMREE 30 months. Boys in the final analysis were on daily doses of AGAMREE ranging from 2 mg/kg to 6 mg/kg. At the beginning of the study, on average, boys were 6 years old, 48 pounds, 3’8” in height, and had a body mass index of 17.7
- Historical comparison group (patient data from a previous study): Information was collected from a group of boys with Duchenne who had taken traditional corticosteroids for at least 6 months
- How groups were matched: The 2 groups were matched by age, how long it took them to stand up (in seconds), and how long it took them to run or walk 10 meters (in seconds)
In the long-term, open-label, 30-month study, the following were observed:
A similar change in average body mass index z scores
in boys taking AGAMREE and boys taking traditional corticosteroids
Differences in height percentile
in boys taking AGAMREE and boys taking traditional corticosteroids
No signs of slowed growth
in boys taking AGAMREE
Throughout the 30-month study, AGAMREE was generally well tolerated, and fewer side effects were observed in boys taking AGAMREE compared with the historical comparison group.
Study limitation: These results should be interpreted with caution because the study compared AGAMREE to historical data rather than a head-to-head study, and both healthcare providers and patients knew which medicine was being taken. Because the study was designed to observe the effects of AGAMREE over time, other factors may have influenced the results.
Additional information is needed to understand the longer-term effects of AGAMREE.
“Now that we’ve been on it for 6 months…he’s growing again, and he’s happier overall.”
– Jessica, mother of Gaven
Based on personal experience; your or your child’s experience may be different.