Pang.qxp 5/10/07 16:42 Page 21
Follistim Pen
®
for the Self-administration of Follitropin Beta in Ovarian Stimulation Treatment Regimens
injecting insulin, 60–80% of diabetics have been estimated to perform
Figure 1: Results of a Comprehension Questionnaire Evaluating
some aspect of the administration process incorrectly.
11,12
Patient Understanding of Preparing and Administering Injections
Using the Pen Device
Local Tolerance
A: In clomiphene citrate-resident women undergoing ovulation induction.
A number of factors may influence the severity of injection site pain, including Source: Pang, et al., 2003.
8
the injection volume, the speed of the injection, osmolarity, additives in the
100
formulation, the injection site, and the size of the injection needle.
6
Comparative studies have reported significantly less injection site pain with the
80
c
ts
Follistim Pen compared with conventional syringe/needle administration.
6,13,14
In
both registration trials, patients reported that administration of follitropin beta
60
with the pen delivery system was very well tolerated.
8,9
This excellent tolerability
is most likely due to the small injection volume of a gonadotropin with the
entage of subje
r
c 40
Pe
purity of a recombinant product (as small as 30µL, which equals 25IU) delivered
Prior to first
practice injection
through a 29-gauge, 13mm micro-fine needle.
20
During second
actual injection
Quality of Life
0
Subjects who properly Subjects who selected the
Few studies have systematically evaluated quality of life for patients
loaded the follitropin beta correct dose of follitropin
cartridge into the pen device beta with the pen device
undergoing assisted reproduction,
15,16
yet products that simplify treatment
B: In women undergoing in vitro fertilization. Source: Kettel et al., 2004.
9
processes and make them less intimating and intrusive should improve quality
of life. One study of 1,700 patients undergoing ovarian stimulation in France
100
recently reported on the impact of gonadotropin injections on the daily life of
patients by collecting their impressions at the time of treatment.
5
The results of
80
this study demonstrated that ease of manipulation was by far the easiest, and
c
ts
the mean time for drug preparation the lowest, with the pen device
60
administering follitropin beta compared with the self-administration of
gonadotropins in individual or multidose vials with conventional syringe/needle.
40
r
c
entage of subje
Pe
Prior to first
More general quality of life aspects also recorded good results for the
20
practice injection
Follistim Pen, with subjects responding that they were mainly not affected During second
“at all” by repercussions on both private and couples’ lives (see Figure 2, A
0
actual injection
Subjects who properly Subjects who selected
and B). This trend was also observed in a patient satisfaction survey that
loaded the follitropin beta the correct dose
cartridge into the pen device
found that 92.6% (versus 54.9%) of patients rated the pen “excellent” or
“good” in terms of being able to continue with daily activities and
Both graphics reproduced by permission of Reproductive Health Ltd.
subsequent impact on quality of life.
5
cartridge via the pen delivery system or the lyophilized product via conventional
syringe and needle.
13
The results indicate that because the pen delivery system
Integration into Treatment Regimens is a precision instrument delivering exactly the dose indicated, it delivers on
Results of the two registration trials mentioned above demonstrated that average an 18% higher amount of follitropin beta due to injection losses
the pen device for the self-administration of follitropin beta is safe, associated with a conventional syringe/needle. The main noticeable outcome for
effective, well-tolerated, and easy to use.
8,9
Since this product became equivalent dosages prescribed using the current pen device was higher patient
commercially available, our clinical experience has shown that the largest response.
1,7
These higher responses can be attributed to the pen delivery system,
benefit of the Follistim Pen delivery system has been the ease of use for where the patients receive the full dose of medication prescribed. Conversely,
patient populations.
1,7
Initial consultation sessions have proved effective and with the vial and injections with needle and syringe, obligatory loss undoubtedly
easy to understand for both patients and HCPs. occurred. To educate HCPs about this increase in delivered activity and to enable
them to integrate the pen delivery system smoothly into treatment regimens, a
Integration into treatment regimens was similarly easy for both doctors and dose conversion table is provided in the prescribing information. Therefore,
their nursing staff. The time spent introducing the system was greatly when administering Follistim AQ (follitropin beta) with the Follistim Pen, a lower
reduced compared with the syringe and vial method.
7
As can be seen in the starting dose for gonadotropin stimulation and dose adjustments during
full Pen Pal Manuscript, this attribute was also reported in a survey of HCPs gonadotropin stimulation should be considered for each patient.
in which 83% of respondents agreed that the pen delivery system for self-
administering follitropin beta required less teaching time. Specifically, HCPs In clinical practice, the starting dose for initiating ovarian stimulation is
observed that training using the pen device would take between five and optimized based on a series of prognostic criteria used to predict the
15 minutes compared with the conventional syringe/needle system, where expected patient response.
17
This starting dose is individualized for each
training time was expected to be between 10 and 30 minutes.
3,4
patient with the aim of ensuring the best possible response to gonadotropin
stimulation while minimizing the risks of ovarian hyperstimulation syndrome
During drug development, a bioequivalence study was conducted that (OHSS). We employed this practice for integrating the pen device into our
compared administration of follitropin beta as either a pre-mixed solution in a clinical practice. Therefore, since our clinical experience is sufficient in this
FERTILITY TREATMENT REVIEW 21
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