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Managing infertility with the follitropin alfa prefilled pen injector - patient considerations.

Bühler K - Ther Clin Risk Manag (2015)

Bottom Line: Accurate and easy-to-use injection devices which minimize pain, difficulty, and stress are essential for patient compliance.The efficacy in comparison to the quite more cumbersome handling with ampoules and syringes has been proven very quickly.In several studies, it has been shown that patients had a preference to the prefilled follitropin alfa pen due to the faster preparation and were more confident of accurate dosing.

View Article: PubMed Central - PubMed

Affiliation: Centre for Gynaecological Endocrinology and Reproductive Medicine, Stuttgart, Germany.

ABSTRACT
Gonadotropin treatment has been used in fertility treatment since the 1930s. First, preparations coming from animals were injected, then, gonadotropins prepared from the pituitary glands of human cadavers. A great step was achieved with the introduction of human menopausal gonadotropin extracted from the urine of postmenopausal women. When cases of Creutzfeld-Jacob disease were recognized after the use of human pituitary-derived hormone injections, urinary gonadotropins were increasingly purified and then produced by the use of recombinant DNA technology. Recombinant gonadotropins were characterized by the extreme high specificity and the nearly 100% purity. This allows for follitropin alfa, the first recombinant-human follicle stimulating hormone (r-hFSH) approved, to be quantified and filled by mass, with a small variance of only ±2% and no more with a bioassay with a variance of 45%. With recombinant preparations, it is also possible to cover the tremendous growing demand for gonadotropins. Ovarian stimulation has become a self-injecting procedure for the patients. Accurate and easy-to-use injection devices which minimize pain, difficulty, and stress are essential for patient compliance. So, two pen injectors adapted from the well-known insulin pen were introduced in fertility treatment, one as a multiple-use device rechargeable with premixed, prefilled cartridges with r-hFSH (follitropin β) and the other a disposable, prefilled drug delivery system with a liquid formulation of follitropin alfa filled by mass. The efficacy in comparison to the quite more cumbersome handling with ampoules and syringes has been proven very quickly. In several studies, it has been shown that patients had a preference to the prefilled follitropin alfa pen due to the faster preparation and were more confident of accurate dosing. The follitropin alfa (filled by mass [FbM]) prefilled pen is a move toward better quality of treatment and also better quality of life for the women within the stressful period of fertility treatment.

No MeSH data available.


Related in: MedlinePlus

Significant milestones in gonadotropin development.Notes: The more the gonadotropins are purified, the higher is the specific activity and consistency, providing a greater safety for the patients. In green: urinary products still on the market; in blue: recombinant gonadotropins up to filled by mass; in black: newer recombinant preparations and the future.Abbreviations: FbM, filled by mass; hp, highly purified; Gn, gonadotropin; rec-h(FSH+LH), fixed combination of recombinant FSH and recombinant LH in the ratio 2:1: Pergoveris® (Merck Senoro, Darmstadt, Germany); FSH, follicle stimulating hormone; LH, leutinizing hormone; hMG, urinary human menopausal gonadotropin; hCG, human chorionic gonadotropin; PMSG, pregnant mare serum gonadotropin; rec, recombinant.
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f2-tcrm-11-995: Significant milestones in gonadotropin development.Notes: The more the gonadotropins are purified, the higher is the specific activity and consistency, providing a greater safety for the patients. In green: urinary products still on the market; in blue: recombinant gonadotropins up to filled by mass; in black: newer recombinant preparations and the future.Abbreviations: FbM, filled by mass; hp, highly purified; Gn, gonadotropin; rec-h(FSH+LH), fixed combination of recombinant FSH and recombinant LH in the ratio 2:1: Pergoveris® (Merck Senoro, Darmstadt, Germany); FSH, follicle stimulating hormone; LH, leutinizing hormone; hMG, urinary human menopausal gonadotropin; hCG, human chorionic gonadotropin; PMSG, pregnant mare serum gonadotropin; rec, recombinant.

Mentions: In the following years, recombinant LH and recombinant hCG, the latter since many years is also available in a pen for self-injection, were available for fertility treatment (Figure 2). In addition, a fixed combination of r-hFSH and r-hLH in a 2:1 ratio (150 IU r-hFSH and 75 IU r-hLH; Pergoveris® [Merck Senoro]) was introduced on the market. A long-acting formulation of recombinant FSH, corifollitropin alfa, has also become available.


Managing infertility with the follitropin alfa prefilled pen injector - patient considerations.

Bühler K - Ther Clin Risk Manag (2015)

Significant milestones in gonadotropin development.Notes: The more the gonadotropins are purified, the higher is the specific activity and consistency, providing a greater safety for the patients. In green: urinary products still on the market; in blue: recombinant gonadotropins up to filled by mass; in black: newer recombinant preparations and the future.Abbreviations: FbM, filled by mass; hp, highly purified; Gn, gonadotropin; rec-h(FSH+LH), fixed combination of recombinant FSH and recombinant LH in the ratio 2:1: Pergoveris® (Merck Senoro, Darmstadt, Germany); FSH, follicle stimulating hormone; LH, leutinizing hormone; hMG, urinary human menopausal gonadotropin; hCG, human chorionic gonadotropin; PMSG, pregnant mare serum gonadotropin; rec, recombinant.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4492655&req=5

f2-tcrm-11-995: Significant milestones in gonadotropin development.Notes: The more the gonadotropins are purified, the higher is the specific activity and consistency, providing a greater safety for the patients. In green: urinary products still on the market; in blue: recombinant gonadotropins up to filled by mass; in black: newer recombinant preparations and the future.Abbreviations: FbM, filled by mass; hp, highly purified; Gn, gonadotropin; rec-h(FSH+LH), fixed combination of recombinant FSH and recombinant LH in the ratio 2:1: Pergoveris® (Merck Senoro, Darmstadt, Germany); FSH, follicle stimulating hormone; LH, leutinizing hormone; hMG, urinary human menopausal gonadotropin; hCG, human chorionic gonadotropin; PMSG, pregnant mare serum gonadotropin; rec, recombinant.
Mentions: In the following years, recombinant LH and recombinant hCG, the latter since many years is also available in a pen for self-injection, were available for fertility treatment (Figure 2). In addition, a fixed combination of r-hFSH and r-hLH in a 2:1 ratio (150 IU r-hFSH and 75 IU r-hLH; Pergoveris® [Merck Senoro]) was introduced on the market. A long-acting formulation of recombinant FSH, corifollitropin alfa, has also become available.

Bottom Line: Accurate and easy-to-use injection devices which minimize pain, difficulty, and stress are essential for patient compliance.The efficacy in comparison to the quite more cumbersome handling with ampoules and syringes has been proven very quickly.In several studies, it has been shown that patients had a preference to the prefilled follitropin alfa pen due to the faster preparation and were more confident of accurate dosing.

View Article: PubMed Central - PubMed

Affiliation: Centre for Gynaecological Endocrinology and Reproductive Medicine, Stuttgart, Germany.

ABSTRACT
Gonadotropin treatment has been used in fertility treatment since the 1930s. First, preparations coming from animals were injected, then, gonadotropins prepared from the pituitary glands of human cadavers. A great step was achieved with the introduction of human menopausal gonadotropin extracted from the urine of postmenopausal women. When cases of Creutzfeld-Jacob disease were recognized after the use of human pituitary-derived hormone injections, urinary gonadotropins were increasingly purified and then produced by the use of recombinant DNA technology. Recombinant gonadotropins were characterized by the extreme high specificity and the nearly 100% purity. This allows for follitropin alfa, the first recombinant-human follicle stimulating hormone (r-hFSH) approved, to be quantified and filled by mass, with a small variance of only ±2% and no more with a bioassay with a variance of 45%. With recombinant preparations, it is also possible to cover the tremendous growing demand for gonadotropins. Ovarian stimulation has become a self-injecting procedure for the patients. Accurate and easy-to-use injection devices which minimize pain, difficulty, and stress are essential for patient compliance. So, two pen injectors adapted from the well-known insulin pen were introduced in fertility treatment, one as a multiple-use device rechargeable with premixed, prefilled cartridges with r-hFSH (follitropin β) and the other a disposable, prefilled drug delivery system with a liquid formulation of follitropin alfa filled by mass. The efficacy in comparison to the quite more cumbersome handling with ampoules and syringes has been proven very quickly. In several studies, it has been shown that patients had a preference to the prefilled follitropin alfa pen due to the faster preparation and were more confident of accurate dosing. The follitropin alfa (filled by mass [FbM]) prefilled pen is a move toward better quality of treatment and also better quality of life for the women within the stressful period of fertility treatment.

No MeSH data available.


Related in: MedlinePlus