Journey through infertility ain’t easy nor cheap. Still, God is good…
Random header image... Refresh for more!

10 Things About Follistim

I noticed that almost half of my blog visitors are looking for information regarding Follistim. So I figured it may be helpful to some that I put this together based on what I learned about it, what to expect, what Follistim dosages are, etc. So here goes…

Follistim’s generic name is follitropin beta.

1. Follistim is a recombinant follicle stimulating hormone (rFSH) versus the human menopausal gonadotropin (hMG) such as Humegon, Pergonal, Repronex and Menopur which are extracted from the urine of menopausal women.

I think the FSH term is self-explanatory, but as for the term “recombinant”? I am not a scientist but what I picked up is that it is a genetic engineering process that uses Chinese hamster ovary (CHO) cells in the manufacturing process. I am sure it is a controlled manufacturing process, but just the thought of injecting myself with something “mixed” with non-human feels creepy.

I guess we do choose our own poison – non-human derivative or human menopausal urine? And no, I am not making these up … see these sources. (a) (b) (c).

Of course, Organon’s website indirectly states “mammalian” host cells vs directly stating Chinese hamster ovary cells! I suppose they don’t want to freak us out!

2. Follistim is prescribed to women with ovulation problems. Typically, women who are clomid-resistant or have PCOS use Follistim. (I have read about other women having protocols that includes clomid and Follistim, though.)

Follistim is also used for ovarian stimulation in preparation for fertilization – usually using assisted reproductive technologies (ART) such as intra-uterine insemination (IUI) or in-vitro fertilization (IVF).

3. Follistim is what it is called in the US. The rest of the world calls it Puregon. They are made by Organon, a Schering Plough company.

Other fertility drugs that are used for similar results are:
- Gonal F (follitropin alfa, rFSH) from Serono
- Bravelle from Ferring (urofollitropin, highly-purified human-derived FSH or hFSH)

4. Follistim is usually used together with human chorionic gonadotropin (hCG such as Ovidrel or Pregnyl) to trigger ovulation.

Follistim is also usually used with an gonadotropin releasing hormone (GnRH) agonist and/or antagonist for IVF protocols. GnRH agonist such as Lupron blocks the production of FSH and LH, and is administered 10-20 days in the previous cycle. GnRH antagonist such as Ganirilex/Antagon or Cetrotide blocks the effect of GnRH, and is administered on the later part of the stimulation cycle. (a)

5. Follistim dosages that you will be prescribed is an ESTIMATE and will latter be dependent on the individual response.
Your Reproductive Endocrinologist or Fertililty Specialist has some baseline dosages in mind based on your individual case and thus will estimate how much you will be asked to order from the pharmacy. The protocol is started on between cycle day 3 (CD3) to CD5.

6. Follistim requires close response monitoring by sonogram and Estradiol blood test every 2-3 days.
Sonogram will show the endometrium lining thickness and the the follicle count and size. A gradual increase is desired from CD3 to CD14. (In my case, my RE wanted to see endometrium lining thickness greater than 9.5mm and mature follicle (size>18mm) count of 3 to 5 follicles before we trigger on the CD13-14.)

Blood work is needed to read the Estradiol (E2) levels as well. As a rule of thumb, it is said that for every mature follicle, expect 200pc/ml. (In my case, the desired level was 1500 pc/ml.) Levels greater than 3000 pc/ml are usually associated with Ovarian Hyper Stimulation Syndrome (OHSS).

See a sample of Follistim response data vs dosages here.

Throughout the protocol, the dosage may be adjusted or “titrated” based on your response to the Follistim. For some, a cycle’s dosage may be too low or was increased too late that the right size and number of follicles is not produced. For some, a cycle’s dosage may be too much or was decreased too late that results to Ovarian Hyper Stimulation Syndrome (OHSS). If the baseline or adjusted dosage works, well and good. Do not be surprised though if it does not work and you will need another Follistim cycle.

Just a note though that there is anecdotal information that one patient’s response could vary from cycle to cycle as well.

7. Follistim is expensive … but DesignRx can give you a big discount.

8. Follistim has an expiration - 28 days from piercing or 3 months at room temp or until expiration date when refrigerated.
How to maximize the use of your precious follistim? Can you use expired follistim? See tomorrow’s post.

9. Follistim has been in use for more than a decade now.
It was first introduced in 1995 in Europe.
It was introduced in 1996 in the US but the Follistim® AQ Cartridge was FDA approved only in 2004.
It was introduced in 2005 only in Japan.

10. Follistim is expected to become cheaper by 2015.
This is when Organon’s Follistim comes off patent. Expect the influx of generic manufacturers to lower the price by then!

Anything of key significance I missed, fellow Follistim-users?

3 comments

1 Beth { 08.22.08 at 11:33 am }

I just called Orgenon and it sounds like the efficacy of the product is still fine its the sterility that they are concerned with. I have a 300IU cartridge that I only took about 75 from. I have kept it in the fridg so I think I will take my chances. I can’t see throwing all of that away.

2 Arpee { 08.25.08 at 12:36 pm }

Hi Beth!

Great initiative to call Organon! I too used a pierced cartridge for the first days (albeit forgotting about their 28 days “expiration”) before I switched to a fresh one and still got good stimulation. (See my other post for the “graph”).

Anyhow, had I been more aware earlier, I would not have used the pierced cartridge (however frugal I am…and I am!). However, it is your own choice.

Also, re reason for 28 days. It should be very easy for Organon to simply document their reasons, basis and studies for the 28 days. If they don’t want to reprint their hardcopy literature because of significant expense, it is very easy and cheap to add this in their website. And yet, they do not. Makes me wonder why…

Nevertheless, wishing you well in your IF journey!

3 Ryan { 08.28.08 at 12:43 pm }

Hi all,

I am just beginning my first IVF cycle and soon will be taking Follistim (next week). Wish me luck!

BTW…Just wanted to give you all a bit more info about the Follistim manufacturing process that was listed above…you know, the one with the Chinese Hamster Ovary (CHO) cells. I happen to work with a similar manufacturing process (not with that company or anything) and use CHO cells everyday to make another therapuetic drug. I assure you that these types of processes are extremely controlled. CHO cells are actually ideal for manufacturing proteins that the human body can recognize and utilize for treating all kinds of diseases. The fact that hamsters are mammals helps that…they can create really complex proteins and perform post translational modifications that help the human body recognize/utilize them.

The way it works is that scientist identify a protein that does what they want it to do(in this case FSH-stimulates the ovaries), then they determine which genetic sequence encodes that protein (basically, which gene generates or creates that protein), then they insert that gene or genes into a CHO cell’s DNA. That way, the CHO cell (actually many CHO cells after the cell multiplies becoming a large volume culture) can be used as a little factory to generate the desired protein under certain controlled conditions (temperature, pH, media, etc.). The protein of choice is then purified, finished, filled into vials and shipped. It’s actually really cool…and really controlled with all kinds of final product quality testing. So try not to stress about it. I hope this info will help you be more comfortable.

Thx

Leave a Comment