Follistim® AQ Cartridge

Follistim® AQ Cartridge (follitropin beta injection) was the first follicle-stimulating hormone (FSH) treatment available in the United States in a pre-filled, pre-mixed solution. The active ingredient in Follistim® AQ Cartridge is recombinant FSH, a highly effective and widely used prescription fertility medication made from state of the art recombinant DNA technology. This hormone is identical to the follicle-stimulating hormone (FSH) produced by the pituitary gland and belongs to the group of gonadotropins, which play an important role in human fertility and reproduction.

FSH is needed in women for the growth and development of follicles in the ovaries. Follicles are small round sacs that contain the egg cells. FSH stimulates the ovaries to produce mature eggs. Follistim® AQ Cartridge is used for the development of eggs in women who have problems with ovulation and who are undergoing Ovulation Induction treatment. Some women will also be using this medicine for the development of more eggs when participating in an Assisted Reproductive Technology (ART) program, such as in vitro fertilization.

Follistim® AQ Cartridge and the Follistim Pen®

Follistim® AQ Cartridge for use with the Follistim Pen®, is administered by subcutaneous injection. The Follistim Pen® is an innovative pen device that facilitates accurate delivery of individualized doses of pre-mixed follitropin beta injection.

Follistim® AQ Cartridge, for use with the Follistim Pen®, provides women with a discreet, convenient method to self-administer fertility treatment with ease and confidence using the unique dial-a-dose feature. In addition, Follistim® AQ Cartridge can be stored at room temperature.*

Follistim® and Follistim® AQ Cartridge

Although both Follistim® and Follistim® AQ Cartridge contain the same active ingredient, FSH, Follistim® AQ Cartridge (follitropin beta injection) is NOT the same formulation as Follistim® in the freeze-dried powder presentation, which is administered with a conventional syringe and needle. This product presentation is no longer available in the US. If you have previously used Follistim®, consult with your doctor or other healthcare provider if you have any questions about the difference between these two products.

Patients should always follow their doctor’s instructions when administering Follistim® AQ Cartridge. Your doctor will individualize the dose to be administered based on medical history. Do not change your dose unless instructed by your doctor.

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Additional information for you

This section of the web site discusses Follistim® AQ Cartridge in detail so you can feel more in control of your treatment. Here you can find information about how Follistim® AQ Cartridge works, how it is administered and how it is prescribed. As with any treatment, it is important to speak to your doctor or a nurse about any concerns or questions you and your partner may have.

*The product may be stored by the patient at 2-8° C (36-46° F) until the expiration date, or at 25° C (77° F) for 3 months, or until the expiration date, whichever occurs first. Once the rubber inlay of the Follistim® AQ Cartridge has been pierced by a needle, the product can only be stored for a maximum of 28 days at 2-25° C (36-77° F). Protect from light. Do not freeze.

Safety Information:

Follistim® AQ Cartridge

- Your healthcare professional will decide on the dose of Follistim® AQ Cartridge to be given. This dose may be increased or decreased as your treatment progresses depending on your individual type of treatment. If you have previously used gonadotropins, your dose may be different with Follistim® AQ Cartridge. Again, your healthcare professional will decide the dose based upon your medical history.

- Always follow your healthcare professional’s dosing instructions when administering Follistim® AQ Cartridge. Your healthcare professional has individualized the dose to be administered based on your medical history. Do not change your dose unless instructed by your healthcare professional.

- Follistim® AQ Cartridge, like all gonadotropins, is a potent substance capable of causing mild to severe side effects including OHSS, with or without pulmonary or vascular complications.

- Follistim® AQ Cartridge should be prescribed only by physicians who are experienced in infertility treatment. Physicians should advise their patients of treatment risks, including OHSS and multiple births.

Please see accompanying Physician Prescribing Information.