Medication Support

Gonal-f® Multi-Dose

Gonal-f® Multi-Dose

Gonal-f® Multi-Dose is the only FSH available in convenient multiple-dose vials. Available as the Gonal-f® 1050 IU vial or Gonal-f® 450 IU vial, each dose offers important benefits:

  • Both presentations of Gonal-f® Multi-Dose come with a prefilled diluent syringe, eliminating the extra step of preparing a diluent syringe.
  • Each Gonal-f® Multi-Dose 1050 IU vial contains as much medicine as fourteen 75 IU single dose vials.
  • Each Gonal-f® Multi-Dose 450 IU vial contains as much medicine as six 75 IU single dose vials.

Why Gonal-f® Multi-Dose is used

For Women

  • Gonal-f® (follitropin alfa for injection) is used for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure.
  • Gonal-f® is also used for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technologies (ART) program.

For Men

  • Gonal-f® (follitropin alfa for injection) is used for the induction of spermatogenesis in men with primary and secondary hypogonadatropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Ask your healthcare provider if Gonal-f® is right for you.

Important Safety Information: Gonal-f® can cause serious side effects including ovarian hyperstimulation syndrome (OHSS), with or without lung or blood vessel problems and multiple births.

The most common side effects observed with the use of Gonal-f® include headache, breast pain, ovarian cysts, upset stomach, sinus infections in women, and skin pimples, breast pain and growth and tiredness in men. Needle injections may cause some discomfort. For complete product details, see the Full Prescribing Information.

You should review with your Fertility Specialist the risks and benefits of using Gonal-f®. As with any medication, report any and all side effects, symptoms or physical changes to your healthcare provider.

Warnings, Side Effects and Important Safety Information

Gonal-f® can cause serious side effects including ovarian hyperstimulation syndrome (OHSS), with or without lung or blood vessel problems and multiple births.

The most common side effects observed with the use of Gonal-f® include headache, breast pain, ovarian cysts, upset stomach, sinus infections in women, and skin pimples, breast pain and growth and tiredness in men. Needle injections may cause some discomfort. For complete product details, see the Full Prescribing Information.

You should review with your Fertility Specialist the risks and benefits of using Gonal-f®. As with any medication, report any and all side effects, symptoms or physical changes to your healthcare provider.

Instructions for Use

Watch this brief video that demonstrates how to administer Gonal-f® Multi-Dose.

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Important Safety Information: Gonal-f® can cause serious side effects including ovarian hyperstimulation syndrome (OHSS), with or without lung or blood vessel problems and multiple births.

The most common side effects observed with the use of Gonal-f® include headache, breast pain, ovarian cysts, upset stomach, sinus infections in women, and skin pimples, breast pain and growth and tiredness in men. Needle injections may cause some discomfort. For complete product details, see the Full Prescribing Information.

You should review with your Fertility Specialist the risks and benefits of using Gonal-f®. As with any medication, report any and all side effects, symptoms or physical changes to your healthcare provider.

Storage

Before Reconstitution

Room temperature or refrigerated (2 – 25°C/36°F – 77°F) until expiration date.

After Reconstitution

Up to 28 days, either at room temperature or refrigerated.

Discard any unused reconstituted Gonal-f® Multi-Dose after 28 days.

Once reconstituted (mixed), write the date of reconstitution on the box in order to keep track of its 28 day shelf life. Record the amount of reconstituted Gonal-f® in the dosing log to keep track of how much is still available in the vial.

Do not store drug in the syringe.

Do not freeze.

Keep away from light.

Important Safety Information: Gonal-f® can cause serious side effects including ovarian hyperstimulation syndrome (OHSS), with or without lung or blood vessel problems and multiple births.

The most common side effects observed with the use of Gonal-f® include headache, breast pain, ovarian cysts, upset stomach, sinus infections in women, and skin pimples, breast pain and growth and tiredness in men. Needle injections may cause some discomfort. For complete product details, see the Full Prescribing Information.

You should review with your Fertility Specialist the risks and benefits of using Gonal-f®. As with any medication, report any and all side effects, symptoms or physical changes to your healthcare provider.

FAQs

What is Gonal-f® and what is it used for?

Gonal-f® is a gonadotropin hormone produced by recombinant DNA technology (rDNA). It consists of recombinant human follicle stimulating hormone (r-hFSH) and contains neither luteinizing hormone (LH) nor urinary proteins.

FSH is primarily used in women and is necessary for the recruitment, growth and maturation of the ovarian follicles, which contain cells known as ova or oocytes. This occurs at the beginning of a woman's menstrual cycle.

After Gonal-f® is given to help develop the ovarian follicle, another hormone, hCG (human chorionic gonadotropin), is given mid-cycle to mature the egg and induce ovulation.

The amount of Gonal-f® given and the length of the treatment may vary from patient to patient.

Gonal-f® treatment is given by injection under the skin as recommended by your Fertility Specialist.

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How is Gonal-f® different from urinary FSH medications?

Gonal-f® is produced through rDNA technology and consists only of highly purified r-hFSH. Certain other FSH products—that are not derived from recombinant technology—may also contain varying amounts urinary proteins.

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Who should not take Gonal-f®?

Most patients can safely use Gonal-f®. However, you should not take Gonal-f® if you answer "yes" to any of the following questions. If you are unsure if you should take Gonal-f®, talk to your healthcare provider.

In both men and women:

  • Do you have an allergy to r-hFSH preparations or any one of the following: sucrose, sodium phosphate, sodium hydroxide, benzyl alcohol or o-phosphoric acid?
  • Have you ever been diagnosed as having cancer of the sex organs (uterus, ovaries, testes)?
  • Do you have high levels of FSH indicating primary gonadal failure?
  • Do you have uncontrolled thyroid or adrenal problems?
  • Do you have a pituitary tumor or other brain tumor?

In women:

  • Are you pregnant or breastfeeding?
  • Do you have unexplained bleeding from the vagina or uterus?
  • Do you have swollen, enlarged or painful ovaries?

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Are there any possible side effects due to Gonal-f®?

You should review with your Fertility Specialist the risks and benefits of using Gonal-f®. As with any medication, report any and all side effects, symptoms or physical changes to your healthcare provider.

Gonal-f® can cause serious side effects including ovarian hyperstimulation syndrome (OHSS), with or without lung or blood vessel problems and multiple births.

The most common side effects observed with the use of Gonal-f® include headache, breast pain, ovarian cysts, upset stomach and sinus infections in women, and skin pimples, breast pain and growth and tiredness in men. Needle injections may cause some discomfort. For complete product details, see the Full Prescribing Information.

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Is there a risk of multiple pregnancies with the Gonal-f®?

Use of fertility medications can be associated with the fertilization of more than one egg. This can lead to complications for the mother and the birth of two or more babies. You should discuss with your Fertility Specialist the risks of multiple births before initiating treatment.

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How much of the Gonal-f® should I inject?

Your team of Fertility Specialists will tell you exactly how many IUs of Gonal-f® you will need to inject each day.

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What should I do if I forget to take my Gonal-f®?

Do not take a double dose to make up for any missed doses. Contact your Fertility Specialist if you forget to take a dose of Gonal-f®.

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Can I take Gonal-f® with other medications?

Inform your Fertility Specialist and pharmacist if you are taking or have taken any other medications, including those that do not require a prescription.

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If you have any additional questions, be sure to contact your Fertility Specialist for more information or guidance. You can also call Fertility LifeLines™ toll-free at 1-866-LETS-TRY (1-866-538-7879). All calls are free and confidential.

Important Safety Information: Gonal-f® can cause serious side effects including ovarian hyperstimulation syndrome (OHSS), with or without lung or blood vessel problems and multiple births.

The most common side effects observed with the use of Gonal-f® include headache, breast pain, ovarian cysts, upset stomach, sinus infections in women, and skin pimples, breast pain and growth and tiredness in men. Needle injections may cause some discomfort. For complete product details, see the Full Prescribing Information.

You should review with your Fertility Specialist the risks and benefits of using Gonal-f®. As with any medication, report any and all side effects, symptoms or physical changes to your healthcare provider.

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Prescribing Information and Important Safety Information

Gonal-f® (follitropin alfa for injection) is indicated for use in infertile patients with oligo-anovulation and patients undergoing ART. Gonal-f® should only be prescribed by physicians who are thoroughly familiar with infertility problems and their management. Gonal-f® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Gonal-f® is contraindicated in women who exhibit prior hypersensitivity to recombinant FSH preparations, primary gonadal failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Women who are nursing should not use Gonal-f®. The most common side effects in patients using Gonal-f® include headache, ovarian cysts, nausea and upper respiratory infections in women and acne, breast pain and growth, and fatigue in men. Injection site reactions were also reported. Reports of multiple births have been associated with Gonal-f treatment. For complete product details, see the Full Prescribing Information and FAQs.

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Indication:
For women, Gonal-f® (follitropin alfa for injection), Gonal-f® RFF (follitropin alfa injection) and Gonal-f® RFF Pen (follitropin alfa injection) are indicated for 1) the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure and 2) for the development of multiple follicles in the ovulatory patient participating in an ART program.

Gonal-f® is also indicated to increase sperm production in men with a rare condition called hypogonadotropic hypogonadism.

Important Safety Information:
These products should only be prescribed by physicians specializing in fertility or reproductive health. Use of Gonal-f® or Gonal-f® RFF by women can result in multiple births. Patients should let their doctor know of any allergic reactions to recombinant FSH preparations or other product ingredients. Patients should also inform their doctor of a history of cancer of the sex organs or brain and uncontrolled thyroid or adrenal disease before starting or continuing treatment. Women with a history of abnormal bleeding from the uterus or vagina, swollen, enlarged, or painful ovaries should speak to their doctor before starting treatment. Gonal-f® and Gonal-f® RFF are potent gonadotropic substances capable of severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women, which can result in hospitalization. Women should inform their doctor if they experience severe stomach pain, vomiting, bloating, or weight gain while taking Gonal-f® or Gonal-f RFF®. The most common side effects are headache, ovarian cysts, upset stomach, and sinus infections in women taking Gonal-f® or Gonal-f® RFF. The most common side effects in men taking Gonal-f® are skin acne, breast pain and growth, and tiredness. Needle injections may cause some discomfort.

For more information, refer to the prescribing and patient information offered below and talk to your doctor.

*RFF Revised Formulation Female


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