Gonal-f

 

GONAL-f®

 

[FOLLITROPIN ALFA FOR INJECTION]

Gonal-f® (follitropin alfa for injection) is a human follicle stimulating hormone (FSH) prepared from recombinant DNA technology. Gonal-f® is a prescription medication manufactured by EMD Serono.
Gonal-f® is currently FDA-approved for use in men and women for infertility treatment. In women, Gonal-f® is indicated to start ovulation for development of multiple follicles in the woman participating in assisted reproductive technology program. Gonal-f® is also used to stimulate sperm production in some men with hypogonadotropic hypogonadism, not due to primary testicular failure.

Gonal-f® requires a valid prescription from your prescriber. Ocean Breeze Healthcare can provide Gonal-f® as well as all the supplies needed to administer Gonal-f®.
 

What form is Gonal-f® currently available?

Gonal-f® is available in 3 dosage forms: multi-dose vial, single-dose vial, and multi-dose injection pen.

The Gonal-f® multi-dose vial is available in 2 strengths: 450 IU and 1050 IU of active drug. All multi-dose vials need to be reconstituted, or mixed, with their diluent (the clear liquid inside the syringe), that are provided in the same box as the drug vial.
The Gonal-f® RFF single-dose vial contains 75 IU of active drug. The vial must be reconstituted, or mixed, with the diluent (the clear liquid inside the syringe) provided in the same box as the drug vial.
The Gonal-f® RFF Pen is a prefilled multi-dose injection pen. It is available as 300 IU, 450 IU, and 900 IU pens.

What are some potential side effects of Gonal-f®?

The most common side effects include, but are not limited to, headache, upset stomach, nausea, and injection related reaction such as bruising, redness or pain at the area of injection.
Gonal-f® can cause ovarian hyperstimulation syndrome (OHSS) in women. Common symptoms of OHSS include severe pelvic pain, shortness of breath, and weight gain. Other serious side effects include breathing problems, and risk of blood clots and strokes.
These are not all the possible side effects of Gonal-f®. If you are experiencing any unwanted side effect(s) or have any specific questions regarding a side effect, contact your doctor or pharmacist. You may also report the side effect(s) to the FDA at www.fda.gov/medwatch, or call 1-800-FDA-1088.

Who should NOT use Gonal-f®?

Do not take Gonal-f® if you are already pregnant. Women with intracranial lesion, uncontrolled thyroid, adrenal dysfunction, primary gonadal failure, or abnormal uterine bleeding of unknown origin should not use Gonal-f®.

Talk to your doctor if you are nursing to discuss the benefit versus risk of using Follistim® AQ. It is not known if the drug will be passed into mothers' milk.

How do you administer Gonal-f®?

Gonal-f® needs to be injected subcutaneously in order for the medication to work.
For Vials:

The single-dose Gonal-f® RFF and multi-dose Gonal-f® vial need to be reconstituted with the diluents before injection. All the syringes and needles required to mix and inject the medication will be supplied together with your medication. For detailed injection instructions on single-dose Gonal-f® RFF, please read its medication information (PDF: Gonal-f_RFF singledose vial PI). For injection instructions on multi-dose Gonal-f®, please read its injection guide (PDF: GONAL-f MultiDose injection guide).

Gonal-f 
 
For Pens:
Gonal-f® RFF pen contains the ready-to-use liquid formulation. Simply insert the pen needle into the device before use. Please read the injection instructions (PDF: Gonal-f RFF Pen instructions for use) for detailed administration instructions.
Gonal-f
 

How do you store Gonal-f®?

Store all Gonal-f® products away from direct light.
Single-dose vials:
Gonal-f® RFF single-dose vials may be stored either in refrigerator or at room temperature (up to 77°F) until the expiration date. Medication must be used immediately after it is reconstituted. Do not store drug in the syringe. Discard any unused material.
Multi-dose vials:
New, unmixed Gonal-f® multi-dose vials may be stored either in refrigerator or at room temperature (up to 77°F) until the expiration date. Once the muti-dose vial is mixed, it can be stored either at room temperature or in refrigerator for up to 28 days. Do not store drug in the syringe.
For Pens:
Gonal-f® RFF pen may be stored either at room temperature up to 77°F, or inside refrigerator (36-46°F).

How long does Gonal-f® last?

Single-dose vials:
Gonal-f® RFF single-dose vials may be stored either in refrigerator or at room temperature until the expiration date. Medication must be used immediately after it is reconstituted. Discard any unused material.
Multi-dose vials:
New, unmixed Gonal-f® multi-dose vials may be stored either in refrigerator or at room temperature until the expiration date. Once the muti-dose vial is mixed, it is stable for up to 28 days.
For Pens:
Before opening, the Gonal-f® RFF pen is stable until the indicated expiration date listed on the packaging when stored in refrigerator. If new Gonal-f® RFF pen is stored in room temperature, it is stable for up to three months unless the expiration date is earlier.
Gonal-f® RFF pen are stable up to 28 days either in refrigerator or room temperature from initial date of opening.

Commonly Asked Questions

Q:How do you mix Gonal-f® for injection?
A: Gonal-f® RFF single-dose vial and Gonal-f® multi-dose vials need to be mixed with diluents prior to administration. Inject the prefilled syringe of bacteriostatic water into the lyophilized powder vial. Do not shake. For instructions, please read the injection guide. (PDF: GONAL-f MultiDose injection guide, PDF: Gonal-f_RFF singledose vial PI) Gonal-f® RFF pen is already pre-mixed by the manufacturer, therefore no additional mixing is required.
 
Q:Are there any preservatives in Gonal-f®?
A: Gonal-f® multi-dose vials contain a type of preservative called benzyl alcohol. However, Gonal-f® RFF single-dose vials and Gonal-f® RFF pens are preservative-free.
 
Q:How do I take Gonal-f®?
A: You should inject Gonal-f® under the skin, exactly at the time and dose prescribed by your doctor.
 

Manufacturer Website

www.emdserono.com/en/therapies/fertility/gonal_f/gonal_f.html

Information on this site is provided for informational purposes and is not meant to substitute for the advice provided by your own physician or other medical professional. You should not use the information contained herein for diagnosing or treating a health problem or disease, or prescribing any medication. You should read carefully all product packaging. If you have or suspect that you have a medical problem, promptly contact your health care provider.

 

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