Follitropin alfa

What is Follitropin alfa?

• Follitropin alfa (Gonal-F) is a gonadotropin [human follicle stimulating hormone (FSH)], a glycoprotein hormone manufactured by recombinant DNA technology.

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Follitropine

What are the uses of this medicine?

• Follitropin alfa (Gonal-F) is a medicine containing follicle-stimulating hormone (FSH).

Gonal-F is used in: infertile women to:

• help healthy ovaries develop (mature) and release an egg to help you get pregnant
• cause your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) program

infertile men to:

• help develop and produce mature sperm

How does this medicine work?

• Gonal-F stimulates ovarian follicular growth in women who do not have primary ovarian failure.
• In order to bring about final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given, following the administration of Gonal-F, when monitoring of the patient indicates that sufficient follicular development is achieved.
• Gonal-F stimulates spermatogenesis in men with hypogonadotropic hypogonadism when administered with hCG.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• is allergic to recombinant human FSH or any of the ingredients in Gonal-F. See the end of this leaflet for a complete list of ingredients in Gonal-F.
• has a high level of FSH in your blood that show your ovaries (women only) or testes (men only) do not work at all.
• has uncontrolled thyroid, adrenal, or pituitary problems.
• has a tumor in your sex organs (uterus, ovaries, or testes) or breasts.
• has a tumor in your brain, such as a tumor in your pituitary gland or hypothalamus.
• has abnormal bleeding from your uterus or vagina from an unknown cause.
• has ovarian cysts or large ovaries from an unknown cause.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Initial U.S. Approval: 1997

How should this medicine be used?

Recommended dosage:

Induction of Ovulation:

• Initial starting dose of the first cycle - 75 International Units of Gonal-F per day for 14 days, administered subcutaneously.
• Individualize doses after 14 days.
• Do not administer doses greater than 300 International Units per day.

Development of Multiple Follicles in Assisted Reproductive Technology (ART):

• Initial starting dose of the first cycle - 150 International Units per day, administered subcutaneously.
• Dosage adjustments after 3 to 5 days and by 75 to 150 International Units at each adjustment.
• Do not administer doses greater than 450 International Units per day.

Males with Hypogonadotropic Hypogonadism and Azoospermia:

• Use in conjunction with hCG.
• Prior to concomitant therapy with Gonal-F and hCG, pretreat with 1,000 to 2,250 USP units of hCG alone two to three times per week to achieve normal serum testosterone levels, which may take 3 to 6 months.
• After normalization of serum testosterone, administer 150 International Units of Gonal-F subcutaneously three times a week and 1,000 USP units of hCG (or the dose required to maintain serum testosterone levels within the normal range) three times a week.

Administration:

• Gonal-F is given by injection under your skin. You can inject Gonal-F under the skin in your stomach (abdomen), upper arm, or upper leg.
• Do not inject Gonal-F at home until your healthcare provider has taught you the right way to inject it.
• Change your injection site as your healthcare provider showed you.
• Do not change your dose or the time you are scheduled to use Gonal-F unless your healthcare provider tells you to.
• If you miss or forget to take a dose, do not double your next dose. Ask your healthcare provider for instructions.
• Your healthcare provider will do blood and urine hormone tests while you are using Gonal-F. Make sure you follow-up with your healthcare provider to have your blood and urine tested when told to do so.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection

This medicine is available in fallowing brand namesː

• Gonal-F
• Cinnal-f
• Fertilex
• Ovaleap
• Bemfola

What side effects can this medication cause?

The most common side effects of this medicine include: In women:

• ovarian cyst
• OHSS
• pelvic pain
• gas
• headache
• stomach pain
• nausea
• bleeding between periods

In men:

• skin problems
• injection site pain
• tiredness
• breast enlargement
• seborrhea

Follitropin alfa may cause serious side effects in women, including:

• severe allergic reactions
• lung problems
• blood clots
• ovarian hyperstimulation syndrome (OHSS)
• twisting (torsion) of your ovary
• ovaries that are too large
• pregnancy with and birth of multiple babies
• birth defects
• ectopic pregnancy (pregnancy outside your womb)
• miscarriage
• tumors of the ovary

What special precautions should I follow?

• Serious systemic hypersensitivity reactions, including anaphylaxis, have been reported with use of Gonal-F and Gonal-F RFF. If an anaphylactic or other serious allergic reaction occurs, initiate appropriate therapy including supportive measures.
• Ovarian Hyperstimulation Syndrome (OHSS) is a medical entity distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical event. A physician experienced in the management of this syndrome, or who is experienced in the management of fluid and electrolyte imbalances should be consulted.
• Serious pulmonary conditions (for example, atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported in women treated with gonadotropins, including Gonal-F. n women with recognized risk factors, the benefits of ovulation induction and Assisted Reproductive Technology (ART) need to be weighed against the risks.
• Ovarian torsion has been reported after treatment with gonadotropins, including Gonal-F. Early diagnosis and immediate detorsion limit damage to the ovary due to reduced blood supply.
• In order to minimize the hazards associated with abnormal ovarian enlargement that may occur with Gonal-F therapy, individualize treatment and use the lowest effective dose.
• Multi-fetal gestation and births have been reported with all gonadotropin therapy, including therapy with Gonal-F. Advise the woman and her partner of the potential risk of multi-fetal gestation and birth before beginning therapy with Gonal-F.
• Since infertile women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased in women who become pregnant as a result of ART. Confirm the presence of an intrauterine pregnancy early by β-hCG testing and transvaginal ultrasound.
• The risk of spontaneous abortion (miscarriage) is increased with gonadotropin products, including Gonal-F.
• Advise women and men to discontinue Gonal-F and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur.
• Advise women not to breastfeed because the secretion of prolactin during lactation can result in inadequate response to ovarian stimulation with Gonal-F.
• Instruct women and men on the correct usage and dosing of Gonal-F. Caution against changing the dosage or the schedule of administration unless instructed to do so by a healthcare provider.
• Inform women and men that if they miss or forget to take a dose of Gonal-F, they should not double the next dose and should call their healthcare provider for further dosing instructions.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Ovarian hyperstimulation syndrome
• multiple gestations

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Gonal-F is not indicated in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: follitropin alfa (r-hFSH)
• Inactive ingredients: dibasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, O-phosphoric acid, sodium hydroxide, sucrose.

Who manufactures and distributes this medicine?

Manufactured for:

• EMD Serono, Inc.,
• Rockland, MA U.S.A.

What should I know about storage and disposal of this medication?

• Before you use Gonal-F for the first time, store the vials:
• in the refrigerator between 36°F to 46°F (2°C to 8°C) until the expiration date, or
• store the vials at room temperature between 68°F to 77°F (20°C to 25°C) until the expiration date.
• After you use Gonal-F and there is still medicine left, store your vial in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature between 68°F to 77°F (20°C to 25°C) up to 28 days. Throw away any unused Gonal-F after 28 days.
• Store your Gonal-F vials in a safe place.
• Store Gonal-F away from light.

• Dailymed label info on Follitropin alfa
• FDA Follitropin alfa

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