Gonal-F 900 IU/1.50ML SOLU INJEC

Product Description:

• GONAL-F  contains a medicine called " FOLLITROPIN  alfa".  FOLLITROPIN  alfa is a type of " follicle stimulating hormone " ( FSH ) that belongs to a group of hormones called " gonadotropins ". 
• Gonadotropins are involved in reproduction and fertility .

What  GONAL-F  is used for:

In adult women ,  GONAL-F  is used:

• To help release an egg from the ovary (ovulation) in women who are not ovulating and have not responded to clomiphene citrate.
• In combination with the drug lutropin alfa (" luteinizing hormone " or lh ) to contribute to ovulation in women who produce very little gonadotropins ( fsh and lh ).
• To help develop more follicles (each with an egg) in women undergoing assisted reproduction (procedures that can help you get pregnant) such as " in vitro fertilisation", "gamete-intrafallopian transfer" or "zygote- intrafallopian transfer”.

In adult men ,  GONAL-F  is used:

• In combination with the medicine human chorionic gonadotropin ( hcg ) to help produce sperm in men who are infertile due to low levels of certain hormones.

How To Use:

• Always use this medicine exactly as your doctor has told you.
• Contact a doctor or pharmacist if you are unsure.

Use of this medicine:

• GONAL-F should be placed directly under the skin ( subcutaneously ). 
• The pre-filled pen can be used for multiple injections.
• The first injection of GONAL-F  should be given under the supervision of your doctor.
• Your doctor or a nurse will show you how to use the GONAL-F  pre-filled pen to inject the medicine.
• If you administer GONAL-F  yourself, you must read and follow the "Instructions for use".

How much to spend:

• Your doctor will decide how much medicine you should use and how often. The doses described below are given in International Units (IU).

Women If you do not ovulate or have irregular or no periods:

• GONAL-F is usually given every day.
• If you have irregular periods, start using GONAL-F  within the first 7 days of your menstrual cycle. If you are not menstruating, you can start using the medicine on any convenient day.
• The usual starting dose of GONAL-F  is 75 to 150 IU each day.
• The GONAL-F  dose can be increased every 7 or every 14 days by 37.5 to 75 IU until you achieve the desired response.
• The maximum daily dose of GONAL-F  is usually not higher than 225 IU.
• When you achieve the desired response, you will be given a single injection of 250 micrograms of "recombinant hcg " (r - hcg , an hcg made in a laboratory using a special DNA technique) or 5,000 to 10,000 IU of hcg , 24 to 48 hours after your last GONAL-F   
• The best time for intercourse is on the same day as the hcg injection and the day after.
• If your doctor does not see a desired response after 4 weeks, the treatment cycle with GONAL-F  will be stopped. 
• For subsequent treatment cycles, your doctor will give you a higher starting dose of GONAL-F  than before.
• If your body reacts too strongly, the treatment will be stopped and you will not be given hcg.
• For the next cycle, your doctor will give you a lower starting dose of GONAL-F  than before.

If you have been diagnosed with very low levels of FSH and LH hormones:

• The usual starting dose of GONAL-F  is 75 to 150 IU together with 75 IU of lutropin alfa.
• You will use these two medicines every day for up to five weeks.
• The GONAL-F  dose can be increased every 7 or every 14 days by 37.5 to 75 IU until you achieve the desired response.
• When you achieve the desired response, you will be given a single injection of 250 micrograms of "recombinant hcg " (r - hcg , an hcg made in a laboratory using a special DNA technique) or 5,000 to 10,000 IU of hcg , 24 to 48 hours after your last injections with GONAL-F  and lutropin alfa. 
• The best time for intercourse is on the same day as the hcg injection and the day after. Alternatively, intrauterine insemination or another medically assisted conception procedure may be performed at your doctor's discretion.
• If your doctor does not see a response after 5 weeks, the treatment cycle with GONAL-F  will be stopped.
• For the following cycle, the doctor will give you a higher starting dose of  GONAL-F  than before.
  If your body reacts too strongly, treatment with  GONAL-F  will be stopped and you will not be given hcg.
• For the following cycle, your doctor will give you a lower starting dose of GONAL-F  than before.

If it is necessary to develop more eggs for retrieval before assisted fertilization:

• The usual starting dose of GONAL-F  is 150 to 225 IU each day, starting on day 2 or 3 of your treatment cycle.
• The GONAL-F  dose may be increased, depending on your response. The maximum daily dose is 450 IU.
• Treatment is continued until your eggs have developed to the desired point. 
• This usually takes about 10 days, but can take anywhere from 5 to 20 days. 
• Your doctor will use blood tests and/or an ultrasound machine to see when this is.
• When your eggs are ready, you will be given a single injection of 250 micrograms of recombinant hcg (r - hcg , an hcg made in a laboratory using a special recombinant DNA technique) or 5,000 to 10,000 IU of hcg , 24 to 48 hours after your last GONAL-F   
• This makes your eggs ready for collection.
• In other cases, your doctor may first prevent ovulation by using a gonadotropin-releasing hormone ( gnrh ) agonist or antagonist .
• GONAL-F  is then started approximately two weeks after the start of the agonist treatment. 
• Then both GONAL-F  and the gnrh agonist are given until your follicles develop as desired. 
• Example: After two weeks of treatment with a gnrh agonist , 150 to 225 IU GONAL-F  are administered for 7 days. 
• The dose is then adjusted according to the response of your ovaries.

Men

• The usual dose of GONAL-F  is 150 IU in combination with hcg .
• You will use these two medicines three times a week for at least 4 months.
• If you have not responded to treatment after 4 months, your doctor may suggest that you continue using these two medicines for at least 18 months.

If you take too much  GONAL-F:

• The effect of taking too much GONAL-F  is unknown. It is still possible that ovarian hyperstimulation syndrome (OHSS) may occur, as described under section 4. However, OHSS will only occur if you are also receiving hcg (see section 2, "Ovarian hyperstimulation syndrome (OHSS)").

If you have forgotten to take  GONAL-F:

• If you forget to take GONAL-F , do not take a double dose to make up for a missed dose. Contact your doctor as soon as you notice that you have forgotten a dose.
• Ask your doctor or pharmacist if you have any questions about the use of this medicine.

Warnings And Precautions:

• Before treatment begins, your and your partner's fertility should be assessed by a doctor experienced in fertility problems.

Do not use  GONAL-F :

• If you are allergic to follicle-stimulating hormone or any of the other ingredients in this medicine.
• If you have a tumor in the hypothalamus or pituitary gland (both are found in the brain).

If you are a woman :

• With large ovaries or fluid-filled cysts surrounding the eggs (ovarian cysts) of unknown origin.
• With vaginal bleeding of unknown cause.
• With ovarian, uterine or breast cancer .
• With a disorder that usually makes it impossible to achieve a normal pregnancy, such as ovarian failure (early menopause ), or malformed reproductive organs.

If you are a man :

• With irreversible testicular damage.
• Do not use GONAL-F  if any of the above applies to you. Consult your doctor before using this medicine if you are not sure.

• Talk to your doctor, pharmacist or nurse before using GONAL-F .

Porphyria:

• Inform your doctor before starting treatment if you or a family member have porphyria (inability to break down porphyrins, a disease that can be passed from parents to children).

Inform your doctor immediately if:

• Your skin becomes fragile and blisters easily, especially on areas that are often exposed to the sun, and/or
• You feel pain in your stomach or in your arms or legs.
• In cases of the above events, your doctor may advise you to stop treatment.

Ovarian hyperstimulation syndrome (OHSS):

• If you are a woman, this medicine increases the risk of developing OHSS. This occurs when your follicles develop too much and turn into large cysts. 
• If you experience pain in the lower abdomen, rapid weight gain, feeling sick and vomiting or if you experience difficulty breathing, you must inform your doctor immediately who may ask you to stop using this medicine.
• If you do not ovulate and if the recommended dosage and usage plan are followed carefully, it is less likely that OHSS will occur.
• Treatment with GONAL-F  rarely leads to severe OHSS as long as the medicine used to induce the last follicle maturation (containing human chorionic gonadotropin hormone - hcg) not given. 
• Your doctor may ask you to refrain from using hcg in this treatment cycle if OHSS occurs, as well as to refrain from intercourse or using mechanical contraceptives for at least 4 days.

Multiple pregnancy:

• When you use GONAL-F  you have a higher risk of becoming pregnant with more than one child at a time ("multiple pregnancy", usually twins), than with normal conception.
• Multiple pregnancy can lead to medical complications for you and your infants. 
• You can reduce the risk of multiple pregnancy by using the right dose of GONAL-F  at the right time.
• When you undergo assisted reproduction , the risk of multiple pregnancy is related to the age, quality and number of fertilized eggs or embryos that are put back into the uterus.

Spontaneous abortion:

• When you undergo assisted reproduction or stimulation of your ovaries to produce eggs, you are at a greater risk of miscarriage than other women.

Problems with blood clotting (thromboembolic events):

• If you have previously or recently had blood clots in your legs or lungs or a heart attack or stroke, or if this has happened to someone in your family, you may be at a higher risk of these problems occurring or getting worse with GONAL-F  treatment .

Men with too much FSH in the blood:

If you are a man, an elevated FSH level in the blood is a sign of testicular damage. 

GONAL-F  usually has no effect in such cases.

To check the treatment, your doctor may ask you to have a semen analysis taken 4 to 6 months after the start of treatment.

Children and youth:

• GONAL-F should not be used by children and adolescents under the age of 18.

Pregnancy and breastfeeding:

• You must not take GONAL-F  if you are pregnant or breastfeeding.

Driving and using machines:

• It is not expected that this medicine will affect the ability to drive and use machines.

Ingredients:

• The active substance is FOLLITROPIN  
• There are 600 IU (44 micrograms) of FOLLITROPIN  alfa per ml of liquid. 
• Each pre-filled pen with multi-dose cartridge delivers 900 IU (66 micrograms) per 1.5 ml.

What  GONAL-F  looks like and the contents of the package:

• GONAL-F is presented as a clear, colorless solution for injection in a pre-filled pen.