150 IU / 0.25 ml, injection solution in prefilled pen
, follitropin alpha
1. What GONAL-f is and what it is used for
What GONAL-f is
GONAL-f contains a medicine called follitropin alfa. Follitropin alfa is a type of “follicle-stimulating hormone” ( FSH ), which belongs to the hormone family “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 who have not responded to treatment with a drug called ‘clomiphene citrate’.
- together with another medicine called “lutropin alfa” ( “Luteinizing Hormone” or LH ) to help release an egg from the ovary (ovulation) in women who are not ovulating because their body is producing very little gonadotropins s ( FSH and LH ).
- to help develop multiple follicles (each containing an egg) in women undergoing assisted reproduction (measures that can help you conceive) such as ” in vitro fertilization”, “gamete transfer to fallopian tubes” or “zygote transfer to fallopian tubes”.
In adult men , GONAL-f is used:
- together with another drug called ‘human chorionic gonadotropin’ ( hCG ) to promote sperm production in men who are infertile due to low levels of certain hormones .
2. What you need to know before using GONAL-f
Before starting treatment, your and your partner’s fertility should be evaluated by a doctor who has experience in assessing fertility disorders.
Do not use GONAL-f:
- if you are allergic to follicle-stimulating hormone or any of the other ingredients of this medicine (listed in section 6.)
- if you have a tumor in your hypothalamus or pituitary gland (both are parts of the brain).
- if you are a woman :
- with large ovaries or fluid-filled blisters in the ovaries (ovarian cysts) of unknown origin
- with unexplained vaginal bleeding
- with cancer of the ovaries, uterus or breasts
- with a condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause) or malformed reproductive organs.
- if you are a man :
- with permanent testicular damage.
Do not use GONAL-f if any of the above apply to you. If you are not sure, talk to your doctor before using this medicine.
Warnings and cautions
Porphyry
Tell your doctor before starting treatment if you or someone in your family has porphyria (an inability to break down porphyrins that can be transmitted from parents to children).
Tell your doctor immediately if:
- your skin becomes brittle and easily gets blisters, especially skin that has often been exposed to sun and / or
- if you get pain in the abdomen, arms or legs.
In the above events, your doctor may recommend that you stop treatment.
Ovarian hyperstimulation syndrome (OHSS)
If you are a woman, this medicine increases the risk of developing OHSS. This is when your follicles develop too much and become large cysts. If you experience lower abdominal pain, rapid weight gain, nausea or vomiting, or difficulty breathing, talk to your doctor immediately, who may ask you to stop using this medicine (see section 4).
If you are not ovulating and if the recommended dose and administration schedule are followed, the occurrence of OHSS is less likely. GONAL-f treatment rarely causes pronounced OHSS unless the drug used for final follicular maturation (containing human chorionic gonadotropin , hCG ) is given. If you develop OHSS, your doctor may not give you any hCG during this treatment cycle and you may be told not to have intercourse or to use barrier contraceptives for at least four days.
Multiple pregnancy
When you use GONAL-f, there is a greater risk that you will become pregnant with more than one child at a time (“multiple births”, usually twins) than if you become pregnant naturally. Multiple pregnancies can cause medical complications for you and your children. You can reduce the risk of multiple pregnancy by using the correct dose of GONAL-f at the right times. When you undergo assisted reproduction, the risk of multiple pregnancies is related to your age, the quality and number of fertilized eggs or embryos that are placed with you.
Miscarriage
When you undergo assisted reproduction or your ovaries are stimulated to produce eggs, you are at greater risk of miscarriage than the average woman.
Problems with blood clots (thromboembolic events)
If you have had blood clots in your legs or lungs before or recently, or a heart attack or stroke , or if someone in your family has had it, the risk of these problems may increase or worsen with GONAL-f treatment.
Men with too much FSH in their blood
If you are a man and have too much FSH in your blood, this could be a sign of damaged testicles. GONAL-f does not work if you have this problem.
If your doctor decides to try treatment with GONAL-f, you may be asked to leave semen for analysis 4 to 6 months after the start of treatment to monitor treatment.
Children
GONAL-f is not intended for use in children.
Other medicines and GONAL-f
Tell your doctor if you are taking, have recently taken or might take any other medicines.
- If you use GONAL-f with other medicines that facilitate ovulation (such as hCG or clomiphene citrate), these may increase the response of your follicles .
- If you are using GONAL-f at the same time as an agonist or antagonist of “gonadotropin-releasing hormone” ( GnRH ) (these medicines lower sex hormone levels and stop ovulation) you may need a higher dose of GONAL-f to produce follicles .
Pregnancy and breastfeeding
Do not use GONAL-f if you are pregnant or breast-feeding.
Driving and using machines
This medicine is not expected to affect your ability to drive or use machines.
GONAL-f contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose , ie essentially ‘sodium-free’.
3. How to use GONAL-f
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Use of this medicine
- GONAL-f is intended to be given by injection just under the skin ( subcutaneously ). The pre-filled pen can be used for several injections .
- The first injection of GONAL-f should be given under the supervision of your doctor.
- Your doctor or nurse will show you how to use the GONAL-f pre-filled pen to inject the medicine.
- If you give GONAL-f to yourself, read carefully and follow the “Instructions for Use”.
How much to use
Your doctor will decide how much medicine to take and how often. The doses shown below are given in International Units (IU).
Women
If you do not ovulate and have irregular or no periods
- GONAL-f is usually given daily.
- 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 a day that suits you.
- The usual starting dose of GONAL-f is 75 to 150 IU each day.
- Dose one of GONAL-f can be increased every 7 or 14 days by 37.5 to 75 IU, until you get the desired answer.
- The maximum daily dose of GONAL-f is usually no higher than 225 IU.
- Once you have received the desired response, you will receive an injection of 250 micrograms of ‘recombinant hCG’ (r- hCG , a laboratory-produced hCG using a special DNA technique) or 5,000 to 10,000 IU of hCG 24 to 48 hours after your last injection of GONAL-f. The best time to have intercourse is the day of hCG – injection one day after.
If your doctor cannot see the desired response after 4 weeks, the GONAL-f treatment cycle should be stopped. In the following treatment cycle, your doctor will give you a higher starting dose of GONAL-f than before.
If your body responds too strongly, treatment will be stopped and you will not receive any hCG (see section 2, OHSS). In the following cycle, your doctor will give you a lower dose of GONAL-f than before.
If you are not ovulating, having no periods and have been diagnosed with very low levels of FSH – and LH – hormone s
- 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.
- Dose one of GONAL-f can be increased every 7 or 14 days by 37.5 to 75 IU, until you get the desired answer.
- Once you have received the desired response, you will receive an injection of 250 micrograms of ‘recombinant hCG’ (r- hCG , a laboratory-produced hCG using a special recombinant DNA technique) or 5,000 to 10,000 IU of hCG 24 to 48 hours after your last injection of GONAL-f and lutropin alfa. The best time to have intercourse is the day of hCG – injection one day after. Alternatively, intrauterine insemination can take place by inserting semen into the uterus.
If your doctor cannot see an answer after 5 weeks, the GONAL-f treatment cycle should be stopped. In the following cycle, your doctor will give you a higher starting dose of GONAL-f than before.
If your body responds too strongly, treatment with GONAL-f will be stopped and you will not receive any hCG (see section 2, OHSS). In the following cycle, your doctor will give you a lower dose of GONAL-f than before.
If you need to develop more eggs for collection before an assisted reproduction
- The usual starting dose of GONAL-f is 150 to 225 IU every day, from day 2 or 3 of the treatment cycle.
- Dose one of GONAL-f may be increased, depending on the treatment response. The maximum daily dose is 450 IU.
- The treatment continues until your eggs have reached the desired development. This usually takes about 10 days, but can take anywhere from 5 to 20 days. Your doctor will use blood samples and / or ultrasound equipment to check when this happens.
- When your eggs are ready, you will receive an injection of 250 micrograms of ‘recombinant hCG’ (r- hCG , a laboratory-produced hCG with a special genetic modification technique) or 5,000 IU to 10,000 IU of hCG 24 to 48 hours after your last injection of GONAL-f. This will get your eggs ready for collection.
Otherwise, your doctor may first stop your ovulation by using a gonadotropin-releasing hormone (GnHR) agonist or antagonist . Thereafter, treatment with GONAL-f is started approximately two weeks after starting agonist therapy. Then, given both GONAL-f and GnRH – agonist one until your follicles develop as desired. For example, after two weeks of treatment with GnRH – agonist , is given 150 to 225 IU of GONAL-f 7 days. Then dose one is adjusted according to the response of your ovaries.
Men
- The usual dose of GONAL-f is 150 IU together with hCG .
- You 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 to use these two medicines for at least 18 months.
If you use more GONAL-f than you should
The effects of too much GONAL-f are unknown. Nevertheless, ovarian hyperstimulation syndrome (OHSS) can be expected to occur. This is described in section 4. However, OHSS only occurs if hCG has also been administered (see section 2, OHSS).
If you forget to use GONAL-f
If you forget to use GONAL-f, do not take a double dose to make up for a forgotten dose . Talk to your doctor as soon as you notice that you have missed a dose .
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Serious side effects are in women
- Lower abdominal pain along with nausea or vomiting may be symptoms of ovarian hyperstimulation syndrome (OHSS). This may indicate that the ovaries are overreacting to the treatment and that large ovarian cysts have developed (see also section 2, under “Ovarian hyperstimulation syndrome (OHSS).” This side effect is common (may affect up to 1 in 10 people).
- OHSS can be pronounced with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing and / or possible fluid accumulation in the abdominal cavity or chest. This side effect is less common (may affect up to 1 in 100 people).
- Complications of OHSS, such as ovarian torsion or blood clots, can occur in rare cases (may affect up to 1 in 1,000 people).
- Severe thrombotic complications (thromboembolic events) sometimes independent of OHSS can occur in very rare cases (may affect up to 1 in 10,000 people). This can cause chest pain, shortness of breath, stroke or heart attack (see also section 2, under “Problems with blood clots (thromboembolic events)”).
Serious side effects are in men and women
- Allergic reactions such as skin rash, reddening of the skin, hives, swelling of the face with difficulty breathing can sometimes be serious. This side effect is very rare (may affect up to 1 in 10,000 people).
If you notice any of the side effects listed above , contact your doctor immediately who may ask you to stop using GONAL-f.
Other side effects are in women
Very common (may affect more than 1 in 10 people):
- Fluid-filled blisters in the ovaries (ovarian cysts)
- Headache
- Local reactions at the injection site, such as pain, redness , bruising, swelling and / or irritation
Common (may affect up to 1 in 10 people):
- Abdominal pain
- Nausea, vomiting, diarrhea, abdominal cramps and flatulence
Very rare (may affect up to 1 in 10,000 people):
- Allergic reactions such as rash, redness of the skin, hives, swelling of the face with difficulty breathing may occur. These side effects can sometimes be serious.
- Your asthma can get worse.
Other side effects are in men
Very common (may affect more than 1 in 10 people):
- Local reactions at the injection site, such as pain, redness , bruising, swelling and / or irritation
Common (may affect up to 1 in 10 people):
- Swollen veins above and behind the testicles (varicocele)
- Development of breasts, acne or weight gain
Very rare (may affect up to 1 in 10,000 people):
- Allergic reactions such as rash, redness of the skin, hives, swelling of the face with difficulty breathing may occur. These side effects can sometimes be serious.
- Your asthma can get worse.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store GONAL-f
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the cartridge, cassette, label after EXP or on the carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C-8 ° C). Do not freeze.
The product can be stored at a maximum of 25 ° C for up to 3 months within the shelf life without being stored in the refrigerator again and must be discarded if it has not been used after 3 months.
Store in the original package. Sensitive to light.
Do not use GONAL-f if you notice visible signs of deterioration, if the liquid contains particles or is not clear.
Write the first use date of the pre-filled pen with GONAL-f. For this purpose, a sticker is included in the “Instructions for use”.
- After opening, the pen can be stored for a maximum of 28 days outside the refrigerator (at a maximum of 25 ° C).
- Do not use medicines left in the pre-filled pen after 28 days.
When the treatment is completed, all unused solution must be discarded.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is follitropin alfa.
- There are 600 IU (44 micrograms) of follitropin alfa in each milliliter of fluid. Each pre- filled pen with flerdoscylinderampull, cartridge contains 150 IU (11 micrograms) in 0.25 ml.
- The other ingredients are poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, concentrated phosphoric acid , sodium hydroxide and water for injections.
What the medicine looks like and contents of the pack
- GONAL-f is supplied as a clear, colorless solution for injection in a pre-filled pen .
- It is delivered in packs of 1 pre-filled pen and 4 disposable needles.
Marketing Authorisation Holder
Merck Europe BV, Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands
Manufacturer
Merck Serono SpA, Via delle Magnolie 15, I-70026 Modugno (Bari), Italy
This leaflet was last modified 12/2019. Further information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Instructions for use
GONAL-f PRE- FILLED INJECTION PEN 150 IU / 0.25 ml
Injection solution in prefilled pen
Follitropin alfa
Content
- How to use the GONAL-f pre-filled pen
- How to use the treatment diary for the GONAL-f pre-filled pen
- Inna n you begin to use your GONAL-f prefilled pen
- Prepare your GONAL-f pre-filled pen for injection
- Set the dose as prescribed by your doctor
- Inject dos en
- After injection one
- Treatment diary for GONAL-f pre-filled pen
Warning! Read this manual before using the GONAL-f pre-filled pen . Follow the instructions carefully as they may differ from your previous injection experience .
1. How to use the GONAL-f pre-filled pen
- Do not share the pen with anyone else. The pen is for subcutaneous injection only .
- The numbers in the dose window indicate international units (IU). Your doctor has told you how many IUs to inject each day.
- The numbers shown in the dosage window help you to:a. Set the prescribed dose .b. Confirm that you have given a complete injection .c. Read the remaining dose to be injected with a second pen .
- Give yourself an injection at the same time each day. Example:
- Your doctor / pharmacist will tell you how many pens you will need to finish your treatment.
2. How to use the treatment diary for the GONAL-f pre-filled pen
On the last page is a treatment diary.
Use the treatment diary to record how many IUs you use each time.
- Record treatment day (1), date (2) and time (3) for injection .
- The volume of your pen (4) is already on the first line of the table.
- Write down your prescribed dose in the column “Prescribed dose ” (5).
- Check that you have set the correct dose before injection (6).
- After injection one, read the figure shown in the dosing window .
- Check that you have received a complete injection (7) or make a note of the number shown in the dose window if it is not “0” (8).
- If necessary, give yourself an injection with a second pen . Set the remaining dose indicated in the column “Amount shown after injection” (8).
- Make a note of the remaining dose in the column ” Amount to inject ” on the next line (6).
| NOTE!If you use the treatment diary to record daily injection (s), you can check every day that you have received the full prescribed dose . |
An example of a treatment diary:
Note: The maximum single dose setting for the 150 IU pen is 150 IU, the maximum single dose setting for the 300 IU pen is 300 IU; the maximum single dose setting for the IU 450 is 450 IU; the maximum single dose setting for the 900 IU pen is 450 IU.
3. Inna n you begin to use your GONAL-f prefilled pen
- Wash your hands with soap and water.
- Find a clean and flat surface .
- Check the expiration date on the pen label.
- Gather everything you need and post it:
| 1. Dose setting button | 5. Threaded needle connection | 9. Internal needle guard |
| 2. Dose Window | 6. Protection for pen | 10. Outer needle guard |
| 3. Flask | 7. Pull-off closure | 11. Alcohol wipes |
| 4. Container | 8. Detachable needle | 12. Container forsharp objects |
4. Prepare your GONAL-f pre-filled pen for injection
4.1. Remove the cover of the pen
4.2. Check that the dosing window is set to “0”.
4.3. Prepare the needle for injection
| NOTE!If the pull-off seal is damaged or loose, do not use the needle. Throw it in a container for sharp objects. Bring out a new needle. |
4.4. Connect the needle
4.5. Look closely at the tip of the needle for a small drop / drops of liquid
- If you notice a small drop / drops of fluid go on to Section 5: Set the dose one prescribed by your doctor. Warning! Check ONLY if there is a drop / drops FIRST using a new GONAL-f prefilled pen to remove air from the system.
| NOTE!If you do not see a small drop / drops at or near the tip of the needle the first time you use a new pen , you must follow the steps on the next page. |
If you do not see a small drop / drops at or near the tip the first time you use a new pen:
- Carefully turn the dose setting knob clockwise until it says 25 in the dose window. You can turn the dose setting knob backwards if you turn it 25.
- Hold the pen with the needle pointing upwards.
- Gently tap the container.
- Press the dose setting button as far as it will go . A small drop of liquid is visible on the tip of the needle.
- Check that it says “0” in the dosing window.
- Proceed to Section 5: Adjust the dose one prescribed by your doctor.
5. Set the dose as prescribed by your doctor
5.1 . The GONAL-f pen contains 150 IU follitropin alfa.
- The maximum single dose setting for the 150 IU pen is 150 IU. The lowest single dose you can set is 12.5 IU and dose one can be increased in increments of 12.5 IU.
5.2 . Turn the dose setting knob until your dose is displayed in the dose window.
| Turn the dose setting knob forward to increase | Turn the dose setting knob backwards to the correct dose |
5.3 . Set the dose prescribed by your doctor (in the example shown in the figure, it is 50 IU).
Warning! Make sure that your full prescribed dose is displayed in the dosing window before proceeding to the next step.
6. Inject dos en
Warning! Always use a new needle for each injection .
7. After injection a
7.1 . Make sure you have given a complete injection .
Warning! If a number higher than “0” appears in the dosing window, the GONAL-f pre-filled pen is empty and you have not received the full prescribed dose .
7.2. End a partial injection (only if necessary)
- The amount that is missing and that you have to inject with a new pen is shown in the dosing window .
- Repeat from section 3 ( “Before you start using your GONAL-f pre-filled pen” ) until section 4 ( “Preparing your GONAL-f pre-filled pen for injection” ) with a second pen .
- Set dose one to the amount that is missing and that you have recorded in the treatment diary or the number that still appears in the dosing window of your previous pen and inject.
7.3. Remove the needle after each injection
7.4. Keep the GONAL-f pre-filled pen
| NOTE!Never store the pen with the needle on.Always remove the needle from the GONAL-f pre-filled pen before replacing the needle cover. |
- Store the pen in the original packaging in a safe place.
- When the pen is empty, ask your pharmacist how to dispose of it.
Warning! Medicines should not be disposed of via wastewater or household waste.
8. Treatment diary for GONAL-f pre-filled pen
Note: The maximum single dose setting for the 150 IU pen is 150 IU; the maximum single dose setting for the 300 IU pen is 300 IU; the maximum single dose setting for the IU 450 is 450 IU; the maximum single dose setting for the 900 IU pen is 450 IU.