Consumer medicine information

Recagon™


Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.


1. Why am I using Recagon?

Recagon contains the active ingredient follitropin beta, a hormone known as follicle stimulating hormone (FSH). Recagon is used to treat infertility in women and men in certain situations.

For more information, see Section 1. Why am I using Recagon? in the full CMI.

2. What should I know before I use Recagon?

Do not use if you have ever had an allergic reaction to Recagon or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Recagon? in the full CMI.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Recagon and affect how it works. For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Recagon?

  • Always use Recagon exactly as your doctor has told you. You should check with your doctor if you are not sure.
  • Your doctor will decide on the dose of Recagon to be given
  • The very first injection of Recagon should be given by a health professional. Recagon solution for injection in cartridges has been developed for use in the Recagon Pen

More instructions can be found in Section 4. How do I use Recagon? in the full CMI.

5. What should I know while using Recagon?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Recagon.
  • See your doctor regularly so you can be monitored closely throughout your treatment.
Things you should not do
  • Do not stop using this medicine suddenly without telling your doctor
  • Do not change the dose unless your doctor tells you to
Driving or using machines
  • Be careful driving or operating machinery until you know how Recagon affects you.
Looking after your medicine
  • Store Recagon in a refrigerator (2-8°C). Do not freeze. Use until the expiry date printed on the label, or
  • Store at room temperature (at or below 25°C) for a single period of not more than 3 months.

Once you have started using a cartridge, store below 25°C (do not freeze) for a maximum of 28 days.

For more information, see Section 5. What should I know while using Recagon? in the full CMI.

6. Are there any side effects?

In women, common side effects are headache, injection site reactions, overly stimulated ovaries, pelvic pain, stomach pain or bloating. Serious side effects may include signs of a blood clot (i.e., pain in arm or leg, dizziness, severe headache). In men, common side effects are acne, hardening of injection site, headache, rash, some breast development, testicular cyst. Other side effects not listed in this leaflet also occur in some people.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Recagon™

Active ingredient(s): follitropin beta[rch]


Consumer Medicine Information (CMI)

This leaflet provides important information about using Recagon. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Recagon.

Where to find information in this leaflet:

1. Why am I using Recagon?
2. What should I know before I use Recagon?
3. What if I am taking other medicines?
4. How do I use Recagon?
5. What should I know while using Recagon?
6. Are there any side effects?
7. Product details

1. Why am I using Recagon?

Recagon contains the active ingredient follitropin beta, a hormone known as follicle stimulating hormone (FSH).

FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction. FSH is needed in women for the growth and development of follicles in the ovaries. Follicles are small round sacs that contain the egg cells.

In men, FSH is needed for the production of sperm.

Recagon is used to treat infertility in any of the following situations:

Women:

  • Recagon can be used to cause ovulation in women who have not responded to treatment with clomiphene citrate.
  • Recagon can be used to bring about the development of multiple follicles in women undergoing assisted reproduction technologies (ART) such as in vitro fertilisation (IVF).

Men:

  • Recagon can be used for the production of sperm in men who are infertile due to a hormonal deficiency.

Recagon is not addictive.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What should I know before I use Recagon?

Warnings

Do not use Recagon if:

  • you are allergic (hypersensitive) to follitropin beta, or any of the ingredients listed at the end of this leaflet.
  • have a tumour of the ovary, breast, uterus, testis, or brain (pituitary gland or hypothalamus)
  • are pregnant or think you may be pregnant
  • have heavy or irregular vaginal bleeding where the cause is not known
  • suffer from primary ovarian failure
  • have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD)
  • have malformations of the sexual organs which make a normal pregnancy impossible
  • have fibroid tumours in the uterus which make a normal pregnancy impossible
  • suffer from primary testicular failure.

Tell your doctor if you:

  • have experienced an allergic reaction to neomycin and/or streptomycin (antibiotics) in the past. Recagon may contain traces of these antibiotics
  • have ever had ovarian hyperstimulation syndrome (OHSS)
  • are pregnant or think that you may be pregnant
  • have ever had stomach (abdominal) surgery
  • have ever had a twisting of an ovary
  • have past or current cysts in your ovary or ovaries
  • you have uncontrolled pituitary gland or hypothalamic problems
  • have an underactive thyroid gland (hypothyroidism)
  • have adrenal glands that are not working properly (adrenocortical insufficiency)
  • have high prolactin levels in the blood (hyperprolactinemia)
  • have been told by a doctor that pregnancy would be dangerous for you
  • have any other medical conditions (for example, diabetes, heart disease, or any other long-term disease).

Tell your doctor if you have or have had any of the following medical conditions:

  • thyroid disorder
  • adrenal gland disorder
  • ovarian cyst
  • cancer or a tumour of the breast, ovary, uterus, prostate, hypothalamus or pituitary gland
  • polycystic ovarian disease (irregular or no periods, acne, obesity, excess hair growth)
  • unexplained vaginal bleeding.

If you have any of the above conditions, tell your doctor before you start to use Recagon.

Tell your doctor if you have or have had any other medical conditions.

Pregnancy and breastfeeding

Ask your doctor for advice before taking any medicine. You should not use Recagon if you are already pregnant, or suspect that you might be pregnant.

After treatment with gonadotrophic preparations, there is an increased risk of having multiple pregnancies, even when only one embryo is transferred into the uterus. Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth.

Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e.g., age of the female, sperm characteristics, genetic background of both parents) may be associated with an increased risk of birth defects.

Generally in women undergoing fertility treatment there may be a slightly higher risk of miscarriage.

There is a slightly increased risk of a pregnancy outside of the uterus (an ectopic pregnancy). Therefore, your doctor should perform an early ultrasound examination to exclude the possibility of pregnancy outside the uterus.

Talk to your doctor if you are breastfeeding or intend to breastfeed

In Women

Close supervision by your doctor is very important. Usually ultrasound scans of the ovaries are regularly made. Your doctor may also check blood hormone levels. The results of these tests allow your doctor to choose the correct dose of Recagon from day to day. This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries are overly stimulated and the growing follicles become larger than normal.

This serious medical condition is called ovarian hyperstimulation syndrome (OHSS).

In rare cases, severe OHSS may be life-threatening. OHSS causes fluid to build up suddenly in your stomach and chest areas and can cause blood clots to form.

Call your doctor right away if you have:

  • severe abdominal swelling
  • pain in the stomach (abdomen), even if this occurs dome days after the last injection has been given
  • nausea (feeling sick)
  • vomiting
  • sudden weight gain
  • diarrhoea
  • decreased urine output
  • trouble breathing.

Regular monitoring of the response to FSH-treatment helps to prevent ovarian overstimulation.

Ovarian Torsion

Ovarian torsion has occurred after treatment with gonadotrophins including Recagon. Ovarian torsion is the twisting of an ovary. Twisting of the ovary could cause the blood flow to the ovary to be cut off.

Before starting this medicine it is important to inform your doctor if you:

  • have ever had ovarian hyperstimulation syndrome (OHSS)
  • are pregnant or think that you may be pregnant
  • have ever had stomach (abdominal) surgery
  • have ever had a twisting of an ovary
  • have past or current cysts in your ovary or ovaries

Blood clot

Treatment with Recagon (like pregnancy itself) may increase the risk of having a blood clot (thrombosis). Thrombosis is the formation of a blood clot in a blood vessel.

  • Blood clots can lead to serious medical conditions, such as:
    – blockage in your lungs (pulmonary embolus)
    – stroke
    – heart attack
    – blood vessel problems (thrombophlebitis)
    – a lack of blood flow (deep venous thrombosis) that may result in a loss of your arm or leg.

Please discuss this with your doctor, before starting treatment, especially if:

  • you already know you have an increased risk of thrombosis
  • you, or anyone in your immediate family, have ever had a thrombosis
  • you are severely overweight.

Ovarian and other reproductive system tumours

There have been reports of ovarian and other reproductive system tumours in women who have had infertility treatment. It is not known if treatment with fertility medicines increases the risk of these tumours in infertile women.

Other medical conditions

You have been told by a doctor that pregnancy would be dangerous for you.

In Men

Elevated FSH blood levels are indicative of testicular damage. Recagon is usually not as effective in such cases. To monitor your treatment, your doctor may ask you for a semen analysis to be performed 4 to 6 months after the beginning of treatment.

Do not use Recagon if the packaging is torn or shows signs of tampering.

Do not use Recagon after the expiry date printed on the pack has passed.

If it has expired or is damaged, return it to your pharmacist or clinic for disposal.

Talk to your doctor if you are not too sure about using Recagon.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

4. How do I use Recagon?

How to inject Recagon

  • The very first injection of Recagon should be given by a health professional.
  • Recagon solution for injection in cartridges has been developed for use in the Puregon Pen. The separate instructions for using the pen must be followed carefully. Do not use the cartridge if the solution contains particles or if the solution is not clear.
  • Using the pen, injections just under the skin (in the stomach or thigh) can be given by you or your partner. Your doctor will tell you when and how to do this. When the instructions are followed carefully, Recagon will be administered properly and with minimal discomfort.

How much to inject

  • Your doctor will decide on the dose of Recagon to be given. This dose may be adjusted as your treatment progresses.
  • There are large differences between women in the response of the ovaries to FSH. This makes it impossible to set a dosage schedule which is suitable for all patients. To find the right dosage, follicle growth is checked by means of ultrasound scanning and measurement of the amount of oestradiol (female sex hormone) in the blood.
  • Follow the instructions provided and use Recagon until your doctor tells you to stop.

The following is a guide to the usual dose:

  • Women who are not ovulating
    Initially, a starting dose is set by your doctor. This dose is continued for at least seven days. If there is no response, the daily dose will be gradually increased until an adequate response is obtained. The daily dose is then maintained until a follicle of adequate size is present.
    An hCG injection (to stimulate ovulation) is given after the last Recagon injection.
  • Women undergoing assisted reproductive technologies
    A starting dose is set by your doctor. This dose is continued for at least the first four days. The dose may be adjusted according to your response. When a sufficient number of follicles of adequate size are present, the final phase of maturation of the follicles is induced by administration of hCG. Oocyte (egg) retrieval is performed 34-35 hours later.
  • Men
    Recagon is usually prescribed at a dose of 75 IU daily or 2-3 times a week, in combination with another hormone (hCG) for at least 3 months.

If you forget to use Recagon

  • If you forget an injection or are not sure what to do, contact your doctor or nurse immediately for advice. Do not double the dose on any day.

If you inject too much Recagon

If you think that you have used too much Recagon, you may need urgent medical attention.

You should immediately:

  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital, or
  • phone the Poisons Information Centre
    (by calling 13 11 26), for advice.

You should do this even if there are no signs of discomfort or poisoning.

In females, too high a dose may cause overstimulation of the ovaries (Ovarian Hyperstimulation Syndrome, OHSS) (see Section 6. Are there any side effects?).

5. What should I know while using Recagon?

Things you should do

See your doctor regularly so you can be monitored closely throughout your treatment.

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Recagon.

If you plan to have surgery, tell your doctor or dentist that you are using Recagon.

Tell all doctors and dentists who are treating you that you are using Recagon.

Things you should not do

Do not stop using Recagon without telling your doctor.

Do not change the dose unless your doctor tells you to.

Changing your dose without telling your doctor can increase your risk of unwanted side effects or can prevent the drug from working properly.

Do not give your medicine to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Recagon affects you.

As far as is known, Recagon has no effect on alertness and concentration.

Looking after your medicine

  • Store Recagon in a refrigerator (2°C – 8°C). Do not freeze. Use until the expiry date printed on the label, or
  • Store at room temperature (at or below 25°C) for a single period of not more than 3 months. Make a note of when you start storing Recagon out of the refrigerator.

Storage after first dose:

Once you have started using a cartridge, store below 25°C (do not freeze) for a maximum of 28 days.

Follow the instructions in the carton on how to take care of your medicine properly.

Keep it where young children cannot reach it.

When to discard your medicine

Do not use Recagon after the expiry date stated on the label after the term ‘Expiry Date’.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

Tell your doctor as soon as possible if you do not feel well while you are using Recagon. All medicines can have side effects. Sometimes they are serious, most of the time they are not.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects What to do
  • Bruising, pain, redness, swelling and itching at the injection site
  • Skin rash

For Women
Common side effects (likely to affect 1 to 10 users in 100):

  • Headache
  • Injection site reactions (such as bruising, pain, redness, swelling and itching)
  • Ovarian hyperstimulation syndrome (OHSS)
  • Pelvic pain
  • Stomach pain and/or bloating

Uncommon side effects (likely to affect 1 to 10 users in 1,000):

  • Ovarian torsion (twisting of the ovary) resulting in extreme lower stomach pain
  • Breast complaints (including tenderness)
  • Diarrhoea, constipation or stomach discomfort
  • Enlargement of the uterus
  • Feeling sick
  • Hypersensitivity reactions (such as rash, redness, hives and itching)
  • Ovarian cysts or enlargement of the ovaries
  • Vaginal bleeding

For men
Common side effects (likely to affect 1 to 10 users in 100):

  • Acne
  • Hardening of the injection site
  • Headache
  • Rash
  • Some breast development
  • Testicular cyst
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects What to do
  • Signs of an allergic reaction such as shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
  • Sudden severe allergic reactions have been reported in users of Recagon. Reactions may include breathing difficulty, swelling, hives, light-headedness, fast heartbeat, sweating, and loss of consciousness. Frequency cannot be estimated from the available data.

For Women

  • Signs of a blood clot such as pain, warmth, redness, numbness, or tingling in your arm or leg; confusion, extreme dizziness or severe headache. This condition is rare.
  • stomach pains or any of the other symptoms of ovarian hyperstimulation (see below section)
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

A complication with FSH treatment is unwanted overstimulation of the ovaries.

The first symptoms of ovarian overstimulation may be noticed as pain in the stomach (abdomen), feeling sick or diarrhoea.

Ovarian overstimulation may develop into a serious medical condition called ovarian hyperstimulation syndrome (OHSS). Signs and symptoms of severe OHSS may include:

  • Acute stomach pain, weight gain (due to the accumulation of fluid in the abdomen and/or chest), shortness of breath and passing less urine
  • In rare cases blood clots. Signs of a blood clots include pain, warmth, redness, numbness, or tingling in your arm or leg; confusion, extreme dizziness or severe headache.

Tell your doctor immediately or go to the Emergency Department at your nearest hospital if you have stomach pains or any of the other symptoms of ovarian hyperstimulation, even if they develop some days after the last injection has been given.

The following side effects are not considered to be related to the use of Recagon, but to Assisted Reproductive Technology (ART) or subsequent pregnancy:

  • Miscarriage
  • Ectopic pregnancy (pregnancy that occurs outside the uterus)
  • Multiple pregnancies.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Recagon contains

Active ingredient
(main ingredient)
Follitropin beta, a hormone known as follicle-stimulating hormone (FSH), at a strength of 833 IU/mL aqueous solution per cartridge.
One cartridge of Recagon contains the following amounts of Recagon solution:

  • 0.480 mL equal to a net dose of 300 IU
  • 0.840 mL equal to a net dose of 600 IU
  • 1.230 mL equal to a net dose of 900 IU
Other ingredients
(inactive ingredients)
  • sucrose
  • sodium citrate
  • methionine
  • polysorbate 20
  • benzyl alcohol
  • water for injections.

The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid anhydrous.

Do not take this medicine if you are allergic to any of these ingredients.

What Recagon looks like

Recagon 300 IU, 600 IU and 900 IU is available in packs containing one cartridge.

Recagon 300 IU: AUST R 393991

Recagon 600 IU: AUST R 393992

Recagon 900 IU: AUST R 393993

Who distributes Recagon

Organon Pharma Pty Ltd
Building A
26 Talavera Road
Macquarie Park, NSW 2113
Australia

This leaflet was prepared in December 2023.

S-CCPPI-OGMK8328-SOi-082023

RCN100003506-AU

Published by MIMS February 2024