Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Ovitrelle 250 micrograms/0.5 ml prefilled pen
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Choriogonadotropin alfa may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
What Ovitrelle is Ovitrelle contains a medicine called 'choriogonadotropin alfa', made in a laboratory by a special recombinant DNA technique. Choriogonadotropin alfa is similar to a hormone found naturally in your body called 'chorionic gonadotropin', which is involved in reproduction and fertility. What Ovitrelle is used for Ovitrelle is used together with other medicines: • To help develop and ripen several follicles (each containing an egg) in women undergoing assisted reproductive technologies (procedure that may help you to become pregnant) such as 'in vitro fertilisation'. Other medicines will be given first to bring about the growth of several follicles. • To help release an egg from the ovary (ovulation induction) in women who cannot produce eggs ('anovulation'), or women who produce too few eggs ('oligo-ovulation'). Other medicines will be given first to develop and ripen the follicles.
2.
What do you need to know before you use Ovitrelle
Do not use Ovitrelle • • • • • •
if you are allergic to choriogonadotropin alfa or any of the other ingredients of this medicine (listed in section 6). if you have a tumour in your hypothalamus or pituitary gland (both are parts of the brain). if you have large ovaries or sacs of fluid within the ovaries (ovarian cysts) of unknown origin. if you have unexplained vaginal bleeding. if you have cancer of your ovaries, womb or breast. if you have severe inflammation of your veins or blood clotting in your veins (active thromboembolic disorders).
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•
if you have any condition that usually makes a normal pregnancy impossible, such as menopause or early menopause (ovarian failure), or malformations of sexual organs.
Do not use Ovitrelle if any of the above applies to you. If you are not sure, talk to your doctor before using this medicine. Warnings and precautions Before the treatment is started, your and your partner's fertility should be evaluated by a doctor experienced in the treatment of fertility problems. Ovarian hyperstimulation syndrome (OHSS) This medicine may increase your risk of developing OHSS. This is when your follicles develop too much and become large cysts. If you get lower abdominal pain, gain any weight rapidly, feel sick or are vomiting, or have difficulty in breathing, do not give yourself the Ovitrelle injection and talk to your doctor straight away (see section 4). If you are developing OHSS, you may be told not to have sex or to use a barrier contraceptive method for at least four days. The risk of OHSS is reduced if the usual dose of Ovitrelle is used, and if you are monitored closely throughout your treatment cycle (e.g. blood tests for estradiol levels and ultrasound). Multiple pregnancy and/or birth defects When using Ovitrelle, you have a higher risk of being pregnant with more than one child at the same time ('multiple pregnancy', usually twins) than if you conceived naturally. Multiple pregnancy may lead to medical complications for you and your babies. When undergoing assisted reproductive technologies, the risk of having a multiple pregnancy is related to your age, the quality and the number of fertilised eggs or embryos placed inside you. Multiple pregnancies and specific characteristics of couples with fertility problems (e.g. age) may also be associated with an increased chance of birth defects. The risk of multiple pregnancy is reduced if you are monitored closely throughout your treatment cycle (e.g. blood tests for estradiol levels and ultrasound). Ectopic pregnancy Pregnancy outside of the womb (an ectopic pregnancy) may occur in women with damaged fallopian tubes (the tubes which carry the egg from the ovary to the womb). Therefore, your doctor should perform an early ultrasound examination to rule out the possibility of pregnancy outside the womb. Miscarriage When undergoing assisted reproductive technologies or stimulation of your ovaries to produce eggs, you are more likely to have a miscarriage than the average woman. Blood clotting problems (thromboembolic events) Talk to your doctor before using Ovitrelle if you or a member of your family have ever had blood clots in the leg or in the lung, or a heart attack or stroke. You may be at a higher risk of serious blood clots or existing clots might become worse with Ovitrelle treatment.
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Tumours of sexual organs There have been reports of tumours in the ovaries and other sex organs, both benign and malignant, in women who have undergone multiple regimens for infertility treatment. Pregnancy tests If you do a pregnancy test with serum or urine after use of Ovitrelle, and up to ten days later, it may happen that you get a false positive test result. If you are not sure, talk to your doctor. Children and adolescents Ovitrelle is not for use in children and adolescents. Other medicines and Ovitrelle Tell your doctor if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding Do not use Ovitrelle if you are pregnant or breast-feeding. If you are pregnant or breast-feeding, ask your doctor for advice before taking this medicine. Driving and using machines It is not expected that Ovitrelle will affect your ability to drive and use machines. Ovitrelle contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodiumfree".
3.
How to take it
Ovitrelle
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. How much to use • •
The recommended dose is 1 pre-filled pen (250 micrograms/0.5 mL) given as a single injection. Your doctor will explain to you exactly when to give the injection.
Using this medicine • • • • • •
If you administer Ovitrelle to yourself, please carefully read and follow the "Instructions for use". Ovitrelle is intended to be given by injection under the skin (subcutaneously). Each pre-filled pen is for single use only. Your doctor or nurse will show you how to use the Ovitrelle pre-filled pen to inject the medicine. Inject Ovitrelle as your doctor or nurse taught you. After the injection, dispose of the used needle safely, and discard the pen.
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If you use more Ovitrelle than you should The effects of an overdose of Ovitrelle are unknown, nevertheless there is a possibility that ovarian hyperstimulation syndrome (OHSS) may occur, which is further described in section 4. If you forget to use Ovitrelle If you forget to use Ovitrelle, please talk to your doctor as soon as you notice. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Ovitrelle and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment: • Allergic reactions such as rash, fast or uneven pulse, swelling of your tongue and throat, sneezing, wheezing, or serious breathing difficulty are very rare (may affect up to 1 in 10,000 people). • Lower abdominal pain, abdominal distension or abdominal discomfort together with nausea (feeling sick) or vomiting may be the symptoms of ovarian hyperstimulation syndrome (OHSS). This may indicate that the ovaries over-reacted to the treatment and that large ovarian cysts developed (see also in section 2. under "Ovarian hyperstimulation syndrome"). This event is common (may affect up to 1 in 10 people). • The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and possible fluid accumulation in your stomach or chest. This event is uncommon (may affect up to 1 in 100 people). • Serious blood clotting complications (thromboembolic events) sometimes independent of OHSS may be found very rarely. This could cause chest pain, breathlessness, stroke or heart attack (see also in section 2. under "Blood clotting problems"). Other side effects Common (may affect up to 1 in 10 people) • Headache. • Local reactions at the injection site, such as pain, redness or swelling. Uncommon (may affect up to 1 in 100 people) • Diarrhoea. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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5.
How to store it
Ovitrelle
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 label and carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2°C-8°C). Do not freeze. Do not use Ovitrelle if you notice any signs of deterioration, if the liquid contains particles or is not clear. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer used. These measures will help to protect the environment.
6.
Contents of the pack and other information
What Ovitrelle contains • • •
The active substance is choriogonadotropin alfa, produced by recombinant DNA technology. Each pre-filled pen contains 250 micrograms choriogonadotropin alfa in 0.5 mL (equivalent to approximately 6,500 International Units, IU). The other ingredients are mannitol, methionine disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, poloxamer 188, phosphoric acid (for pH adjustment), sodium hydroxide (for pH adjustment) and water for injections.
What Ovitrelle looks like and contents of the pack • • •
Ovitrelle comes as a clear, colourless to slightly yellow liquid for injection in a pre-filled pen. Each pen contains 0.5 mL of solution. It is supplied in packs of 1 pre-filled pen and 2 injection needles (one spare).
Marketing Authorisation Holder Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK Manufacturer Merck Serono S.p.A., Via delle Magnolie 15, 70026 Modugno (Bari), Italy
This leaflet was last revised in 07/2025
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INSTRUCTIONS FOR USE Ovitrelle 250 micrograms Solution for injection in pre-filled pen Choriogonadotropin alfa
Important information about the Ovitrelle pre-filled pen • • • • • • •
Read the Instructions for Use and the Package Leaflet before using your Ovitrelle pre-filled pen. Always follow all directions in this Instructions for Use and training provided by your healthcare provider as they may differ from your past experience. This information will allow to prevent incorrect treatment or infection by needle stick or broken glass injury. The Ovitrelle pre-filled pen is for subcutaneous injection only. The Ovitrelle pre-filled pen is for single use only. Each Ovitrelle pre-filled pen pack contains one needle for your injection and one spare needle. Only use the Ovitrelle pre-filled pen if your healthcare provider trains you on how to use it correctly. Store in a refrigerator.
Do not freeze Do not share the pen and/or needles with another person Do not use the Ovitrelle pre-filled pen if it has been dropped, or the pen is cracked or damaged as this can cause injury.
Get familiar with your Ovitrelle pre-filled pen
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Step 1 Gather your supplies 1.1
Prepare a clean area and a flat surface, such as a table or countertop, in a well-lit area.
1.2
You will also need (not included in the pack):
- Alcohol swabs and a sharps container (Figure 1)
1.3
Wash your hands with soap and water and dry them well (Figure 2).
1.4
Use your hand to remove the Ovitrelle pre-filled pen from the pack.
Do not use any tools, using tools might damage the pen. 1.5 1.6
Check the name on the pre-filled pen says Ovitrelle. Check the expiration date on the pen label (Figure 3).
Do not use the Ovitrelle pre-filled pen if the expiration date has passed or if your pre-filled pen does not say Ovitrelle.
Step 2 Get ready for injection 2.1 2.2
Pull-off the pen cap (Figure 4). Check that medicine is clear, colourless to slightly yellow and does not contain particles. Do not use the pre-filled pen if the medicine is discolored or cloudy, as this can cause an infection. Choose your injection site: 2.3 Your healthcare provider should show you the injection sites to use around your stomach area (Figure 5). 2.4 Clean the skin at the injection site by wiping with an alcohol swab. Do not touch or cover the cleaned skin.
Step 3 Attach your needle 3.1 3.2 3.3
Get a new needle. Only use one of the single-use needles supplied. Check that the outer needle cap is not damaged. Hold the outer needle cap firmly.
3.4
Check that the peel-off seal on the outer needle cap is not damaged or loose, and that the expiration date has not passed. (Figure 6).
3.5
Remove the peel-off seal (Figure 7).
Do not use the needle if it is damaged, expired or if the outer needle cap or the peel-off seal is damaged or loose. Using expired needles or needles with damaged peel-off seal or outer needle cap can lead to infection. Throw it away in a sharps container, and use the other needle provided in the pack. 7
Ask your healthcare provider if you have questions. 3.6
Screw the outer needle cap onto the threaded needle connector of the Ovitrelle pre-filled pen until you feel a light resistance (Figure 8).
Do not attach the needle too tightly; the needle could be difficult to remove after the injection. 3.7
Remove the outer needle cap by pulling it gently (Figure 9).
3.8
Put it aside for later use (Figure 10).
Do not discard the outer needle cap, as it will prevent needle stick injury and infection when detaching the needle from the pre-filled pen. 3.9
Hold the Ovitrelle pre-filled pen with the needle pointing upward (Figure 11). 3.10 Carefully remove and discard the inner shield (Figure 12). Do not recap the needle with the inner shield, as it can lead to needle stick injury and infection. 3.11 Look closely at the tip of the needle for tiny droplet(s) of liquid (Figure 13). If You see a tiny droplet of liquid
Then Proceed directly to Step 4: Dial the dose to 250.
You do not see a tiny droplet at or near the needle tip
You must perform the steps in the following section to remove air in the system.
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If you do not see a tiny droplet(s) of liquid at or near the tip when you use a new pen:
1.
Gently turn the dose setting knob forward until you see a dot (●) in the Dose Feedback Window (Figure 14).
- You can turn the dose setting knob backward if you turn it past the dot (●).
2. 3. 4.
Hold the pen with the needle pointing upward. Tap the reservoir holder gently (Figure 15). Press the dose setting knob as far as it will go. A tiny droplet of liquid will appear at the top of the needle (Figure 16)*. Check that the Dose Feedback Window reads "0" (Figure 17).
5.
*Note: If you do not see any liquid, you may restart at step 1(in this section) one more time only. If a tiny droplet of liquid does not appear the second time either, contact your healthcare provider.
Step 4 Dial the dose to 250 Gently turn the dose setting knob forward until "250" shows in the Dose Feedback Window.
- The Dose Feedback Window will show a straight line while turning until you can read the number '250' (Figure 18). Do not push or pull the dose setting button while you turn it. 4.1
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4.2
Check that the Dose Feedback Window displays "250" (Figure 19) before you move on to Step 5 below.
Contact your healthcare provider if you need help.
Step 5 Inject your dose Important: Inject the dose as you were trained to do by your healthcare provider. 5.1
Slowly push the needle into the skin entirely (Figure 20).
5.2
Place your thumb in the middle of the dose setting knob. Slowly press the dose knob down as far as it will go and hold it to complete the full injection (Figure 21).
5.3
Hold the dose knob down for a minimum of 5 seconds before you remove the needle from your skin (Figure 22).
- The dose number shown in the Dose Feedback Window will turn back to "0".
- After a minimum of 5 seconds, pull the needle out of the skin while keeping the dose setting knob pressed down (Figure 23).
- When the needle is out of the skin, release the dose setting knob.
Do not release the dose knob until you remove the needle from the skin.
Step 6 Remove the needle after your injection 6.1
Place the outer needle cap on a flat surface.
6.2
Hold the Ovitrelle pre-filled pen firmly with one hand and slip the needle into the outer needle cap (Figure 24). Continue by pushing the capped needle against a firm surface until you hear a "click" (Figure 25). Grip the outer needle cap and unscrew the needle by turning it in the opposite direction (Figure 26). Dispose of the used needle safely in a sharps container (Figure 27). Handle the need with care to avoid getting injured by the needle.
6.3 6.4 6.5
Do not reuse or share any needle with another person.
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Step 7 After the injection 7.1
Check you have given a complete injection:
- Check that the Dose Feedback Window shows "0" (Figure 28)
If the Dose Feedback Window shows "0", you have completed your dose. If the Dose Feedback Window does not show "0", please contact your healthcare provider. Do not attempt to inject a second time.
Step 8 Dispose of the Ovitrelle pre-filled pen Important: The Ovitrelle pre-filled pen and needles supplied are single-use only. 8.1
Put the pen cap back onto the pen (Figure 29).
8.2
Ask your healthcare provider how to dispose of the empty Ovitrelle pre-filled pen.
Contact your healthcare provider if you have questions.
This Instructions for Use was last revised in: 07/2025
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Frequently asked questions about Ovitrelle 250 micrograms/0.5 ml prefilled pen
What is the active substance in Ovitrelle 250 micrograms/0.5 ml prefilled pen?
The active substance in Ovitrelle 250 micrograms/0.5 ml prefilled pen is choriogonadotropin alfa.
Are there equivalent medicines to Ovitrelle 250 micrograms/0.5 ml prefilled pen?
Medicines with the same active substance, strength and form include: Ovitrelle 250 micrograms/0.5 ml prefilled syringe. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Ovitrelle 250 micrograms/0.5 ml prefilled pen, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Ovitrelle 250 micrograms/0.5 ml prefilled pen without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: choriogonadotropin alfa
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Ovitrelle is indicated in the treatment of:
• Adult women undergoing superovulation prior to assisted reproductive technologies (ART) such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth,
• Anovulatory or oligo-ovulatory adult women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory women after stimulation of follicular growth.
4.2. Posology and method of administration
Treatment with Ovitrelle should be performed under the supervision of a physician experienced in the treatment of fertility problems.
Posology
The maximum dose is 250 micrograms. The following dose regimen should be used:
• Women undergoing superovulation prior to assisted reproductive technologies (ART) such as in vitro fertilisation (IVF):
One pre-filled pen of Ovitrelle (250 micrograms) is administered 24 to 48 hours after the last administration of a follicle stimulating hormone (FSH) or human menopausal gonadotropin (hMG) preparation, i.e. when optimal stimulation of follicular growth is achieved.
• Anovulatory or oligo-ovulatory women:
One pre-filled pen of Ovitrelle (250 micrograms) is administered 24 to 48 hours after optimal stimulation of follicular growth is achieved. The patient is recommended to have coitus on the day of, and the day after, Ovitrelle injection.
Special populations
Renal or hepatic impairment
Safety, efficacy and pharmacokinetics of Ovitrelle in patients with renal or hepatic impairment have not been established.
Paediatric population
There is no relevant use of Ovitrelle in the paediatric population.
Method of administration
For subcutaneous use. Self-administration of Ovitrelle should only be performed by patients who are adequately trained and have access to expert advice.
Ovitrelle is for single use only.
For instructions on the administration with the pre-filled pen, see section 6.6 and the “Instructions for use” provided in the carton.
4.3. Contraindications
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
• Tumours of the hypothalamus or pituitary gland
• Ovarian enlargement or cyst unrelated to polycystic ovarian syndrome
• Gynaecological haemorrhages of unknown aetiology
• Ovarian, uterine or mammary carcinoma
• Active thromboembolic disorders
Ovitrelle must not be used in conditions when an effective response cannot be obtained, such as
• primary ovarian failure
• malformations of sexual organs incompatible with pregnancy
• fibroid tumours of the uterus incompatible with pregnancy
• postmenopausal women
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
General precautions
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
There is no clinical experience with Ovitrelle in the treatment of other conditions (such as corpus luteum insufficiency or male conditions); therefore, Ovitrelle is not indicated in these conditions.
Ovarian hyperstimulation syndrome (OHSS)
A certain degree of ovarian enlargement is an expected effect of controlled ovarian stimulation. It is more commonly seen in women with polycystic ovarian syndrome and usually regresses without treatment.
In distinction to uncomplicated ovarian enlargement, OHSS is a condition that can manifest itself with increasing degrees of severity. It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
Mild manifestations of OHSS may include abdominal pain, abdominal discomfort and distension, and enlarged ovaries. Moderate OHSS may additionally present with nausea, vomiting, ultrasound evidence of ascites and marked ovarian enlargement.
Severe OHSS further includes symptoms such as severe ovarian enlargement, weight gain, dyspnoea or oliguria. Clinical evaluation may reveal signs such as hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, pleural effusions, or acute pulmonary distress. Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events, such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotropins, high absolute or rapidly rising serum estradiol levels and previous episodes of OHSS, large number of developing ovarian follicles and large number of oocytes retrieved in ART cycles.
Adherence to recommended Ovitrelle dosage and regimen of administration can minimise the risk of ovarian hyperstimulation. Monitoring of stimulation cycles by ultrasound scans as well as estradiol measurements are recommended to early identify risk factors.
There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs. Therefore, if signs of ovarian hyperstimulation occur, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or use barrier contraceptive methods for at least 4 days.
As OHSS may progress rapidly (within 24 hours) or over several days to become a serious medical event, patients should be followed for at least two weeks after hCG administration.
Mild or moderate OHSS usually resolves spontaneously. If severe OHSS occurs, it is recommended that gonadotropin treatment be stopped and that the patient be hospitalised and appropriate therapy be started.
Multiple pregnancy
In patients undergoing induction of ovulation, the incidence of multiple pregnancy and births is increased compared with natural conception. The majority of multiple conceptions are twins. Multiple pregnancies, especially high order, carry an increased risk of adverse maternal and perinatal outcomes.
To minimise the risk of higher order multiple pregnancy, careful monitoring of ovarian response is recommended. In patients undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age.
Pregnancy loss
The incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction or ART than following natural conception.
Ectopic pregnancy
Women with a history of tubal disease are at increased risk for ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments. The prevalence of ectopic pregnancy after ART in this population was reported to be higher than in the general population.
Congenital malformations
The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions. This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and the higher incidence of multiple pregnancies.
Thromboembolic events
In women with recent thromboembolic disease or women with generally recognised risk factors for thromboembolic events, such as personal or family history, treatment with gonadotropins may further increase the risk for aggravation or occurrence of such events. In these women, the benefits of gonadotropin administration need to be weighed against the risks. It should be noted, however, that pregnancy itself as well as OHSS also carry an increased risk of thromboembolic events.
Reproductive system neoplasms
There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility. It is not yet established whether or not treatment with gonadotropins increases the risk of these tumours in infertile women.
Interference with serum or urinary testing
Following administration, Ovitrelle may interfere for up to ten days with the immunological determination of serum or urinary hCG, potentially leading to a false positive pregnancy test.
Patients should be made aware of this.
Sodium content
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
4.5. Interaction with other medicinal products and other forms of interaction
No specific interaction studies with Ovitrelle and other medicinal products have been performed; however, no clinically significant medicinal product interactions have been reported during hCG therapy.
4.6. Fertility, pregnancy and lactation
Pregnancy
There is no indication for the use of Ovitrelle during pregnancy. Data on a limited number of exposed pregnancies indicate no increased risks of malformation or foeto/neonatal toxicity. No reproduction studies with choriogonadotropin alfa in animals were performed (see section 5.3). The potential risk for humans is unknown.
Breast-feeding
Ovitrelle is not indicated during breastfeeding. There are no data on the excretion of choriogonadotropin alfa in milk.
Fertility
Ovitrelle is indicated for use in infertility (see section 4.1).
4.7. Effects on ability to drive and use machines
Ovitrelle has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
In comparative trials with different doses of Ovitrelle, OHSS was found to be associated with Ovitrelle in a dose-related fashion. OHSS was observed in approximately 4% of patients treated with Ovitrelle. Severe OHSS was reported in less than 0.5% of patients (see section 4.4).
List of adverse reactions
The following definitions apply to the frequency terminology used hereafter: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Immune system disorders
Very rare:
Mild to severe hypersensitivity reactions including rash, anaphylactic reactions and shock
Nervous system disorders
Common:
Headache
Vascular disorders
Very rare:
Thromboembolism (both in association with and separate from OHSS)
Gastrointestinal disorders
Common:
Abdominal pain, abdominal distension, nausea, vomiting
Uncommon:
Abdominal discomfort, diarrhoea
Reproductive system and breast disorders
Common:
Mild or moderate OHSS
Uncommon:
Severe OHSS
General disorders and administration site conditions
Common:
Injection site reactions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
The effects of an overdose of Ovitrelle are unknown. Nevertheless, there is a possibility that OHSS may result from an overdose of Ovitrelle (see section 4.4).
💬 Ask about this leaflet
Ask anything about Ovitrelle 250 micrograms/0.5 ml prefilled pen. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.