Quoted from the official patient leaflet (emc). Always follow your doctor or pharmacist.
Lubion contains the active ingredient progesterone. Progesterone is a naturally occurring female sex hormone. The medicine works on the lining of the womb and helps you to become pregnant and to stay pregnant.
Lubion is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme who are unable to use or tolerate vaginal preparations.
Do not use Lubion • If you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6).
• If you are suffering from vaginal bleeding (other than normal periods) that has not been evaluated by your doctor.
• If you have a miscarriage and your doctor suspects some tissue is still in the womb.
• If you currently have a pregnancy outside of the womb (ectopic pregnancy).
• If you currently have or have had severe liver problems.
• If you have known or suspected breast cancer or cancer of the reproductive tract.
• If you currently have or have had blood clots in the legs, lungs, eyes or elsewhere in the body.
• If you have porphyria disorders (a group of inherited or acquired disorders of certain enzymes).
• If during pregnancy you have suffered from jaundice (yellowing of eyes and skin due to liver problems), severe itching and/or blisters on the skin.
• If you are under 18 years of age.
Warnings and precautions Take special care with Lubion
If you experience any of the following during treatment, tell your doctor immediately as your treatment may need to be stopped. Also tell your doctor immediately if you experience these a few days after the last dosage:
• Heart attack (pains in the chest, or back pain and/or deep aching and throbbing in one or both arms, a sudden shortness of breath, sweating, dizziness, lightheadedness, nausea, palpitations)
• Stroke (severe headache or vomiting, dizziness, faintness, or changes in vision or speech, weakness or numbness of an arm or leg)
• Blood clots in the eyes or anywhere in the body (pain in your eyes or pain and swelling in your ankles, feet and hands)
• Worsening of depression
• Severe headaches, changes in vision
Before treatment with Lubion
Tell your doctor if you have had or have any of the following before using Lubion :
• Liver problems (mild or moderate)
• Epilepsy
• Migraine
• Asthma
• Heart or kidney problems
• Diabetes
• Depression
If any of the above applies to you, your doctor will monitor you carefully during treatment.
Children and adolescents The product is not to be used by children or adolescents.
Other medicines and Lubion Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription and herbal medicines. Some medicines may interact with Lubion. For example:
• Carbamazepine (used to treat seizures/fits)
• Rifampicin (an antibiotic)
• Griseofulvin (an antifungal medicine)
• Phenytoin and Phenobarbital (used to treat epilepsy)
• St. John’s Wort-containing herbal products
• Ciclosporine (a medicine for some types of inflammation and after organ transplants)
• Diabetic medicines
• Ketoconazole (an antifungal medicines)
Do not administer Lubion at the same time as any other injectable medicine.
Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine.
• Lubion can be used during the first three months of pregnancy.
• This medicine should not be used during breast-feeding.
Driving and using machines Do not drive or use any tools or machines if you feel drowsy and/or dizzy whilst taking Lubion .
Lubion contains hydroxypropylbetadex If you have a kidney disease, talk to your doctor before you receive this medicine.
Lubion contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Remember, Lubion should only be used under the supervision of a doctor experienced in treating fertility problems.
How much Lubion should you use and for how long? The recommended dose is a once daily injection of 25 mg usually until 12 weeks of confirmed pregnancy (i.e. 10 weeks of treatment).
How Lubion should be given Lubion should be given under your skin (subcutaneous injection, i.e. SC).
You will be able to administer 25 mg of Lubion subcutaneously after suitable advice and training by your doctor or healthcare professional.
Before you inject Lubion you will receive the following training and advice:
• Practice giving subcutaneous injections.
• Where to inject your medicine.
• How to administer your medicine.
Please read instruction below on preparation and administration of Lubion.
The steps for self-administration are:
A Preparing your injection
B Checking pack
C Injection
D Disposal of used items.
These steps are explained in full below.
A. Preparing your injection
It is important to keep everything as clean as possible, so start by washing your hands thoroughly and drying on a clean towel. Choose a clean area to prepare your injection.
The following items are not supplied with your medicine. Your doctor or pharmacist will supply these items.
• Two alcohol wipes
• A sharps container (for safe disposal of pre-filled syringe etc.)
B. Checking pack
• Do not use the product if the packaging is open or damaged.
• Make sure that the pre-filled syringe of Lubion contains the solution.
• Make sure that the expiry date is still valid on the pre-filled syringe of Lubion . Do not use the products if outside the expiry date.
C. Injection
• Your doctor or healthcare professional will have already shown you where to inject Lubion (e.g. tummy or front of thigh).
• Open the alcohol wipe and carefully clean the area of skin to be injected and allow it to dry.
• Remove the cap. Once the cap is removed, do not allow the needle to touch anything. This is to make sure the needle remains clean (sterile).
• Hold the syringe with the needle pointing upwards and slowly press the plunger until all the air is out of the syringe and at least one drop of solution comes out of the tip of the needle.
• Hold the syringe in one hand. Use the other hand to gently pinch the skin in the injection site area between your thumb and index finger.
• Using a dart–like motion, insert the needle into the skin so that the skin and the needle form a right angle.
• Insert the needle all the way into the skin. Do not inject directly into a vein.
• Inject the solution by pushing gently on the plunger in a slow and steady motion until all the solution is injected beneath the skin. Inject all the solution.
• Release the skin and pull the needle straight out.
• Wipe the skin at the injection site with an alcohol swab using a circular motion.
Each pre-filled syringe is for single-use only.
D. Disposal of used items
• Once you have finished your injection, put the pre-filled syringe into a sharps container.
If you use more Lubion than you should Tell your doctor or pharmacist. The symptoms of an overdose include drowsiness.
If you forget to use Lubion Take the dose as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten dose. Tell your doctor what you have done.
If you stop using Lubion Do not stop using Lubion without speaking to your doctor or pharmacists first. Abrupt discontinuation of Lubion may cause increased anxiety, moodiness, and increase your risk of having seizures (fits).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking this medicine and seek immediate medical help if you have any of the following symptoms: • Overstimulation of the ovaries (symptoms include lower stomach pain, feeling thirsty and sick, and sometimes being sick, passing reduced quantities of concentrated urine and weight gain),
• Depression,
• Yellowing of your skin and the whites of your eyes (jaundice),
• Severe allergic reaction which may cause difficulty breathing, swelling of the face and throat or a severe rash (anaphylactoid reactions).
Very common: may affect more than 1 in 10 people
• Pain, redness, itching, irritation or swelling at the injection site
• Uterine spasm
• Vaginal bleeding
Common: may affect up to 1 in 10 people
• Headache
• Bloated stomach
• Stomach pain
• Constipation
• Being sick and feeling sick
• Breast tenderness and/or pain
• Vaginal discharge
• A tingling or uneasy irritation or itching of the skin of the vagina and surrounding area
• Hardening of area around injection site
• Bruising around injection site
• Fatigue (excessive tiredness, exhaustion, lethargy)
Uncommon: may affect up to 1 in 100 people
• Changes in mood
• Dizziness
• Insomnia
• Stomach and intestinal disturbance (including stomach discomfort and/or tenderness, wind, painful spasms and retching)
• Skin rashes (including red warm skin, or raised, itchy bumps or wheals or dry, cracked or blistered or swollen skin)
• Breast swelling and/or enlargement
• Feeling hot
• General feeling of discomfort or “feeling out of sorts”
• Pain
Not known: frequency cannot be estimated from the available data
The following disorders, although not reported by patients in clinical studies using Lubion , have been described with other progestins: inability to sleep (insomnia), premenstrual like syndrome and menstrual disturbances, hives, acne, excessive hair growth, hair loss (alopecia), weight gain.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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.
Keep out of the sight and reach of children.
Do not refrigerate or freeze.
Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
If the expiry date is reported as month/year, the expiry date refers to the last day of that month.
Do not use this medicine if you notice particles in the solution or if the solution is not clear.
Each pre-filled syringe is for single-use only.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Lubion contains The active substance is progesterone. Each pre-filled syringe (1.112 ml) contains 25 mg progesterone (22.48 mg/ml).
The other ingredients are: hydroxypropylbetadex, disodium phosphate, sodium dihydrogen phosphate dihydrate, water for injections.
What Lubion looks like and contents of the pack Lubion is a clear colourless solution for injection in pre-filled syringe supplied in a glass syringe.
Each carton box contains 7 or 14 pre-filled syringes. Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi
Italy
This leaflet was last revised in 11/2025.
Lubion 25 mg subcutaneous injection Pre-filled syringe comes as injection containing 25mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Lubion 25 mg subcutaneous injection Pre-filled syringe is progesterone.
Medicines with the same active substance, strength and form include: Lubion 25 mg subcutaneous injection Vial. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Lubion 25 mg subcutaneous injection Pre-filled syringe, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Lubion is indicated in adults for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations.
Posology Adults Once daily injection of 25 mg from day of oocyte retrieval, usually until 12 weeks of confirmed pregnancy. As the indications for Lubion are restricted to women of child-bearing age, dosage recommendations for children and the elderly are not appropriate. Lubion is given subcutaneously (25 mg) by the patient herself after instruction or by a healthcare professional or a doctor. Special populations Elderly No clinical data have been collected in patients over age 65. Renal and hepatic impairment There is no experience with use of Lubion in patients with impaired liver or renal function. Paediatric population The safety and efficacy of Lubion in children (0 to 18 years) has not been established. There is no relevant use of Lubion in the paediatric population or elderly in the indication for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women. Method of administration Treatment with Lubion should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Lubion is intended for subcutaneous administration. Choose an appropriate area (front of thigh, lower abdomen), swab proposed area, pinch the skin together firmly and insert the needle at an angle of 45° to 90°. The product should be injected slowly to minimise local tissue damage. Each pre-filled syringe is intended for single-use injection only.
Lubion should not be used in individuals with any of the following conditions: • Hypersensitivity to progesterone or to any of the excipients listed in section 6.1 • Undiagnosed vaginal bleeding • Known missed abortion or ectopic pregnancy • Severe hepatic dysfunction or disease • Known or suspected breast or genital tract cancer • Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events • Porphyria • A history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy.
Lubion should be discontinued if any of the following conditions are suspected: myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis, or retinal thrombosis. Caution is indicated in patients with mild to moderate hepatic dysfunction. Caution is indicated in patients with moderate to severe renal dysfunction, because accumulation of cyclodextrins may occur. Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen. Because progesterone may cause some degree of fluid retention, conditions that might be influenced by this factor (e.g. epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation. A decrease in insulin sensitivity and thereby in glucose tolerance has been observed in a small number of patients on oestrogen-progestogen combination drugs. The mechanism of this decrease is not known. For this reason, diabetic patients should be carefully observed while receiving progesterone therapy (see section 4.5). Sex steroid use may also increase the risk of retinal vascular lesions. To prevent these latter complications, caution is to be taken in users >35 years, in smokers, and in those with risk factors for atherosclerosis. Use should be terminated in case of transient ischemic events, appearance of sudden severe headaches, or vision impairments related to papillary oedema or retinal haemorrhage. Abrupt discontinuation of progesterone dosing may cause increased anxiety, moodiness, and increased sensibility to seizures. Before starting treatment with Lubion, the patient and her partner should be assessed by a doctor for causes of infertility or pregnancy complications. This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free'.
Drugs known to induce the hepatic cytochrome-P450-3A4 system (e.g. rifampicin, carbamazepine, griseofulvin, phenobarbital, phenytoin or St. John's Wort (Hypericum perforatum-containing herbal products) may increase the elimination rate and thereby decrease the bioavailability of progesterone. In contrast ketoconazole and other inhibitors of cytochrome P450-3A4 may decrease elimination rate and thereby increase the bioavailability of progesterone. Since progesterone can influence diabetic control an adjustment in antidiabetic dosage could be required (see section 4.4). Progestogens may inhibit ciclosporin metabolism leading to increased plasma-ciclosporin concentrations and a risk of toxicity The effect of concomitant injectable products on the exposure of progesterone from Lubion has not been assessed. Concomitant use with other drugs is not recommended.
Fertility Lubion is used in the treatment of some forms of infertility (see section 4.1 for full details). Pregnancy Lubion is indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women. There is limited and inconclusive data on the risk of congenital anomalies, including genital abnormalities in male or female infants, following intrauterine exposure during pregnancy. The rates of congenital anomalies, spontaneous abortion and ectopic pregnancies observed during the clinical trial were comparable with the event rate described in the general population although the total exposure is too low to allow conclusions to be drawn. Breast-feeding Progesterone is excreted in human milk and Lubion should not be used during breast-feeding.
Lubion has minor or moderate influence on the ability to drive and use machines. Progesterone may cause drowsiness and/or dizziness; therefore caution is advised in drivers and those operating machinery.
The most frequently reported adverse drug reactions during treatment with Lubion during clinical trial are administration site reactions, breast and vulvo-vaginal disorders. The table below displays the main adverse drug reactions in women treated with Lubion in the pivotal clinical trial. Data is expressed by system organ class (SOC) and frequency. System Organ Class (SOC) Very common (≥ 1/10) Common (≥ 1/100 to< 1/10) Uncommon (≥ 1/1000 to < 1/100) Psychiatric disorders Mood altered Nervous system disorders Headache Dizziness, Somnolence Gastrointestinal disorders Abdominal distension Abdominal pain Nausea Vomiting Constipation Gastrointestinal disturbances Skin and subcutaneous tissue disorders Pruritus Rash Reproductive system and breast disorders Uterine spasm Vaginal haemorrhage Breast tenderness Breast pain Vaginal discharge Vulvo vaginal pruritus Vulvo vaginal discomfort Vulvo vaginal inflammation OHSS Breast disorders General disorders and administration site conditions Administration site reactions* Injection site haematoma Injection site induration Fatigue Feeling hot, Malaise Pain *Administration site reactions, such as irritation, pain, pruritus and swelling. Class effects The following disorders although not reported by patients in clinical studies using Lubion have been described with other drugs in this class of medicines. System Organ Class (SOC) Psychiatric disorders Depression Nervous system disorders Insomnia Hepatobiliary disorders Jaundice Reproductive system and breast disorders Menstrual disturbances Premenstrual like syndrome Skin and subcutaneous tissue disorders Urticaria, Acne, Hirsutism, Alopecia General disorders and administration site conditions Weight gain Anaphylactoid 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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
High doses of progesterone may cause drowsiness. Treatment of overdose consists of discontinuation of Lubion together with initiation of appropriate symptomatic and supportive care.
Ask anything about Lubion 25 mg subcutaneous injection Pre-filled syringe. 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.
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