LUBION

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.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

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. 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.

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.