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Intrarosa is a brand name for Prasterone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
Verbatim from this product's EMA label. Tap a section to expand.
5 mg prasterone (one pessary) administered once daily, at bedtime. For the treatment of postmenopausal symptoms, Intrarosa should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk.
If a dose is forgotten, it should be taken as soon as the patient remembers. However, if the next dose is due in less than 8 hours, the patient should skip the missed pessary. Two pessaries should not be used to make up for a forgotten dose.
Special populations Elderly No dose adjustment is considered necessary in elderly women. Patients with renal and/or hepatic impairment Since Intrarosa acts locally in the vagina, no dose adjustment is needed for postmenopausal women having renal or hepatic impairment or any other systemic anomaly or disease.
Paediatric population There is no relevant use of Intrarosa in female children of any age group for the indication of vulvar and vaginal atrophy due to menopause. 3 Method of administration Vaginal use Intrarosa can be inserted in the vagina with the finger or with an applicator provided within the identified pack.
The pessary should be inserted in the vagina as far as it can comfortably go without force. If inserted with an applicator, the following steps should be followed: 1. The applicator should be activated (by pulling back the plunger) before use.
2. The flat end of the pessary should be placed into the open end of the activated applicator. 3. The applicator should be inserted into the vagina as far as it can comfortably go without force. 4. The plunger of the applicator should be pressed to release the pessary.
5. The applicator should then be withdrawn and disassembled, and the two pieces of the applicator should be rinsed for 30 seconds under running water before wiping with paper towel and reassembled. The applicator should be kept in a clean place until next use.
6. Each applicator should be discarded after one week of usage (two extra applicators are provided).
Summary of safety profile The most frequently observed adverse reaction was vaginal discharge. This is due to melting of the hard fat used as vehicle, added to the expected increase in vaginal secretions due to treatment. 4). 5 mg pessaries obtained from clinical studies are tabulated in Table 1 below.
5 mg pessaries in clinical studies MedDRA System Organ Class Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) General disorders and administration site conditions Application site discharge - Reproductive system and breast disorders Abnormal Pap smear (mostly ASCUS or LGSIL) Cervical/ uterine polyps Breast mass (benign) Investigations Weight fluctuation - Breast cancer risk • An up to 2-fold increased risk of having breast cancer diagnosed is reported in women taking combined oestrogen-progestagen therapy for more than 5 years.
• Any increased risk in users of oestrogen-only therapy is substantially lower than that seen in users of oestrogen-progestagen combinations. 4). • Results of the largest randomised placebo-controlled study (WHI-study) and largest epidemiological study (MWS) are presented.
2 1-2 (0-3) #Overall risk ratio. The risk ratio is not constant but will increase with increasing duration on use Note: Since the background incidence of breast cancer differs by EU country, the number of additional cases of breast cancer will also change proportionately.
4). 56). For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users. In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
e. deep vein thrombosis or pulmonary embolism. 4). 4). 5 fold increased relative risk of ischaemic stroke. The risk of haemorrhagic stroke is not increased during use of HRT. 4. 6) 3 (1-5) Other adverse reactions have been reported in association with oestrogen/progestagen treatment: – Gall bladder disease.
For the treatment of postmenopausal symptoms, Intrarosa should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk following discussions with their doctor.
Medical examination/follow-up Before initiating Intrarosa, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and special warnings and precautions for use according to the decision of their doctor.
During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer’ below).
Investigations, including Pap smears and blood pressure measurements should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual. 4 Conditions which need supervision • If any of the following conditions are present, have occurred previously, and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.
g. g. liver adenoma) – Diabetes mellitus with or without vascular involvement – Cholelithiasis – Migraine or (severe) headache – Systemic lupus erythematosus. – A history of endometrial hyperplasia (see below) – Epilepsy – Asthma – Otosclerosis Reasons for immediate withdrawal of therapy Therapy should be discontinued in case a contraindication is discovered and in the following situation: – Jaundice or deterioration in liver function – Significant increase in blood pressure – New onset of migraine-type headache – Pregnancy.
Endometrial hyperplasia and carcinoma • Estrogen is a metabolite of prasterone. In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when exogenous oestrogens are administered for prolonged periods.
g. g. angina, myocardial infarction); • Porphyria.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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– Skin and subcutaneous disorders: chloasma, erythema multiforme, erythema nodosum, vascular purpura. 4). 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 national reporting system listed in Appendix V.
No cases of endometrial hyperplasia have been reported in women treated for 52 weeks during the clinical studies. Intrarosa has not been studied in women with endometrial hyperplasia. • For oestrogen products for vaginal application of which the systemic exposure to oestrogen remains within the normal postmenopausal range, it is not recommended to add a progestagen.
• Endometrial safety of long-term of local vaginally administered prasterone has not been studied for more than one year. Therefore, if repeated, treatment should be reviewed at least annually. • If bleeding or spotting appears at any time on therapy, the reason should be investigated, which may include endometrial biopsy to exclude endometrial malignancy.
• Unopposed oestrogen stimulation may lead to premalignant or malignant transformation in the residual foci of endometriosis. Therefore, caution is advised when using this product in women who have undergone hysterectomy because of endometriosis, especially if they are known to have residual endometriosis since intravaginal prasterone has not been studied in women with endometriosis.
Prasterone is metabolised into estrogenic compounds. The following risks have been associated with systemic Hormone Replacement Therapy (HRT) and apply to a lesser extent for oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains within the normal postmenopausal range.
However, they should be considered in case of long term or repeated use of this product. Breast cancer The overall evidence suggests an increased risk of breast cancer in women taking combined oestrogen- progestagen and possibly also oestrogen-only systemic HRT, that is dependent on the duration of 5 taking HRT.
The excess risk becomes apparent within a few years of use but returns to baseline within a few (at most five) years after stopping treatment. Intrarosa has not been studied in women with active or past breast cancer. 5 mg dose which is below the incidence rate observed in the normal population of the same age.
Ovarian cancer Ovarian cancer is much rarer than breast cancer. Epidemiological evidence from a large meta-analysis suggests a slightly increased risk in women taking oestrogen-only systemic HRT, which becomes apparent within 5 years of use and diminishes over time after stopping.
Intrarosa has not been studied in women with active or past ovarian cancer. 5 mg dose which is above the incidence rate observed in the normal population of the same age. Of note, this case was present before start of treatment and was bearing a BRCA1 mutation.
Abnormal Pap smear Intrarosa has not been studied in women with abnormal Pap smears (Atypical Squamous Cells of Undetermined Significance (ASCUS)) or worse. 5 mg dose (common frequency). Venous thromboembolism Intrarosa has not been studied in women with current or previous venous thromboembolic disease.
e. deep vein thrombosis or pulmonary embolism. 8). • Patients with known […]