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Lenzetto 1.53 mg/spray, transdermal spray, solution

Lenzetto 1.53 mg/spray, transdermal spray, solution

Lenzetto

Prescription-only hormone replacement therapy (HRT) medicine
  • UK Marketing Authorisation: PL 04854/0130 (Lenzetto 1.53 mg/spray, transdermal spray, solution), held by Gedeon Richter Plc.
  • Classified as a Prescription Only Medicine (POM) in the UK; listed on the electronic Medicines Compendium (emc) with SmPC and PIL, last text revision dated 03/09/2025 (as of the latest update).
  • ATC code G03CA03 – natural and semisynthetic oestrogens, plain, consistent with systemic oestrogen HRT classification.
  • Included in national lists of authorised medicinal products in the EU/EEA under decentralised procedure HU/H/0361/001 and corresponding national licences.
  • Listed in the UK Drug Tariff and NHSBSA dm+d as "Lenzetto 1.53mg/dose transdermal spray" with 56 Dose pack size and Gedeon Richter (UK) Ltd as manufacturer.
  • Subject to MHRA and other national competent authority pharmacovigilance requirements, including Yellow Card reporting for suspected adverse drug reactions.
  • Risk Management Plan summarised in EU/EEA regulatory documentation, identifying Lenzetto as authorised for HRT for oestrogen deficiency symptoms in postmenopausal women and outlining important identified and potential risks and routine risk Minimisation measures.
Estradiol-only transdermal spray for systemic oestrogen replacement

Description

Lenzetto 1.53 mg/spray, transdermal spray, solution is an oestrogen-only hormone replacement therapy (HRT) used in postmenopausal women. It contains estradiol (as estradiol hemihydrate), a synthetic 17β-estradiol that is chemically and biologically identical to endogenous human oestrogen. Each metered-dose actuation delivers 90 microlitres of clear, colourless to pale yellow solution containing 1.53 mg estradiol (equivalent to 1.58 mg estradiol hemihydrate). When sprayed onto the skin as directed, estradiol passes through the skin into the systemic circulation to substitute for the loss of ovarian oestrogen production and relieve menopausal symptoms. Lenzetto is licensed as HRT for oestrogen deficiency symptoms in postmenopausal women (at least 6 months since last menses or surgical menopause, with or without a uterus). In many markets it is also used for the prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products. The product is presented as a small metered-dose transdermal spray device containing 6.5 ml of solution, designed to deliver 56 sprays after priming. As a transdermal preparation, Lenzetto delivers estradiol directly through the skin and into the bloodstream, avoiding first-pass hepatic metabolism associated with oral oestrogens and providing relatively stable serum estradiol concentrations with once-daily dosing.

Bnefits

  • Provides systemic oestrogen replacement therapy in postmenopausal women by delivering body-identical estradiol through the skin.
  • Licensed to relieve symptoms of oestrogen deficiency after menopause, such as hot flushes, night sweats and other vasomotor symptoms.
  • HRT with estradiol helps alleviate urogenital atrophy symptoms, including vaginal dryness, burning and discomfort, when systemic treatment is appropriate.
  • Transdermal delivery bypasses first-pass metabolism in the liver, which may reduce some hepatic effects associated with oral oestrogens and provides relatively stable serum estradiol levels over 24 hours.
  • Metered-dose spray allows adjustable dosing (one, two or three sprays once daily) according to symptom control, within a defined maximum daily dose.
  • Convenient, discreet and quick application to the skin of the inner forearm (or, if needed, alternate forearm or inner thigh), supporting adherence to therapy.
  • In postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicines approved for the prevention of osteoporosis, estradiol-based HRT can help maintain bone mineral density and reduce fracture risk when used according to licensed indications.
  • Pack provides 56 actuations after priming, corresponding to up to 56 days of treatment at one spray per day or shorter durations at higher daily spray numbers.

Indications

  • Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women (women at least 6 months since their last natural menstrual period or with surgical menopause, with or without a uterus).
  • Relief of symptoms occurring after menopause, including hot flushes and other vasomotor complaints, as per the approved Patient Information Leaflet and SmPC.
  • Lenzetto can also be used in women who have had surgery to remove their ovaries (oophorectomy), which causes instant menopause, for relief of oestrogen deficiency symptoms.
  • In many national product information documents, Lenzetto (estradiol transdermal spray) is also indicated for the prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or have contraindications for, other medicinal products approved for the prevention of osteoporosis (wording may vary by territory; prescribers must consult local product information).
  • Use as oestrogen-only HRT in women without a uterus, or in combination with a suitable progestogen in women with an intact uterus to reduce the risk of endometrial hyperplasia and carcinoma, following local prescribing guidance.

Composition

  • Active substance: estradiol (as estradiol hemihydrate). Each metered-dose spray delivers 90 microlitres of solution containing 1.53 mg estradiol, equivalent to 1.58 mg estradiol hemihydrate.
  • Excipients (full list, per SmPC section 6.1): Octisalate; Ethanol 96%.
  • Excipient with known effect: each spray contains 65.47 mg ethanol (96%).
  • The solution is clear, colourless to pale yellow.
  • No additional excipients are listed beyond octisalate and ethanol 96% in the UK SmPC.
  • ATC code: G03CA03 (natural and semisynthetic oestrogens, plain).

Formulation

  • Pharmaceutical form: transdermal spray, solution.
  • Qualitative and quantitative composition: each actuation delivers 90 microlitres of solution containing 1.53 mg estradiol (as estradiol hemihydrate).
  • The solution is clear, colourless to pale yellow, containing octisalate and ethanol 96% as excipients.
  • The product is supplied as a metered-dose transdermal spray device consisting of a glass vial of solution fitted with a metered-dose pump, encased in a plastic housing with a conical bell opening to control the distance, angle and area of application.
  • Systemic oestrogen exposure is achieved via absorption of estradiol through the skin of the inner forearm or inner thigh; studies show relatively stable serum concentrations over 24 hours after once-daily dosing.
  • Lenzetto is an oestrogen-only HRT; in women with an intact uterus, a progestogen approved for addition to oestrogen therapy must be co-prescribed in a continuous-sequential regimen to protect the endometrium.

Packaging

  • Each container is a glass vial with metered-dose pump, encased in a plastic housing with a conical bell opening to standardise spray application.
  • Each container is filled with 6.5 ml of transdermal spray solution and is designed to deliver 56 sprays (doses) after priming (three priming sprays into the cover before first use).
  • Pack sizes authorised include: one plastic container 6.5 ml (56 sprays) and three plastic containers 3 x 6.5 ml (3 x 56 sprays); not all pack sizes may be marketed in all territories.
  • Outer carton includes a dosing table to record the number of sprays used; after 56 sprays the container must be discarded, even if a small amount of solution remains.
  • The pack is supplied with a Patient Information Leaflet (PIL) and professional prescribing information (SmPC) in the relevant language of the marketing territory.
  • In UK prescribing references (e.g. Drug Tariff, NHSBSA AMP), the product is listed as Lenzetto 1.53 mg/dose transdermal spray (56 doses) manufactured by Gedeon Richter (UK) Ltd.

Usage

  • Lenzetto is a prescription-only medicine and must be initiated and supervised by healthcare professionals experienced in menopausal management and HRT.
  • Posology (general): Lenzetto is administered once daily, either as oestrogen-only therapy (in women without a uterus) or as continuous sequential therapy combined with a suitable progestogen in women with an intact uterus.
  • Starting dose: one metered-dose spray once daily to the dry, healthy skin of the inner forearm (between the elbow and the wrist).
  • Dose adjustment: based on the severity and persistence of menopausal symptoms. If symptom control is insufficient after at least 4 weeks of continuous treatment, the dose may be increased to two metered-dose sprays once daily; if further increase is needed, a maximum of three sprays once daily (4.59 mg/day) may be used. Dose increases should be discussed with the prescriber.
  • Application technique: hold the container upright and vertical for spraying. Before first use, prime the pump by spraying three times into the cover. Place the cone flat against the application site, then press the button fully down once for each spray.
  • If two or three sprays are prescribed, apply each spray to adjacent, non-overlapping 20 cm² areas on the inner forearm between the elbow and wrist. Allow the spray to dry for approximately 2 minutes before dressing. The application site should not be washed for 60 minutes after application.
  • If it is difficult to apply the prescribed number of sprays to distinct areas on one forearm, Lenzetto may also be applied to the alternate inner forearm or to the inner thigh; absorption is similar for inner thigh and somewhat lower for abdomen compared with inner forearm.
  • Avoid allowing another person (especially children) to touch the application site for at least 60 minutes after application. If contact occurs, that person should wash the area with soap and water as soon as possible.
  • Sunscreen and heat exposure: when sunscreen is applied about one hour after Lenzetto, estradiol absorption may decrease by about 10%; application one hour before Lenzetto does not significantly affect absorption. Use with caution in extreme temperature conditions such as sunbathing or sauna.
  • In women with a uterus: a progestogen approved for addition to oestrogen therapy must be added for at least 12–14 days of every 28-day cycle in a continuous-sequential regimen to reduce the risk of endometrial hyperplasia and carcinoma. Withdrawal bleeding may occur during progestogen days.
  • In women without a uterus: progestogen addition is generally not recommended unless there is residual endometriosis or other specific indication.
  • Missed dose: if a dose is missed, it should be applied as soon as remembered and the next dose taken at the usual time. If it is almost time for the next dose, skip the missed dose and continue as normal. Missing doses may increase the likelihood of breakthrough bleeding or spotting.
  • Duration and review: for treating postmenopausal symptoms, HRT should only be started for symptoms that adversely affect quality of life. The lowest effective dose should be used for the shortest duration, with periodic re-evaluation (typically every 3–6 months) to assess the ongoing need for treatment.
  • Safety advice: do not spray near the face or eyes, and do not apply to the breasts or irritated/broken skin. Keep away from naked flame and sources of ignition until dry due to ethanol content. Do not allow children to come into contact with the application site.

Contraindications

  • Known, past or suspected breast cancer.
  • Known or suspected oestrogen-dependent malignant tumours, such as endometrial cancer.
  • Undiagnosed genital (vaginal) bleeding.
  • Untreated endometrial hyperplasia.
  • Previous or current venous thromboembolism (VTE), including deep venous thrombosis and pulmonary embolism.
  • Known thrombophilic disorders, such as deficiencies of protein C, protein S or antithrombin.
  • Active or recent arterial thromboembolic disease, e.g. angina or myocardial infarction.
  • Acute liver disease, or a history of liver disease as long as liver function tests have not returned to normal.
  • Porphyria.
  • Hypersensitivity to estradiol or any of the excipients (octisalate or ethanol 96%).
  • HRT is generally contraindicated in pregnancy; if pregnancy occurs, Lenzetto must be discontinued immediately.
  • Full contraindication list and detailed clarifications are provided in section 4.3 of the SmPC and must be consulted by prescribers.

Adverse Effects

  • Lenzetto shares the class adverse reaction profile of systemic oestrogen HRT. Detailed frequencies are provided in section 4.8 of the SmPC; common or important reactions include:
  • Breast and reproductive system: breast tenderness or pain, breast enlargement, breast oedema, breast discomfort, irregular uterine bleeding or spotting (especially in the first months of therapy), dysmenorrhoea, vaginal discharge.
  • Gastrointestinal: nausea, abdominal pain or discomfort, flatulence; less commonly vomiting or diarrhoea.
  • Central nervous system: headache (including migraine or migraine-like headache), dizziness; very rarely changes in libido or mood may be reported.
  • Skin and subcutaneous tissue: rash, pruritus, urticaria; application-site reactions such as erythema, irritation or pruritus at the spray site.
  • General: peripheral oedema, weight change (increase or decrease), fatigue.
  • Serious but less common or rare risks associated with systemic oestrogen-containing HRT (outlined in SmPC warnings) include: increased risk of breast cancer with prolonged use; increased risk of endometrial hyperplasia and carcinoma when oestrogen is given without adequate progestogen in women with a uterus; increased risk of venous thromboembolism; small increased risk of ischaemic stroke; possible increased risk of ovarian cancer; cholelithiasis; possible fluid retention that may worsen cardiac or renal conditions; and very rare retinal vascular thrombosis.
  • Post-marketing reports of secondary exposure to estradiol spray in children (through skin contact with the application site) include breast budding and breast masses in prepubertal girls, and gynaecomastia and breast masses in prepubertal boys; these effects usually resolved after the estradiol exposure was removed.
  • Patients should be counselled on potential adverse effects and instructed to seek medical advice promptly if they experience symptoms suggestive of thromboembolic events (e.g. painful leg swelling, sudden chest pain, dyspnoea), jaundice, significant elevation in blood pressure, new-onset migraine-type headache, or breast changes.

Storage Conditions

  • Do not store above 25°C.
  • Do not refrigerate or freeze.
  • Contains ethanol and is flammable: store away from heaters, open flames and other sources of ignition.
  • Store in the original container and outer carton to protect from light and to keep track of doses used.
  • Shelf life: 3 years unopened; after first use, the container should be used within 56 days and then discarded, even if some solution remains.
  • Keep out of the sight and reach of children.
  • Do not dispose of used containers via household waste; due to residual active substance, empty containers should be returned to a pharmacy for safe destruction in line with local requirements.

Duration

According to the SmPC, for the treatment of postmenopausal symptoms, Lenzetto should be used at the lowest effective dose for the shortest duration, and treatment should be reviewed at least every 3\u20136 months to determine if continuation is necessary. For women using estradiol-containing HRT for the prevention of osteoporosis, long-term therapy may be required, with regular re-assessment of the individual benefit\u2013risk balance; exact duration is individualised and determined by the prescriber.

Onset

Not publicly listed (no precise, quantitative onset-of-action time in hours or days is specified in the SmPC or PIL for Lenzetto; clinical improvement in menopausal symptoms typically occurs over weeks of treatment but no exact timeframe is formally stated).

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