Lenzetto Dosage/Direction for Use

Recommended Dosage: Lenzetto is administered once daily, either as a monotherapy or as a continuous sequential treatment (when combined with a progestogen).
One metered-dose spray is administered once daily to the dry and healthy skin of the forearm as a starting dose. The dose may be increased to two metered-dose sprays daily to the forearm based on clinical response. Dose increase should be based on the degree of the woman's menopausal symptoms and should be made only after at least 4 weeks of continuous treatment with Lenzetto. The maximum daily dose is 3 metered-dose sprays (4.59 mg/day) to the forearm. Dose increase should be discussed with the physician.
For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see Precautions) should be used.
When the degree of the woman's menopausal symptoms is not reduced after a dose increase, the patient should be back-titrated to the previous dose.
Patients should be re-evaluated periodically as clinically appropriate (e.g. 3-month to 6-month intervals) to determine if treatment is still necessary (see Precautions).
When estrogen is prescribed for a postmenopausal woman with a uterus, a progestagen approved for addition to estrogen treatment should also be initiated to reduce the risk of endometrial cancer. Only progestagens approved for addition to estrogen treatment should be administered.
In women with a uterus: In women with an intact uterus, the product should be combined with a progestagen approved for addition to estrogen treatment in a continuous sequential dosing scheme: the estrogen is dosed continuously. The progestagen is added for at least 12 to 14 days of every 28-day cycle, in a sequential manner.
Advice on how to initiate treatment should be given for treatment naive patients and for patients changing from other HRTs (cyclic, sequential or continuous combined).
In the period in which the estrogen is combined with the progestagen, a withdrawal bleeding can occur. A new 28-day treatment cycle is started without a break.
In women without a uterus: Unless there is a previous diagnosis of endometriosis, it is not recommended to add progestagen for women without a uterus.
Overweight and obese women: There is some limited data that the rate and extent of absorption of Lenzetto can be reduced in overweight and obese women. During the treatment, the dose of Lenzetto may require adjustment. Dose modification should be discussed with the physician.
Elevated skin temperature: The effect of increased ambient temperature with Lenzetto has been studied and clinically relevant difference in the extent of absorption of Lenzetto was not observed. However, Lenzetto should be used with caution in extreme temperature conditions, such as sunbathing or sauna.
Application of sunscreen: When sunscreen is applied about one hour following Lenzetto, estradiol absorption may be decreased by 10%. When sunscreen was applied about one hour prior to Lenzetto, no effect on absorption was observed.
Paediatric population: There is no relevant use of Lenzetto in the paediatric population.
Missed dose: If a dose is missed, the patient should make up for the missed dose as soon as she remembers and take the next dose at the usual time. If it is almost time for the next dose, she should skip the missed dose and take the next dose at the usual time. If one or more doses are missed one primer spraying with the cover on is needed.
Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting.
Route of Administration: Transdermal use.
The container should be held upright and vertical for spraying. Before a new applicator is used for the first time, the pump should be primed by spraying three times into the cover.
The daily dose is one metered-dose spray on the inner forearm. If two or three sprays are prescribed as the daily dose, they should be applied to adjacent non-overlapping (side-by-side) 20 cm² areas on the inner surface of the arm between the elbow and the wrist and allowed to dry for approximately 2 minutes. Women should cover the application site with clothing if another person may come into contact with that area of skin after the spray dries. The site of application should not be washed for 60 minutes. Do not allow another person to touch the site of application within 60 minutes of application. For patients who have difficulty applying the prescribed dose to distinct, non-overlapping areas of the same forearm, Lenzetto may also be applied to sites on the alternate forearm, or to sites on the inner thigh.
Do not allow children to come in contact with the area of the arm where Lenzetto was sprayed. If a child comes in contact with the part of the arm where Lenzetto was sprayed, wash the child's skin with soap and water as soon as possible.
Do not allow pets to lick or touch the arm where Lenzetto was sprayed. Small pets may be especially sensitive to the estrogen in Lenzetto. Contact a veterinarian if your pet exhibits mammary/nipple enlargement and/or vulvar swelling, or any other sign of illness.
Studies suggest that compared to applying it to the inner surface of the forearm, absorption of estradiol is similar when Lenzetto is applied to the skin of the thigh, but is lower when applied to the skin of the abdomen.
If the product is used according to the instructions, irrespective of different spray shape or pattern on the skin each puff will deliver the same amount of ingredient on the skin.