VAGIFEM Estradiol 10mcg Vaginal Film-Coated Tablet 1's

Treatment of atrophic vaginitis due to estrogen deficiency.

 

Initial Dose: 1 vaginal tablet daily for 2 weeks. Maintenance Dose: 1 vaginal tablet twice a week.
Treatment may be started on any convenient day.
If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided.
For initiation and continuation of treatment of menopausal symptoms, the lowest effective dose for the shortest duration (see Precautions) should be used.
Vagifem may be used in women with or without an intact uterus.
During treatment especially during the first 2 weeks minimal absorption may be seen but as plasma estradiol levels after the first 2 weeks usually do not exceed postmenopausal levels the addition of a progestagen is not recommended.
Administration: Vagifem is administered intravaginally using the applicator.

 

Overdosage

Hypersensitivity to estradiol or to any of the excipients of Vagifem.
Known, past or suspected breast cancer; known or suspected estrogen-dependent malignant tumors (eg, endometrial cancer); undiagnosed genital bleeding; untreated endometrial hyperplasia; previous idiopathic or current venous thromboembolism (deep venous thrombosis, pulmonary embolism); porphyria.
Use in pregnancy & lactation: Vagifem is not indicated during pregnancy. If pregnancy occurs during medication with Vagifem, treatment should be withdrawn immediately.
The results of most epidemiological studies to date relevant to inadvertent fetal exposure to estrogens indicate no teratogenic or fetotoxic effects.
Vagifem is not indicated during lactation.

For the treatment of postmenopausal symptoms, hormone replacement therapy (HRT) 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 undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.
Medical Examination/Follow-Up: Before initiating or reinstituting hormone therapy, 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 warnings for use. During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised which changes in their breasts should be reported to the physician or nurse. Investigations including mammography should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.
Conditions Needing 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. It should be taken into account that these conditions may recur or be aggravated during systemic estrogen treatment, in particular: Leiomyoma (uterine fibroids) or endometriosis; a history of, or risk factors for, thromboembolic disorders (see as follows); hypertension; liver disorders (eg, liver adenoma); diabetes mellitus with or without vascular involvement; cholelithiasis; migraine or (severe) headache; systemic lupus erythematosus; history of endometrial hyperplasia (see as follows); epilepsy; asthma; otosclerosis.
Due to the local administration of low dose estradiol in Vagifem, the recurrence or aggravation of the previously mentioned conditions is less likely than with systemic estrogen treatment.
Reasons for Immediate Withdrawal of Therapy: Therapy should be discontinued in case a contraindication is discovered and in the following situations: Jaundice or deterioration in liver function; significant increase in blood pressure; new onset of migraine-type headache; pregnancy.
Endometrial Hyperplasia: Women with an intact uterus with abnormal bleeding of unknown etiology or women with an intact uterus who have previously been treated with unopposed estrogens should be examined with special care in order to disclose a possible hyperstimulation/malignancy of the endometrium before initiation of treatment with Vagifem.
The risk of endometrial cancer after treatment with oral unopposed estrogens is dependent on both duration of treatment and on estrogen dose. The dose of estradiol in Vagifem is low and treatment is local. A minor degree of systemic absorption may occur in some patients. However, Vagifem has not been associated with an increased risk of endometrial hyperplasia or uterine cancer. Because there is no systemic effect under the local estrogen treatment with Vagifem, the addition of a progestagen is not recommended.
As a general rule, estrogen replacement therapy should not be prescribed for longer than 1 year without another physical examination including gynecological examination being performed.
Vagifem is a local low dose estradiol preparation and therefore, the occurrence of the conditions as follows is less likely than with systemic estrogen treatment.
Breast Cancer: Systemic estrogen or estrogen-progestagen treatment may increase the risk of breast cancer. Relative risk of breast cancer with conjugated equine estrogens (CEE) or estradiol (E2) was greater when a progestagen was added, either sequentially or continuously, and regardless of type of progestagen.
Venous Thromboembolism: Systemic HRT is associated with a higher relative risk of developing venous thromboembolism (VTE) ie, deep vein thrombosis (DVT) or pulmonary embolism (PE). One randomized, controlled trial and epidemiological studies found a 2- to 3-fold higher risk for users compared with non-users. For non-users, it is estimated that the number of cases of VTE that will occur over a 5-year period is about 3 per 1,000 women 50-59 years and 8 per 1,000 women 60-69 years. It is estimated that in healthy women who use HRT for 5 years, the number of additional cases of VTE over a 5-year period will be between 2 and 6 (best estimate=4) per 1,000 women 50-59 years and between 5 and 15 (best estimate=9) per 1,000 women 60-69 years. The occurrence of such an event is more likely in the 1st year of HRT than later.
Generally, recognized risk factors for VTE include a personal or family history, severe obesity [body mass index (BMI) >30 kg/m²] and systemic lupus erythematosus (SLE). There is no consensus about the possible role of varicose veins in VTE.
Patients with a history of VTE or known thrombophilic states have an increased risk of VTE. Hormone replacement therapy may add to this risk. Personal or strong family history of thromboembolism or recurrent spontaneous abortion should be investigated in order to exclude a thrombophilic predisposition. Until a thorough evaluation of thrombophilic factors has been made or anticoagulant treatment initiated, use of HRT in such patients should be viewed as contraindicated. Those women already on anticoagulant treatment require careful consideration of the benefit-risk of use of HRT.
The risk of VTE may be temporarily increased with prolonged immobilization, major trauma or major surgery. As in all postoperative patients, scrupulous attention should be given to prophylactic measures to prevent VTE following surgery. Where prolonged immobilization is liable to follow elective surgery, particularly abdominal or orthopedic surgery to the lower limbs, consideration should be given to temporarily stopping HRT 4-6 weeks earlier, if possible. Treatment should not be restarted until the woman is completely mobilized.
If VTE develops after initiating therapy, the drug should be discontinued. Patients should be told to contact their doctors immediately when they are aware of a potential thromboembolic symptom (eg, painful swelling of a leg, sudden pain in the chest, dyspnea).
Stroke: One (1) large randomized clinical trial (WHI-trial) found, as a secondary outcome, an increased risk of ischemic stroke in healthy women during treatment with continuous combined conjugated estrogens and medroxyprogesterone acetate (MPA). For women who do not use HRT, it is estimated that the number of cases of stroke that will occur over a 5-year period is about 3 per 1,000 women 50-59 years and 11 per 1,000 women 60-69 years. It is estimated that for women who use conjugated estrogens and MPA for 5 years, the number of additional cases will be between 0 and 3 (best estimate=1) per 1,000 users 50-59 years and between 1 and 9 (best estimate=4) per 1,000 users 60-69 years. It is unknown whether the increased risk also extends to other HRT products.
Ovarian Cancer: Long-term (at least 5-10 years) use of estrogen-only HRT products in hysterectomized women has been associated with an increased risk of ovarian cancer in some epidemiological studies. It is unlikely that long-term use of combined HRT leads to any risk increase for ovarian cancer.
Other Conditions: Estrogens may cause fluid retention and therefore, patients with cardiac or renal dysfunction should be carefully observed during the first weeks of treatment. Patients with terminal renal insufficiency should also be closely observed since it is expected that the level of circulating active ingredients in Vagifem is increased.
There is no conclusive evidence for improvement of cognitive function. There is some evidence from the WHI trial of increased risk of probable dementia in women who start using continuous combined CEE and MPA after the age of 65. It is unknown whether the findings apply to younger postmenopausal women or other HRT products.
Effects on the Ability to Drive or Operate Machinery: No effects known.
Use in the elderly: The experience of treating women >65 years is limited.

Breast pain, peripheral edema & postmenopausal bleedings; headache; abdominal pain; vag hemorrhage/discharge/discomfort; vulvovag mycotic infection; nausea; rash; increased wt; hot flush, HTN.

Due to a topical administration of the low dose of estradiol in Vagifem, interactions of clinical relevance are not expected.

 

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Oestrogens, Progesterones & Related Synthetic Drugs