Vagifem 10 mcg

/ Novo Nordisk

The drug is administered intravaginally as a local oesrogen therapy by use of an applicator.
Initial dose: One vaginal tablet daily for two weeks.
Maintenance dose: One 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 postmenopausal symptoms, the lowest effective dose for the shortest duration should be used.
The drug is a local vaginal therapy and in women with an intact uterus, progestagen treatment is not necessary, may be used in women with or without an intact uterus.
Vaginal infections should be treated before start of the Vagifem® therapy.
See prescribing information for full details.

Treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women. The experience treating women older than 65 years is limited.

Known, past or suspected breast cancer; Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer); Undiagnosed genital bleeding; Untreated endometrial hyperplasia; Previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism); Known thrombophilic disorders (e.g. protein C, protein S, or antithrombin deficiency); Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction); Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal; Known hypersensitivity to the active substances or to any of the excipients; Porphyria.

For the treatment of postmenopausal symptoms, 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 obtained. 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 what changes in their breasts should be reported to their doctor or nurse. Investigations including appropriate imaging tools, e.g. mammography, should be carried out in accordance with currently accepted screening practices, modified to the clinical needs of the individual.  The pharmacokinetic profile of the drug shows that there is very low systemic absorption of  estradiol during treatment , however, being a HRT product the following need to be considered, especially for long term or repeated use of this product.
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. It should be taken into account that these conditions may recur or be aggravated during oestrogen treatment, in particular:
– Leiomyoma (uterine fibroids) or endometriosis
– Risk factors for thromboembolic disorders (see below)
– Risk factors for oestrogen-dependent tumours, e.g. 1st degree heredity for breast cancer
– Hypertension
– Liver disorders (e.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.
The pharmacokinetic profile of Vagifem® shows that there is very low absorption of estradiol during treatment. Due to this, the recurrence or aggravation of the above mentioned conditions is less likely than with systemic oestrogen treatment.
See prescribing information for full details.

Common: Headache, Abdominal pain, vaginal haemorrhage, vaginal discharge or vaginal discomfort nausea.
See prescribing information for full details.

As the oestrogen is administered within the vagina and due to the low levels of estradiol released, it is unlikely that any clinically relevant drug interactions will occur.
However, the metabolism of oestrogens may be increased by concomitant use of substances known to induce drug-metabolising enzymes, specifically cytochrome P450 enzymes, such as anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz).
Ritonavir and nelfinavir, although known as strong inhibitors, by contrast exhibit inducing properties when used concomitantly with steroid hormones. Herbal preparations containing St John’s Wort (Hypericum perforatum) may induce the metabolism of oestrogens.

Pregnancy: 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 foetal exposure to oestrogens indicate no teratogenic or foetotoxic effects.
Lactation: Vagifem® is not indicated during lactation.

The drug intended for intravaginal use and the dose of estradiol is very low. Overdose is therefore unlikely, but if it occurs, treatment is symptomatic.