Vagifem

What is Vagifem?

Vagifem is a vaginal tablet that belongs to a class of medications known as hormone replacement therapy (HRT). Each tablet contains 10 micrograms of estradiol, a form of the natural female hormone oestrogen and comes with an applicator to help you safely and easily insert it into your vagina.

Estradiol in Vagifem is identical to the oestrogen naturally produced by the ovaries before menopause and is suitable for post-menopausal women who have not had a period for at least 12 months.

Because Vagifem is inserted directly into the vagina, it slowly releases oestrogen to the surrounding tissues to help relieve symptoms such as vaginal dryness and irritation. Vagifem may be a suitable form of HRT if you are experiencing localised menopause symptoms.

What is Vagifem Used For?

Vagifem is a type of HRT that’s used to treat specific symptoms of menopause in women. As women age and approach menopause, their bodies produce less oestrogen, leading to various physiological changes throughout the body, including hot flushes, night sweats, mood changes, and vaginal dryness.

Vagifem contains the active ingredient estradiol, which replenishes these declining oestrogen levels, offering relief from some menopause symptoms.

Vagifem is specifically formulated to treat symptoms of vulvar and vaginal atrophy (VVA) due to menopause. VVA is a condition where the vaginal walls become thin, dry, and inflamed due to a decrease in oestrogen levels. Symptoms of VVA include:

• Vaginal dryness
• Burning sensations
• Vaginal irritation
• Discomfort during intercourse

By addressing the root cause of these symptoms, Vagifem provides relief and improves the quality of life for many postmenopausal women.

How Does Vagifem Work?

Vagifem’s mechanism of action is centred around its ability to replace the declining levels of oestrogen in postmenopausal women. It does this in 4 main ways:

1. Oestrogen Replenishment: When Vagifem pessaries are inserted into the vagina, the estradiol they contain is released and absorbed by the vaginal tissues. This local application ensures targeted delivery, directly addressing vaginal symptoms.
2. Restoration of Vaginal Tissue: With the reintroduction of oestrogen, the vaginal tissues begin to thicken and regain their elasticity. This process helps reduce dryness and inflammation, alleviating the symptoms of VVA.
3. Maintenance of pH Balance: Oestrogen helps restore a healthy vaginal pH and supports beneficial bacteria, thereby maintaining the normal vaginal environment.
4. Enhanced Lubrication: By rejuvenating the vaginal tissues, Vagifem also aids in natural lubrication, reducing discomfort during intercourse.

How Long Does it Take for Vagifem to Work?

Once Vagifem has been inserted, it slowly releases estradiol over time. Some people notice initial relief from their symptoms in as little as 2 to 4 weeks of daily use. However, it can take up to 3 months to feel the full benefits of HRT.

If your symptoms have not improved or have got worse after 12 weeks, contact your clinician for advice, as they may suggest an alternative form of HRT.

How Long Does it Take for Vagifem to Dissolve?

It takes several hours for Vagifem to fully dissolve. Sometimes, it can take up to 24 hours. Because it is a slow-release tablet, it is recommended to insert it at night before going to bed to help keep it in place.

How Effective are Vagifem Vaginal Tablets?

Research shows that after 12 weeks, 39% of people given Vagifem 10 mcg had a vaginal pH of less than 5, compared with 21% of those given a placebo. After 3 months of taking Vagifem 10 mcg, there was an increase in the number of superficial cells within the vagina, 13.2% in the Vagifem group compared to 3.8% in the placebo group.  

Vagifem has very low systemic absorption. Studies lasting up to one year did not show an increased risk of endometrial hyperplasia or cancer, but the product information states that endometrial safety with repeated or longer-term use is uncertain. Treatment should be reviewed at least annually, and any bleeding or spotting should be assessed by a clinician.

How to Take Vagifem Tablets

Vagifem is a vaginal tablet which is inserted directly inside the vagina. It is not a pill that you swallow. You can start using Vagifem on any day which is best for you. You will insert one vaginal tablet every day for 2 weeks. Then you will insert one twice a week, leaving 3 or 4 days between doses. 

To insert Vagifem, you should:

1. Tear off one single blister pack and open it at the push-button end.
2. Insert the applicator carefully into the vagina, stopping when you can feel some resistance.
3. Gently press the push button until you feel a click to release the Vagifem tablet. The tablet will stick to the vaginal wall immediately.
4. Take out the applicator and throw it away.

Many people choose to insert Vagifem just before going to bed to help them remember to take it and to help it remain in place while they are lying down. However, Vagifem will not fall out if you stand up and walk.

What if You Forget to Use Vagifem

If you forget to insert Vagifem, use the medication as soon as you remember. Never use a double dose to make up for one you have forgotten. 

What if You Use Too Much Vagifem

If you have used more Vagifem than you should, it’s important to seek advice from a clinician or doctor. Because Vagifem tablets are for localised treatment, the dose of estradiol is so low that a considerable number would need to be taken to approach the dose typically used with oral tablets. 

Can I Stop Using Vagifem?

If you are thinking about stopping Vagifem, consult a clinician or doctor beforehand. Do not make any changes to your medication before seeking medical advice. This is so your doctor or clinician can explain the effects of stopping treatment and discuss other possibilities with you. 

Vagifem Side Effects and Cautions

Like all medications, Vagifem can cause side effects, so it is important to understand what they are along with any potential risks. This will give you a clearer idea of what to look out for and when to seek medical advice.

Possible Side Effects of Vagifem Tablets

Vagifem side effects can affect anyone, but not everyone who uses it will get them. For many people, the side effects are mild and temporary, improving as their bodies get used to the medication.

 

The table above does not contain a complete list of potential Vagifem side effects. More information can be found within the Patient Information Leaflet that comes with the medication.

If you get any side effects while using Vagifem, you should report them to a doctor or via the Yellow Card Scheme. This will help medical professionals better assess the medication's safety.

Vagifem Serious Side Effects

If you get any of the following serious Vagifem side effects, stop using it and see a doctor immediately, or in an emergency, call 999:

• Migraine-like headaches which happen for the first time
• Yellowing of your skin or the whites of your eyes (jaundice)
• Swelling of your face, tongue, or throat
• Difficulty swallowing and/or breathing
• Hives
• Large rise in blood pressure, which may cause headaches, tiredness, and dizziness
• You become pregnant
• Signs of a blood clot, including painful swelling and redness of the legs, sudden chest pain, or difficulty breathing

Side Effects Associated With Systemic Oestrogen Treatment

These side effects have been reported with systemic oestrogen treatment:

• Gall bladder disease
• Various skin disorders (skin discolouration known as chloasma, painful reddish skin nodules (erythema nodosum), or a rash with target-shaped reddening or sores called erythema multiforme)

Vagifem Interactions and Warnings

Because Vagifem is a local vaginal oestrogen with very low systemic absorption, risks associated with systemic HRT are
expected to apply to a lesser extent. The blood-clot and ovarian-cancer figures below relate to systemic HRT and are not specific estimates of risk with Vagifem.

Do not use Vagifem pessaries if you:

• Are allergic to estradiol or any other ingredients listed in the medication
• Have or have ever had breast cancer or are suspected of having it
• Have or have ever had cancer which is sensitive to oestrogens, such as womb cancer or are suspected of having it
• Have any unexplained vaginal bleeding
• Have excessive thickening of the womb lining, called endometrial hyperplasia, that is not being treated
• Have or have ever had a blood clot in a vein, such as the legs or lungs
• Have a blood-clotting disorder
• Have recently had a disease caused by blood clots in the arteries, such as a heart attack, stroke, or angina
• Have or have ever had a liver disease, and your liver function tests have not returned to normal
• Have a rare, inherited blood problem called porphyria

If you get any of the above conditions for the first time while using Vagifem, stop using it immediately and speak to your doctor as soon as possible.

Blood Clot Risk

Research shows that the risk of blood clots in the veins is about 1.3 to 3 times higher in HRT users than in people who do not use it, particularly during the first year of taking it.

The risk of blood clots while using systemic HRT is as follows:

• In women in their 50s who are not taking HRT, on average, 4 to 7 in 1000 would be expected to get a blood clot in a vein
• In women in their 50s who have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases per 1000

Breast Cancer Risk

Evidence suggests that Vagifem does not increase the risk of breast cancer in people who have not had breast cancer before. However, it is not known if it is safe for people who have a history of breast cancer to use Vagifem.

Ovarian Cancer Risk

Ovarian cancer is rarer than breast cancer, and taking oestrogen-only HRT has been linked to a slightly increased risk of getting ovarian cancer.

Precautions Before Using Vagifem Tablets

Before using Vagifem to manage your menopause symptoms, tell the clinician during your consultation if you have or have had any of the following conditions:

• Asthma
• Epilepsy
• Diabetes
• High blood pressure
• Migraines or severe headaches
• Very high blood fat levels (triglycerides)
• Fluid retention due to heart or kidney problems

This is not a full list of Vagifem precautions. You should read the Patient Information Leaflet before starting Vagifem to make sure you are not affected. 

Vagifem and Other Medications

Before starting Vagifem, it is important that you let your clinician know about any prescribed, over-the-counter, or herbal medications you are taking. Because Vagifem is a local treatment in the vagina, it is unlikely to affect other medications, but it may affect other vaginally applied treatments.

Pregnancy and Breastfeeding

Vagifem is only intended to be used by postmenopausal women. If you become pregnant, stop using Vagifem and speak to your doctor. You must not use Vagifem while breastfeeding. If you are unsure, speak to your doctor for more information.

Frequently Asked Questions About Vagifem Pessaries