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Vagifem Patient, Information, Instructions - Estradiol

Vagifem Patient, Information, Instructions - Estradiol INFORMATION FOR PATIENTS

Introduction

This leaflet describes when and how to use VAGIFEM® (estradiol vaginal tablets) and the risks and benefits of estrogen treatment. Please read this information carefully before starting treatment.

Estrogens have important benefits but also some risks. You must decide, with your doctor or health care provider, whether the risks to you of estrogen use are acceptable because of their benefits. If you use estrogens, check with your health care provider to be sure you are using the dose that is appropriate for you, and that you don't use them longer than necessary. How long you need to use estrogens should be decided by you and your health care provider. Estrogens are hormones made by the ovaries of normal women. Between ages 45 and 55, the ovaries normally stop making estrogens. This leads to a drop in body estrogen levels which causes the "change of life" or menopause (the end of monthly menstrual periods). If both ovaries are removed during an operation before natural menopause takes place, the sudden drop in estrogen levels causes "surgical menopause."

When the estrogen levels begin dropping, some women develop very uncomfortable symptoms, such as feeling of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating ("hot flashes" or "hot flushes"). Using estrogen drugs can help the body adjust to lower estrogen levels and reduce these symptoms. Most women have only mild menopausal symptoms or none at all and may not need to use estrogen drugs. VAGIFEM DOES NOT PROVIDE ENOUGH ESTROGEN TO REDUCE THESE SYMPTOMS.

The declining estrogen levels associated with advancing age after menopause may also result in thinning and drying of the tissue in the vagina and urinary tract (urogenital atrophy). Vaginal symptoms of this condition include dryness in the vagina (atrophic vaginitis), genital itching and burning, and pain with intercourse. Urinary symptoms may include urinary urgency and pain on urination. Small amounts of estrogens delivered directly to the local tissue can be used to help reduce these symptoms.

Use of VAGIFEM®

(estradiol vaginal tablets)

VAGIFEM is a local estrogen therapy designed to relieve vaginal symptoms, a major component of the urogenital symptoms found in post-menopausal estrogen deficiency. VAGIFEM® (estradiol vaginal tablets) exerts its effect locally in the lower urogenital tract, particularly the vagina, and has not been associated with significant effects in other estrogen-sensitive organs or tissues of the body. Consequently, VAGIFEM provides relief of local symptoms of menopause only.

Description

VAGIFEM® (estradiol vaginal tablets) contains 25µg (micrograms) of estrogen (estradiol). VAGIFEM releases estradiol into the vagina. A gel layer forms when the tablet comes in contact with the vagina. The estradiol is released from this gel layer.

Dosage

One (1) VAGIFEM tablet inserted vaginally once daily for the first two (2) weeks. Then one (1) tablet twice weekly. (See table below).

 

Administration Regimen
Days:
1 2 3 4 5 6 7
Week 1
1 Vagifem tablet everyday
/
/
/
/
/
/
/
Week 2
1 Vagifem tablet everyday
/
/
/
/
/
/
/
Week 3 and Thereafter
1 Vagifem tablet twice weekly
/
/


Directions for use of VAGIFEM®:

Step 1: Tear off a single applicator.

Step 2: Separate the plastic wrap and remove the applicator from the plastic wrap.

Step 3: First select the best position for vaginal insertion of VAGIFEM® (estradiol vaginal tablets) that is most comfortable for you.

Step 4: The applicator should be held so that the finger of one hand can press the applicator plunger.

Step 5: The other hand should be used to guide the applicator gently and comfortably through the vaginal opening (see Figures 3 and 4 above). If the tablet has come out of the applicator prior to insertion, do not attempt to replace it. Use a fresh tablet-filled applicator.

Step 6: The applicator should be inserted (without forcing) as far as comfortably possible, or until half of the applicator is inside your vagina, whichever is less.

Step 7: Once the tablet-filled applicator has been inserted, gently press the plunger until a click is heard and the plunger is fully depressed. This will eject the tablet inside your vagina where it will dissolve slowly over several hours.

Step 8: After depressing the plunger, gently remove the applicator and dispose of it the same way you would a plastic tampon applicator. The applicator is of no further use and should be discarded properly. Insertion may be done at any time of the day. It is advisable to use the same time daily for all applications of VAGIFEM® (estradiol vaginal tablets). If you have any questions, please consult your health care provider or pharmacist.

Who Should Not Use VAGIFEM®

(estradiol vaginal tablets)

VAGIFEM should not be used:

During pregnancy Women who are definitely postmenopausal cannot become pregnant. Women who believe they are postmenopausal because their menstrual cycles have recently stopped should confirm that they are not pregnant before using any form of estrogen-containing drug. Using estrogens while pregnant may cause the unborn child to have birth defects. Estrogens do not prevent miscarriage.

In the presence of unusual vaginal bleeding which has not been evaluated by a health care provider. Unusual vaginal bleeding after menopause can be a warning sign of cancer of the uterus. Estrogens may increase the risk of cancer of the uterus in women who have had their menopause ("change of life"). If you use any estrogen-containing drug, it is important to visit your health care provider regularly and report any unusual vaginal bleeding right away. Your health care provider should evaluate any unusual vaginal bleeding to find out the cause.

If there is a history of certain types of cancer Estrogens may increase the risk of certain types of cancer, usually uterine or breast. VAGIFEM has not been associated with an increased risk of uterine cancer. Although there are reports of increased risk of breast cancer in women on hormone replacement therapy, VAGIFEM is administered locally and is not expected to pose an increased risk.

After childbirth or when breast-feeding a baby VAGIFEM should not be used to try to stop the breasts from filling with milk after a baby is born. Women who are breast-feeding should avoid using any drugs because many drugs pass through to the baby in the milk. While nursing a baby, drugs should only be taken on the advice of your healthcare giver.

Possible Risks from Treatment with Estrogens

The following risk factors apply to estrogens in general:

Cancer of the uterus Estrogens increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus (endometrial cancer).

The risk of endometrial cancer is greater in estrogen users than nonusers. Studies have shown that this increased risk depends on estrogen dose, duration of treatment, and treatment regimen.

Using progestin therapy together with estrogen therapy may reduce the higher risk of uterine cancer related to estrogen use.

If the uterus has been removed (total hysterectomy), there is no danger of developing cancer of the uterus.

Cancer of the breast Most studies have not shown a higher risk of breast cancer in women who have ever used estrogens. However, some studies have reported that breast cancer developed more often (up to twice the usual rate) in women who used estrogens for long periods of time (especially more than 10 years) or who used higher doses for shorter time periods. VAGIFEM® (estradiol vaginal tablets) is not expected to increase the risk since it is a low dose, applied topically in the vagina, is minimally absorbed into the systemic circulation and is used for relatively short periods of time.

Regular breast examinations by a health professional and monthly self-examination are recommended for all women.

Gallbladder disease and abnormal blood clotting Gallbladder disease and abnormal blood clotting are risk factors associated with medium to high doses of estrogen. Most studies of low-dose estrogen usage by women do not show an increased risk of these complications, and to date there have not been complications with VAGIFEM (estradiol vaginal tablets) treatment.

Side Effects

Few side effects have been reported: vaginal spotting, vaginal discharge, allergic reaction and skin rash.

Estrogens in General

In addition to the risks listed above, the following side effects have been reported with estrogen use:

Nausea and vomiting, breast tenderness or enlargement, enlargement of benign tumors ("fibroids") of the uterus, retention of excess fluid.

Estrogen may worsen some conditions, such as asthma, epilepsy, migraine, heart disease, or kidney disease. Spotty darkening of the skin, particularly on the face.

If you use estrogens, you may reduce your risks by doing these things: See your health care provider regularly. While you are using estrogens, it is important to visit your health care provider at least annually for a check-up. If you develop vaginal bleeding while taking estrogens, call your health care provider; you may need further evaluation. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram (breast X-ray), you may need to have more frequent breast examinations. Reassess your need for estrogens. You and your health care provider should reevaluate whether or not you still need estrogens at least every six months.

Be alert for warning signs. If any of these warning signals (or any other unusual symptoms) happen while you are using estrogens, call your health care provider immediately: Abnormal bleeding from the vagina (possible uterine cancer); pains in the calves or chest, sudden shortness of breath, or coughing blood (possible clot in the legs, heart, or lungs); severe headache or vomiting, dizziness, faintness, changes in vision or speech, weakness or numbness of an arm or leg (possible clot in the brain or eye); breast lumps (possible breast cancer; ask your health care provider to show you how to examine your breasts monthly); yellowing of skin or eyes (possible liver problem); pain, swelling, or tenderness in the abdomen (possible gallbladder problem).

  1. Estrogens increase the risk of developing a condition called endometrial hyperplasia that may lead to cancer of the lining of the uterus. Progestin, another hormone drug, is usually prescribed with higher-dose estrogen preparations in order to lower the risk of developing endometrial hyperplasia. Progestins are not usually needed for women using VAGIFEM® (estradiol vaginal tablets) alone.
  2. Vaginal infection is generally more common in postmenopausal women. Vaginal infections should be treated by your health care provider with the appropriate antimicrobial therapy before initiation of VAGIFEM. If a vaginal infection develops during use of VAGIFEM, it may be continued while the infection is being treated. See your health care provider if you have vaginal discomfort or suspect you have a vaginal infection.
  3. Your health care provider has prescribed this drug for you and you alone. Do not give the drug to anyone else.
  4. Keep this and all drugs out of the reach of children.
  5. This leaflet provides a summary of important information about VAGIFEM. If you want more information, ask your health care provider or pharmacist to show you the professional labeling. The professional labeling is also published in a book called the "Physicians' Desk Reference" which is available in book stores and public libraries. Generic drugs carry virtually the same labeling information as their brand name versions.

 

See text of patient Package Insert which appears above.

C. Drug/Laboratory Test Interactions

Certain endocrine and liver function tests may be affected by estrogen-containing oral contraceptives. The following similar changes may be expected with larger doses of estrogens:

  1. Increased prothrombin and factors VII, VIII, IX, and X, decreased antithrombin III; increased norepinephrine induced platelet aggregability.
  2. Increased thyroid binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by PBI, T 4 by column, or T 4 by radioimmunoassay. Free T 4 resin uptake is decreased, reflecting the elevated TBG, free T 4 concentration is unaltered.
  3. Impaired glucose tolerance.
  4. Reduced response to metyrapone test.
  5. Reduced serum folate concentration.
  6. Increased serum triglyceride and phospholipid concentration.

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