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Información de la droga para Vagifem (estradiol vaginal tablets) Initial U.S. Approval: 1999 (Novo Nordisk): 17.5 FDA-Approved Patient Labeling
- WARNING: CARDIOVASCULAR DISORDERS, ENDOMETRIAL CANCER, BREAST CANCER and PROBABLE DEMENTIA
- 3 DOSAGE FORMS AND STRENGTHS
- 4 CONTRAINDICATIONS
- 6 ADVERSE REACTIONS
- 7 DRUG INTERACTIONS
- 10 OVERDOSAGE
- 11 DESCRIPTION
- 15 REFERENCES
- 17 PATIENT COUNSELING INFORMATION
- 17.5 FDA-Approved Patient Labeling
- Principal Display panel - VAGIFEM 25 µg
- Principal Display panel - VAGIFEM 10 µg
Vagifem® (estradiol vaginal tablets)
Read this PATIENT INFORMATION before you start using Vagifem and read the patient information each time you refill your Vagifem prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms and their treatment.
What is the most important information I should know about VAGIFEM
(an estrogen hormone)
- Using estrogen-alone may increase your chance of getting cancer of the uterus (womb)
Report any unusual vaginal bleeding right away while you are using Vagifem. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.
- Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline of brain function)
- Using estrogen-alone may increase your chances of getting strokes or blood clots
- Using estrogen-alone may increase your chance of getting dementia, based on a study of women age 65 years or older
- Do not use estrogens with progestins to prevent heart disease, heart attack, or dementia
- Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots
- Using estrogens with progestin may increase your chance of getting dementia, based on a study of women 65 years and older
- You and your healthcare provider should talk regularly about whether you still need treatment with Vagifem
What is Vagifem?
Vagifem is a medicine that contains estradiol (an estrogen hormone) in a vaginal tablet.
What is Vagifem used for?
Vagifem is used after menopause to:
- Treat menopausal changes in and around the vagina
You and your healthcare provider should talk regularly about whether you still need treatment with Vagifem to control these problems.
Who should not use Vagifem?
Do not start using Vagifem if you:
- Have unusual vaginal bleeding
- Currently have or have had certain cancers
Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have, have had or suspect cancer, talk with your healthcare provider about whether you should use Vagifem.
- Had a stroke or heart attack
- Currently have or have had blood clots
- Currently have or have had liver problems
- Are allergic to Vagifem or any of its ingredients
See the list of ingredients in Vagifem at the end of this leaflet.
- Think you may be pregnant
Tell your health care provider:
- If you have any unusual vaginal bleeding
Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find the cause.
- About all of your medical problems
Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood.
- About all the medicines you take
This includes prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Vagifem works. Vagifem may also affect how your other medicines work.
- If you are going to have surgery or will be on bed rest
You may need to stop using Vagifem.
- If you are breast feeding
The hormone in Vagifem can pass into your milk.
How should I use Vagifem?
Vagifem is a tablet that you place in your vagina with an applicator.
- Take the dose recommended by your healthcare provider and talk to him or her about how well that dose is working for you
- Estrogens should be used at the lowest dose possible for your treatment only as long as needed
You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Vagifem.
Step 1: Tear off a single applicator.
Step 2: Separate the plastic wrap and remove the applicator from the plastic wrap as shown in Figure A.
Step 3: Hold the applicator so that the finger of one hand can press the applicator plunger as shown in Figure B.
Step 4: Next select the best position for vaginal insertion of Vagifem (estradiol vaginal tablets) that is most comfortable for you. See suggested reclining Figure C or standing Figure D position illustrated below:
Step 5: Using the other hand, guide the applicator gently and comfortably through the vaginal opening (see Figures C and D 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 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 healthcare provider or pharmacist.
Vagifem therapy consists of the following dosing regimen:
One (1) Vagifem tablet inserted vaginally once daily for the first two (2) weeks, then one (1) tablet inserted twice weekly (for example Tuesday and Friday) for as long as you use Vagifem.
What are the possible side effects of Vagifem?
Vagifem is only used in the vagina; however, the risks associated with oral estrogens should be taken into account.
Side effects are grouped by how serious they are and how often they happen when you are treated.
Serious but less common side effects include:
- Breast cancer
- Cancer of the uterus
- Heart attack
- Blood clots
- Gallbladder disease
- Ovarian cancer
- High blood pressure
- Liver problems
- High blood sugar
- Enlargement of benign tumors of the uterus (“fibroids”)
Some of the warning signs of serious side effects include:
- Breast lumps
- Unusual vaginal bleeding
- Dizziness and faintness
- Changes in speech
- Severe headaches
- Chest pain
- Shortness of breath
- Pains in your legs
- Changes in vision
- Yellowing of the skin, eyes or nail beds
Call your healthcare provider right away if you get any of these warning signs, or any other unusual symptoms that concern you.
Less serious, but common, side effects include:
- Breast pain
- Irregular vaginal bleeding or spotting
- Stomach/abdominal cramps, bloating
- Nausea and vomiting
- Hair loss
- Fluid retention
- Vaginal yeast infection
These are not all the possible side effects of Vagifem. For more information, ask your healthcare provider or pharmacist for advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What can I do to lower my chances of a serious side effect with Vagifem?
- Talk with your healthcare provider regularly about whether you should continue using Vagifem
- If you have a uterus, talk with your healthcare provider about whether the addition of a progestin is right for you
The addition of a progestin is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus. See your healthcare provider right away if you get vaginal bleeding while using Vagifem.
- Have a pelvic exam, breast exam and mammogram (breast X-ray) every year unless your healthcare provider tells you something else
If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram, you may need to have breast exams more often.
- If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have higher chances for getting heart disease
Ask your healthcare provider for ways to lower your chances for getting heart disease.
General information about the safe and effective use of Vagifem.
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Vagifem for conditions for which it was not prescribed. Do not give Vagifem to other people, even if they have the same symptoms you have. It may harm them. Keep Vagifem out of the reach of children.
This leaflet provides a summary of the most important information about Vagifem. If you would like more information, talk with your healthcare provider or pharmacist. You can ask for information about Vagifem that is written for health professionals. You can get more information by calling the toll free number 1-888-824-4336.
What are the ingredients in Vagifem?
Vagifem (estradiol vaginal tablets) are small, white, film-coated tablets containing estradiol. Each tablet also contains hypromellose, lactose monohydrate, maize starch and magnesium stearate. The film coating contains hypromellose and polyethylene glycol.
Each Vagifem tablet is contained in a disposable applicator, packaged in a blister pack. Cartons contain 8 or 18 applicators with inset tablets.
Store at 25ºC (77ºF); excursions permitted to 15ºC - 30ºC (59ºF - 86ºF). Do not refrigerate.
[see USP Controlled Room Temperature].
Vagifem® is a registered trademark owned by Novo Nordisk FemCare AG.
© 2003-2009 Novo Nordisk A/S
Date of Issue: November 25, 2009
For Information contact:
Novo Nordisk Inc.
100 College Road West
Princeton, NJ 08540, USA
Novo Nordisk A/S
2880 Bagsvaerd, Denmark
- Drug Information Provided by National Library of Medicine (NLM).