How to take Vagifem^® 10 mcg.

Vagifem^® (estradiol vaginal inserts) 10 mcg is an insert that’s inserted into the vagina with a preloaded, single-use applicator. This isn’t the complete set of instructions for use, so be sure to read all of the information in the Patient Information before starting.

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. If after opening the package you see that the insert has come out of the applicator but has not fallen out of the package, carefully put it back into the applicator for insertion. Please keep your hands clean and dry while handling the insert.

Open vaginal applicator and remove the wrap

Hold the applicator horizontally before delivering vaginal inserts

Position the vagina and insert the vaginal applicator

Press the plunger to administer Vagifem® 10 mcg estradiol vaginal inserts

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 inserts) that is most comfortable for you. See suggested reclining Figure C or standing Figure D position.

Step 5.

Using the other hand, guide the applicator gently and comfortably through the vaginal opening (see Figures C and D). If prior to insertion the insert falls out of the applicator, throw the insert and applicator away and use a new insert-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 insert-filled applicator has been inserted, gently press the plunger until the plunger is fully depressed. This will eject the insert 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 inserts). If you have any questions, please consult your health care provider or pharmacist.

Related FAQs.

What time of day should I use Vagifem^® 10 mcg?: You can use Vagifem^® 10 mcg any time of the day, but you should try to use it at the same time every day.
What if the insert has come out of the applicator inside the package?: If, after opening the package, you see that the insert has come out of the applicator but has not fallen out of the package, carefully put it back into the applicator for insertion. Please keep your hands clean and dry while handling the insert.
What if the insert falls out of the applicator?: If, prior to insertion, the insert falls out of the applicator, throw the insert and applicator away and use a new insert-filled applicator.
Do I need to wash or reuse the applicator?: No, the applicators are disposable. After use, dispose of the applicator as you would a plastic tampon applicator.

Important Safety Information

Who should not use Vagifem^®?

Do not start using Vagifem^® if you:

have unusual bleeding

have been diagnosed with a bleeding disorder

currently have or have had certain cancers

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 the ingredients in it

Before you use Vagifem^®, tell your healthcare provider about all of your medical conditions, including if you:

have any unusual vaginal bleeding

have any other medical conditions that may become worse while you are using Vagifem^®

are going to have surgery or will be on bed rest

are pregnant or think you may be pregnant

are breastfeeding

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of Vagifem^®?

Serious but less common side effects include: heart attack, stroke, blood clots, breast cancer, cancer of the lining of the uterus (womb), cancer of the ovary, dementia, high and low blood calcium, gallbladder disease, visual abnormalities, high blood pressure, high levels of fat (triglyceride) in your blood, liver problems, changes in your thyroid hormone levels, fluid retention, cancer changes of endometriosis, enlargement of benign tumors of the uterus (fibroids), worsening of swelling of face and tongue (angioedema) in women with a history of angioedema

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

new breast lumps

unusual vaginal bleeding

changes in vision or speech

sudden new severe headaches

severe pains in your chest or legs with or without shortness of breath, weakness, and fatigue

Common side effects of Vagifem^® include headache, breast pain, irregular vaginal bleeding or spotting, stomach or abdominal cramps, bloating, nausea and vomiting, hair loss, fluid retention, and vaginal yeast infection.

Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

Talk to your health care provider and find out if Vagifem^® 10 mcg is right for you.