Yuvafem Estradiol

Get an overview of YUVAFEM (estradiol tablet), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Yuvafem can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Yuvafem.

Drug Basics

Brand Name: Yuvafem

Generic Name: ESTRADIOL

Drug Type: HUMAN PRESCRIPTION DRUG

Route: VAGINAL

Dosage Form: TABLET

Data Current As Of: 2020-01-27

Warnings and Precautions, Malignant Neoplasms (5.3) 11/2017

indications & usage

  •  Yuvafem are an estrogen (estradiol) indicated for the treatment of atrophic vaginitis due to menopause (1.1)

treatment of atrophic vaginitis due to menopause

.

drug interactions

No drug-drug interaction studies have been conducted for Yuvafem.

  • Inducers and inhibitors of CYP3A4 may affect estrogen drug metabolism (7.1)

metabolic interactions

In-vitro and in-vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St. John’s wort ( Hypericum perforatum) preparations, phenobarbital, carbamazepine and rifampin, may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects.

patient counseling information

See FDA-Approved Patient Labeling.

vaginal bleeding

Inform postmenopausal women of the importance of reporting vaginal bleeding to their healthcare provider as soon as possible [see Warnings and Precautions (5.3) ].

possible serious adverse reactions with estrogen-alone therapy

Inform postmenopausal women of possible serious adverse reactions of estrogen-alone therapy including Cardiovascular Disorders, Malignant Neoplasms and Probable Dementia [see Warnings and Precautions (5.2, 5.3, 5.4) ].

possible less serious but common adverse reactions with estrogen-alone therapy

Inform postmenopausal women of possible less serious but common adverse reactions of estrogen-alone therapy such as headache, breast pain and tenderness, nausea and vomiting.

instructions for use of applicator

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.

estradiol vaginal inserts usp 2.jpg

Figure A

Step 3: Hold the applicator so that the finger of one hand can press the applicator plunger as shown in Figure B.

estradiol vaginal inserts usp 3.jpg

Figure B

Step 4: Next select the best position for vaginal insertion of Yuvafem that is most comfortable for you. See suggested reclining Figure C or standing Figure D position illustrated below:

estradiol vaginal inserts usp 4.jpg

Figure C

estradiol vaginal inserts usp 5.jpg

Figure D

Step 5: Using the other hand, guide the applicator gently and comfortably through the vaginal opening (see Figures C and D above). 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 Yuvafem (estradiol vaginal insert). If you have any questions, please consult your healthcare provider or pharmacist.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478
YUVAFEM is a registered trademark of Amneal Pharmaceuticals LLC

Mfg. Rev. 11-2017-03 AV 11/17

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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