Vagifem

The active ingredient in Vagifem is estradiol. It is a bio-similar of estrogen. Estrogen is a natural hormone made in the ovaries, so Vagifem is simply replacing the estrogen that has been lost through menopause.

Unlike systemic hormone therapy, which affects the entire body, Vagifem vaginal tablets are designed to deliver estrogen directly to the vaginal tissues. This targeted approach helps alleviate symptoms without the risks associated with systemic estrogen use. However, the lack of systemic absorption means that Vagifem only treats symptoms of menopause in and around the vagina.

Follow all directions given by your doctor and read all documents provided, including the full prescribing information, FDA-approved product labeling, Instructions for Use, and Medication Guide before using Vagifem. However, the following is a synopsis of the general guidelines for the use of Vagifem:

• Vagifem is recommended to be inserted a few hours before having sex. It will take a few hours for the medication to dissolve fully in your vagina; having sex right after you have inserted estradiol will not allow you to experience the full benefits of Vagifem.
• When you want to insert Vagifem, wash your hands with soap and warm water. Do not remove the applicator from the packaging it comes in until you know that you are ready to use it. The applicator should be thrown away after each daily use.
• Never take Vagifem by mouth; throw the tablet away if it falls out of the applicator before you have inserted it.
• To insert it, place the applicator as comfortably as you can into your vagina and press the plunger to release the tablet. You may choose any time of day that works for you, just make sure that you take it at the same time each day. This is a single-use applicator and medicine; throw the applicator away after you have taken your dose for the day.
• Especially after your first dose, watch for side effects such as irritation. Make sure you wash your hands after you have applied Vagifem.
• If you miss a dose, do not take two doses at once. Instead, take the missed dose as soon as you can on the same day. The next day, return to your normal schedule.
• You should ensure that you get complete physical exams, such as breast exam (mammogram), blood pressure, pelvic exam, and pap smear throughout your treatment course with Vagifem.
• Continue to take all prescribed medications as your doctor instructs. Your healthcare professional may recommend that you take a progestin as well to decrease your chances of developing endometrial hyperplasia.
• Vagifem should be used at the lowest effective dose that relieves your menopausal symptoms for the shortest time possible, as directed by your doctor.

The most common side effects of Vagifem seen in clinical trials as compared to placebo include:

• Itching in the vagina or vulva area (pruritus)
• Vaginal irritation can also occur after you’ve used the applicator. Speak to your doctor if the symptoms do not go away.
• Back pain
• Vaginal yeast infection
• Fluid retention
• Diarrhea
• Bloating
• Depression
• Trouble sleeping
• Vulvovaginal mycotic infection

Some individuals may experience serious side effects while using Vagifem. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Heart attack
• You are at higher risk if you have high blood pressure, high cholesterol, diabetes, or are obese, among other factors.
• Symptoms could include:
• Pain that moves up to your shoulder, neck, arm, or jaw
• Chest pain or tightness
• Stroke. Symptoms could include:
• Trouble walking
• Sudden trouble talking
• Numbness on one side of your body or face
• Severe headache
• Blood clots. Symptoms could include:
• If in your legs: swelling, pain, muscle tightness, cramps
• If in the lungs: trouble breathing, chest pain, cough, shortness of breath
• Severe allergic reaction. Symptoms could include:
• Swelling of your lips, face, throat, or tongue
• Trouble breathing
• Unusual vaginal bleeding
• Increased risk of developing specific cancers such as breast cancer and ovarian cancer.
• Breast pain
• Breast lumps
• Increased risk of gallbladder disease
• Severe hypercalcemia
• Discontinue Vagifem if severe hypercalcemia occurs including severe hypertriglyceridemia or cholestatic jaundice occurs

These are not all of the possible side effects of Vagifem. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Vagifem, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Heart disease
• Abnormal genital bleeding that has gone undiagnosed
• History of breast cancer or currently have breast cancer
• Estrogen-dependent neoplasia
• Liver problems or jaundice that have been caused by pregnancy
• Kidney or liver disease
• Seizure disorders, such as epilepsy
• Thyroid issues
• Thyroid function should be monitored in women who have been on or are on thyroid replacement therapy.
• Gallbladder disease
• Endometriosis or uterine fibroid tumors
• History or active PE or DVT
• Porphyria
• High triglyceride levels (fats)
• Known hypersensitivity, angioedema, or anaphylactic reaction to Vagifem
• Hepatic impairment or disease
• High or low levels of calcium in your blood
• Active arterial thromboembolic diseases, such as stroke or myocardial infarction.
• Thrombophilic disorders, including Protein C, protein S, or antithrombin deficiency.

Boxed warnings

As of right now, there is a boxed warning for Vagifem. The warning consists of cardiovascular disorders, endometrial cancer, and increased risk of breast cancer. The warning is broken down as follows:

Estrogen-alone therapy:

• If you are a woman with a uterus & use unopposed estrogens, there is an increased risk of endometrial cancer.
• The Women’s Health Initiative (WHI) estrogen-alone substudy has reported that there is an increased risk of deep vein thrombosis and stroke.
• WHI conducted a memory study known as an estrogen-alone ancillary study that reported that there is an increased risk of dementia if you are a postmenopausal woman 65 years of age or older.
• Estrogen-alone therapy should not be used in the prevention of dementia or cardiovascular disease.

Estrogen with progestin therapy:

• The WHI conducted an estrogen plus progestin substudy that has reported an increased risk of pulmonary embolism (PE), stroke, DVT, and myocardial infarction (MI).
• The WHI also found that estrogen plus progestin has an increased risk of invasive breast cancer.
• The WHIMS estrogen plus progestin ancillary study of WHI has reported that there is an increased risk of probable dementia in postmenopausal women who are 65 years of age or older.
• Estrogen plus progestin should not be used in the prevention of cardiovascular disease or dementia.

• Breast cancer, or a history of breast cancer

• Estrogen-dependent neoplasia

• Undiagnosed abnormal genital bleeding

• Active PE, DVT, or a history of these conditions

• Known anaphylactic reaction, angioedema, or hypersensitivity to Vagifem, or any of the ingredients in Vagifem

• Hepatic disease or impairment

• Protein S, protein C, or antithrombin deficient, or other known thrombophilic disorders

• Active arterial thromboembolic disease, such as stroke or MI, or a known history of these conditions.

Vagifem typically starts working within a few weeks, but some people may notice symptom relief in as little as 2 weeks. For full benefits, it may take up to 8 weeks of consistent use, especially for symptoms like vaginal dryness or discomfort. It's important to follow your healthcare provider’s instructions for dosage and duration to achieve the best results.

When Vagifem is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking so they can check for drug interactions, including:

• Inducers and inhibitors of CYP3A4.
• These medications may affect the estrogen drug’s ability to metabolize and increase or decrease the estrogen plasma concentration.

Vagifem comes as a film-coated vaginal insert in the following dosage:

• 10 mcg (also known as Vagifem 10) that contains 10.3 mcg of estradiol hemihydrate equivalent to 10 mcg of estradiol.

Vagifem should be stored in a closed container at room temperature, away from moisture, heat, and direct light. Keep from freezing.

Vagifem is manufactured by Novo Nordisk.

There are lower-cost generics available, including estradiol, for the brand-name Vagifem.

To stop taking Vagifem, consult your healthcare provider to determine the best approach, as sudden discontinuation might cause a return of symptoms. Depending on your condition, your doctor may recommend gradually reducing the dose to minimize any side effects or manage symptom recurrence. Always follow your doctor's advice to ensure safe discontinuation and monitor for any changes in symptoms.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Currently, the recommendation is not to take Vagifem while pregnant as there are chances of miscarriages and birth defects.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. Research has shown that estrogens have been found in lactating females and have the potential to reduce milk production. The effects on the newborn baby have not been well-established, however, a discussion with your healthcare professional on the pros and cons is advised.