Imvexxy Maintenance Pack

Imvexxy Maintenance Pack (for use in the vagina) is used by menopausal adult women to treat specific symptoms of menopause like dryness, itching, irritation, and pain during sexual intercourse.

Imvexxy Maintenance Pack may also be used for reasons not mentioned in this medication guide.

You should not use Imvexxy Maintenance Pack if you have or have ever had: vaginal bleeding that has not been checked by your doctor, liver disease, a bleeding or blood clotting disorder, a heart attack, a stroke, a blood clot, or cancer of the breast or uterus.

Do not use if you are pregnant. Tell your doctor right away if you become pregnant.

Imvexxy Maintenance Pack may increase your risk of developing uterine cancer. Report any unusual vaginal bleeding right away.

Using this medicine can increase your risk of blood clots, dementia, stroke, heart attack, or breast cancer. Estrogens should not be used to prevent heart disease, stroke, or dementia.

You should not use Imvexxy Maintenance Pack if you are allergic to it or any of its ingredients, or if you have or have ever had:

• unusual vaginal bleeding that has not been checked by a doctor;
• a bleeding or blood clotting disorder;
• a heart attack, stroke, or blood clot;
• hormone-related cancer such as breast or uterine cancer; or
• liver disease.

Estradiol should not be used to prevent heart disease, stroke, or dementia. Using this medicine may increase your risk of blood clots, dementia, stroke, or heart attack, especially if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Tell your doctor if you have or have ever had:

• heart disease;
• gallbladder disease;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• bone cancer;
• a family history of breast cancer;
• systemic lupus erythematosus (SLE);
• endometriosis or uterine fibroid tumors;
• hereditary angioedema;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• high triglycerides;
• a thyroid disorder;
• hypoparathyroidism;
• high or low levels of calcium in your blood;
• endometrial hyperplasia (overgrowth of cells lining the uterus);
• if you have had your uterus removed (hysterectomy);
• liver problems such as a liver tumor or jaundice (caused by pregnancy or hormones); or
• kidney disease.

Long-term use of estradiol vaginal may increase your risk of cancer of the breast or uterus. Talk with your doctor about this risk.

Do not use Imvexxy Maintenance Pack if you are pregnant. Tell your doctor right away if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Remove the vaginal ring and seek emergency medical attention if you experience: fever with nausea, vomiting, diarrhea, muscle pain, dizziness, fainting, and/or a sunburn-like skin rash. These may be signs of a serious condition called toxic shock syndrome.

Imvexxy Maintenance Pack can raise your risk of blood clots, stroke, or heart attack. Get emergency medical help if you experience: chest pain, pain, swelling or warmth in your leg, sudden numbness or weakness on one side of your body, slurred speech, feeling short of breath, or having trouble breathing.

Imvexxy Maintenance Pack may lead to serious side effects. Contact your doctor immediately if you have:

• a change in the pattern or severity of migraine headaches;
• memory issues, confusion, unusual behavior;
• unusual vaginal bleeding;
• vaginal pain, soreness, irritation, redness, or swelling in the vagina;
• a lump in your breast;
• changes in vision;
• abnormal lab results such as increased fat in your blood (triglycerides) or thyroid hormone levels;
• signs of gallbladder, liver, or pancreas issues—chalky-colored stools, stomach pain after eating, nausea, heartburn, bloating, loss of appetite, upper stomach pain (that may spread to your back), vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);
• fluid retention—shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection);
• increased blood pressure—severe headache, pounding in your neck or ears; or
• low or high blood calcium levels—constipation, increased thirst or urination, muscle spasms, weight loss, tingly feeling (around your mouth, or in your fingers and toes).

Common side effects of Imvexxy Maintenance Pack may include:

• nausea, vomiting, bloating, diarrhea;
• back pain, stomach pain or cramps;
• headache;
• swelling or rapid weight gain;
• hair loss;
• breast pain or tenderness;
• vaginal itching or discharge, irregular vaginal bleeding or spotting; or
• vaginal burning or irritation where the medicine is applied.

This is not a full list of side effects and others may occur. Contact your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not take by mouth. Vaginal medicine is for use only inside the vagina.

Read and carefully follow any Instructions for Use provided on how to use Imvexxy Maintenance Pack. Ask your doctor or pharmacist if you do not understand these instructions.

Wash your hands before and after using this medicine.

If you are using the vaginal cream, use the applicator provided to measure the prescribed dose of cream. Take apart the cream applicator and wash it with mild soap and warm water after each use.

Certain formulations of estradiol vaginal are also available in single use prefilled applicators. These applicators should only be used once. Do not clean or reuse a disposable applicator. Throw the applicator away after one use, even if there is still some medicine left inside.

If you are using the vaginal ring, you should not be able to feel it once it is in place inside the vagina. Leave it in place for 90 days, then remove it. Your doctor may want you to replace it with a new ring. The ring does not need to be removed during sexual intercourse. If the ring is bothersome, you may remove it, rinse it with warm water, and reinsert it after intercourse

To remove the ring, loop a finger through the ring and gently pull it from the vagina. Call your doctor if you have trouble removing a vaginal ring.

You may need frequent medical tests and your doctor will need to check your progress on a regular basis to determine how long you should use Imvexxy Maintenance Pack. You may need a pelvic exam, breast exam, and mammogram every year while using this medicine. Follow your doctor's instructions.

If you need surgery, or will be on bed rest, tell your healthcare provider ahead of time that you are using Imvexxy Maintenance Pack. You may need to stop using the medicine for a short time.

Imvexxy Maintenance Pack may increase your risk of developing a condition that can lead to uterine cancer. To lower this risk, your doctor may also want you to take a progestin. Report any unusual vaginal bleeding right away.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Imvexxy Maintenance Pack.

Store at room temperature away from moisture and heat.

Use the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not use two doses at the same time.

If you are using the vaginal ring, take out the vaginal ring and insert a new one as soon as you remember. Do not use an extra vaginal ring to make up for the missed wearing time.

If a vaginal ring falls out, rinse it with warm water and put it back in. If it slides down into the lower part of the vagina, use your finger to push it in further.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid smoking. It can greatly increase your risk of blood clots, dementia, stroke, or heart attack while using Imvexxy Maintenance Pack.

Do not use other vaginal products without your doctor's advice.

Grapefruit may interact with Imvexxy Maintenance Pack and cause side effects. Do not consume grapefruit products.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Many drugs can affect Imvexxy Maintenance Pack. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you are using.

• How does Imvexxy work to treat dyspareunia (painful sex) due to menopause?