Hormone Replacement Therapy (HRT)
This page contains the Important Safety Information for the hormone replacement and menopause symptom treatments that may be prescribed through Allara.
See Important Safety Information, including Boxed Warning, about:
Transdermal Estradiol — Patches & Topicals (Vivelle-Dot®, Climara®, Doti®)
Indication
Transdermal estradiol is used to treat moderate to severe vasomotor symptoms (hot flashes) and certain other symptoms due to menopause. When you have a uterus, estrogen is generally prescribed together with a progestogen to reduce the risk of endometrial cancer. Use the lowest effective dose for the shortest duration consistent with your treatment goals.
Boxed Warning
Endometrial Cancer, Cardiovascular Disorders, Breast Cancer, and Probable Dementia. Estrogen-alone therapy increases the risk of endometrial cancer in women with a uterus. Estrogens should not be used for the prevention of cardiovascular disease or dementia.
Contraindications
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer.
- Active or history of DVT or PE.
- Active arterial thromboembolic disease (e.g., stroke, myocardial infarction).
- Known liver impairment or disease.
- Known or suspected pregnancy; known protein C, protein S, or antithrombin deficiency.
Warnings & Precautions
- Gallbladder disease.
- Hypercalcemia.
- Visual abnormalities / retinal vascular thrombosis.
- Elevated blood pressure; elevated triglycerides; effects on thyroid and other lab tests.
Drug Interactions
Tell your provider all medications you take. CYP3A4 inhibitors (e.g., some antifungals, grapefruit juice) may increase estrogen levels, and inducers (e.g., St. John's wort, certain anticonvulsants) may decrease them.
Use in Specific Populations
- Pregnancy: should not be used during pregnancy.
- Breastfeeding: estrogens can reduce milk production; use only if needed.
- Use with caution in patients with hepatic impairment, and in older adults (higher risk of stroke and probable dementia).
Common Side Effects
Headache, breast tenderness, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea, vomiting, and hair loss.
Storage & Application
Apply patches to clean, dry, intact skin (not on or near the breasts) and rotate sites; apply gels/creams to the prescribed area and let dry before dressing or contact with others. Store as directed. Do not stop abruptly without talking to your provider.
Read the Medication Guide and Patient Information provided with your prescription before you start taking this medication and each time you get a refill.
You are encouraged to report negative side effects of prescription products to the FDA: visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Vivelle-Dot® and Doti® are registered trademarks of Novartis AG.
Climara® is a registered trademark of Bayer.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death. A prescription is provided only if an Allara-affiliated provider determines it is appropriate for you.
The information on these pages is not comprehensive and does not replace a conversation with your provider. Please read the FDA-approved Medication Guide and Patient Information that accompany your prescription, and see the full Prescribing Information for each medication for complete safety information.
Progesterone (Bioidentical / Micronized) — Oral & Combination HRT
Indication
Micronized progesterone is used together with estrogen to protect the uterine lining (reduce the risk of endometrial hyperplasia/cancer) in women with a uterus, and to support cycle regularity and sleep as part of a personalized hormone plan.
Boxed Warning
Cardiovascular Disorders, Breast Cancer, and Probable Dementia. Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.
Contraindications
- Known or suspected pregnancy.
- Undiagnosed abnormal genital bleeding.
- Known, suspected, or history of breast cancer.
- Active or history of DVT, PE, stroke, or myocardial infarction.
- Liver impairment or disease; known allergy to peanuts (some oral capsules contain peanut oil).
Warnings & Precautions
- Fluid retention.
- Dizziness and drowsiness — take at bedtime and avoid driving until you know how it affects you.
- Depression; effects on glucose tolerance.
Drug Interactions
CYP3A4 inhibitors and inducers can raise or lower progesterone levels; tell your provider all medications and supplements you take, including St. John's wort.
Use in Specific Populations
- Pregnancy: contraindicated unless specifically prescribed for a pregnancy-related indication.
- Breastfeeding: detectable in breast milk; use only if needed.
- Use with caution in hepatic impairment and in older adults.
Common Side Effects
Headache, breast tenderness, joint pain, depression, dizziness, abdominal bloating, hot flashes, and vaginal discharge.
Storage & Missed Dose
Store at room temperature. Take at bedtime as directed. If you miss a dose, take it when you remember unless it is near the next dose — do not double up.
Read the Medication Guide and Patient Information provided with your prescription before you start taking this medication and each time you get a refill.
You are encouraged to report negative side effects of prescription products to the FDA: visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death. A prescription is provided only if an Allara-affiliated provider determines it is appropriate for you.
The information on these pages is not comprehensive and does not replace a conversation with your provider. Please read the FDA-approved Medication Guide and Patient Information that accompany your prescription, and see the full Prescribing Information for each medication for complete safety information.
Veozah® (fezolinetant) — Non-Hormonal
Indication
Veozah is a prescription medicine used to reduce moderate to severe vasomotor symptoms (hot flashes / night sweats) due to menopause.
Boxed Warning
Hepatic Transaminase Elevation and risk of liver injury, including rare cases of serious liver injury. Liver blood tests must be evaluated prior to initiation and periodically thereafter (e.g., at months 3, 6, and 9) to check for liver injury. Stop Veozah and contact your provider for signs of liver problems (nausea, vomiting, unusual fatigue, right upper-abdominal pain, jaundice, or dark urine).
Contraindications
- Known cirrhosis.
- Severe renal impairment or end-stage renal disease.
- Concomitant use with CYP1A2 inhibitors.
Drug Interactions
Do not use with CYP1A2 inhibitors (e.g., fluvoxamine, certain others), which can substantially increase Veozah levels. Tell your provider all medications you take.
Use in Specific Populations
- Pregnancy/breastfeeding: not for use in pregnancy or while breastfeeding; Veozah is for postmenopausal women.
- Not recommended in moderate-to-severe hepatic impairment or severe renal impairment.
Common Side Effects
Abdominal pain, diarrhea, insomnia, back pain, hot flush, and elevated hepatic transaminases.
Storage & Missed Dose
Take one tablet by mouth once daily, with or without food, swallowed whole. Store at room temperature. If you miss a dose, take it as soon as you remember on the same day; otherwise skip it — do not double up.
Read the Medication Guide and Patient Information provided with your prescription before you start taking this medication and each time you get a refill.
You are encouraged to report negative side effects of prescription products to the FDA: visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death. A prescription is provided only if an Allara-affiliated provider determines it is appropriate for you.
The information on these pages is not comprehensive and does not replace a conversation with your provider. Please read the FDA-approved Medication Guide and Patient Information that accompany your prescription, and see the full Prescribing Information for each medication for complete safety information.