Bijuva

Bijuva is used after menopause to reduce moderate to severe hot flashes in women with a uterus. Bijuva contains two female hormones, estradiol and progesterone, and is taken once daily.

Estrogens, such as estradiol, are hormones produced by the ovaries that naturally decline when women reach their mid-40s to mid-50s, triggering menopause and the end of monthly periods. This can also occur suddenly after surgical removal of the ovaries. Falling estrogen levels cause symptoms ranging from mild to severe, including hot flashes, which are intense feelings of heat and sweating in the face, neck, and chest. Some women require treatment to manage these symptoms, while others do not. Progesterone must be added to estrogens in women with an intact uterus to protect the lining of the uterus and decrease the risk of cancer.

Bijuva (estradiol and progesterone) gained FDA approval on October 28, 2018.

Take Bijuva exactly as your healthcare provider tells you to take it.

• Take 1 capsule by mouth each evening with food.
• Estrogens should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with Bijuva.

Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, ordementia (decline of brain function).

• Using estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.

Do not use Bijuva if you have had your uterus (womb) removed (hysterectomy).

• Bijuva contains a progestogen to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestogen, and you should not use this medicine.

Do not start using Bijuva if you:

• Have any unusual vaginal bleeding. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
• Have been diagnosed with a bleeding disorder.
• Currently have or have had certain cancers. Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus (womb). If you have or have had cancer, talk with your healthcare provider about whether you should use Bijuva.
• Currently have or have had blood clots.
• Had a stroke or heart attack.
• Currently have or have had liver problems.
• Are allergic to Bijuva, estrogens, progesterone, or any of the ingredients in the capsules. See the list of ingredients in Bijuva at the end of this guide.

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

• Have high levels of fat in your blood (triglycerides)
• Have any unusual vaginal bleeding
• Have any other medical conditions that may become worse while you are using Bijuva. Your healthcare provider may need to check you more carefully if you have certain conditions, such as: Asthma (wheezing) Diabetes A genetic problem called porphyria Lupus Hypertension (high blood pressure) Have high calcium in your blood Epilepsy (seizures) Migraine Endometriosis Angioedema (swelling of face or tongue) Problems with your heart, liver, thyroid, or kidneys
• Are going to have surgery or will be on bed rest. Your healthcare provider will let you know if you need to stop using Bijuva.
• Are pregnant or think you may be pregnant. Bijuva is not for pregnant women
• Are breastfeeding. The hormones in Bijuva can pass into your breast milk.

Common Side Effects

The most common side effects of Bijuva are:

• Breast tenderness
• Headache
• Nausea
• Vaginal bleeding
• Vaginal discharge
• Pelvic pain.

Serious Side Effects

Serious, but less common side effects of Bijuva are:

• Heart attack
• Stroke
• Blood clots
• Breast cancer
• Cancer of the lining of the uterus (womb)
• Cancer of the ovary
• Dementia
• Gallbladder disease
• High or low blood calcium levels
• Changes in vision
• High blood pressure
• High levels of fat in your blood (triglycerides)
• Liver problems
• Changes in your thyroid hormone levels
• Swelling or fluid retention
• Cancer changes of endometriosis
• Enlargement of benign tumors of the uterus (“fibroids”)
• Worsening swelling of the face or tongue (angioedema) in women who have a history of angioedema
• Changes in laboratory test results, such as bleeding time and high blood sugar levels.

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
• Memory loss or confusion

Tell your healthcare provider if you have any side effects that bother you or do not go away. These are not all of the possible side effects of Bijuva. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Mayne Pharma at 1-844-825-8500.

What can I do to lower my chances of a serious side effect with Bijuva?

• Talk with your healthcare provider regularly about whether you should continue using Bijuva.
• If you have a uterus, talk with your healthcare provider about whether Bijuva is right for you.
• In general, the addition of a progestogen is recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).
• See your healthcare provider right away if you get vaginal bleeding while using Bijuva.
• Have a pelvic exam, breast exam, and mammogram (breast X-ray) every year unless your healthcare provider tells you something else.
• If members of your family have had breast cancer, or if you have ever had breast lumps or an abnormal mammogram (breast X-ray), you may need to have breast exams more often.
• If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher chance of getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease.

The timing of Bijuva initiation can affect the overall risk-benefit profile.

• Consider initiating Bijuva in women < 60 years old or < 10 years from the onset of menopause.

Dose of Bijuva for Vasomotor Symptoms

• Initial: 1 capsule (0.5 mg estradiol/100 mg progesterone) orally once daily.
• Maintenance: Make dosage adjustments based on the clinical response.
• Attempt to taper or discontinue Bijuva at 3 to 6 month intervals.

If you miss a dose of Bijuva, take the missed dose as soon as possible with food, unless it is within two hours of the next evening's dose of Bijuva.

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, stroke, or heart attack while using this medicine.

Grapefruit may interact with this medicine and lead to unwanted side effects. Avoid the use of grapefruit products.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Bijuva works. Some other medicines and food products may increase or decrease the concentrations of the hormones in Bijuva in the blood. Bijuva may affect how your other medicines work, and other medicines may affect how Bijuva works.

Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get new medicine.

Store at room temperature between 68°F and 77°F (20°C and 25ºC).

Keep out of the reach of children.

Active ingredients: estradiol and progesterone.Inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, FD&C Red #40, gelatin, glycerin, hydrolyzedgelatin, isopropyl alcohol, lauroyl polyoxyl-32 glycerides, lecithin, medium chain mono and di-glycerides, mediumchain triglycerides, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, purified water, and titaniumdioxide.

Bijuva is supplied in 2 strengths:

• 0.5 mg estradiol/100 mg progesterone
• 1 mg estradiol/100 mg progesterone

Bijuva is distributed by Mayne Pharma, Raleigh, NC 27609. Bijuva is a registered trademark of TherapeuticsMD, Inc., used under license.

• Does Bijuva contain bio-identical hormones?