Climara Pro

• Risk factors: Personal or family history of blood clots | High blood pressure | Diabetes (high blood sugar) | High cholesterol | Tobacco use | People who are considered obese | Systemic lupus erythematosus (SLE)

There's a small risk that estrogen-progestin combination therapy, like Climara Pro (estradiol / levonorgestrel), and estrogen-only therapy can raise your risk for blood clots. These clots can block blood from reaching other parts of your body, such as your legs, lungs, heart, or brain. Some clots can lead to dangerous complications, like heart attack or stroke.

Before you start taking Climara Pro (estradiol / levonorgestrel), make sure to discuss with your primary care provider about whether the medication is safe for you. This is because there are many factors that raise your risk for blood clots. Let your primary care provider know at least 4 to 6 weeks before any planned surgeries or periods of time when you won't be moving much. They'll tell you when you should stop before and restart Climara Pro (estradiol / levonorgestrel) after this planned event to lower your blood clot risk. Don't take this medication to prevent heart disease.

Take off the Climara Pro (estradiol / levonorgestrel) patch and get emergency medical help right away if you have any of the following symptoms of a blood clot, heart attack, or stroke.

Clot in the leg (deep vein thrombosis, DVT): swelling, tenderness, or pain in the leg Clot in the lung (pulmonary embolism, PE): shortness of breath Heart attack: chest pain, arm pain, shortness of breath, a cold sweat, lightheadedness Stroke: sudden weakness on one side of your body, drooping face, trouble breathing, bad headaches, changes in your speech or vision.

• Risk factors: Personal or family history of breast cancer | Have taken hormonal replacement therapy in the past | Taking hormonal replacement therapy for a long period of time

Studies show that estrogen-progestin combination therapy like Climara Pro (estradiol / levonorgestrel) can raise your risk for invasive breast cancer. The risk with estrogen-progestin combination therapy might be higher than that with estrogen-only therapy. You're also at greater risk if you've taken hormonal replacement therapy for a long period of time. Don't take Climara Pro (estradiol / levonorgestrel) if you currently have or have had breast cancer in the past.

To lower your risk for breast cancer, your primary care provider will prescribe Climara Pro (estradiol / levonorgestrel) for the shortest period of time possible. It's important that you regularly perform a self-exam to check for any abnormal changes to your breasts and to get scheduled breast scans (mammograms) done. Let your primary care provider know if you notice any unusual changes in breast shape, size, or color.

• Risk factors: Estrogen therapy without additional progestin | People with a healthy uterus | Taking estrogen therapy for more than 1 year | High estrogen dose

Climara Pro contains estradiol, which works like estrogen in your uterus. Estrogens can thicken and change the lining of your uterus called the endometrium. Uncontrolled growth of the uterus lining can cause uterine or endometrial cancer in people with a healthy uterus.

People who take Climara Pro (estradiol / levonorgestrel) might not have as high of a risk for endometrial cancer as people who take estrogen therapy without a progestin. Progestins help balance out estrogen's effect on the growth of the uterine lining. And Climara Pro has a progestin in it called levonorgestrel.

To be safe, it's important to be aware of the warning signs of endometrial cancer, including vaginal bleeding that doesn't go away or keeps coming back. Let your care team know if you notice any unusual vaginal bleeding that doesn't go away. Speak with your primary care provider if you're concerned about the risk for endometrial cancer.

Studies show that estrogen-progestin combination therapy, like Climara Pro (estradiol / levonorgestrel), and estrogen-only therapy can potentially raise the risk for ovarian cancer in people who've gone through menopause. Talk with your primary care provider if you notice any pelvic pain, bloating, or trouble eating. These can be signs of ovarian cancer.

• Risk factors: Age 65 years or older

Studies suggest that people who've gone through menopause and are taking estrogen-progestin combinations or estrogen-only therapy might be at greater risk for dementia. This risk appears higher if you start hormonal replacement therapy like Climara Pro (estradiol / levonorgestrel) after age 65. Be aware of the early signs of dementia, such as memory loss, confusion about time, getting lost, and misplacing things often. Speak with your primary care provider if the risk of dementia worries you. Don't take Climara Pro (estradiol / levonorgestrel) to prevent dementia.

• Risk factors: History of liver problems or jaundice

Estrogen therapy such as Climara Pro (estradiol / levonorgestrel) can raise the risk of gallbladder problems in people who've gone through menopause. Let your primary care provider know if you've had jaundice, or yellowing of your skin or eyes, that's related to previous estrogen therapy or pregnancy. It's possible for your jaundice to come back while you're taking Climara Pro (estradiol / levonorgestrel). Talk to your primary care provider if you have jaundice while you're taking this medication because it can be a sign of gallbladder disease. You might have to stop taking the medication.

• Risk factors: Breast cancer | Cancer that has spread to the bones | Low parathyroid hormone levels

Estrogen therapy can change the calcium levels in your blood. People with breast cancer or other cancer that's spread to the bones who take estrogens are at higher risk of having extremely high calcium levels. On the other hand, people with low parathyroid hormone levels from the parathyroid gland who take estrogens are at risk of having low calcium levels during estrogen therapy.

Tell your care team if you notice any symptoms of abnormal calcium levels. These can include tiredness, weakness, low appetite, constipation, muscle spasms, and a numbness or tingling sensation. Your primary care provider might check your calcium levels.

Although very rare, some people who took estrogens reported having changes in their vision due to a clot that formed in the eyes. Stop taking Climara Pro (estradiol / levonorgestrel) and let your primary care provider know if you have sudden partial or complete vision loss, bulging eyes, double vision, or migraines.

• Risk factors: History of high triglyceride levels in the blood

Estrogen therapy might make the triglyceride (fat) levels in your blood go up. Too much triglyceride in your blood can lead to problems with your pancreas, including swelling or pancreatitis. The risk for these pancreas problems might be higher for people who already have high triglyceride levels. Call your primary care provider right away if you notice symptoms of pancreatitis, like stomach pain that spreads to your back, stomach tenderness, fever, nausea, or vomiting.

• Risk factors: Low thyroid hormone levels (hypothyroidism)

Estrogens can cause changes in the thyroid hormone levels in your body. Normally, your body can adjust to these changes accordingly. But it might be harder to do if you have low thyroid hormone levels (hypothyroidism). To help your body adjust to changes to thyroid hormone levels while you're taking Climara Pro (estradiol / levonorgestrel), you might need to take a higher dose of your thyroid hormone replacement medication for your thyroid condition. Continue to get blood tests done as instructed by your primary care provider to check your thyroid hormone levels.

• Risk factors: Heart failure | Kidney problems

It's possible for estrogen-progestin combination therapies like Climara Pro (estradiol / levonorgestrel) to cause your body to hold onto extra fluid. Signs of fluid retention include swelling of your hands, feet, or ankles.

Let your primary care provider know if you have heart failure or kidney problems. You're at higher risk for fluid retention, which can worsen your medical condition. Contact your primary care provider if you notice swelling and signs of worsening of your heart or kidney problem while you're taking this medication.