woman in blue shirt

Climara Pro® may deliver more than symptom relief for moderate to severe hot flashes—it can also help prevent postmenopausal osteoporosis

woman in blue shirt

Climara Pro® may deliver more than symptom relief for moderate to severe hot flashes—it can also help prevent postmenopausal osteoporosis

The only once-weekly combination dose patch designed to reduce moderate to severe hot flashes due to menopause and prevent postmenopausal osteoporosis in women with an intact uterus. If you use Climara Pro® only to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.

What is Climara Pro®?

Climara Pro® is a prescription medicine patch (Transdermal System) that contains two kinds of hormones, an estrogen and a progestin. 

 

What is Climara Pro® used for?

Climara Pro® is used after menopause to: 

 

hot flashes

Reduce moderate to severe hot flashes

 

Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the "change of life" or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause." 

 

When the estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ("hot flashes" or "hot flushes"). In some women, the symptoms are mild, and they will not need to take estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether or not you still need treatment with Climara Pro®

hot flashes

Reduce moderate to severe hot flashes

 

Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the "change of life" or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes "surgical menopause." 

 

When the estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ("hot flashes" or "hot flushes"). In some women, the symptoms are mild, and they will not need to take estrogens. In other women, symptoms can be more severe. You and your healthcare provider should talk regularly about whether or not you still need treatment with Climara Pro®

Osteoporosis

Help reduce your chances of getting osteoporosis (thin weak bones)

 

If you use Climara Pro® only to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you still need treatment with Climara Pro®.

Osteoporosis

Help reduce your chances of getting osteoporosis (thin weak bones)

 

If you use Climara Pro® only to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you still need treatment with Climara Pro®.

Proven effective in reducing moderate to severe hot flashes 

In a 12-week study of 183 postmenopausal women with moderate to severe hot flashes, patients either received a treatment patch containing the same dose of E2 as Climara Pro® with a higher dose of LNG (0.03 mg compared with 0.015 mg for Climara Pro®), or an inactive patch. Patients evaluated during the 12-week treatment period experienced significantly fewer moderate to severe hot flashes at weeks 4 and 12 compared with those treated with an inactive patch.

 

E2=estradiol; LNG=levonorgestrel.

 

Summary of average daily number of moderate to severe hot flashes

 

  • Before treatment, the average number of moderate to severe hot flashes was 10.13 per day for 92 women who took Climara Pro® compared with 10.8 per day for 88 women who took placebo
  • At week 4, the average number of moderate to severe hot flashes was 2.69 per day for 88 women who took Climara Pro® compared with 6.13 per day for 82 women who took placebo
  • At week 8, the average number of moderate to severe hot flashes was 1.22 per day for 80 women who took Climara Pro® compared with 5.35 per day for 73 women who took placebo
  • At week 12, the average number of moderate to severe hot flashes was 1.06 per day for 73 women who took Climara Pro® compared with 5.59 per day for 69 women who took placebo
  • Only values at weeks 4 and 12 were significant

Number of daily moderate to severe hot flashes

number of daily moderate to severe hot flashes graph

Proven effective in reducing the severity of moderate to severe hot flashes 

In the same study, patients who received the treatment patch experienced a reduction in the severity of moderate to severe hot flashes at 12 weeks compared with those treated with an inactive patch. 

 

Summary of average severity of moderate to severe hot flashes

 

  • Before treatment, the average severity of moderate to severe hot flashes was 2.48 per day for 92 women who took Climara Pro® compared with 2.42 per day for 89 women who took placebo
  • At week 4, the average severity of moderate to severe hot flashes was 1.1 per day for 83 women who took Climara Pro® compared with 1.99 per day for 76 women who took placebo
  • At week 8,  the average severity of moderate to severe hot flashes was 0.82 per day for 72 women who took Climara Pro® compared with 1.93 per day for 68 women who took placebo
  • At week 12, the average severity of moderate to severe hot flashes was 0.44 per day for 55 women who took Climara Pro® compared with 1.8 per day for 57 women who took placebo
  • Only values at weeks 4 and 12 were significant

Severity of daily moderate to severe hot flashes

severity of daily moderate to severe hot flashes graph

Hot flashes were evaluated by their severity and were given a severity score of: 1 = Mild; 2 = Moderate; 3 = Severe. The average severity score by day throughout the treatment period was calculated by ([2X number of moderate hot flashes] + [3X number of severe hot flashes]) / total number of moderate to severe hot flashes on that day. If no moderate to severe hot flashes were indicated, the mean severity was 0; for example: ([2x10=20]+[3x5=15]/15=2.33, which is scored as Moderate. 

 

Who should not use Climara Pro®

Do not use Climara Pro® if you have had your uterus (womb) removed (hysterectomy). 

 

Climara Pro® contains a progestin to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not use Climara Pro®

 

Do not start using Climara Pro® if you: 

 

  • Have 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. 
  • Currently have or have had certain cancers
    Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Climara Pro®
  • Had a stroke or heart attack 
  • Currently have or have had blood clots 
  • Currently have or have had liver problems 
  • Have been diagnosed with a bleeding disorder 
  •  Are allergic to Climara Pro® or any of its ingredients 
  • Think you may be pregnant
    Climara Pro® is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use Climara Pro® if the test is positive and talk to your healthcare provider.

 

What should I tell my healthcare provider before I use Climara Pro®
Before you use Climara Pro®, tell your healthcare provider 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 any other medical conditions
    Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood. 
  • Are going to have surgery or will be on bed rest
    Your healthcare provider will let you know if you need to stop using Climara Pro®
  • Are breastfeeding
    The hormones in Climara Pro® can pass into your breast milk. 

 

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Climara Pro® works. Climara Pro® may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. 

 

What are possible side effects of Climara Pro®?

Side effects are grouped by how serious they are and how often they happen when you are treated. 

Serious, but less common side effects include:

 

  • Heart attack 
  • Stroke 
  • Blood clots 
  • Dementia 
  • Breast cancer 
  • Cancer of the lining of the uterus (womb) 
  • Cancer of the ovary 
  • High blood pressure 
  • High blood sugar 
  • Gallbladder disease 
  • Liver problems 
  • Changes in your thyroid hormone levels 
  • Enlargement of benign tumors of the uterus (“fibroids”)

 

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

 

Less serious, but common side effects include:  

 

  • Headache 
  • Breast pain 
  • Irregular vaginal bleeding or spotting 
  • Stomach or abdominal cramps, bloating 
  • Nausea and vomiting 
  • Hair loss 
  • Fluid retention 
  • Vaginal yeast infection 
  • Redness or irritation at the patch placement site 

 

These are not all the possible side effects of Climara Pro®. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away. 

 

You may report side effects to Bayer Healthcare Pharmaceuticals at 1-888-842-2937 or to FDA at 1-800-FDA-1088.

 

What can I do to lower my chances of a serious side effect with Climara Pro®

 

  • Talk with your healthcare provider regularly about whether you should continue using Climara Pro®
  • See your healthcare provider right away if you get vaginal bleeding while using Climara Pro®
  • 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, 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 higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease

 

Who should not use Climara Pro®

Do not use Climara Pro® if you have had your uterus (womb) removed (hysterectomy). 

 

Climara Pro® contains a progestin to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need a progestin and you should not use Climara Pro®

 

Do not start using Climara Pro® if you: 

 

  • Have 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. 
  • Currently have or have had certain cancers
    Estrogens may increase the chance of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should use Climara Pro®
  • Had a stroke or heart attack 
  • Currently have or have had blood clots 
  • Currently have or have had liver problems 
  • Have been diagnosed with a bleeding disorder 
  •  Are allergic to Climara Pro® or any of its ingredients 
  • Think you may be pregnant
    Climara Pro® is not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results. Do not use Climara Pro® if the test is positive and talk to your healthcare provider.

 

What should I tell my healthcare provider before I use Climara Pro®
Before you use Climara Pro®, tell your healthcare provider 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 any other medical conditions
    Your healthcare provider may need to check you more carefully if you have certain conditions, such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis, lupus, angioedema (swelling of face and tongue), or problems with your heart, liver, thyroid, kidneys, or have high calcium levels in your blood. 
  • Are going to have surgery or will be on bed rest
    Your healthcare provider will let you know if you need to stop using Climara Pro®
  • Are breastfeeding
    The hormones in Climara Pro® can pass into your breast milk. 

 

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how Climara Pro® works. Climara Pro® may also affect how your other medicines work. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. 

 

What are possible side effects of Climara Pro®?

Side effects are grouped by how serious they are and how often they happen when you are treated. 

Serious, but less common side effects include:

 

  • Heart attack 
  • Stroke 
  • Blood clots 
  • Dementia 
  • Breast cancer 
  • Cancer of the lining of the uterus (womb) 
  • Cancer of the ovary 
  • High blood pressure 
  • High blood sugar 
  • Gallbladder disease 
  • Liver problems 
  • Changes in your thyroid hormone levels 
  • Enlargement of benign tumors of the uterus (“fibroids”)

 

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

 

Less serious, but common side effects include:  

 

  • Headache 
  • Breast pain 
  • Irregular vaginal bleeding or spotting 
  • Stomach or abdominal cramps, bloating 
  • Nausea and vomiting 
  • Hair loss 
  • Fluid retention 
  • Vaginal yeast infection 
  • Redness or irritation at the patch placement site 

 

These are not all the possible side effects of Climara Pro®. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effects that bother you or do not go away. 

 

You may report side effects to Bayer Healthcare Pharmaceuticals at 1-888-842-2937 or to FDA at 1-800-FDA-1088.

 

What can I do to lower my chances of a serious side effect with Climara Pro®

 

  • Talk with your healthcare provider regularly about whether you should continue using Climara Pro®
  • See your healthcare provider right away if you get vaginal bleeding while using Climara Pro®
  • 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, 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 higher chances for getting heart disease. Ask your healthcare provider for ways to lower your chances of getting heart disease

 

Climara Pro® is used after menopause in women with an intact uterus to reduce moderate to severe hot flashes. Climara Pro® can also help reduce your chances of osteoporosis (thin, weak bones)

 

If you use Climara Pro® only to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you. You and your healthcare provider should talk regularly about whether you still need treatment with Climara Pro®

 

 

Osteoporosis

Bone mineral density, or BMD, is a measurement of how much calcium and minerals are in your bones. BMD varies from bone to bone. The higher your BMD, the stronger the measured bone is likely to be.

Osteoporosis

Bone mineral density, or BMD, is a measurement of how much calcium and minerals are in your bones. BMD varies from bone to bone. The higher your BMD, the stronger the measured bone is likely to be.

The effects on BMD were studied in 154 postmenopausal women who had undergone a hysterectomy (the removal of the uterus). The study lasted for 2 years (728 days). Women were treated with either a treatment patch containing the same amount of estrogen as Climara Pro® or an inactive patch. The estrogen-only treatment patch was used because the women who participated in the study had their uterus removed. The change in BMD over 2 years was measured at the lower spine and the hip. 

Average BMD of the lower spine and hip was significantly improved
over a 2-year period compared with the inactive patch

Average BMD of the lower spine and hip was significantly improved over a 2-year period compared with the inactive patch

BMD lower spine improvement graph
BMD hip improvement graph

If you’re thinking about a treatment for your moderate to severe postmenopausal
hot flashes that can also help prevent postmenopausal osteoporosis, ask your doctor about the once-weekly combination patch, Climara Pro®.
If you use Climara Pro® only to prevent osteoporosis due to menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.