levonorgestrel / ethinyl estradiol

• Risk factors: Females over 35 years old who smoke cigarettes

If you smoke cigarettes, taking combined oral contraceptives (COCs) like Setlakin (levonorgestrel / ethinyl estradiol) raises your risk for serious health problems, such as stroke, heart attack, and blood clots. Females ages 35 years and older who smoke are at even higher risk for these problems. If you smoke, talk with your OB-GYN provider or healthcare professional (HCP) about safer birth control alternatives.

• Risk factors: Females over 35 years old who smoke | Females over 40 years old who don't smoke | Recent surgery with a long period of bed rest | Starting Setlakin (levonorgestrel / ethinyl estradiol) less than a month after childbirth | High blood pressure | People identified as obese | High cholesterol | Diabetes | Higher dose of estrogen

Setlakin (levonorgestrel / ethinyl estradiol) raises your risk of blood clots. These clots can occur anywhere in your body, including your lungs (pulmonary embolism or PE), legs (deep vein thrombosis or DVT), brain (stroke), and heart (heart attack). Get emergency help right away if you have any signs of a blood clot:

• Brain: weakness or numbness in your arms, legs, or face on one side of the body, trouble speaking, blurred vision, dizziness, loss of balance, trouble walking, or confusion
• Eyes: trouble seeing, bulging eye, double vision
• Heart: chest pain, sweating, nausea, or dizziness
• Lungs: trouble breathing, chest pain, or cough
• Legs: cramps, swelling, pain, or muscle tightness

If you need to have surgery, tell your healthcare team you're taking Setlakin (levonorgestrel / ethinyl estradiol). They might have you stop taking it 4 weeks before until 2 weeks after your surgery to lower your risk of blood clots.

• Risk factors: History of breast cancer | Taking COCs for a long time

Study results are mixed, but there's a possibility that Setlakin (levonorgestrel / ethinyl estradiol) and other COCs can raise your risk for breast and cervical cancer.

Don't take Setlakin (levonorgestrel / ethinyl estradiol) if you have breast cancer because some types of breast cancer grow faster in the presence of estrogen, an ingredient in this birth control pill. To help with early breast cancer detection, you can do monthly breast self-checks at home and yearly breast exams with your healthcare professional. Call your HCP if you notice any abnormal changes or feel lumps, pain, or swelling in your breasts.

Get medical help right away if you experience abnormal vaginal bleeding, discharge, or pain during sex, since these could be signs of cervical cancer.

• Risk factors: Liver problems or infection in the liver | Taking COCs with 50 mcg of estrogen or higher

Though rare, Setlakin (levonorgestrel / ethinyl estradiol) can cause liver problems, such as liver damage and liver tumors. These problems are linked more with earlier formulations of COCs that contained higher doses of estrogen (50 mcg or higher), and less so with Setlakin (levonorgestrel / ethinyl estradiol) since it only contains 30 mcg of estrogen. Don't take this medication if you already have liver problems. Call your HCP right away if you experience symptoms of liver problems, such as tiredness, stomach pain, or yellowing of the skin or whites of the eyes.

• Risk factors: Prediabetes or diabetes | Personal or family history of high triglycerides | High dose

COCs like Setlakin (levonorgestrel / ethinyl estradiol) might raise your blood sugar and triglyceride (fat) levels. If you have diabetes, let your HCP know if you experience any changes in your blood sugar. Make sure to go to all of your check-ups so your healthcare team can monitor any changes.

• Risk factors: High blood pressure | Older age | Using COCs for a long time | Kidney problems

Setlakin (levonorgestrel / ethinyl estradiol) and other COCs can raise your blood pressure. Your HCP might ask you to check your blood pressure regularly. If you notice your blood pressure is higher while you're taking this medication, contact your HCP. If you have uncontrolled high blood pressure, Setlakin (levonorgestrel / ethinyl estradiol) might not be the best option for you.

Headaches are a common side effect of COCs like Setlakin (levonorgestrel / ethinyl estradiol). But, if you experience a new migraine, a migraine that's worse than normal, or a new headache that keeps coming back or is severe, call your HCP so you can be checked out.

Breakthrough bleeding and spotting are common side effects of hormonal birth control pills. This is more common during the first 3 months of taking Setlakin (levonorgestrel / ethinyl estradiol) and might get better over time. Let your HCP know if you experience any vaginal bleeding outside of your period, or if your period has stopped completely. There are other causes besides your birth control pills for irregular bleeding that your HCP will evaluate.

• Risk factors: History of depression

Let your HCP know if you experience symptoms of depression or worsening depression while taking Setlakin (levonorgestrel / ethinyl estradiol). In cases of serious depression, your OB-GYN provider or HCP might have you stop taking it.

Some studies suggest that Setlakin (levonorgestrel / ethinyl estradiol) can raise the risk of gallbladder disease since more progestin and estrogen can lead to higher chance of gallstones. Although the risk is low, talk to your gynecologist if you a history of gallbladder disease before starting Setlakin (levonorgestrel / ethinyl estradiol).

Let your healthcare team know if you or someone in your family has a genetic condition called hereditary angioedema. Taking estrogen-containing medications can trigger swelling attacks in people who have this condition. Get medical help right away if you notice swelling in the face, arms, legs, or if you have trouble breathing.

Certain medications can make Setlakin (levonorgestrel / ethinyl estradiol) get broken down faster in your body, making it less effective. And this can lead to pregnancy. Some examples include carbamazepine (Tegretol) and phenytoin (Dilantin). Use a back-up method or other form of birth control for at least 28 days after stopping any of these medications. Other medications can raise the amount of Setlakin (levonorgestrel / ethinyl estradiol) in your body, which can lead to more side effects. Make sure to tell your HCP or pharmacist all of your medications so they can make sure they don't interact with Setlakin (levonorgestrel / ethinyl estradiol).

If you're taking medications to treat hepatitis C, immediately let your HCP know that you're taking a COC. Certain hepatitis C medications can affect the level of Setlakin (levonorgestrel / ethinyl estradiol) in your body, either making it work not as well in preventing pregnancy or raising your risk of side effects. Your healthcare team can give you instructions about what to do if you're taking a hepatitis C medication that can interact with Setlakin (levonorgestrel / ethinyl estradiol).