Annovera

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

If you smoke cigarettes, using CHCs that contain estrogen (such as Annovera (segesterone acetate / ethinyl estradiol)) can raise your risk for serious blood clots. This means you’re more likely to experience heart or blood vessel problems, such as heart attacks or strokes. If you're 35 years or older and smoke cigarettes, talk to your doctor about safer birth control options because you’re at higher risk for serious blood clots.

• Risk factors: Females age 35 years and older | People identified as obese | People who smoke | High blood pressure | High blood sugar | History of blood clots | Not moving for a long time | Recent surgery (<2 weeks ago) | Recent childbirth (<1 month ago)

Annovera (segesterone acetate / ethinyl estradiol) can raise your risk for serious blood clots. These blood clots can form anywhere in your body, including the eyes, heart, and brain. If you have medical conditions that put you at higher risk for clots, such as high blood sugar or blood pressure, you might not be able to use Annovera (segesterone acetate / ethinyl estradiol). Before starting Annovera (segesterone acetate / ethinyl estradiol), talk to your prescriber about any family or personal history of clotting problems. Look out for symptoms of clots in any area of your body:

• Brain: sudden weakness in one arm, leg, or on one side of the body; face drooping; changes in speech, vision, balance, or coordination; severe headache
• Eyes: double vision, partial or complete blindness, trouble seeing
• Lungs: shortness of breath
• Heart: chest pain, arm pain, dizziness, cold sweat
• Legs: swelling or pain in the leg

Get immediate medical attention and call 911 if you have any of these symptoms.

• Risk factors: Blood pressure that’s not under control | Older females | Long-term use of CHCs

CHCs, like Annovera (segesterone acetate / ethinyl estradiol), can raise your blood pressure. You shouldn’t use Annovera (segesterone acetate / ethinyl estradiol) if you have blood vessel damage from high blood pressure or if your blood pressure isn’t under control. If you have well-controlled blood pressure and are using Annovera (segesterone acetate / ethinyl estradiol), then continue to monitor your blood pressure at home and at your follow-up appointments. Contact your primary care provider if you notice symptoms of very high blood pressure such as irregular heartbeats, vision changes, confusion, chest pain.

Annovera (segesterone acetate / ethinyl estradiol) might raise your blood sugars and triglyceride (fat) levels. If you have diabetes, check with your primary care provider if Annovera (segesterone acetate / ethinyl estradiol) is safe for you before you start. You won’t be able to use it if you have diabetes plus other risk factors, such as age over 35 years old and high blood pressure, because you’re at higher risk for blood clots. When you use Annovera (segesterone acetate / ethinyl estradiol), your primary care provider might ask you to monitor your blood sugar at home. Inform your primary care provider of any changes in your blood sugar levels.

If you currently have high cholesterol, using Annovera (segesterone acetate / ethinyl estradiol) might raise your risk for pancreatitis. Let your primary care provider know if you have symptoms of pancreatitis, such as nausea, vomiting, stomach pain, and fever.

• Risk factors: Long-term use of CHCs | Hepatitis C | Other liver problems | Taking certain medications for hepatitis C

Though rare, you might be at higher risk for liver problems or liver tumors if you use CHCs, such as Annovera (segesterone acetate / ethinyl estradiol). Contact a healthcare professional if you notice symptoms of liver problems, such as yellowing of the skin or eyes, stomach pain/swelling, dark urine color, chronic fatigue,

Don’t use Annovera (segesterone acetate / ethinyl estradiol) if you’re also taking certain hepatitis C medications, like Viekira Pak that contain ombitasvir, paritaprevir, and ritonavir. Doing so can cause further liver damage. You can use Annovera (segesterone acetate / ethinyl estradiol) again once it has been at least 2 weeks since you’ve completed the hepatitis C treatment.

• Risk factors: Gallbladder problems | people identified as overweight

Some studies have shown that CHCs, like Annovera (segesterone acetate / ethinyl estradiol), might cause gallbladder problems. You’re at higher risk if you already have gallbladder problems or if you’ve experienced these problems in the past while taking CHCs. If you notice yellowing of eyes or skin, dark urine, fever, chills, nausea, or vomiting, contact a healthcare professional.

Annovera (segesterone acetate / ethinyl estradiol) can change your period bleeding patterns. You might experience bleeding in between your periods (also known as breakthrough bleeding or spotting) when you use the Annovera (segesterone acetate / ethinyl estradiol) ring. This is more common within the first 3 months after you start this birth control. It’s also possible that you might have periods less often or none at all for some time. If you’ve missed 2 periods in a row, take a pregnancy test to make sure that you’re not pregnant. If the abnormal bleeding continues or happens again even after you have a normal cycle, let your gynecologist know so they can check your health.

If you’re taking Annovera (segesterone acetate / ethinyl estradiol) and have a history of depression, monitor yourself for any signs and symptoms of depression or changes to your mood. Talk to a healthcare professional if your mood changes while you're using Annovera (segesterone acetate / ethinyl estradiol).

• Risk Factors: Using a tampon at the same time

Some people who used vaginal rings have reported having toxic shock syndrome (TSS). TSS is a serious, life-threatening condition caused by bacteria toxin. It occurs when bacteria enters your bloodstream through open wounds, cuts, or abrasions. Your risk for TSS is higher if you’re using a tampon at the same time. While there are no reports of TSS linked with Annovera (segesterone acetate / ethinyl estradiol) use so far, you should still look out for TSS symptoms, such as flu-like symptoms, nausea, diarrhea, and headaches. If you experience any of these, remove Annovera and get medical help right away.

• Risk factors: Using CHCs for a long time (8 years or longer) | Family history of breast cancer

Research isn't clear about whether or not CHCs cause breast cancer. A few studies report that CHCs might raise your risk for breast cancer, especially if you've been taking it for a long time. Talk to your prescriber if you have any concerns about CHCs and cancer. Let them know if you notice possible signs of breast cancer, such as new lumps on your breasts, swollen breast, breast pain, or redness or flaky skin on the breast.

Don't use CHCs, like Annovera (segesterone acetate / ethinyl estradiol), if you have or have had breast cancer in the past. It's possible that your cancer is sensitive to estrogen, meaning that it'll grow faster when there is estrogen around. Ask your prescriber for birth control options that don't contain estrogen.

• Risk factors: Using CHCs for a long time (8 years or longer)

Although the research isn’t clear, there’s a possibility that CHCs might raise your risk for cervical cancer. It might also put you at risk for having abnormal tissue cells on the surface or lining of certain organs (intraepithelial neoplasia). If you notice symptoms such as more blood spotting than usual, light bleeding between your periods or after your period, bleeding that is longer in duration and heavier, more vaginal discharge than usual, pain during sex, let your gynecologist know right away.