Tri-VyLibra Lo: Uses, Side Effects and Dosage

What is the most important information I should know about Tri-VyLibra Lo?

Do not use Tri-VyLibra Lo if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

What is Tri-VyLibra Lo?

Tri-VyLibra Lo is a birth control pill (oral contraceptive) used by women to prevent pregnancy.

How does Tri-VyLibra Lo work for contraception?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.

Based on the results from the clinical study, about 3 out of 100 women may get pregnant during the first year they use Tri-VyLibra Lo.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Who should not take Tri-VyLibra Lo?

Do not take Tri-VyLibra Lo if you:

• smoke and are over 35 years of age
• had blood clots in your arms, legs, lungs, or eyes
• had a problem with your blood that makes it clot more than normal
• have certain heart valve problems or irregular heart beat that increases your risk of having blood clots
• had a stroke
• had a heart attack
• have high blood pressure that cannot be controlled by medicine
• have diabetes with kidney, eye, nerve, or blood vessel damage
• have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you are over 35 years of age
• have liver problems, including liver tumors
• take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.
• have any unexplained vaginal bleeding
• are pregnant
• had breast cancer or any cancer that is sensitive to female hormones

If any of these conditions happen while you are taking Tri-VyLibra Lo, stop taking Tri-VyLibra Lo right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Tri-VyLibra Lo.

What should I tell my healthcare provider before taking Tri-VyLibra Lo?

Tell your healthcare provider if you:

• are pregnant or think you may be pregnant
• are depressed now or have been depressed in the past
• had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy)
• are breastfeeding or plan to breastfeed. Tri-VyLibra Lo may decrease the amount of breast milk you make. A small amount of the hormones in Tri-VyLibra Lo may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Tri-VyLibra Lo may affect the way other medicines work, and other medicines may affect how well Tri-VyLibra Lo works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Tri-VyLibra Lo?

Read the Instructions for Use at the end of this Patient Information.

What are the possible serious side effects of Tri-VyLibra Lo?

• Like pregnancy, Tri-VyLibra Lo may cause serious side effects, including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes.

Serious blood clots can happen especially if you smoke, are obese, or are older than 35 years of age. Serious blood clots are more likely to happen when you:

• first start taking birth control pills
• restart the same or different birth control pills after not using them for a month or more

Call your healthcare provider or go to a hospital emergency room right away if you have:

• leg pain that will not go away
• sudden severe shortness of breath
• sudden change in vision or blindness
• chest pain
• a sudden, severe headache unlike your usual headaches
• weakness or numbness in your arm or leg
• trouble speaking

Other serious side effects include:

• liver problems, including:

  • rare liver tumors
  • jaundice (cholestasis), especially if you previously had cholestasis of pregnancy. Call your healthcare provider if you have yellowing of your skin or eyes.
• high blood pressure. You should see your healthcare provider for a yearly check of your blood pressure.
• gallbladder problems
• changes in the sugar and fat (cholesterol and triglycerides) levels in your blood
• new or worsening headaches including migraine headaches
• irregular or unusual vaginal bleeding and spotting between your menstrual periods, especially during the first 3 months of taking Tri-VyLibra Lo.
• depression
• possible cancer in your breast and cervix
• swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher is you have a history of angioedema.
• dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). Women who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking Tri-VyLibra Lo. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of Tri-VyLibra Lo?

• headache (including migraine)
• nausea and vomiting

• breast problems

  • tenderness, pain and discomfort
  • enlargement and swelling
  • discharge
  • nipple pain
• stomach pain
• pain with your periods (menstrual cycle)
• mood changes, including depression
• acne
• vaginal infections
• bloating
• weight gain
• fatigue

These are not all the possible side effects of Tri-VyLibra Lo. For more information, ask your healthcare provider or pharmacist.

You may report side effects to the FDA at 1-800-FDA-1088.

What else should I know about taking Tri-VyLibra Lo?

• If you are scheduled for any lab tests, tell your healthcare provider you are taking Tri-VyLibra Lo. Certain blood tests may be affected by Tri-VyLibra Lo.
• Tri-VyLibra Lo does not protect against HIV infection (AIDS) and other sexually transmitted infections.

How should I store Tri-VyLibra Lo?

• Store Tri-VyLibra Lo at room temperature between 20°C to 25°C (68°F to 77°F).
• Keep Tri-VyLibra Lo and all medicines out of the reach of children.
• Store away from light.

General information about the safe and effective use of Tri-VyLibra Lo.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tri-VyLibra Lo for a condition for which it was not prescribed. Do not give Tri-VyLibra Lo to other people, even if they have the same symptoms that you have.

This Patient Information summarizes the most important information about Tri-VyLibra Lo. You can ask your pharmacist or healthcare provider for information about Tri-VyLibra Lo that is written for health professionals.

For more information, call Afaxys Pharma, LLC at 855-888-2467.

Does hormonal birth control cause cancer?

It is not known if hormonal birth control pills causes breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.

If you have breast cancer now, or have had it in the past, do not use hormonal birth control because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What if I want to become pregnant?

You may stop taking the pill whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop taking the pill.

What should I know about my period when taking Tri-VyLibra Lo?

Your periods may be lighter and shorter than usual. Some women may miss a period. Irregular vaginal bleeding or spotting may happen while you are taking Tri-VyLibra Lo, especially during the first few months of use. This usually is not a serious problem. It is important to continue taking your pills on a regular schedule to prevent a pregnancy.

What are the ingredients in Tri-VyLibra Lo?

Active ingredients: Each white to off white, pale blue to bluish white, and blue to light blue pill contains norgestimate and ethinyl estradiol.

Inactive ingredients:

White to off white pills: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

Pale blue to bluish white pills: croscarmellose sodium, FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

Blue to light blue pills: croscarmellose sodium, FD&C Blue #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

Green pills: anhydrous lactose, FD&C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone.