Tri-Nymyo (Page 5 of 7)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

[See Warnings and Precautions ( 5.2 , 5.11 ) and Use in Specific Populations ( 8.1 ).]

14 CLINICAL STUDIES

14.1 Contraception

In four clinical trials with tri-cycle norgestimate and ethinyl estradiol tablets, 4,756 women aged 15 to 41 years were studied for 24 cycles, providing a total of 45,244 cycles of exposure. The racial demographic was about 87-90% Caucasian, 6-10% African-American, with the remainder Asian ( 1%) or Other (2-5%). There were no exclusions on the basis of weight; the weight range for women treated was 80-310 lbs, with a mean weight of about 132 lbs. The pregnancy rate was approximately 1 pregnancy per 100 women-years.

14.2 Acne

Tri-cycle norgestimate and ethinyl estradiol tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, six- (28 day) cycle studies. Two hundred twenty- one patients received tri-cycle norgestimate and ethinyl estradiol tablets and 234 patients received placebo. Mean age at enrollment for both groups was 28 years. At the end of 6 months, the mean total lesion count changed from 55 to 31 (42% reduction) in patients treated with tri-cycle norgestimate and ethinyl estradiol tablets and from 54 to 38 (27% reduction) in patients similarly treated with placebo. Table 4 summarizes the changes in lesion count for each type of lesion. Based on the investigator’s global assessment conducted at the final visit, patients treated with tri-cycle norgestimate and ethinyl estradiol tablets showed a statistically significant improvement in total lesions compared to those treated with placebo.

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16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tri-Nymyo Tablets are available in a compact blister card (NDC 51862-646-01).

Each blister card (28 tablets) contains in the following order:

• 7 green, round, biconvex, tablets imprinted “C1” on one side of the tablet and contains 0.180 mg norgestimate and 0.035 mg ethinyl estradiol

• 7 light blue, round, biconvex tablets imprinted “C2” on one side of the tablet and contains 0.215 mg norgestimate and 0.035 mg ethinyl estradiol

• 7 blue, round, biconvex tablets imprinted “C3” on one side of the tablet and contains 0.250 mg norgestimate and 0.035 mg ethinyl estradiol

• 7 white, round, biconvex tablets (non-hormonal placebo) imprinted “P” on one side and “N” on the other side contains inert ingredients

Tri-Nymyo is available in the following packaging configurations:

Carton of 1 blister card NDC 51862-646-02

Carton of 3 blister cards NDC 51862-646-03

Carton of 6 blister cards NDC 51862-646-06

16.2 Storage Conditions

  • Store at 20° to 25°C (68° to 77°F), [see USP Controlled Room Temperature].
  • Protect from light.
  • Keep out of the reach of children.

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use).

Counsel patients about the following information:

  • Cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs [see Boxed Warning].
  • Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions (5.1)].
  • Tri-Nymyo does not protect against HIV infection (AIDS) and other sexually transmitted infections.
  • Tri-Nymyo is not to be used during pregnancy; if pregnancy occurs during use of Tri-Nymyo instruct the patient to stop further use[see Warnings and Precautions ( 5.9)].
  • Take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event tablets are missed[see Dosage and Administration ( 2.2)].
  • Use a back-up or alternative method of contraception when enzyme inducers are used with Tri-Nymyo[see Drug Interactions ( 7.1)].
  • COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established[see Use in Specific Populations ( 8.3)].
  • Women who start COCs postpartum, and who have not yet had a period, should use an additional method of contraception until they have taken an active tablet for 7 consecutive days[see Dosage and Administration ( 2.2)].
  • Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles[see Warnings and Precautions ( 5.8)].

Distributed by: Mayne Pharma

Greenville, NC 27834

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Patient Information

Tri-Nymyo [Tri-NIH-me-oh]

(norgestimate and ethinyl estradiol) Tablets

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

Do not use Tri-Nymyo 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-Nymyo?

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

Tri-Nymyo is also used to treat moderate acne vulgaris in females 15 years of age and older, who have no known history of allergies or problems taking birth control pills, and have started their menstrual cycle (“period”). Tri-Nymyo should only be used to treat acne in women who want to take birth control pills to prevent pregnancy.

How does Tri-Nymyo 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 of clinical studies, about 1 out of 100 women may get pregnant during the first year they use Tri-Nymyo.

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.

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Who should not take Tri-Nymyo? Do not take Tri-Nymyo 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-Nymyo, stop taking Tri-Nymyo right away and talk to your healthcare provider.

Use non-hormonal contraception when you stop taking Tri-Nymyo.

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

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-Nymyo may decrease the amount of breast milk you make. A small amount of the hormones in Tri-Nymyo 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-Nymyo may affect the way other medicines work, and other medicines may affect how well Tri-Nymyo 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-Nymyo?

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

What are the possible serious side effects of Tri-Nymyo?

  • Like pregnancy, Tri-Nymyo 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
  • a sudden, severe headache unlike your usual headaches
  • sudden severe shortness of breath
  • weakness or numbness in your arm or leg
  • sudden change in vision or blindness
  • trouble speaking
  • chest pain

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-Nymyo.
  • 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 if 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-Nymyo. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of Tri-Nymyo?

  • headache (migraine)
  • breast pain or tenderness, enlargement or discharge
  • stomach pain, discomfort, and gas
  • vaginal infections and discharge
  • mood changes, including depression
  • nervousness
  • changes in weight
  • skin rash

These are not all the possible side effects of Tri-Nymyo. 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-Nymyo?

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

How should I store Tri-Nymyo?

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

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

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

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

For more information, call Mayne Pharma at 1-844-825-8500.

Do birth control pills cause cancer?

Birth control pills do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills 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-Nymyo?

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-Nymyo, 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-Nymyo?

Active ingredients: Each green, light-blue, and blue pill contains norgestimate and ethinyl estradiol.

Inactive ingredients:

Green pills: FD&C Blue No.2 Aluminum Lake,FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 10 Aluminum Lake, titanium dioxide, iron oxide black, iron oxide yellow, macrogol/ polyethylene glycol 3350 NF, lecithin, talc, polyvinyl alcohol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

Light Blue pills: FD&C Blue #2 Aluminum Lake,FD&C Red #40 Aluminum Lake, titanium dioxide,iron oxide black, polyvinyl alcohol, talc, macrogol/polyethylene glycol 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

Blue pills: FD&C Blue No. 2 Aluminium Lake,FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol,talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

White pills: titanium dioxide, polydextrose,hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.

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