Tri Femynor (Page 6 of 9)

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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

14 CLINICAL STUDIES

14.1 Contraception

In four clinical trials with Tri Femynor, 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 to 90% Caucasian, 6 to 10% African-American, with the remainder Asian (≤1%) or Other (2 to 5%). There were no exclusions on the basis of weight; the weight range for women treated was 80 to 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 Femynor was 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 Femynor and 234 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 Femynor 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 Femynor showed a statistically significant improvement in total lesions compared to those treated with placebo.

Table 4: Acne Vulgaris Indication. Combined Results: Two Multicenter, Placebo-Controlled Trials. Observed Means at Six Months (LOCF)* and at Baseline. Intent-to-Treat Population.

Tri Femynor (N=221)

Placebo (N=234)

Difference in Counts between Tri Femynor and Placebo at 6 Months

# of Lesions

Counts

% Reduction

Counts

% Reduction

INFLAMMATORY LESIONS

Baseline Mean

19

19

Sixth Month Mean

10

48%

13

30%

3 (95% CI: -1.2, 5.1)

NON-INFLAMMATORY LESIONS

Baseline Mean

36

35

Sixth Month Mean

22

34%

25

21%

3 (95% CI: -0.2, 7.8)

TOTAL LESIONS

Baseline Mean

55

54

Sixth Month Mean

31

42%

38

27%

7 (95% CI: 2.0, 11.9)

* LOCF: Last Observation Carried Forward

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tri Femynor™ (norgestimate and ethinyl estradiol tablets, USP) are available in a blister pack (NDC 69238-1607-6):

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

  • 7 light pink, round, biconvex, film-coated tablets debossed with “E1” on one side of the tablet containing 0.18 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP
  • 7 light red, round, biconvex, film-coated tablets debossed with “E2” on one side of the tablets containing 0.215 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP
  • 7 red, round, biconvex, film-coated tablets debossed with “E3” on one side of the tablets containing 0.25 mg norgestimate, USP and 0.035 mg ethinyl estradiol, USP
  • 7 white, round, biconvex, film-coated tablets (non-hormonal placebo) debossed with “C2” on one side containing inert ingredients

Keep out of reach of children.

16.2 Storage Conditions

  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Protect from light.

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 Femynor does not protect against HIV infection (AIDS) and other sexually transmitted infections.
  • Tri Femynor is not to be used during pregnancy; if pregnancy occurs during use of Tri Femynor instruct the patient to stop further use [see Warnings and Precautions (5.8) ].
  • 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 Femynor [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 a red “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 (5.7) ].

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Bridgewater, NJ 08807

Rev. 08-2016-00

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