Tri-Estarylla (Page 6 of 9)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

[See WARNINGS AND PRECAUTIONS (5.2, 5.10) and USE IN SPECIFIC POPULATIONS (8.1).]

14 CLINICAL STUDIES

14.1 Contraception

In three US clinical trials with norgestimate and ethinyl estradiol, 1,651 women aged 18 to 38 years were studied for up to 24 cycles, proving a total of 24,272 cycles of exposure. The racial demographic was about 73 to 86% Caucasian, 8 to 13% African-American, 6 to 14% Hispanic with the remainder Asian or Other (≤1%). There were no exclusions on the basis of weight; the weight range for women treated was 82 to 303 lbs, with a mean weight of about 135 lbs. The pregnancy rate was approximately 1 pregnancy per 100 women-years.

In four clinical trials with norgestimate and ethinyl estradiol, 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 80-310 lbs, with a mean weight of about 132 lbs. The pregnancy rate was approximately 1 pregnancy per 100 women-years.

14. 2 Acne

Norgestimate and ethinyl estradiol 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-norgestimate and ethinyl estradiol 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 norgestimate and ethinyl estradiol 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 norgestimate and ethinyl estradiol 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- Estarylla

(N=221)

Placebo

(N=234)

Difference in Counts

Between Tri- Estarylla

and Placebo at

6 Months

# of Lesions

Counts

% Reduction

Counts

% Reduction

INFLAMMATORY LESIONS

Baseline Mean

19

48%

19

30%

Sixth Month Mean

10

13

3 (95% CI: -1.2, 5.1)

NON­INFLAMMATORY LESIONS

Baseline Mean

36

34%

35

21%

Sixth Month Mean

22

25

3 (95% CI: -0.2, 7.8)

TOTAL LESIONS

Baseline Mean

55

42%

54

27%

7 (95% CI: 2.0, 11.9)

Sixth Month Mean

31

38

*LOCF: Last Observation Carried Forward

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tri- EstaryllaTM (norgestimate and ethinyl estradiol tablets, USP) is available in blisters containing 28 tablets as follows:

Each blister card contains 21 active tablets and 7 inactive tablets.

7 white (active) tablets are round, debossed with SZ on one side and T2 on the other side and contains 0.18 mg of norgestimate and 0.035 mg of ethinyl estradiol .

7 light blue (active) tablets are round, debossed with SZ on one side and T3 on the other side and contains 0.215 mg of norgestimate and 0.035 mg of ethinyl estradiol .

7 blue (active) tablets are round, debossed with SZ on one side and T4 on the other side and contains 0.25 mg of norgestimate and 0.035 mg of ethinyl estradiol .

7 green (inert) tablets are round, debossed with SZ on one side and J1 on the other side.

NDC 70700-121-84, one box containing 1 individual unit carton

NDC 70700-121-85, one box containing 3 individual unit cartons

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 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-Estarylla™ does not protect against HIV infection (AIDS) and other sexually transmitted infections.
Tri-Estarylla™ is not to be used during pregnancy; if pregnancy occurs during use of Tri-Estarylla™ 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-Estarylla™ [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)].

Manufactured by Laboratorios Leon Farma S.A., Spain for

Xiromed, LLC. Florham Park, NJ 07932

Jan. 2018

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