Tri-Sprintec (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 four clinical trials with Tri-Sprintec, 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-Sprintec 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-Sprintec 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-Sprintec 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-Sprintec showed a statistically significant improvement in total lesions compared to those treated with placebo.

*
LOCF: Last Observation Carried Forward

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-Sprintec

(N=221)

Placebo

(N=234)

Difference in Counts between Tri-Sprintec 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

7 (95% CI: 2,11.9)

Sixth Month Mean

31

42%

38

27%

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) 0.18 mg/0.035 mg are gray, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 985 on the other side; 0.215 mg/0.035 mg are light blue, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 986 on the other side; 0.25 mg/0.035 mg are blue, round, flat-faced, beveled-edge, unscored tablets debossed with stylized b on one side and 987 on the other side; placebo tablets are white, round, flat-faced, beveled-edge, unscored tablets, debossed with stylized b on one side and 143 on the other side.

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) are packaged in cartons of six blister cards. Each card contains 28 tablets as follows: Each gray tablet contains 0.18 mg of the progestational compound, norgestimate, USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol, USP. Each light blue tablet contains 0.215 mg of the progestational compound, norgestimate, USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol, USP. Each blue tablet contains 0.25 mg of the progestational compound, norgestimate, USP, together with 0.035 mg of the estrogenic compound, ethinyl estradiol, USP, and the 7 white placebo tablets contain inert ingredients.

NDC: 0555-9108-58

KEEP THIS AND ALL MEDICATIONS OUT OF THE 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-Sprintec does not protect against HIV infection (AIDS) and other sexually transmitted infections.
Tri-Sprintec is not to be used during pregnancy; if pregnancy occurs during use of Tri-Sprintec 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-Sprintec [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 (5.7)].

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. B 5/2015

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