Tri Femynor

Product Type: HUMAN PRESCRIPTION DRUG

Route:

Dosage Form:

NDC: 69238-1607

Application: ANDA203870

Effective: 20160830

1 INDICATIONS AND USAGE Tri Femynor is estrogen/progestin COCs, indicated for use by women to prevent pregnancy. (1.1) Tri Femynor is also indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri Femynor should be used for the treatment of acne only if the patient desires an oral contraceptive birth control. (1.2) 1.1 Oral Contraceptive Tri Femynor Tablets are indicated for use by females of reproductive potential to prevent pregnancy [ see Clinical Studies (14) ]. 1.2 Acne Tri Femynor is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri Femynor should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [ see Clinical Studies (14) ].

2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. (2.2) Take tablets in the order directed on the blister pack. (2.2) Do not skip or delay tablet intake. (2.2) 2.1 How to Start Tri Femynor Tri Femynor tablets are dispensed in a blister pack [ see How Supplied/Storage and Handling (16) ]. Tri Femynor may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration. 2.2 How to Take Tri Femynor Table 1: Instructions for Administration of Tri Femynor Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: Tri Femynor active tablets are light pink (Day 1 to day 7), light red (Day 8 to Day 15) and red (Day 16 to Day 21). Tri Femynor has white inactive tablets (Day 22 to Day 28). Day 1 Start: Take first light pink “active” tablet without regard to meals on the first day of menses. Take subsequent light pink, light red or red “active” tablets once daily at the same time each day for a total of 21 days. Take one white “inactive” tablet daily for 7 days and at the same time of day that “active” tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last white “inactive” tablet) Sunday Start: Take first light pink “active” tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Tri Femynor . Take subsequent light pink, light red or red “active” tablets once daily at the same time each day for a total of 21 days. Take one white “inactive” tablet daily for the following 7 days and at the same time of day that “active” tablets were taken. Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last white “inactive” tablet) and additional non-hormonal contraceptive is not needed. Switching to Tri Femynor from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to Tri Femynor Start Tri Femynor : Transdermal patch On the day when next application would have been scheduled Vaginal ring On the day when next insertion would have been scheduled Injection On the day when next injection would have been scheduled Intrauterine contraceptive On the day of removal If the IUD is not removed on first day of the patient's menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack. Implant On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. Starting Tri Femynor after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, Tri Femynor may be started immediately. An additional method of contraception is not needed if Tri Femynor is started immediately. If Tri Femynor is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Tri Femynor. Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Tri Femynor, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient's first cycle pack of Tri Femynor. [ See Contraindications (4) , Warnings and Precautions (5.1) , and FDA-Approved Patient Labeling .] Starting Tri Femynor after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri Femynor following the instructions in Table 1 for women not currently using hormonal contraception. Tri Femynor is not recommended for use in lactating women [ see Use in Specific Populations (8.3) ]. If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Tri Femynor. [ See Contraindications (4) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1 and 8.3) , and FDA-Approved Patient Labeling ]. SET THE DAY:  Day 1 Start: Take the first pill of the first blister pack during the first 24 hours of your period.  Sunday Start: Take the first pill of the first blister pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the blister pack that same day. blister for PI 2.3 Missed Tablets Table 2: Instructions for Missed Tri Femynor If one light pink, light red or red “active” tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. If two light pink or light red “active” tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two “active” tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. If two red “active” tablets are missed in the third week or three or more light pink, light red or red “active” tablets are missed in a row in Weeks 1, 2, or 3 Day 1 start : Throw out the rest of the pack and start a new pack that same day. Sunday start : Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. 2.4 Advice in Case of Gastrointestinal Disturbances In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking a light pink, light red or red “active” tablet, handle this as a missed tablet [ see FDA-Approved Patient Labeling ]. 2.5 Tri Femynor Use for Acne The timing of initiation of dosing with Tri Femynor for acne should follow the guidelines for use of Tri Femynor as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section (2.1) for instructions.

4 CONTRAINDICATIONS Do not prescribe Tri Femynor to women who are known to have the following conditions: A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [ see Boxed Warning and Warnings and Precautions (5.1) ] Have deep vein thrombosis or pulmonary embolism, now or in the past [ see Warnings and Precautions (5.1) ] Have inherited or acquired hypercoagulopathies [ see Warnings and Precautions (5.1) ] Have cerebrovascular disease [ see Warnings and Precautions (5.1) ] Have coronary artery disease [ see Warnings and Precautions (5.1) ] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [ see Warnings and Precautions (5.1) ] Have uncontrolled hypertension [ see Warnings and Precautions (5.3) ] Have diabetes mellitus with vascular disease [ see Warnings and Precautions (5.5) ] Have headaches with focal neurological symptoms or migraine headaches with aura [ see Warnings and Precautions (5.6) ] Women over age 35 with any migraine headaches [ see Warnings and Precautions (5.6) ] Liver tumors, benign or malignant, or liver disease [ see Warnings and Precautions (5.2) ] Undiagnosed abnormal uterine bleeding [ see Warnings and Precautions (5.7) ] Pregnancy, because there is no reason to use COCs during pregnancy [ see Warnings and Precautions (5.8) and Use in Specific Populations (8.1) ] Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [ see Warnings and Precautions (5.10) ] A high risk of arterial or venous thrombotic diseases (4) Liver tumors or liver disease (4) Undiagnosed abnormal uterine bleeding (4) Pregnancy (4) Breast cancer or other estrogen- or progestin-sensitive cancer (4)

Not available.

6 ADVERSE REACTIONS The following serious adverse reactions with the use of COCs are discussed elsewhere in labeling: Serious cardiovascular events and stroke [ see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [ see Warnings and Precautions (5.1) ] Liver disease [ see Warnings and Precautions (5.2) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions reported during clinical trials (≥2%) were: headache/migraine, breast issues (including breast pain, enlargement, and discharge), vaginal infection, abdominal/gastrointestinal pain, mood disorders (including mood alteration and depression), genital discharge, changes in weight (including weight increased or decreased). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of Tri Femynor was evaluated in 4,826 healthy women of child-bearing potential who participated in 6 clinical trials and received at least 1 dose of Tri Femynor for contraception. Two trials were randomized active-controlled trials and 4 were uncontrolled open-label trials. In 3 trials, subjects were followed for up to 24 cycles; in 2 trials, subjects were followed for up to 12 cycles; and in 1 trial, subjects were followed for up to 6 cycles. Common Adverse Reactions (≥ 2% of subjects) : The most common adverse reactions reported by at least 2% of the 4,826 women were the following in order of decreasing incidence: headache/migraine (33.6%), breast issues (including breast pain, enlargement, and discharge) (8.0%), vaginal infection (7.1%), abdominal/gastrointestinal pain (5.6%), mood disorders (including mood alteration and depression) (3.8%), genital discharge (3.2%), and changes in weight (including weight fluctuation, increased or decreased) (2.5%). Adverse Reactions Leading to Study Discontinuation : Over the three trials, between 9 to 27% of subjects discontinued the trial due to an adverse reaction. The most common adverse reactions (≥1%) leading to discontinuation were: metrorrhagia (4.3%), nausea/vomiting (2.8%), headache/migraine (2.4%), mood disorders (including depression and mood altered) (1.1%), and weight increased (1.1%). Serious Adverse Reactions : breast cancer (1 subject), carcinoma of the cervix in situ (1 subject), hypertension (1 subject), and migraine (2 subjects). 6.2 Postmarketing Experience The following additional adverse drug reactions have been reported from worldwide postmarketing experience with norgestimate/ethinyl estradiol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Infections and Infestations : Urinary tract infection; Neoplasms Benign, Malignant and Unspecified (Incl. Cysts and Polyps) : Breast cancer, benign breast neoplasm, hepatic adenoma, focal nodular hyperplasia, breast cyst; Immune System Disorders : Hypersensitivity; Metabolism and Nutrition Disorders : Dyslipidemia; Psychiatric Disorders : Anxiety, insomnia; Nervous System Disorders : Syncope, convulsion, paresthesia, dizziness; Eye Disorders : Visual impairment, dry eye, contact lens intolerance; Ear and Labyrinth Disorders : Vertigo; Cardiac Disorders : Tachycardia, palpitations; Vascular Events : Deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, hot flush; Arterial Events : Arterial thromboembolism, myocardial infarction, cerebrovascular accident; Respiratory, Thoracic and Mediastinal Disorders : Dyspnea; Gastrointestinal Disorders : Pancreatitis, abdominal distension, diarrhea, constipation; Hepatobiliary Disorders : Hepatitis; Skin and Subcutaneous Tissue Disorders : Angioedema, erythema nodosum, hirsutism, night sweats, hyperhidrosis, photosensitivity reaction, urticaria, pruritus, acne; Musculoskeletal, Connective Tissue, and Bone Disorders : Muscle spasms, pain in extremity, myalgia, back pain; R eproductive System and Breast Disorders : Ovarian cyst, suppressed lactation, vulvovaginal dryness; General Disorders and Administration Site Conditions : Chest pain, asthenic conditions.