Tri-Linyah

TRI-LINYAH — norgestimate and ethinyl estradiol
Northstar Rx LLC

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ( 4 )].

1 INDICATIONS AND USAGE

1.1 Oral Contraceptive

Tri-Linyah Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14)].

1.2 Acen

Tri-Linyah 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-Linyah 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

2.1 How to Start Tri-Linyah

Tri-Linyah is dispensed in 28-tablet blister [see How Supplied/Storage and Handling ( 16)]. Tri-Linyah may be started using either a Day 1 start or a Sunday start (see Table 1). The plastic compact is pre-set for a Sunday start. Day 1 Start day-label stickers are available. 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-Linyah

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Starting Tri-Linyah after Abortion or Miscarriage

First-trimester

  • After a first-trimester abortion or miscarriage, Tri-Linyah may be started immediately. An additional method of contraception is not needed if Tri-Linyah is started immediately.
  • If Tri-Linyah 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-Linyah.

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-Linyah, 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-Linyah.[see Contraindications ( 4), Warnings and Precautions ( 5.1), and FDA-Approved Patient Labeling.]

Starting Mono-Liyah after Childbirth

  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Tri-Linyah following the instructions in Table 1 for women not currently using hormonal contraception.
  • Tri-Linyah 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-Linyah. [See Contraindications( 4) , Warnings and Precautions( 5.1) , Use in Specific Populations (8.1and 8.3), and FDA-Approved Patient Labeling].

Compact Blister Dispenser

If the patient starts pill-taking on Sunday,the first active pill should be taken on the first Sunday after the patient’s menstrual period begins.Remove the first active pill at the top of the dispenser (Sunday) by pressing the pill through the blister foil.

If the patient will start pill-taking on “Day 1,”place a day-label sticker on the compact which starts with the day of the week the patient will take the first pill.Remove the first active pill at the top of the dispenser(Day 1)by pressing the pill through the blister foil.

2.3 Missed Tablets

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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 an active tablet, handle this as a missed tablet [see FDA-Approved Patient Labeling].

2.5 Tri-Linyah Use for Acne

The timing of initiation of dosing with Tri-Linyah for acne should follow the guidelines for use of Tri-Linyah as an oral contraceptive. Consult the DOSAGE AND ADMINISTRATION section (2.1) for instructions.

3 DOSAGE FORMS AND STRENGTHS

Tri-Linyah Tablets are available in blister cards. Each blister card contains 28 tablets 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

4 CONTRAINDICATIONS

Do not prescribe Tri-Linyah 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 (5.4)]
    • Have diabetes mellitus with vascular disease[see Warnings and Precautions (5.6)]
    • Have headaches with focal neurological symptoms or have migraine headaches with aura[see Warnings and Precautions (5.7)]
  • Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]
  • Liver tumors, benign or malignant, or liver disease[see Warnings and Precautions (5.2)]
  • Undiagnosed abnormal uterine bleeding[see Warnings and Precautions (5.8)]
  • Pregnancy, because there is no reason to use COCs during pregnancy[ see Warnings and Precautions (5.9)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 (5.11)]
  • Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations[see Warnings and Precautions (5.3)]

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