Nymyo

NYMYO — norgestimate and ethinyl estradiol
Mayne Pharma Inc.

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

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

2 DOSAGE AND ADMINISTRATION

2.1 How to Start Nymyo

Nymyo is dispensed in 28-tablet blister [see How Supplied/Storage and Handling ( 16)]. Nymyo 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 Nymyo

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Starting Nymyo after Abortion or Miscarriage

First-trimester

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

Second-trimester

  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Nymyo, 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 Nymyo.[see Contraindications ( 4), Warnings and Precautions ( 5.1), and FDA-Approved Patient Labeling.]

Starting Nymyo after Childbirth

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

3 DOSAGE FORMS AND STRENGTHS

Nymyo Tablets are available in blister cards. Each blister card contains 28 tablets in the following order:

  • 21 blue, round, biconvex, coated tablet 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 Nymyo 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)]

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic Disorders and Other Vascular Problems

  • Stop Nymyo if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
  • Stop Nymyo if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately[see Adverse Reactions ( 6.2)].
  • If feasible, stop Nymyo at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization.
  • Start Nymyo no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
  • The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued.
  • Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke.
  • Use COCs with caution in women with cardiovascular disease risk factors.

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