Ayuna (Page 4 of 7)

8. Pediatric Use

Safety and efficacy of Ayuna have been established in females of reproductive potential. Use of Ayuna before menarche is not indicated.

9. Geriatric Use

Ayuna has not been studied in postmenopausal women and is not indicated in this population.

10. PATIENT COUNSELING INFORMATION

  • Counsel patients that 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 and CONTRAINDICATIONS).
  • Counsel patients that this product does not protect against HIV-infection (AIDS) and other sexually transmitted infections.
  • Counsel patients to take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed (see DOSAGE AND ADMINISTRATION).
  • Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with COCs [see PRECAUTIONS (4.1)].
  • Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established [see PRECAUTIONS (7)].
  • Counsel any patient who starts Ayuna postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken an orange tablet for 7 consecutive days (see DOSAGE AND ADMINISTRATION).
  • Counsel patients that amenorrhea may occur. Pregnancy should be considered in the event of amenorrhea, and should be ruled out if amenorrhea is associated with symptoms of pregnancy, such as morning sickness or unusual breast tenderness [see WARNINGS (9)].
  • Depression may occur. Women should contact their healthcare provider if depression occurs, including shortly after initiating the treatment [see WARNINGS (10)].

ADVERSE REACTIONS

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

Adverse reactions reported by COC users and described elsewhere in the labeling are:

Post Marketing Experience

Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 2).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 to 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8 to 10 years of COC use.

Figure 2: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives

Figure 2: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives
(click image for full-size original)

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related: Breast tenderness, pain, enlargement, secretion; Nausea, vomiting and gastrointestinal symptoms (such as abdominal pain, cramps and bloating); Change in menstrual flow; Temporary infertility after discontinuation of treatment; Change in weight or appetite (increase or decrease); Change in cervical erosion and secretion; Cholestatic jaundice; Rash (allergic); Vaginitis, including candidiasis; Change in corneal curvature (steepening); Intolerance to contact lenses; Mesenteric thrombosis; Decrease in serum folate levels; Exacerbation of systemic lupus erythematosus; Exacerbation of porphyria; Exacerbation of chorea; Aggravation of varicose veins; Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.

The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted: Congenital anomalies; Premenstrual syndrome; Cataracts; Optic neuritis, which may lead to partial or complete loss of vision; Cystitis-like syndrome; Nervousness; Dizziness; Hirsutism; Loss of scalp hair; Erythema multiforme; Erythema nodosum; Hemorrhagic eruption; Impaired renal function; Hemolytic uremic syndrome; Budd-Chiari syndrome; Acne; Changes in libido; Colitis; Sickle-cell disease; Cerebral-vascular disease with mitral valve prolapse; Lupus-like syndromes; Pancreatitis; Dysmenorrhea.

OVERDOSAGE

There have been no reports of serious adverse outcomes from overdose of COCs, including ingestion by children. Overdose may cause uterine bleeding in females and nausea.

DOSAGE AND ADMINISTRATION

1. How to Start and Take Ayuna

Ayuna is dispensed in a blister pack containing 28 tablets (see HOW SUPPLIED). Ayuna may be started using either a Day 1 start or a Sunday start (see Table 3). 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.

Table 3: Instructions for Administration of Ayuna

Starting Ayuna in females with no current use of hormonal contraception Day 1 start
  • Take first tablet without regard to meals on the first day of menses
  • Take subsequent tablets once daily at the same time each day
  • 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 tablet)
Sunday start
  • Take first tablet without regard to meals on the first Sunday after the onset of menstrual period
  • Take subsequent tablets once daily at the same time each day
  • Use additional nonhormonal contraception for the first seven days of product use
  • 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 tablet)
Switching from another contraceptive method
  • A COC
  • Transdermal patch
  • Vaginal ring
  • Injection
  • Intrauterine contraceptive
  • Implant
Start Ayuna:
  • On the day when the new pack of the previous COC would have been started
  • On the day when next application would have been scheduled
  • On the day when next insertion would have been scheduled
  • On the day when next injection would have been scheduled
  • On the day of removal
  • On the day of removal

Starting Ayuna after Abortion or Miscarriage

First-trimester

  • After a first-trimester abortion or miscarriage, Ayuna may be started immediately. An additional method of contraception is not needed if Ayuna is started immediately.
  • If Ayuna is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first cycle of Ayuna.

Second-trimester

  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Ayuna following the instructions in Table 3 for Day 1 or Sunday start. Use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of the patient’s first cycle of Ayuna (see CONTRAINDICATIONS, WARNINGS (1), PRECAUTIONS (10) and FDA-APPROVED PATIENT LABELING).

Starting Ayuna after Childbirth

  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Ayuna following the instructions in Table 3 for women not currently using hormonal contraception.
  • Ayuna is not recommended for use in lactating women (see PRECAUTIONS (7) and FDA-APPROVED PATIENT LABELING).
  • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Ayuna (see CONTRAINDICATIONS, WARNINGS (9), PRECAUTIONS (6) and FDA-APPROVED PATIENT LABELING).

2. Dosing Ayuna

Instruct patients to take one tablet by mouth at the same time every day. To achieve maximum contraceptive effectiveness, patients must take Ayuna as directed, in the order directed on the blister pack. The failure rate may increase when pills are missed or taken incorrectly.

3. Missed doses

Instruct patients about the handling of missed doses (e.g., to take single missed pills as soon as possible) and to follow the dosing instructions provided in the FDA-approved patient labeling.

Table 4: Instructions for Missed Ayuna Tablets

  • If one 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 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 nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
  • If two active tablets are missed in the third week or three or more 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 nonhormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.

4. Advice in Case of Gastrointestinal Disturbances

If vomiting occurs within 3 to 4 hours after taking Ayuna, the patient should proceed as if she missed a tablet. In case of prolonged vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken.

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