GIANVI- drospirenone and ethinyl estradiol
Teva Pharmaceuticals USA Inc
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (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 should not be used by women who are over 35 years of age and smoke [see Contraindications (4)].
1 INDICATIONS AND USAGE
1.1 Oral Contraceptive
Gianvi® is indicated for use by women to prevent pregnancy.
1.2 Premenstrual Dysphoric Disorder (PMDD)
Gianvi is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of Gianvi for PMDD when used for more than three menstrual cycles has not been evaluated.
The essential features of PMDD according to the Diagnostic and Statistical Manual-4th edition (DSM-IV) include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. In this disorder, these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school, or with usual social activities and relationships with others. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders.
Gianvi has not been evaluated for the treatment of premenstrual syndrome (PMS).
Gianvi is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Gianvi should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
2 DOSAGE AND ADMINISTRATION
2.1 How to Take Gianvi
Take one tablet by mouth at the same time every day. The failure rate may increase when pills are missed or taken incorrectly.
To achieve maximum contraceptive and PMDD effectiveness, Gianvi must be taken exactly as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
2.2 How to Start Gianvi
Instruct the patient to begin taking Gianvi either on the first day of her menstrual period (Day 1 Start) or on the first Sunday after the onset of her menstrual period (Sunday Start).
Day 1 Start
During the first cycle of Gianvi use, instruct the patient to take one light pink Gianvi daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one light pink Gianvi daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Gianvi should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Gianvi can be taken without regard to meals. If Gianvi is first taken later than the first day of the menstrual cycle, Gianvi should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
During the first cycle of Gianvi use, instruct the patient to take one light pink Gianvi daily, beginning on the first Sunday after the onset of her menstrual period. She should take one light pink Gianvi daily for 24 consecutive days, followed by one white inert tablet daily on Days 25 through 28. Gianvi should be taken in the order directed on the package at the same time each day, preferably after the evening meal or at bedtime with some liquid, as needed. Gianvi can be taken without regard to meals. Gianvi should not be considered effective as a contraceptive until after the first 7 consecutive days of product administration. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.
The patient should begin her next and all subsequent 28-day regimens of Gianvi on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her light pink tablets on the next day after ingestion of the last white tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Gianvi is started later than the day following administration of the last white tablet, the patient should use another method of contraception until she has taken a light pink Gianvi daily for seven consecutive days.
When switching from a different birth control pill
When switching from another birth control pill, Gianvi should be started on the same day that a new pack of the previous oral contraceptive would have been started.
When switching from a method other than a birth control pill
- When switching from a transdermal patch or vaginal ring, Gianvi should be started when the next application would have been due. When switching from an injection, Gianvi should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Gianvi should be started on the day of removal.
Withdrawal bleeding usually occurs within 3 days following the last light pink tablet. If spotting or breakthrough bleeding occurs while taking Gianvi, instruct the patient to continue taking Gianvi by the regimen described above. Counsel her that this type of bleeding is usually transient and without significance; however, advise her that if the bleeding is persistent or prolonged, she should consult her healthcare provider.
Although the occurrence of pregnancy is low if Gianvi is taken according to directions, if withdrawal bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue Gianvi if pregnancy is confirmed.
The risk of pregnancy increases with each active light pink tablet missed. For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS ” section in the FDA Approved Patient Labeling. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more white tablets, she should still be protected against pregnancy provided she begins taking a new cycle of light pink tablets on the proper day.
For postpartum women who do not breastfeed or after a second trimester abortion, start Gianvi no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Gianvi postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Gianvi for 7 consecutive days.
2.3 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 occurs within 3–4 hours after tablet-taking, this can be regarded as a missed tablet.
3 DOSAGE FORMS AND STRENGTHS
Gianvi (drospirenone/ethinyl estradiol tablets) is available in blister packs.
Each blister pack (28 film-coated tablets) contains in the following order:
- 24 light pink tablets each containing 3 mg drospirenone (DRSP) and 0.02 mg ethinyl estradiol (EE) as betadex clathrate
- 4 white inert tablets
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