Vestura

VESTURA- 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

Vestura® (drospirenone and ethinyl estradiol) tablets are indicated for use by females of reproductive potential to prevent pregnancy.

1.2 Premenstrual Dysphoric Disorder (PMDD)

Vestura is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potential who choose to use an oral contraceptive as their method of contraception. The effectiveness of Vestura 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.

Vestura has not been evaluated for the treatment of premenstrual syndrome (PMS).

1.3 Acne

Vestura 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. Vestura 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 Vestura

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, Vestura 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 Vestura

Instruct the patient to begin taking Vestura 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 Vestura use, instruct the patient to take one pink Vestura daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one pink Vestura daily for 24 consecutive days, followed by one peach inert tablet daily on Days 25 through 28. Vestura 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. Vestura can be taken without regard to meals. If Vestura is first taken later than the first day of the menstrual cycle, Vestura 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.

Sunday Start

During the first cycle of Vestura use, instruct the patient to take one pink Vestura daily, beginning on the first Sunday after the onset of her menstrual period. She should take one pink Vestura daily for 24 consecutive days, followed by one peach inert tablet daily on Days 25 through 28. Vestura 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. Vestura can be taken without regard to meals. Vestura 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 Vestura on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her pink tablets on the next day after ingestion of the last peach tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Vestura is started later than the day following administration of the last peach tablet, the patient should use another method of contraception until she has taken a pink Vestura daily for seven consecutive days.

When switching from a different birth control pill

When switching from another birth control pill, Vestura 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, Vestura should be started when the next application would have been due. When switching from an injection, Vestura should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Vestura should be started on the day of removal.

Withdrawal bleeding usually occurs within 3 days following the last pink tablet. If spotting or breakthrough bleeding occurs while taking Vestura, instruct the patient to continue taking Vestura 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 Vestura 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 Vestura if pregnancy is confirmed.

The risk of pregnancy increases with each active pink tablet missed. If breakthrough bleeding occurs following missed tablets, it will usually be transient and of no consequence. If the patient misses one or more peach tablets, she should still be protected against pregnancy provided she begins taking a new cycle of pink tablets on the proper day.

For postpartum women who do not breastfeed or after a second trimester abortion, start Vestura no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Vestura 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 Vestura for 7 consecutive days.

2.3 Missed Doses

Table 1: Instructions for Vestura Missed Doses

If one pink active tablet is missed

Take the missed active tablet as soon as possible. Take the next tablet at the regular time. This means two tablets may be taken in one day. A back-up birth control method is not required if the patient has sex.

If two pink active tablets in a row are missed in Week 1 or Week 2

Take two active tablets as soon as possible and two tablets the next day. Then take one tablet a day until the pack is finished. Additional nonhormonal 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 pink active tablets in a row are missed in Week 3 or Week 4

Day 1 Start: Throw out the rest of the tablet pack and start a new pack that same day.

Sunday Start: Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day. Additional nonhormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. The patient may not have their period this month but this is expected. However, if they miss their period two months in a row, they should call their healthcare provider because they might be pregnant.

If three or more pink active tablets in a row are missed during any week

Day 1 Start: Throw out the rest of the tablet pack and start a new pack that same day.

Sunday Start: Keep taking one tablet every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack of tablets that same day. The patient could become pregnant if they have sex in the 7 days after they restart their tablets. They must use another birth control method (such as condoms and spermicides) as a back-up for those 7 days. They should call their healthcare provider if they miss their period, because they might be pregnant.

If any of the four peach inactive tablets are missed in Week 4

Throw away the tablets that were missed. Keep taking one tablet each day until the pack is empty. They do not need a back-up method.

Finally, if they are still not sure what to do about the tablets they have missed:

Use nonhormonal contraception (such as condoms and spermicides) anytime they have sex. Contact their healthcare provider and continue taking one active pink tablet each day until otherwise directed.


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