JASMIEL- drospirenone and ethinyl estradiol
Afaxys Pharma, LLC
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)].
Jasmiel® is indicated for use by women to prevent pregnancy.
Jasmiel 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 Jasmiel 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.
Jasmiel 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. Jasmiel should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
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, Jasmiel must be taken exactly as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
Instruct the patient to begin taking Jasmiel 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 Jasmiel use, instruct the patient to take one light pink to pink Jasmiel daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one light pink to pink Jasmiel daily for 24 consecutive days, followed by one green inert tablet daily on Days 25 through 28. Jasmiel 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. Jasmiel can be taken without regard to meals. If Jasmiel is first taken later than the first day of the menstrual cycle, Jasmiel 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 Jasmiel use, instruct the patient to take one light pink to pink Jasmiel daily, beginning on the first Sunday after the onset of her menstrual period. She should take one light pink to pink Jasmiel daily for 24 consecutive days, followed by one green inert tablet daily on Days 25 through 28. Jasmiel 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. Jasmiel can be taken without regard to meals. Jasmiel 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 Jasmiel on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her light pink to pink tablets on the next day after ingestion of the last green tablet, regardless of whether or not a menstrual period has occurred or is still in progress. Anytime a subsequent cycle of Jasmiel is started later than the day following administration of the last green tablet, the patient should use another method of contraception until she has taken a light pink to pink Jasmiel daily for seven consecutive days.
When switching from a different birth control pill
When switching from another birth control pill, Jasmiel 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, Jasmiel should be started when the next application would have been due. When switching from an injection, Jasmiel should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Jasmiel should be started on the day of removal.
Withdrawal bleeding usually occurs within 3 days following the last light pink to pink tablet. If spotting or breakthrough bleeding occurs while taking Jasmiel, instruct the patient to continue taking Jasmiel 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 Jasmiel 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 Jasmiel if pregnancy is confirmed.
The risk of pregnancy increases with each active light pink to 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 green tablets, she should still be protected against pregnancy provided she begins taking a new cycle of light pink to pink tablets on the proper day.
For postpartum women who do not breastfeed or after a second trimester abortion, start Jasmiel no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Jasmiel 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 Jasmiel for 7 consecutive days.
In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3 to 4 hours after tablet-taking, this can be regarded as a missed tablet.
Jasmiel (drospirenone and ethinyl estradiol tablets, USP) are available in blister packs. Each blister pack (28 tablets) contains in the following order:
- 24 light pink to pink tablets each containing 3 mg drospirenone USP (DRSP) and 0.02 mg ethinyl estradiol USP (EE)
- 4 green inert tablets
Do not prescribe Jasmiel to women who are known to have the following:
- Renal impairment
- Adrenal insufficiency
- 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 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 inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
- Have uncontrolled hypertension [see Warnings and Precautions (5.6)]
- Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.8)]
- Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.9)]
- Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.10)]
- Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past [see Warnings and Precautions (5.3)]
- Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.4) and Use in Specific Populations (8.7)]
- Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1)]
- 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 (5.5) and Drug Interactions (7.3)].
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