See also:
What is the most important information I should know about Yamini?
Combined oral contraceptives (COCs) should not be used in the presence of any of the conditions listed as follows. Should any of these conditions appear for the 1st time during COC use, Yaz should be stopped immediately.
Presence or a history of venous or arterial thrombotic/thromboembolic events (eg, deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident.
Presence or history of prodromi of a thrombosis (eg, transient ischemic attack, angina pectoris).
The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication.
History of migraine with focal neurological symptoms.
Diabetes mellitus with vascular involvement.
Severe hepatic disease as long as liver function values have not returned to normal.
Severe renal insufficiency or acute renal failure.
Presence or history of liver tumors (benign or malignant).
Known or suspected sex-steroid influenced malignancies (eg, of the genital organs or the breasts).
Undiagnosed vaginal bleeding.
Known or suspected pregnancy.
Hypersensitivity to Yaz or to any of the excipients.
See also:
What are the possible side effects of Yamini?
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:
Adverse reactions commonly reported by COC users are:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Contraception And Acne Clinical TrialsThe data provided reflect the experience with the use of Yaz in the adequate and well-controlled studies for contraception (N=1,056) and for moderate acne vulgaris (N=536).
For contraception, a Phase 3, multicenter, multinational, open-label study was conducted to evaluate safety and efficacy up to one year in 1,027 women aged 17 - 36 who took at least one dose of Yaz. A second Phase 3 study was a single center, open-label, active-controlled study to evaluate the effect of 7 28-day cycles of Yaz on carbohydrate metabolism, lipids and hemostasis in 29 women aged 18-35. For acne, two multicenter, double-blind, randomized, placebo-controlled studies, in 536 women aged 14-45 with moderate acne vulgaris who took at least one dose of Yaz, evaluated the safety and efficacy during up to 6 cycles.
The adverse reactions seen across the 2 indications overlapped, and are reported using the frequencies from the pooled dataset. The most common adverse reactions ( ≥ 2% of users) were: headache/migraine (6.7%), menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia (4.7%), nausea/vomiting (4.2%), breast pain/tenderness (4%) and mood changes (mood swings, depression, depressed mood and affect lability) (2.2%).
PMDD Clinical TrialsSafety data from trials for the indication of PMDD are reported separately due to differences in study design and setting in the Contraception and Acne studies as compared to the PMDD clinical program.
Two (one parallel and one crossover designed) multicenter, double-blind, randomized, placebocontrolled trials for the secondary indication of treating the symptoms of PMDD evaluated safety and efficacy of Yaz during up to 3 cycles among 285 women aged 18-42, diagnosed with PMDD and who took at least one dose of Yaz.
Common adverse reactions ( ≥ 2% of users) were: menstrual irregularities (including vaginal hemorrhage [primarily spotting] and metrorrhagia) (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).
Adverse Reactions ( ≥ 1%) Leading To Study DiscontinuationContraception Clinical TrialsOf 1,056 women, 6.6% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were headache/migraine (1.6%) and nausea/vomiting (1.0%).
Acne Clinical TrialsOf 536 women, 5.4% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was menstrual irregularities (including menometrorrhagia, menorrhagia, metrorrhagia and vaginal hemorrhage) (2.2%).
PMDD Clinical TrialsOf 285 women, 11.6% discontinued from the clinical trials due to an adverse reaction; the most frequent adverse reactions leading to discontinuation were: nausea/vomiting (4.6%), menstrual irregularity (including vaginal hemorrhage, menorrhagia, menstrual disorder, menstruation irregular and metrorrhagia) (4.2%), fatigue (1.8%), breast tenderness (1.4%), depression (1.4%), headache (1.1%), and irritability (1.1%).
Serious Adverse ReactionsContraception Clinical Trialsmigraine and cervical dysplasia
Acne Clinical Trialsnone reported in the clinical trials
PMDD Clinical Trialscervical dysplasia
Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of Yaz. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions are grouped into System Organ Classes, and ordered by frequency.
Vascular disorders: Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, cerebral thrombosis, retinal thrombosis, myocardial infarction and stroke), hypertension (including hypertensive crisis)
Hepatobiliary disorders: Gallbladder disease, liver function disturbances, liver tumors
Immune system disorders: Hypersensitivity (including anaphylactic reaction)
Metabolism and nutrition disorders: Hyperkalemia, hypertriglyceridemia, changes in glucose tolerance or effect on peripheral insulin resistance (including diabetes mellitus)
Skin and subcutaneous tissue disorders: Chloasma, angioedema, erythema nodosum, erythema multiforme
Gastrointestinal disorders: Inflammatory bowel disease
Musculoskeletal and connective tissue disorders: Systemic lupus erythematosus
Yamini™ is indicated for use by women to prevent pregnancy.
Premenstrual Dysphoric Disorder (PMDD)
Yamini 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 Yamini 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.
Yamini has not been evaluated for the treatment of premenstrual syndrome (PMS).
Acne
Yamini 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. Yamini should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.
Yamini is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). Yamini also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.
Yamini is used as contraception to prevent pregnancy. This medicine is also used to treat moderate acne in women who are at least 14 years old and have started having menstrual periods, and who wish to use birth control pills.
Yaz is also used to treat the symptoms of premenstrual dysphoric disorder (PMDD), such as anxiety, depression, irritability, trouble concentrating, lack of energy, sleep or appetite changes, breast tenderness, joint or muscle pain, headache, and weight gain.
Yamini may also be used for purposes not listed in this medication guide.
Each active tab consists of ethinylestradiol 0.02 mg and Drospirenone (Yamini) 3 mg. It also contains the following excipients: Lactose monohydrate, maize starch, magnesium stearate, hydroxypropylmethylcellulose, talc, titanium dioxide E 171, red ferric oxide pigment E172 and povidone 25000 in inactive tablets.
Yaz is a combined oral contraceptive ("the combined pill") consisting of 24 tablets with active ingredients and 4 inactive tablets (last row of the blister pack). Each active tablet contains a small amount of 2 different female hormones. These are Drospirenone (Yamini) (a progestogen) and ethinylestradiol (an estrogen). Because of the small amounts of hormones, Yaz is considered a low-dose oral contraceptive. As all active tablets in the pack combine the same hormones in the same dose, it is considered a monophasic combined oral contraceptive.
Use Yamini as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Yamini.
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 effectiveness, Yamini must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
How to Start Yamini
Instruct the patient to begin taking Yamini 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 Yamini use, instruct the patient to take one blue Yamini daily, beginning on Day 1 of her menstrual cycle. (The first day of menstruation is Day 1.) She should take one blue Yamini daily for 21 consecutive days, followed by one peach tablet daily on Days 22 through 28. Yamini 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. Yamini can be taken without regard to meals. If Yamini is first taken later than the first day of the menstrual cycle, Yamini 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 Yamini use, instruct the patient to take one blue Yamini daily, beginning on the first Sunday after the onset of her menstrual period. She should take one blue Yamini daily for 21 consecutive days, followed by one peach tablet daily on Days 22 through 28. Yamini 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. Yamini can be taken without regard to meals. Yamini 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 Yamini on the same day of the week that she began her first regimen, following the same schedule. She should begin taking her blue 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 Yamini 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 blue Yamini daily for seven consecutive days.
When switching from a different birth control pill
When switching from another birth control pill, Yamini 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, Yamini should be started when the next application would have been due. When switching from an injection, Yamini should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Yamini should be started on the day of removal.
Withdrawal bleeding usually occurs within 3 days following the last blue tablet. If spotting or breakthrough bleeding occurs while taking Yamini, instruct the patient to continue taking Yamini 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 Yamini 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 Yamini if pregnancy is confirmed.
The risk of pregnancy increases with each active blue 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 peach tablets, she should still be protected against pregnancy provided she begins taking a new cycle of blue tablets on the proper day.
For postpartum women who do not breastfeed or after a second trimester abortion, start Yamini no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts Yamini 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 Yamini for 7 consecutive days.
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.
See also:
What other drugs will affect Yamini?
Effects of Other Medicaments on Yaz: Interactions of other drugs (enzyme inducers, some antibiotics) with oral contraceptives may lead to breakthrough bleeding and/or contraceptive failure. Women on treatment with any of these drugs should temporarily use a barrier method in addition to the COC or choose another method of contraception. With microsomal enzyme-inducing drugs, the barrier method should be used during the time of concomitant drug administration and for 28 days after their discontinuation. Women on treatment with antibiotics (except rifampicin and griseofulvin) should use the barrier method until 7 days after discontinuation. If the period during which the barrier method is used runs beyond the end of the hormone-containing light pink film-coated tablets in the COC pack, the hormone-free white film-coated tablets should be omitted and the next COC pack be started.
Substances Diminishing the Efficacy of COCs (Enzyme Inducers and Antibiotics): Enzyme induction (increase of hepatic metabolism): Interactions can occur with drugs that induce microsomal enzymes which can result in increased clearance of sex hormones (eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and products containing St. John's wort).
Also HIV protease (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg, nevirapine) and combinations of them have been reported to potentially increase hepatic metabolism.
Antibiotics (interference with enterohepatic circulation): Some clinical reports suggest that enterohepatic circulation of estrogens may decrease when certain antibiotic agents are given which may reduce ethinylestradiol concentrations (eg, penicillins, tetracyclines).
Substances Interfering with the Metabolism of Combined Hormonal Contraceptives (Enzyme Inhibitors): The main metabolites of Drospirenone (Yamini) in human plasma are generated without involvement of the cytochrome P-450 system. Inhibitors of this enzyme system are therefore unlikely to influence the metabolism of Drospirenone (Yamini).
Effects of COCs on Other Medicaments:
Oral contraceptives may affect the metabolism of certain other drugs. Accordingly, plasma and tissue concentrations may either increase (eg, cyclosporin) or decrease (eg, lamotrigine).
Based on in vitro inhibition studies and in vivo interaction studies in female volunteers using omeprazole, simvastatin and midazolam as marker substrates, an interaction of Drospirenone (Yamini) at doses of 3 mg with the metabolism of other drugs is unlikely.
Other Forms of Interactions: Serum Potassium: There is a theoretical potential for an increase in serum potassium in women taking Yaz hormone-containing light pink film-coated tablets with other drugs that may increase serum potassium levels. Such drugs include angiotensin II receptor antagonists, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of Drospirenone (Yamini) (combined with estradiol) with an ACE inhibitor or indomethacin, no clinically or statistically significant differences in serum potassium concentrations were observed.
Laboratory Tests: The use of contraceptive steroids may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins, eg corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal laboratory range. Drospirenone (Yamini) causes an increase in plasma renin activity and plasma aldosterone induced by its mild antimineralocorticoid activity.
Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.
