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Zumandimine is a brand name for Drospirenone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Zumandimine ® (drospirenone and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy. Zumandimine (drospirenone and ethinyl estradiol tablets) is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. 1 ) Tablets must be taken in the order directed on the blister pack. 1 How to Take Zumandimine 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, Zumandimine must be taken as directed, in the order directed on the blister pack. Single missed pills should be taken as soon as remembered.
2 How to Start Zumandimine Instruct the patient to begin taking Zumandimine 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 Zumandimine use, instruct the patient to take one light pink to pink Zumandimine daily, beginning on Day 1 of her menstrual cycle.
) She should take one light pink to pink Zumandimine daily for 21 consecutive days, followed by one green tablet daily on Days 22 through 28. Zumandimine 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.
Zumandimine can be taken without regard to meals. If Zumandimine is first taken later than the first day of the menstrual cycle, Zumandimine 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 Zumandimine use, instruct the patient to take one light pink to pink Zumandimine daily, beginning on the first Sunday after the onset of her menstrual period.
She should take one light pink to pink Zumandimine daily for 21 consecutive days, followed by one green tablet daily on Days 22 through 28. Zumandimine 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.
Zumandimine can be taken without regard to meals. Zumandimine 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.
3%). 1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.
03 mg EE) in the adequate and well-controlled studies for contraception (N=2,837). The US pivotal clinical study (N=326) was a multicenter, open-label trial in healthy women aged 18 to 35 who were treated for up to 13 cycles. The second pivotal study (N=442)was a multicenter, randomized, open-label comparative European study of Zumandimine vs.
03 mg EE conducted in healthy women aged 17 to 40 who were treated for up to 26 cycles. 3%). 5%).
Serious Adverse Reactions:
Depression, pulmonary embolism, toxic skin eruption, and uterine leiomyoma. 12 (Figure 3). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 3). One of these studies reported no association between breast cancer risk and COC use.
33 with current or recent use. 4 with more than 8 to 10 years of COC use.
Figure 3:
Relative Studies of Risk of Breast Cancer with Combined Oral Contraceptives RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.
The following adverse reactions have been identified during post-approval use of Zumandimine. 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.
5 WARNINGS AND PRECAUTIONS Vascular risks: Stop Zumandimine if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. 1 ). COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins.
1 ).
Hyperkalemia :
DRSP has anti-mineralocorticoid activity. Do not use in patients predisposed to hyperkalemia. Check serum potassium concentration during the first treatment cycle in women on long-term treatment with medications that may increase serum potassium concentration.
2 ) Liver disease : Discontinue Zumandimine if jaundice occurs. 4 ) High blood pressure : Do not prescribe Zumandimine for women with uncontrolled hypertension or hypertension with vascular disease. 6 ) Carbohydrate and lipid metabolic effects : Monitor prediabetic and diabetic women taking Zumandimine.
Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. 8 ) Headache : Evaluate significant change in headaches and discontinue Zumandimine if indicated. 9 ) Uterine bleeding : Evaluate irregular bleeding or amenorrhea.
1 Thromboembolic Disorders and Other Vascular Problems Stop Zumandimine if an arterial or venous thrombotic (VTE) event occurs. Based on presently available information on Zumandimine, DRSP-containing COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins.
Epidemiologic studies that compared the risk of VTE reported that the risk ranged from no increase to a three-fold increase. Before initiating use of Zumandimine in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE.
4 CONTRAINDICATIONS Zumandimine is contraindicated in females who are known to have or develop the following conditions: Renal impairment Adrenal insufficiency A high risk of arterial or venous thrombotic diseases. 2) ]. Renal impairment ( 4 ) Adrenal insufficiency ( 4 ) A high risk of arterial or venous thrombotic diseases ( 4) Undiagnosed abnormal uterine bleeding ( 4) Breast cancer ( 4 ) Liver tumors or liver disease ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir, with or without dasabuvir ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 Zumandimine 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 Zumandimine 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 Zumandimine daily for seven consecutive days.
When switching from a different birth control pill When switching from another birth control pill, Zumandimine 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, Zumandimine should be started when the next application would have been due.
When switching from an injection, Zumandimine should be started when the next dose would have been due. When switching from an intrauterine contraceptive or an implant, Zumandimine 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 Zumandimine, instruct the patient to continue taking Zumandimine 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 Zumandimine 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 Zumandimine if pregnancy is confirmed. The risk of pregnancy increases with each active light pink to 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 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 Zumandimine no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts Zumandimine 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 Zumandimine for 7 consecutive days.
3 Missed Doses Table 1: Instructions for Zumandimine Missed Doses If one pink to pink active tablet is missed Take it 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 to pink active tablets in a row are missed in Week 1 or Week 2 Take two 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 to pink active tablets in a row are missed in Week 3 or Week 4 Day 1 Start : Throw out the rest of the 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 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 to pink active tablets in a row are missed during any week Day 1 Start : Throw out the rest of the 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 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 any of the seven green 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 to pink tablet each day until otherwise directed. 4 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 to 4 hours after tablet-taking, this can be regarded as a missed tablet.
Adverse reactions, including fatalities, are grouped into System Organ Classes and ordered by frequency.
Vascular disorders:
Venous and arterial thromboembolic events (including pulmonary emboli, deep vein thrombosis, intracardiac thrombosis, intracranial venous sinus thrombosis, sagittal sinus thrombosis, retinal vein occlusion, myocardial infarction and stroke), hypertension Hepatobiliary disorders: Gallbladder disease Immune system disorders: Hypersensitivity Metabolism and nutrition disorders: Hyperkalemia Skin and subcutaneous tissue disorders: Chloasma Figure 3: Relative Studies of Risk of Breast Cancer with Combined Oral Contraceptives
Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs [see Contraindications (4) ] . A number of studies have compared the risk of VTE for users of Zumandimine to the risk for users of other COCs, including COCs containing levonorgestrel.
Those that were required or sponsored by regulatory agencies are summarized in Table 2. 8) In addition to these “regulatory studies,” other studies of various designs have been conducted. Overall, there are two prospective cohort studies (see Table 2): the US post-approval safety study Ingenix [Seeger 2007], the European post-approval safety study EURAS (European Active Surveillance Study) [Dinger 2007].
An extension of the EURAS study, the Long-Term Active Surveillance Study (LASS), did not enroll additional subjects, but continued to assess VTE risk. There are three retrospective cohort studies: one study in the US funded by the FDA (see Table 2), and two from Denmark [Lidegaard 2009, Lidegaard 2011].
There are two case-control studies: the Dutch MEGA study analysis [van Hylckama Vlieg 2009] and the German case-control study [Dinger 2010]. There are two nested case-control studies that evaluated the risk of non-fatal idiopathic VTE: the PharMetrics study [Jick 2011] and the GPRD study [Parkin 2011].
The results of all of these studies are presented in Figure 1.
Figure 1:
VTE Risk with Zumandimine Relative to LNG-Containing COCs (adjusted risk # ) Risk ratios displayed on logarithmic scale; risk ratio < 1 indicates a lower risk of VTE for DRSP, > 1 indicates an increased risk of VTE for DRSP. *Comparator “Other COCs”, including LNG- containing COCs † LASS is an extension of the EURAS study #Some adjustment factors are indicated by superscript letters: a) Current heavy smoking, b) hypertension, c) obesity, d) family history, e) age, f) BMI, g) duration of use, h) VTE history, i) period of inclusion, j) calendar year, k) education, l) length of use, m) parity, n) chronic disease, o) concomitant medication, p) smoking, q) duration of exposure, r) site (References: Ingenix [Seeger 2007] 1 , EURAS (European Active Surveillance Study) [Dinger 2007] 2 , LASS (Long-Term Active Surveillance Study) [Dinger, unpublished document on file], FDA-funded study [Sidney 2011] 3 , Danish [Lidegaard 2009] 4 , Danish re-analysis [Lidegaard 2011] 5 , MEGA study [van Hylckama Vlieg 2009] 6 , German Case-Control study [Dinger 2010] 7 , PharMetrics [Jick 2011] 8 , GPRD study [Parkin 2011] 9 ) Although the absolute VTE rates are increased for users of hormonal contraceptives compared to non-users, the rates during pregnancy are even greater, especially during the post-partum period (see Figure 2).
The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use.
Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.
Figure 2 shows the risk of developing a VTE for women who are not pregnant and do not use oral contraceptives, for women who use oral contraceptives, for pregnant women, and for women in the postpartum period.
To put the risk of developing a VTE into perspective:
If 10,000 women who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these women will develop a VTE.
Figure 2:
Likelihood of Developing a VTE If feasible, stop Zumandimine at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start Zumandimine no earlier than 4 weeks after delivery, in women who are not breastfeeding.
The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.
COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke.
COCs also increase the risk for stroke in women with other underlying risk factors. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors. Stop Zumandimine if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.
Evaluate for retinal vein thrombosis immediately. 2 Hyperkalemia Zumandimine contains 3 mg of the progestin DRSP, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk patients, comparable to a 25 mg dose of spironolactone.
Zumandimine is contraindicated in patients with conditions that predispose to hyperkalemia (that is, renal impairment, hepatic impairment, and adrenal insufficiency). Women receiving daily, long-term treatment for chronic conditions or diseases with medications that may increase serum potassium concentration should have their serum potassium concentration checked during the first treatment cycle.
Medications that may increase serum potassium concentration include ACE inhibitors, angiotensin–II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs. Consider monitoring serum potassium concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly.
g. 3) ] . 3 Malignant Neoplasms Breast Cancer Zumandimine is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications (4) ]. Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk.
Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. 2) ]. Cervical Cancer Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia.
However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors. 4 Liver Disease Discontinue Zumandimine if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function.
Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Hepatic adenomas are associated with COC use. 3 cases/100,000 COC users.
Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users.
Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use. 5 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs.
Discontinue Zumandimine prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4) ] . Zumandimine can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
6 High Blood Pressure For women with well-controlled hypertension, monitor blood pressure and stop Zumandimine if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentration of progestin.
7 Gallbladder Disease Studies suggest a small increased relative risk of developing gallbladder disease among COC users. 8 Carbohydrate and Lipid Metabolic Effects Carefully monitor prediabetic and diabetic women who are taking Zumandimine.
COCs may decrease glucose tolerance in a dose-related fashion. Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
9 Headache If a woman taking Zumandimine develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Zumandimine if indicated. An increase in frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event) may be a reason for immediate discontinuation of the COC.
10 Bleeding Irregularities Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy.
If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different COC. Data from ten contraceptive efficacy clinical trials (N=2,467) show that the percent of women who took Zumandimine and experienced unscheduled bleeding decreased over time from 12% at cycle 2 to 6% (cycle 13).
A total of 24 subjects out of 2,837 in the Zumandimine trials (<1%) discontinued due to bleeding complaints. These are described as metrorrhagia, vaginal hemorrhage, menorrhagia, abnormal withdrawal bleeding, and menometrorrhagia. The average duration of scheduled bleeding episodes in the majority of subjects (86% to 88%) was 4 to 7 days.
Women who use Zumandimine may experience absence of withdrawal bleeding, even if they are not pregnant. Based on subject diaries from contraceptive efficacy trials, during cycles 2 to 13, 1 to 11% of women per cycle experienced no withdrawal bleeding.
Some women may encounter post-pill amenorrhea or oligomenorrhea, especially when such a condition was pre-existent. 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. 11 Depression Women with a history of depression should be carefully observed and Zumandimine discontinued if depression recurs to a serious degree .
12 Interference with Laboratory Tests The use of COCs may change the results of some laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. 2) ] . DRSP causes an increase in plasma renin activity and plasma aldosterone induced by its mild anti-mineralocorticoid activity.
13 Monitoring A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare. 14 Other Conditions In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking COCs.