Slynd
(Drospirenone)Dosage & Administration
Take one tablet taken daily for 28 days; one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days. (
Take one tablet taken daily for 28 days; one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days.
SLYND is dispensed in a blister card. SLYND should be started using a Day 1 start.
| Starting SLYND in females with no current use of hormonal contraception (Day 1 Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: • SLYND active tablets are white (Day 1 to Day 24). • SLYND inert tablets are green (Day 25 to Day 28). | Day 1 Start: • Take first white active tablet on the first day of menses. • Take subsequent white active tablets once daily at the same time each day for a total of 24 days. • Take one green inert tablet daily for 4 days and at the same time of day that active tablets were taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet). |
| Switching from another contraceptive method to SLYND | Start SLYND: |
Refer to the Patient Information and Instructions for Use for additional instructions for counseling patient concerning proper use | |
SLYND (white active and green inert tablets) is swallowed whole once a day. Take one tablet daily for 28 consecutive days; one white active tablet daily during the first 24 days and one green inert tablet daily during the 4 following days. Tablets must be taken every day at about the same time of the day so that the interval between two tablets is always 24 hours.
| Take the missed tablet as soon as possible. Continue taking one tablet a day until the pack is finished. | |
| Take the last missed tablet as soon as possible. Continue one tablet a day until the pack is finished (one or more missed tablet(s) will remain in the blister pack). Additional non-hormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. | |
| Skip the missed pill days and continue taking one tablet a day until the pack is finished. |
If vomiting or diarrhea occurs within 3-4 hours after tablet taking, the new tablet (scheduled for the next day) should be taken as soon as possible. The new tablet should be taken within 12 hours of the usual time of tablet-taking if possible. If more than two tablets are missed, the advice concerning missed tablets, including using backup non-hormonal contraception, given above is applicable.
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Slynd Prescribing Information
SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy.
Take one tablet taken daily for 28 days; one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days. (
Take one tablet taken daily for 28 days; one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days.
SLYND is dispensed in a blister card. SLYND should be started using a Day 1 start.
| Starting SLYND in females with no current use of hormonal contraception (Day 1 Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product. Tablet Color: • SLYND active tablets are white (Day 1 to Day 24). • SLYND inert tablets are green (Day 25 to Day 28). | Day 1 Start: • Take first white active tablet on the first day of menses. • Take subsequent white active tablets once daily at the same time each day for a total of 24 days. • Take one green inert tablet daily for 4 days and at the same time of day that active tablets were taken. • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet). |
| Switching from another contraceptive method to SLYND | Start SLYND: |
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Refer to the Patient Information and Instructions for Use for additional instructions for counseling patient concerning proper use | |
SLYND (white active and green inert tablets) is swallowed whole once a day. Take one tablet daily for 28 consecutive days; one white active tablet daily during the first 24 days and one green inert tablet daily during the 4 following days. Tablets must be taken every day at about the same time of the day so that the interval between two tablets is always 24 hours.
| Take the missed tablet as soon as possible. Continue taking one tablet a day until the pack is finished. |
| Take the last missed tablet as soon as possible. Continue one tablet a day until the pack is finished (one or more missed tablet(s) will remain in the blister pack). Additional non-hormonal contraception (such as condoms or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. |
| Skip the missed pill days and continue taking one tablet a day until the pack is finished. |
If vomiting or diarrhea occurs within 3-4 hours after tablet taking, the new tablet (scheduled for the next day) should be taken as soon as possible. The new tablet should be taken within 12 hours of the usual time of tablet-taking if possible. If more than two tablets are missed, the advice concerning missed tablets, including using backup non-hormonal contraception, given above is applicable.
SLYND is supplied in blister cards, each containing 24 round, film-coated, unscored, white tablets and 4 round, film-coated, unscored green tablets.
- Each white tablet contains 4 mg of drospirenone. White tablets are debossed with an "E" on one side and a "D" on the other side
- Each green tablet is inert and does not contain drospirenone. Green tablets are debossed with an "E" on one side and a "4" on the other side.
SLYND is contraindicated in females with the following conditions:
- Renal impairment [seeand
5.1 HyperkalemiaSLYND contains drospirenone, a progestin, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk females, comparable to a 25 mg dose of spironolactone. SLYND is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Females 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 prior to starting treatment and during the first treatment cycle. Consider monitoring serum potassium concentration in females at increased risk for hyperkalemia i.e., those females who take a strong CYP3A4 inhibitor long-term and concomitantly with SLYND. Strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir), and clarithromycin
[see Drug Interactions (7)]. Monitor females taking SLYND who later develop medical conditions and/or begin medication that put them at an increased risk for hyperkalemia.Most females with hyperkalemia in the clinical development studies of SLYND had mild potassium elevations and/or isolated increases that returned to normal while still on study medication. No concurrent adverse reactions were attributed to hyperkalemia. In the pivotal trial, two females (0.2%) with persistent potassium elevations discontinued SLYND.
]8.7 Renal ImpairmentSLYND is contraindicated in females with renal impairment
[see Contraindications (4), Warnings and Precautions (5.1)].In subjects with creatinine clearance (CLcr) of 50–79 mL/min, serum DRSP levels were comparable to those in a control group with CLcr ≥ 80 mL/min. In subjects with CLcr of 30–49 mL/min, serum DRSP concentrations were on average 37% higher than those in the control group. In addition, there is a potential to develop hyperkalemia in subjects with renal impairment whose serum potassium is in the upper reference range, and who are concomitantly using potassium sparing drugs
[see Drug Interactions (7.2)and Clinical Pharmacology (12.3)]. - Adrenal insufficiency [see]
5.1 HyperkalemiaSLYND contains drospirenone, a progestin, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk females, comparable to a 25 mg dose of spironolactone. SLYND is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Females 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 prior to starting treatment and during the first treatment cycle. Consider monitoring serum potassium concentration in females at increased risk for hyperkalemia i.e., those females who take a strong CYP3A4 inhibitor long-term and concomitantly with SLYND. Strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir), and clarithromycin
[see Drug Interactions (7)]. Monitor females taking SLYND who later develop medical conditions and/or begin medication that put them at an increased risk for hyperkalemia.Most females with hyperkalemia in the clinical development studies of SLYND had mild potassium elevations and/or isolated increases that returned to normal while still on study medication. No concurrent adverse reactions were attributed to hyperkalemia. In the pivotal trial, two females (0.2%) with persistent potassium elevations discontinued SLYND.
- Presence or history of cervical cancer or progestin sensitive cancers [see]
5.4 Cervical CancerSome studies suggest that use of combination hormonal contraceptives containing progestin and estradiol has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors.
- Liver tumors, benign or malignant, or hepatic impairment [seeand
5.5 Liver DiseaseDiscontinue SLYND if jaundice or acute or chronic disturbances of liver function develop. Do not resume use until markers of liver function return to normal and SLYND causation has been excluded.
SLYND is contraindicated in females with liver tumors, benign or malignant, or hepatic impairment
[see Use in Specific Populations (8.6)].]8.6 Hepatic ImpairmentSLYND is contraindicated in females with hepatic impairment
[see Contraindications (4), Warnings and Precautions (5.5)].The mean exposure to drospirenone in females with moderate liver impairment is approximately three times higher than the exposure in females with normal liver function. SLYND has not been studied in females with severe hepatic impairment[see Clinical Pharmacology (12.3)]. - Undiagnosed abnormal uterine bleeding [see]
5.8 Bleeding Irregularities and AmenorrheaFemales using SLYND may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first three months of use. Bleeding irregularities may resolve over time or by changing to a different contraceptive product. If bleeding persists or occurs after previously regular cycles, evaluate for causes such as pregnancy or malignancy.
Based on subject diaries from four clinical trials of SLYND, 64.4% of females experienced unscheduled bleeding at Cycle 1. This percentage decreased to 40.3% by Cycle 13.
A total of 91 out of 2593 subjects (3.5%) discontinued SLYND due to menstrual bleeding disorders including metrorrhagia, menstrual irregular, vaginal hemorrhage, menorrhagia, uterine hemorrhage, and amenorrhea.
If scheduled bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or two 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 perform appropriate diagnostic measures. If the patient has adhered to the prescribed dosing schedule and misses two consecutive periods, rule out pregnancy.
The following clinically significant adverse reactions are described elsewhere in other sections of the labeling:
- Hyperkalemia [see]
5.1 HyperkalemiaSLYND contains drospirenone, a progestin, which has anti-mineralocorticoid activity, including the potential for hyperkalemia in high-risk females, comparable to a 25 mg dose of spironolactone. SLYND is contraindicated in females with conditions that predispose to hyperkalemia (e.g. renal impairment, hepatic impairment, and adrenal insufficiency). Females 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 prior to starting treatment and during the first treatment cycle. Consider monitoring serum potassium concentration in females at increased risk for hyperkalemia i.e., those females who take a strong CYP3A4 inhibitor long-term and concomitantly with SLYND. Strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir), and clarithromycin
[see Drug Interactions (7)]. Monitor females taking SLYND who later develop medical conditions and/or begin medication that put them at an increased risk for hyperkalemia.Most females with hyperkalemia in the clinical development studies of SLYND had mild potassium elevations and/or isolated increases that returned to normal while still on study medication. No concurrent adverse reactions were attributed to hyperkalemia. In the pivotal trial, two females (0.2%) with persistent potassium elevations discontinued SLYND.
- Bleeding Irregularities and Amenorrhea [see]
5.8 Bleeding Irregularities and AmenorrheaFemales using SLYND may experience unscheduled (breakthrough or intracyclic) bleeding and spotting, especially during the first three months of use. Bleeding irregularities may resolve over time or by changing to a different contraceptive product. If bleeding persists or occurs after previously regular cycles, evaluate for causes such as pregnancy or malignancy.
Based on subject diaries from four clinical trials of SLYND, 64.4% of females experienced unscheduled bleeding at Cycle 1. This percentage decreased to 40.3% by Cycle 13.
A total of 91 out of 2593 subjects (3.5%) discontinued SLYND due to menstrual bleeding disorders including metrorrhagia, menstrual irregular, vaginal hemorrhage, menorrhagia, uterine hemorrhage, and amenorrhea.
If scheduled bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or two 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 perform appropriate diagnostic measures. If the patient has adhered to the prescribed dosing schedule and misses two consecutive periods, rule out pregnancy.
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.
The data described below reflect the exposure of SLYND in females of reproductive potential desiring to prevent pregnancy based on four clinical studies including Study CF111/303
The efficacy of SLYND was evaluated in Study CF111/303 (NCT02269241). This single arm multicenter, clinical trial was conducted in the U.S. The efficacy population consisted of 953 females ≤ 35 years of age with 5,547 evaluable cycles. The demographic profile for females was: mean age 26.4 years and mean BMI 28.5 kg/m2. The racial distribution was 53.3% Caucasian; 38.5% African American; 2.2% Asian and 6% other. During these cycles, a total of 17 (1.8%) females reported pregnancy, leading to a Pearl Index (95% CI) of 4.0 (2.3, 6.4).
One female who became pregnant during the study was breastfeeding and not included in the Pearl Index (PI) calculation. The confidence interval for the PI was calculated assuming that events of pregnancy had a Poisson distribution.
Out of the 953 females evaluated for efficacy, 332 subjects had a baseline BMI ≥ 30 (35%) and 173 females had a baseline BMI ≥ 35 (18%). Data were insufficient to analyze PI by BMI subgroups.
| SLYND (N = 953) | |
|---|---|
| Subjects with pregnancy, n (%) | 17 (1.8) |
| Subjects without pregnancy, n (%) | 936 (98.2) |
| Total number of evaluable cycles | 5547 |
| Pearl Index for evaluable cycles | 4.0 |
| 95% Confidence Interval for Pearl Index, Lower Limit, Upper Limit | 2.3, 6.4 |
The bleeding pattern with SLYND was assessed systematically using patient diaries in Study CF111/303 in adult females.
The percentage of females experiencing scheduled bleeding or unscheduled bleeding/spotting decreased over time. Overall, the percentage of females with scheduled bleeding or spotting decreased from 81% in Cycle 1 to 26% in Cycle 13. Similarly, the overall percentage of females with unscheduled bleeding or spotting decreased from 61% in Cycle 1 to 40% in Cycle 13. The percentages of females with scheduled and unscheduled bleeding or spotting generally decreased through Cycle 10 and were maintained at a consistent level thereafter.
| Scheduled | Unscheduled | |||
|---|---|---|---|---|
| Cycle | n/mAbbreviations: m = number of subjects with cycle data; n = number of subjects with bleeding or spotting. | Rate and 95% CI (%) | n/m | Rate and 95% CI (%) |
| Cycle 1 | 1768/2178 | 81.2 (79.5, 82.8) | 1337/2178 | 61.4 (59.3, 63.4) |
| Cycle 6 | 507/1482 | 34.2 (31.8, 36.6) | 703/1482 | 47.4 (44.9, 50.0) |
| Cycle 13 | 185/700 | 26.4 (23.2, 29.7) | 282/700 | 40.3 (36.7, 43.9) |
In Study CF111/304 conducted in Europe in post-menarchal, female, adolescents (12 through 17 years of age), bleeding data were generally consistent with those from Study CF111/303 in adult females. SLYND was associated with a decrease in the percentage of adolescent females experiencing bleeding or spotting over time. The percentage of adolescent females with scheduled bleeding or spotting decreased from 98.0% in Cycle 1 to 28.4% in Cycle 13. The percentage of adolescent females with scheduled bleeding or spotting generally decreased through Cycle 9 and was maintained at a consistent level thereafter. In contrast, the percentage of adolescent females with unscheduled bleeding or spotting was maintained at a relatively consistent level during the study (53.0% in Cycle 1 versus 52.2% in Cycle 13).
In addition to Studies CF111/303 and CF111/304, two additional studies evaluated bleeding associated with SLYND. A total of 91 females (3.5%) from these four studies discontinued SLYND due to problems with irregular bleeding or amenorrhea.
2; racial distribution was 83% White; 14% Black; 1% Asian and 2% Other.
| Adverse Reaction | Total N = 2598 n (%) |
|---|---|
| Any adverse reaction | 627 (24.1) |
| Acne | 98 (3.8) |
| Metrorrhagia | 72 (2.8) |
| Headache | 71 (2.7) |
| Breast pain | 57 (2.2) |
| Weight increased | 50 (1.9) |
| Dysmenorrhea | 49 (1.9) |
| Nausea | 47 (1.8) |
| Vaginal hemorrhage | 45 (1.7) |
| Libido decreased | 33 (1.3) |
| Breast tenderness | 31 (1.2) |
| Menstruation irregular | 30 (1.2) |
Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.