Slynd
(drospirenone, inert ingredients)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. ( 2)
Slynd Prescribing Information
SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy.
How to Use SLYND
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 | |
How to Take SLYND
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.
Missed Doses
| 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. |
Advice in Case of Gastrointestinal Disturbances
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.
Pregnancy
Risk Summary
Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use oral progestins during early pregnancy ( See Data).
Discontinue SLYND if pregnancy occurs, because there is no reason to use hormonal contraceptives during pregnancy
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Data
Human Data
Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following maternal use of oral progestins before conception or during early pregnancy.
Lactation
Risk Summary
Negligible amounts of drospirenone are excreted in the breast milk (see Data) . Thus, at therapeutic doses of SLYND, no effects on breastfed newborns/infants are anticipated. In general, no adverse effects have been found on milk production or on the health, growth, or development of the infant with use of progestin-only pills (POPs).
Human Data
After daily administration of 4 mg SLYND tablets, the average DRSP concentration in breast milk over a 24-hour period is 5.6 ng/mL. Based on this concentration, the estimated average infant daily dosages for an exclusively breastfed infant is 840 ng/kg/day (relative infant dose is 1.5%).
Pediatric Use
Safety and efficacy of SLYND have been established in females of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and users 16 years and older.
Study CF111/304 evaluated the bleeding associated with SLYND in females ≥12 years of age. Bleeding data were generally consistent with those from Study CF111/303 in adult females [see Clinical Studies (14)] .
Use of this product before menarche is not indicated.
Geriatric Use
SLYND has not been studied in postmenopausal females and is not indicated in this population.
Hepatic Impairment
SLYND 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)] .
Renal Impairment
SLYND 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)].
SLYND is contraindicated in females with the following conditions:
- Renal impairment [see Warnings and Precautions (5.1) and Use in Specific Populations (8.7)]
- Adrenal insufficiency [see Warnings and Precautions (5.1)]
- Presence or history of cervical cancer or progestin sensitive cancers [see Warnings and Precautions (5.4)]
- Liver tumors, benign or malignant, or hepatic impairment [see Warnings and Precautions (5.5) and Use in Specific Populations (8.6)]
- Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.8)]
Hyperkalemia
SLYND 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.
Thromboembolic Disorders
Epidemiological studies have not indicated an association between progestin-only preparations and an increased risk of myocardial infarction, cerebral thromboembolism, or venous thromboembolism.
Combined oral contraceptives containing drospirenone and ethinyl estradiol may be associated with a higher risk of venous thromboembolism (VTE) than those containing some other progestins in combination with ethinyl estradiol. It is unknown whether the risk of VTE is increased with drospirenone alone; however, if there is a risk, it is expected to be lower than that of drospirenone in combination with ethinyl estradiol.
When prescribing SLYND, consider the increased risk of thromboembolism inherent in the postpartum period and in females with a history of thromboembolism.
Discontinue SLYND if arterial or venous thromboembolic events occur. Consider discontinuing SLYND, if feasible, in case of prolonged immobilization due to surgery or illness.
Bone Loss
Treatment with SLYND leads to decreased estradiol serum levels. It is unknown if this may cause a clinically relevant loss of bone mineral density.
Cervical Cancer
Some 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 Disease
Discontinue 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)].
Ectopic Pregnancy
Be alert to the possibility of ectopic pregnancy in females who become pregnant or complain of lower abdominal pain while on SLYND.
Risk of Hyperglycemia in Patients with Diabetes
Some patients receiving progestins, including SLYND, may exhibit a decrease in insulin sensitivity. Therefore, patients with diabetes may be at greater risk of hyperglycemia and may require additional medication adjustments or monitoring.
Bleeding Irregularities and Amenorrhea
Females 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.
Depression
Carefully observe females for a history of depression and discontinue SLYND if depression recurs to a serious degree. Data on the association of progestin-only contraceptive products with onset of depression and exacerbation of depression are limited.
The following clinically significant adverse reactions are described elsewhere in other sections of the labeling:
- Hyperkalemia [see Warnings and Precautions (5.1)]
- Bleeding Irregularities and Amenorrhea [see Warnings and Precautions (5.8)]
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 [see Clinical Studies (14)]. The mean time of SLYND exposure ranged from 197 to 328 days. The demographic profile for the pooled study data was: mean age 28 years; mean BMI 25 kg/m 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.
Effects of other Drugs on Hormonal Contraceptives
Substances decreasing the systemic concentrations of hormonal contraceptives (HCs) and potentially diminishing the efficacy of HCs:
Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the systemic concentrations of HCs and potentially diminish the effectiveness of HCs or increase breakthrough bleeding.
Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, rifabutin, rufinamide, aprepitant, and products containing St. John's wort.
Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel females to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.
Substances increasing the systemic concentrations of hormonal contraceptives (HCs):
In a clinical drug-drug interaction study conducted in premenopausal females, once daily co-administration of drospirenone (DRSP) 3 mg/ethinyl estradiol (EE) 0.02 mg containing tablets with strong CYP3A4 inhibitor, ketoconazole 200 mg twice daily for 10 days, resulted in a moderate increase of DRSP systemic exposure.
Influence of SLYND on other Medicinal Products
Based on in vitro studies and in vivo interaction studies in female volunteers using omeprazole, simvastatin and midazolam as marker substrate, an interaction of drospirenone with the metabolism of other active substances is unlikely.
Potential to increase serum potassium concentration:
There is a potential for an increase in serum potassium concentration in females taking SLYND with other drugs that may increase serum potassium concentration (for example, ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDS [see Warnings and Precautions (5.1)].
SLYND (drospirenone) is for use as an oral contraceptive. It is supplied as clear to a slightly opaque PVC-PVDC/Aluminum blister cards, each holding of 24 white tablets each containing 4 mg of drospirenone, a synthetic progestational compound and 4 green inert tablets.
Drospirenone is chemically described as (6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-1,3',4',6,6a,7,8,9,10,11, 12,13,14,15,15a,16-hexadecahydro10,13-dimethylspiro-[17H-dicyclopropa- [6,7:15,16]cyclopenta[a]phenanthrene-17,2'(5H)-furan]-3,5'(2H)-dione). It has a molecular weight of 366.5, a molecular formula of C 24H 30O 3, and the structural formula below:
Drospirenone is a white to almost white or slightly yellow crystalline powder. It is a progestin and neutral molecule with slight solubility in water
The active tablet is a 5 mm, round, unscored, film-coated, white tablet that contains 4mg of drospirenone as the active ingredient, and microcrystalline cellulose NF, anhydrous lactose NF, colloidal silicon dioxide NF, magnesium stearate NF, polyvinyl alcohol partially hydrolyzed NF, talc NF, titanium dioxide NF, and polyethylene glycol NF as the inactive ingredients. Each tablet is debossed with the letter "E" on one side and the letter "D" on the other side.
The inert tablet is a 5 mm, round, unscored, film-coated, green tablet that does not contain drospirenone. Each inert green tablet contains the following inactive ingredients: lactose monohydrate NF, corn starch NF, povidone 30000 NF, colloidal silicon dioxide NF, magnesium stearate NF, hypromellose 2910 NF, titanium dioxide USP, polysorbate 80 NF, triacetin NF, FD&C blue 2 aluminum lake and yellow ferric oxide.
Mechanism of Action
SLYND progestin-only oral contraceptive lowers the risk of becoming pregnant primarily by suppressing ovulation.
Pharmacodynamics
Drospirenone is a spironolactone analogue with anti-mineralocorticoid activity.
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, serum levels of (carrier) proteins, e.g., corticosteroid binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis.
Pharmacokinetics
Absorption
The pharmacokinetics of oral drospirenone is dose-proportional following single doses ranging from 1-10 mg. Maximum concentrations (C max) of drospirenone in plasma of about 27 ng/ml are reached at about 2-6 hours after single ingestion of SLYND. During a treatment cycle, maximum steady-state concentrations of drospirenone in serum of about 41 ng/ml are reached after about 10 days of treatment. Plasma drospirenone C max and area under the curve (AUC) accumulate by a factor of about 1.5 to 2 following multiple dose administration of SLYND. Concomitant ingestion of food has no influence on the extent of absorption of drospirenone.
Distribution
Drospirenone is 95% to 97% bound to serum albumin and does not bind to sex hormone binding globulin (SHBG) or corticosteroid binding globulin (CBG). The apparent volume of distribution of drospirenone is approximately 4 L/kg
Elimination
Metabolism
Drospirenone is extensively metabolized after oral administration. The two main metabolites of DRSP found in human plasma were identified to be the acid form of DRSP generated by opening of the lactone ring and the 4,5-dihydrodrospirenone-3-sulfate, formed by reduction and subsequent sulfation. These metabolites were shown not to be pharmacologically active. Drospirenone is also subject to oxidative metabolism catalyzed by CYP3A4.
Excretion
DRSP serum concentrations are characterized by a terminal disposition phase half-life of approximately 30 hours after both single and multiple dose regimens. Excretion of DRSP was nearly complete after ten days and amounts excreted were slightly higher in feces compared to urine. DRSP was extensively metabolized and only trace amounts of unchanged DRSP were excreted in urine and feces.
Specific Populations
Patients with Hepatic Impairment:
The mean exposure to DRSP 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 Contraindications (4) and Warnings and Precautions (5.5)].
Patients with Renal Impairment:
The effect of renal impairment on the pharmacokinetics of DRSP (3 mg daily for 14 days) and the effect of DRSP on serum potassium concentrations were investigated in three separate groups of female subjects (n = 28, age 30–65). All subjects were on a low potassium diet. During the study, 7 subjects continued the use of potassium-sparing drugs for the treatment of their underlying illness. On the 14th day (steady-state) of DRSP treatment, the serum DRSP concentrations in the group with CLcr of 50–79 mL/min were comparable to those in the control group with CLcr ≥ 80 mL/min. The serum DRSP concentrations were on average 37% higher in the group with CLcr of 30–49 mL/min compared to those in the control group. DRSP treatment did not show any clinically significant effect on serum potassium concentration. Although hyperkalemia was not observed in the study, in five of the seven subjects who continued use of potassium-sparing drugs during the study, mean serum potassium concentrations increased by up to 0.33 mEq/L. [See Contraindications (4) and Warnings and Precautions (5.1). ]
Drug Interaction Studies:
In a clinical drug-drug interaction study conducted in 20 premenopausal females, co-administration of a product containing DRSP (3 mg)/EE (0.02 mg) COC with the strong CYP3A4 inhibitor ketoconazole (200 mg twice daily) for 10 days increased the AUC(0-24h) and Cmax of DRSP by 2.68-fold (90% CI: 2.44, 2.95) and 1.97-fold (90% CI: 1.79, 2.17), respectively.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 24-month oral carcinogenicity study in mice with doses up to 10 mg/kg/day DRSP, equating to 2 times the maximum clinical exposure (based on AUC), there was an increase in carcinomas of the harderian gland in the high dose DRSP group. In a similar study in rats given doses up to 10 mg/kg/day DRSP, 10 times the maximum clinical exposure (based on AUC), there was an increased incidence of benign and total (benign and malignant) adrenal gland pheochromocytomas in the high dose DRSP group. Mutagenesis studies for DRSP were conducted in vivo and in vitro and no evidence of mutagenic activity was observed.
Pregnancy Prevention
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/m 2. 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 |
Effect on Bleeding Patterns
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/m * | Rate and 95% CI (%) | n/m * | Rate and 95% CI (%) |
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| 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.
How Supplied
SLYND (drospirenone) tablets is packaged in clear to a slightly opaque PVC-PVDC/Aluminum blister cards. Each blister card holds 24 white round active film-coated tablets, each containing 4mg of drospirenone and 4 green round inert film-coated tablets that do not contain drospirenone. SLYND is supplied in cardboard cartons containing a blister card of 28 tablets: NDC 0642-7470-01.
Storage and Handling
Store at 25°C (77°F); excursions permitted from 15 to 30°C (59 to 86°F) [ see USP Controlled Room Temperature].
Important Information about taking SLYND
Before you start taking SLYND
- Decide what time of day you want to take your pill. It is important to take it at the same time every day and in the order as directed on your blister pack.
- Have backup contraception (condoms or spermicide) available.
How to take SLYND
- Take 1 pill every day at the same time. Take the pills in the order directed on your blister pack.
- Both the white pills and the green pills should be swallowed whole.
- Do not skip your pills, even if you do not have sex often. If you miss pills (including starting the blister pack late) you could get pregnant. The more pills you miss, the more likely you are to get pregnant.
- If you have trouble remembering to take SLYND, talk to your healthcare provider. When you first start taking SLYND, spotting or light bleeding in between your periods may occur. Contact your healthcare provider if this does not go away after a few months.
- You may feel sick to your stomach (nauseous), especially during the first few months of taking SLYND. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If your nausea does not go away, call your healthcare provider.
- Missing pills can also cause spotting or light bleeding, even when you take the missed pills later. On the days you take 2 pills to make up for missed pills (see below), you could also feel a little sick to your stomach.
- Some females miss periods on hormonal birth control, even when they are not pregnant. However, if you miss a period and have not taken SLYND according to directions, or miss 2 periods in a row, or feel like you may be pregnant, call your healthcare provider. If you have a positive pregnancy test, you should stop taking SLYND.
- If you have vomiting or diarrhea within 3 to 4 hours of taking your pill, take a new pill (the pill scheduled for the next day) from your blister pack within 12 hours of the usual time you take your pill, if possible. Continue taking all your remaining pills in order. Start the first pill of your next blister pack the day after finishing your current blister pack. This will be 1 day earlier than originally scheduled. Continue on your new schedule.
- If you have vomiting or diarrhea for more than 1 day, your birth control pills may not work as well. If you have sex within 7 days after 1 or more days of vomiting or having diarrhea, use an additional form of birth control, like condoms or spermicide, as back-up contraception.
When should I start taking SLYND?
If you start taking SLYND and you are not currently using a hormonal birth control method:
- Start SLYND on the first day (Day 1) of your natural menstrual period (Day 1 Start). Your healthcare provider should tell you when to start taking your birth control pill.
If you start taking SLYND and you are switching from another birth control pill:
- Start your new SLYND blister pack on the same day that you would start the next pack of your previous birth control method.
- Do not continue taking the pills from your previous birth control pack.
If you start taking SLYND and you are switching from a vaginal ring or transdermal patch:
- Start taking SLYND on the day you would have inserted the next ring or applied the next patch.
If you start taking SLYND and you are switching from a progestin-only method such as an implant or injection:
- Start taking SLYND on the day of removal of your implant or on the day when you would have had your next injection.
If you start taking SLYND and you are switching from an intrauterine device or system (IUD or IUS):
- Start taking SLYND on the day of removal of your IUD or IUS.
Keep a calendar to track your period:
SLYND Day 1 Start:
You will use a Day 1 Start if your healthcare provider told you to take your first pill (Day 1) on the first day of your period.
- Take 1 pill every day in the order of the blister pack, at the same time each day, for 28 days.
- After taking the last pill on Day 28 from the blister pack, start taking the first pill from a new pack, on the same day of the week as the first pack. Take the first pill in the new pack whether or not you are having your period.
Instructions for using your pill blister pack:
Step 1. Look at your SLYND pill pack. See Figure A.
The SLYND pill pack has:
- 24 white (active) pills with hormone for Week 1 through Week 3 and the first 3 days of Week 4 (Days 1-24)
- 4 green (inactive) pills without hormones for the last 4 days of Week 4 (Days 25-28).
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| FIGURE A | |
Step 2.
Place the day label strip (see Figure B) that starts with the first day of your period (Day 1) on top of the pill blister pack over "Place the label here". See Figure C. For example, if your period begins on Monday, place the day label strip with Monday as the first day on the top of your pill pack. See Figure C.
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| FIGURE B | |
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| FIGURE C | |
Step 3.
Remove the white pill by pressing the pill through the foil in the bottom of the pill blister pack. Continue taking the white pills for 24 days.
Step 4.
In the middle of Week 4 start taking the green pills. Take the green pill for 4 days. Your period should start during this time.
Step 5.
When you have taken all of the green pills in your pill pack, get a new pill pack and start taking the white pills from the new pill blister pack at your usual time the following day, starting with the Day 1 pill.
For a Day 1 start:
- Begin your next pill pack on the same day of the week as your first cycle pill pack.
What should I do if I miss any SLYND pills?
If you miss 1 white pill (active pills):
- Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
- Then continue taking 1 pill every day until you finish the pack.
- You do not need to use a back-up birth control method if you have sex.
If you miss 2 or more white pills (active pills), follow these steps:
- Take a pill as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
- Then continue to take 1 pill every day until you finish the pack (this will mean one or more missed white pills will remain in the blister pack).
- Use a non-hormonal birth control method (such as a condom or spermicide) as a back-up if you have sex during the first 7 days after missing your pills.
If you miss 1 or more green pills (inactive pill):
- You do not need to take 1 or more missed green pills. Take the next green pill at your regular time, every day until you finish the pack (this means 1 or more missed green pill will remain in the blister pack).
If you have any questions or are unsure about the information in this leaflet, call your healthcare provider. You can ask your healthcare provider or pharmacist for information about SLYND that is written for health professionals.
This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Distributed by: Exeltis USA, Inc. Florham Park, NJ 07932
© 2024 All rights reserved. Slynd is a registered trademark of Chemo Research SL.
Revised: 07/2024 4700101-02
Mechanism of Action
SLYND progestin-only oral contraceptive lowers the risk of becoming pregnant primarily by suppressing ovulation.
Request Slynd Samples
Is my patient eligible for Slynd samples?
- Your rep will communicate with you how to receive samples, when you can receive samples, the amount and more.
How do I find out who my Slynd rep is?
- Not sure who your local Slynd pharma rep is? Reach out to Exeltis USA, Inc. and they can help you identify your rep.
Slynd Prior Authorization Resources
Most recent state uniform prior authorization forms
Financial Assistance Programs
Slynd retails for $8 per dose without insurance or financial assistance.
- Program Expires
- $ Annual Cap