SLYND

SLYND is an FDA-registered drug product whose active ingredient is DROSPIRENONE. It is labelled by Exeltis USA, Inc. and marketed as a human prescription drug product. Identifiers on file: NDC 0642-7470, application NDA211367, label effective 20260827. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing DROSPIRENONE are most often described in connection with: slynd progestin, females reproductive, potential prevent. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy. SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

2 DOSAGE AND 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 ) 2.1 How to Use SLYND SLYND is dispensed in a blister card. SLYND should be started using a Day 1 start. Table 1 Instructions for Starting or Switching SLYND 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: A Combined Oral Contraceptive (COC) On the day when the new pack of the previous COC would have started. Transdermal Patch On the day when next application would have been scheduled. Vaginal ring On the day when next insertion would have been scheduled. Injection On the day when next injection would have been scheduled. Intrauterine contraceptive On the day of removal Implant On the day of removal Refer to the Patient Information and Instructions for Use for additional instructions for counseling patient concerning proper use 2.2 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. 2.3 Missed Doses Table 2 Instructions for Missed SLYND If one white active tablet is missed Take the missed tablet as soon as possible. Continue taking one tablet a day until the pack is finished. If two or more white active tablets are missed 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. If one or more green inert tablets are missed Skip the missed pill days and continue taking one tablet a day until the pack is finished. 2.4 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.

4 CONTRAINDICATIONS 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) ] Renal impairment ( 4 ) Adrenal insufficiency ( 4 ) Presence or history of progestin sensitive cancers ( 4 ) Liver tumors, benign or malignant, or hepatic impairment ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 )

6 ADVERSE REACTIONS 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. Table 3 Adverse Reactions Occurring in ≥ 1% of Females Receiving SLYND in Four Pooled Studies 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) Most common adverse reactions (>1%) are: acne, metrorrhagia, headache, breast pain, weight increased, dysmenorrhea, nausea, vaginal hemorrhage, libido decreased, breast tenderness, menstruation irregular ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Exeltis USA, Inc. at 1-877-324-9349 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is SLYND used for?
1 INDICATIONS AND USAGE SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy. SLYND is a progestin indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

Who makes SLYND?
Exeltis USA, Inc. is the labeler of record for SLYND.

Is SLYND prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has SLYND been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.