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SLYND Drospirenone Kit — NDC 00642-7470-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

SLYND Drospirenone Kit — NDC 0642-7470-02 (Billing 00642-7470-02)

by Exeltis USA, Inc. · 1 KIT in 1 CARTON * 4 TABLET, FILM COATED in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of SLYND Drospirenone Kit from Exeltis USA, Inc., marketed since Jun 2019 and currently FDA-listed; retail pharmacies pay about $6.61 per unit (NADAC).

NDC 00642-7470-02
🏷️ FDA NDC (as labeled) 0642-7470-02 billing pads the labeler segment with a zero
This package
Contains1 kit in 1 carton * 4 tablet, film coated in 1 blister pack * 24 tablet, film coated in 1 blister pack Cost per ea$6.61 NADAC Pack sizes2 compare ↓
Product page 00642-7470-01 Also comes in: 4 tablets 0642-7470-01
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0642-7470-02 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0642 labeler · 7470 product · 02 package
Package marketed since
Sep 1, 2019
Sample package
Yes — professional sample, not for sale
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0642747002 1
FDA record last changed
Sep 10, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0642-7470-02
Product NDC 0642-7470
11-digit billing NDC 00642747002
NCPDP billing unit EA — each (per item)
RxCUI 748797, 2171000, 2171001, 2171002
Application # NDA211367
SPL Set ID db32bc55-f295-4d87-9dbb-0a2f45573dcf
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-06
Dosage form KIT

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 079800
GCN 46373
HICL code 045765
Ingredient (HICL) Drospirenone
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G8
Therapeutic class — intermediate (HIC2) Systemic Antifertility Agents
HIC3 code G8A
Therapeutic class — specific (HIC3) Contraceptives,Oral
AHFS code 68:12.00.00
AHFS class Contraceptives
FDB label name SLYND 4 MG TABLET
FDB brand name Slynd
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079800
  • GCN: 46373
  • HICL (First Databank): 045765
  • AHFS class code: 68:12.00.00
  • RxCUI (RxNorm): 748797
Why two NDCs? The FDA registers this code as 0642-7470-02 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00642-7470-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name SLYND 4 MG TABLET Ingredient Drospirenone
2
Nutrient depletion considerations

Drospirenone may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Drospirenone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $6.613 —
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Apr 2022 Jan 2026 May 2026 Sep 2026 $6.645 $6.612
Flat over the last 13 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00642-7470-01 0642-7470-01 Main listing 1 KIT in 1 CARTON * 4 TABLET, FILM COATED in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK $6.61 / ea — 2019-09-01 — Active
00642-7470-02 You're viewing this 1 KIT in 1 CARTON * 4 TABLET, FILM COATED in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK Sample $6.61 / ea — 2019-09-01 — Active

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($6.61 NADAC).

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 kit in 1 carton * 4 tablet, film coated in 1 blister pack * 24 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of SLYND Drospirenone Kit?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Slyndthis 00642-7470-02 Exeltis 4 tablets $6.613 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
First FDA approval
May 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jun 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 23, 2019 RLD RS ⏳ ~4.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 10179140 — method of use (U-2553)
US 12090231 — method of use (U-2553)
US 9603860 — method of use (U-2553)
US 10603281 — method of use (U-2553)
US 11413249 — method of use (U-2553)
US 10849857 — method of use (U-2553)
US 11951213 — method of use (U-2553)
US 11478487 — drug product
US 11504334 — drug product
US 11123299 — drug product
US 10987364 — drug product
US 11291632 — drug product
US 11291633 — drug product
US 12280151 — drug product
US 11351122 — drug product
2019 2021 2023 2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (15)
PatentTypeUse codeExpires
US 10179140 ↗ Method of use U-2553 Jun 28, 2031
US 12090231 ↗ Method of use U-2553 Jun 28, 2031
US 9603860 ↗ Method of use U-2553 Jun 28, 2031
US 10603281 ↗ Method of use U-2553 Jun 28, 2031
US 11413249 ↗ Method of use U-2553 Jun 28, 2031
US 10849857 ↗ Method of use U-2553 Jun 28, 2031
US 11951213 ↗ Method of use U-2553 Jun 28, 2031
US 11478487 ↗ Drug product — Jun 28, 2031
US 11504334 ↗ Drug product — Jun 28, 2031
US 11123299 ↗ Drug product — Jun 28, 2031
US 10987364 ↗ Drug product — Jun 28, 2031
US 11291632 ↗ Drug product — Jun 28, 2031
US 11291633 ↗ Drug product — Jun 28, 2031
US 12280151 ↗ Drug product — Jun 28, 2031
US 11351122 ↗ Drug product — Jun 28, 2031
Common questions
Is there a generic version of SLYND 4 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for SLYND 4 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Jun 2031 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white / green
ShapeRound
ImprintE;4
Size5 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerExeltis USA, Inc.
Application holderEXELTIS USA INC
FDA applicationNDA211367 (NDA)
Labeler code00642
First marketedJun 2019
Product typeHuman Prescription Drug
Portfolio10 products on file

More NDCs from Exeltis USA, Inc. labeler code 00642

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 37 words ▾

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 )

⏱️ Dosage and Administration ~3 min read ▾

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 )

2.1How 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

2.2How 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.

2.3Missed 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.

2.4Advice 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.

💊 Dosage Forms and Strengths 98 words ▾

3 DOSAGE FORMS AND STRENGTHS 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 consists of 24 white tablets each containing 4 mg of drospirenone and 4 green inert tablets. ( 3 )

⛔ Contraindications 117 words ▾

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 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hyperkalemia: Check serum potassium levels during the first treatment cycle in females receiving daily, long-term treatment for chronic conditions of diseases with medications that may increase serum potassium concentrations. ( 5.1 ) Thromboembolic disorders: Discontinue SLYND if a thromboembolic event occurs. ( 5.2 ) Bone loss: It is unknown if SLYND may cause a clinically relevant loss of bone mineral density.

( 5.3 ) Liver Disease: Discontinue use if jaundice or acute or chronic disturbances of liver function develop. ( 5.5 ) Ectopic pregnancy: Be alert to the possibility of ectopic pregnancy in females who become pregnant or complain of lower abdominal pain while on SLYND. ( 5.6 ) Risk of Hyperglycemia in Patients with Diabetes: Patients with diabetes may be at greater risk of hyperglycemia and may require additional medication adjustments or monitoring.

( 5.7 ) Bleeding Irregularities and Amenorrhea: May cause irregular bleeding or amenorrhea. Evaluate for other causes, such as pregnancy, if irregular bleeding or amenorrhea persists. ( 5.8 )

5.1Hyperkalemia 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.

5.2Thromboembolic 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.

5.3Bone 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.

5.4Cervical 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 cont… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~1 min read ▾

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.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. Drugs or herbal products that induce certain enzymes (for example, CYP3A4) may decrease the effectiveness of SLYND or increase breakthrough bleeding. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with SLYND.

( 7.1 )

7.1Effects 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.

7.2Influence 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) ].

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Discontinue SLYND if pregnancy occurs ( 8.1 )

8.1Pregnancy 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.

8.2Lactation 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%).

8.4Pediatric 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.

8.5Geriatric Use SLYND has not been studied in postmenopausal females and is not indicated in this population.

8.6Hepatic 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) ] .

8.7Renal 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) ].

🤰 Pregnancy 120 words ▾

8.1Pregnancy 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.

🧒 Pediatric Use 81 words ▾

8.4Pediatric 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 18 words ▾

8.5Geriatric Use SLYND has not been studied in postmenopausal females and is not indicated in this population.

🆘 Overdosage 63 words ▾

10 OVERDOSAGE There have been no reports of serious deleterious effects from overdosage of SLYND. Symptoms that may occur include nausea, vomiting, and vaginal bleeding. There are no antidotes and treatment should be to provide symptomatic support. Drospirenone is a spironolactone analogue which has anti-mineralocorticoid properties. Therefore, serum potassium and sodium, and evidence of metabolic acidosis, should be monitored in cases of overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action SLYND progestin-only oral contraceptive lowers the risk of becoming pregnant primarily by suppressing ovulation.

12.2Pharmacodynamics 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.

12.3Pharmacokinetics 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-adminis… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 18 words ▾

12.1Mechanism of Action SLYND progestin-only oral contraceptive lowers the risk of becoming pregnant primarily by suppressing ovulation.

📦 How Supplied / Storage and Handling 88 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How 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.

16.2Storage and Handling Store at 25°C (77°F); excursions permitted from 15 to 30°C (59 to 86°F) [ see USP Controlled Room Temperature ].

📦 Storage and Handling 24 words ▾

16.2Storage and Handling Store at 25°C (77°F); excursions permitted from 15 to 30°C (59 to 86°F) [ see USP Controlled Room Temperature ].

📋 Description ~1 min read ▾

11 DESCRIPTION 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 24 H 30 O 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.

Chemical Structure

💬 Information for Patients 177 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved Patient Labeling (Patient Information and Instructions for Use). SLYND and Dosing Instructions Advise females on proper daily use of SLYND and what to do if she misses a pill [ see Dosage and Administration (2) and FDA-approved Patient Information ] . Inform patient that amenorrhea may occur and instruct patient to check for pregnancy if she misses two consecutive periods.

Counsel patients on the following information Recommendation to check serum potassium levels during the first treatment cycle in females receiving daily, long-term treatment for chronic conditions of diseases with medications that may increase serum potassium concentrations Sexually Transmitted Infections SLYND does not protect against HIV-infection (AIDS) and other sexually transmitted infections. Use during Pregnancy SLYND is not to be used during pregnancy; instruct the patient to stop use if pregnancy is confirmed during treatment [ see Use in Specific Populations (8.1) ].

Drug Interactions Advise females to inform their healthcare provider if they take herbal supplements such as St. John's wort [see Drug Interactions (7.1) ].

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics 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.

🧬 Pharmacodynamics 57 words ▾

12.2Pharmacodynamics 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.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES 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. Table 4 Pearl Index Based on Evaluable Cycles and Reported Pregnancies in Females ≤ 35 Years of Age in Study CF111/303 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,

6.4Effect 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. Table 5 Adult Females with Scheduled and Unscheduled Bleeding or Spotting: (Safety Set) Scheduled Unscheduled Cycle n/m Abbreviations: 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.

🧪 Nonclinical Toxicology 113 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, 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.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 110 words ▾

13.1Carcinogenesis, 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.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION SLYND (slind) (drospirenone) tablets, for oral use Progestin pills help to lower the chance of becoming pregnant when taken as directed. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs). What is SLYND?

SLYND is a birth control pill (oral contraceptive) also called a POP (progestin only pill) that is used by females who can become pregnant to prevent pregnancy. The progestin drospirenone may increase potassium levels in your blood. You should not take SLYND if you have kidney, liver or adrenal disease because this could cause serious heart problems as well as other health problems.

Other medicines may also increase potassium levels in your blood. If you are currently on daily, long-term treatment for a chronic health condition with any of the medicines listed below, talk to your healthcare provider about whether SLYND is right for you. If you take any of the medicines listed below for a chronic health condition you should have a blood test to check the potassium level in your blood before you start taking SLYND and during the first month that you take SLYND. medicines to treat fungal infections, such as ketoconazole, itraconazole, or voriconazole medicines to treat Human Immunodeficiency Virus (HIV) infection or Hepatitis C infection, such as indinavir or boceprevir clarithromycin How does SLYND work for contraception?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant. Based on the results of one clinical study of a 28-day regimen of SLYND about 4 out of 100 females may get pregnant within the first year they use SLYND.

The following chart shows the chance of getting pregnant for females who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart.

The box on the bottom of the chart shows the chance of getting pregnant for females who do not use birth control and are trying to get pregnant. Do not take SLYND if you: have kidney disease or kidney failure. have reduced adrenal gland function (adrenal insufficiency). have or have had cervical cancer or any cancer that is sensitive to female hormones. have liver disease, including liver tumors. have unexplained vaginal bleeding. Tell your healthcare provider if you have or have had any of these conditions.

Your healthcare provider can suggest a different method of birth control. If any of these conditions happen while you are taking SLYND, stop taking SLYND right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking SLYND.

Before you take SLYND, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or think you may be pregnant. have ever had blood clots in your legs (deep vein thrombosis), lungs (pulmonary embolism) or a stroke or heart attack (myocardial infarction). have or have had depression Tell your healthcare provider about all the medicine you take including prescription and over-the-counter medicines, vitamins and herbal supplements, such as St. John's Wort. SLYND may affect the way other medicines work, and other medicines may affect how well SLYND works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take SLYND?

Read the detailed Instructions for Use at the end of this Patient Information leaflet about the right way to take SLYND. What are the possible serious side effects of SLYND? SLYND may cause serious side effects, including: High potassium levels in your blood (hyperkalemia).

Certain medicines and conditions can also increase the potassium levels in your blood. Your healthcare provider may check the potassium levels in your blood before and durin… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

Instructions For Use SLYND (slind) (drospirenone) tablets, for oral use 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 th… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 57 words ▾

PRINCIPAL DISPLAY PANEL - 4 mg Tablet Blister Card Carton NDC 0642-7470-01 Rx only Slynd ® (drospirenone) tablets, 4 mg 1 blister card with 28 tablets / Oral Use Exeltis THIS PRODUCT (LIKE ALL ORAL CONTRACEPTIVES) IS INTENDED TO PREVENT PREGNANCY. IT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES. Slynd Trade Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
4 tablets00642-7470-01 257,460 Rx · $81,866,325
4 tablets this page00642-7470-02 No Medicaid data
Drug total (last 4 qtrs): 257,460 Rx · 12,077,663 units · $81,866,325 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Exeltis USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 4 tablets (00642-7470-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Exeltis USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00642-7466-05 · Exeltis 00642-7471-01 · Exeltis →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.