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Nextstellis drospirenone and estetrol Kit — NDC 51862-0258-00 package photo

Nextstellis drospirenone and estetrol Kit

by Mayne Pharma · 1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04)
NDC 51862-0258-00
🏷️ FDA NDC (as labeled) 51862-258-00 billing pads the product segment with a zero
This package
Contains1 kit in 1 blister pack * 24 tablet, film coated in 1 blister pack * 4 tablet, film coated in 1 blister pack Pack sizes2 compare ↓
Also priced by: Part D plans $7.76/unit — full pricing hub ↓
Also comes in: 24 tablets 51862-0258-01
Rx only Brand On market Non-controlled
🗂️ Data synced Jul 24, 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

🆔 Identity & classification

FDA NDC (as labeled) 51862-258-00
Product NDC 51862-258
11-digit billing NDC 51862025800
RxCUI 748797, 2539032, 2539033, 2539036
Application # NDA214154
SPL Set ID c5270073-d083-4109-ae4b-156986175e0a
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-16
Dosage form KIT
GPI-14 25990002140320
GPI class Nextstellis
GCN Seq No 082186
GCN 49528
HICL code 047298
Ingredient (HICL) Drospirenone/Estetrol
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 NEXTSTELLIS 3-14.2 MG TABLET
FDB brand name Nextstellis
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 51862-258-00 — a 5-3-2 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 product segment → 51862-0258-00. 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.

🏭 Manufacturer & labeler

LabelerMayne Pharma
Application holderMAYNE PHARMA LLC
FDA applicationNDA214154 (NDA)
Labeler code51862
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio29 products on file
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.

🩺 Clinical

Label name NEXTSTELLIS 3-14.2 MG TABLET Ingredient Drospirenone/Estetrol
📖 What it is MedlinePlus · NLM

Oral contraceptives (birth-control pills) containing estetrol (an estrogen) and drospirenone (a progestin) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). Oral contraceptives are an effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

💊 What it looks like

Color Pink / White
ShapeRound
Size6 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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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 · Q2 2026 $7.76 —
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nextstellisthis 51862-0258-00 Mayne 24 tablets — — FDA listed —
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

🏛️
2021
First FDA approval
Apr 2021
📍
2026
Currently FDA-listed
5 years listed
🛡️
2043
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 Oct 2043. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 15, 2021 RLD RS ⏳ ~17 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 12458649 — method of use (U-3152)
US 12233074 — method of use (U-3152)
US 12427114 — method of use (U-3152)
US 7732430 — method of use (U-3152)
US 11957694 — drug product
US 11793760 — drug product
US 11964055 — drug product
Exclusivity NCE
2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
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 (7)
PatentTypeUse codeExpires
US 12458649 ↗ Method of use U-3152 Oct 1, 2043
US 12233074 ↗ Method of use U-3152 Feb 9, 2043
US 12427114 ↗ Method of use U-3152 Jun 17, 2036
US 7732430 ↗ Method of use U-3152 Jan 15, 2028
US 11957694 ↗ Drug product — Jun 17, 2036
US 11793760 ↗ Drug product — Jun 17, 2036
US 11964055 ↗ Drug product — Jun 17, 2036
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Apr 15, 2026
Common questions
Is there a generic version of NEXTSTELLIS 3-14.2 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for NEXTSTELLIS 3-14.2 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2043 — 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.

💊 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.
24 tablets51862-0258-01 30,754 Rx · $10,691,922
24 tablets this page51862-0258-00 No Medicaid data
Drug total (last 4 qtrs): 30,754 Rx · 1,432,052 units · $10,691,922 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Nextstellis — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Nextstellis. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$37.9K
Claims incl. refills
110
Beneficiaries
67
Spend / beneficiary
$565.89
Spend / claim
$344.68
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Drospirenone and estetrol — the ingredient across all brands.

Top reported reactions

Intermenstrual Bleeding24
Heavy Menstrual Bleeding21
Headache16
Dizziness13
Mood Swings11
Migraine10
Nausea10

Age at onset

Adult17
Elderly1

Reporter sex

274 reports
Male · 1%
Female · 99%
Unknown · 1%

Serious outcomes

Hospitalization21
Life-threatening3
Disabling3
Death3
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 55 28
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
51862-0258-00 You're viewing this 1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) — — 2021-04-16 Active
51862-0258-01 1 BLISTER PACK in 1 CARTON (51862-258-01) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) $7.67 / ea — 2021-04-16 Active

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 NDC 51862-0258-00?
NDC 51862-0258-00 is listed by the FDA — 1 blister pack in 1 carton / 1 kit in 1 blister pack * 24 tablet, film coated in 1 blister pack * 4 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Nextstellis drospirenone and estetrol Kit?
Bill NDC 51862-0258-00 — the 11-digit billing format is 51862025800. 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.

🧭 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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 FDA registers it as 51862-258-00, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51862-0258-00, written without dashes as 51862025800. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51862-0258-00, the first segment (51862) is the labeler code FDA assigned to Mayne Pharma; the middle segment (0258) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Mayne Pharma. 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 24 tablets (51862-0258-01). 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?
Mayne Pharma 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 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
🚨 Boxed Warning 118 words ▾

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in females over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including NEXTSTELLIS, are contraindicated in females who are over 35 years of age and smoke. [See Contraindications (4) and Warnings and Precautions (5.1) ] WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning .

Females over 35 years old who smoke should not use NEXTSTELLIS ( 4 ) Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )

🎯 Indications and Usage 121 words ▾

1 INDICATIONS AND USAGE NEXTSTELLIS is indicated for use by females of reproductive potential to prevent pregnancy. NEXTSTELLIS is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Use NEXTSTELLIS may be less effective in females with a BMI ≥ 30 kg/m 2 .

In females with BMI ≥ 30 kg/m 2 , decreasing effectiveness may be associated with increasing BMI ( 14 ). Limitations of Use NEXTSTELLIS may be less effective in females with a BMI ≥ 30 kg/m 2 . In females with BMI ≥ 30 kg/m 2 , decreasing effectiveness may be associated with increasing BMI [see Clinical Studies (14) ].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Take one tablet by mouth at the same time every day. ( 2.1 ) Take tablets in the order directed on the blister pack. ( 2.1 )

2.1Recommended Dosage and Administration Start NEXTSTELLIS using a Day 1 start. Take one tablet by mouth at the same time every day with or without food.

2.2Additional Administration Information To achieve maximum contraceptive effectiveness, take one tablet every day at about the same time each day. The recommended dosage of NEXTSTELLIS is one tablet daily for 28 consecutive days: one pink active tablet daily during the first 24 days followed by one white inactive tablet daily during the 4 following days (see Table 1 ). Table 1 NEXTSTELLIS Administration Instructions Starting NEXTSTELLIS in females with no current use of hormonal contraception Important: In females with irregular menstrual cycles, pregnancy testing may be necessary prior to initiation of this product.

Day 1 Start : Take the first pink active tablet on the first day of menses. Take subsequent pink active tablets once daily at the same time each day for a total of 24 days. Take one white inert tablet daily for 4 days and at the same time of day that active tablets were taken.

Begin each subsequent 28-day pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet) If not starting on the first day of menses, use a non-hormonal contraceptive (e.g. condoms and/or spermicide) as back-up until one active tablet has been taken daily for 7 days in a row. Switching to NEXTSTELLIS from another contraceptive method Start NEXTSTELLIS on the day: Combined Oral Contraceptive (COC) When the new pack of the previous COC would have started. Transdermal System When the next application would have been scheduled.

Vaginal Insert When the next insertion would have been scheduled. Injection When the next injection would have been scheduled. Intrauterine System (IUS) After removal.

Implant After removal. Progestin-only pill After the last tablet was taken. Starting NEXTSTELLIS after delivery (>20 weeks gestation) Must not start earlier than 4 weeks after delivery (due to the increased risk of thromboembolism [see Contraindications (4) and Warnings and Precautions (5.1) ] If menstrual cycles have returned, follow instructions for "Starting NEXTSTELLIS in females with no current use of hormonal contraception".

If menstrual cycles have not resumed, consider the possibility of ovulation and pregnancy. If not pregnant, use additional nonhormonal contraception for the first 7 days of NEXTSTELLIS use. Starting NEXTSTELLIS after Abortion or Miscarriage ≤14 weeks gestation Within the first 7 days of complete first trimester abortion or miscarriage, use additional nonhormonal contraception for the next 7 days.

After the first 7 days, follow instructions for "Starting NEXTSTELLIS in females with no current use of hormonal contraception". > 14 weeks but ≤ 20 weeks gestation After 4 weeks following second trimester abortion or miscarriage. Consider duration of pregnancy and increased risk of thromboembolism [see Warnings and Precautions (5.1) ] If menstrual cycles have returned, follow instructions for "Starting NEXTSTELLIS in females with no current use of hormonal contraception." If menstrual cycles have not resumed, consider the possibility of ovulation and pregnancy.

If not pregnant, use additional nonhormonal contraception for the first 7 days of NEXTSTELLIS use.

2.3Missed Doses Table 2 Instructions for Missed NEXTSTELLLIS Tablets in a Monthly Dosing Regimen If one pink active tablet is missed Take the missed tablet as soon as possible and take the next tablet at the scheduled time, even if two active tablets are taken in one day. Continue taking one tablet a day until the pack is finished. If two or more pink active tablets are missed in Week 1 or Week 2 Take one missed tablet as soon as possible and take the tablet for the current day (that means taking two tablets in one day) and discard the…

💊 Dosage Forms and Strengths 88 words ▾

3 DOSAGE FORMS AND STRENGTHS NEXTSTELLIS (drospirenone and estetrol tablets) is available in a blister card, with 28 6-mm round, bi-convex film-coated tablets in the following order: 24 pink active tablets containing 3 mg drospirenone and 14.2 mg estetrol embossed with a drop-shaped logo on one side. 4 white inert tablets embossed with a drop-shaped logo on one side. NEXTSTELLIS consists of 28 tablets in the following order ( 3 ): 24 pink active tablets each containing drospirenone 3 mg and estetrol 14.2 mg 4 white inert tablets

⛔ Contraindications ~2 min read ▾

4 CONTRAINDICATIONS NEXTSTELLIS is contraindicated in females who are known to have or develop the following conditions: A history of, increased risk for, or current arterial or venous thrombotic/thromboembolic diseases. Examples include females who are known to: - Smoke, if 35 years of age and older [see Boxed Warning and Warnings and Precautions (5.1) ] - Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions (5.1) ] - Have cerebrovascular disease [see Warnings and Precautions (5.1) ] - Have coronary artery disease [see Warnings and Precautions (5.1) ] - Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1) ] - Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ] - Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.1) ] - Have diabetes mellitus with hypertension or end-organ damage; or diabetes mellitus of > 20 years duration [see Warnings and Precautions (5.9) ] - Have migraine headaches with aura [see Warnings and Precautions (5.4) ] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.5) ] Hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or severe (decompensated) cirrhosis [see Warnings and Precautions (5.6) ] Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.7) ] Abnormal uterine bleeding that has an undiagnosed etiology [see Warnings and Precautions (5.5) ] Renal Impairment [see Warnings and Precautions (5.2) ] Adrenal insufficiency [see Warnings and Precautions (5.2) ] A high risk of arterial or venous thrombotic diseases ( 4 ) Breast cancer or history of breast cancer ( 4 ) Hepatic adenoma, hepatocellular carcinoma, acute hepatitis or decompensated cirrhosis ( 4 ) Co-administration with hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 , 7.1 ) Abnormal uterine bleeding that has an undiagnosed etiology ( 4 ) Renal impairment ( 4 ) Adrenal insufficiency ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Thromboembolic Disorders and Other Vascular Problems : Stop NEXTSTELLIS if a thrombotic or thromboembolic event occurs. Start no earlier than 4 weeks after delivery. Consider all cardiovascular risk factors before initiating in any female, particularly in the presence of multiple risk factors.

( 5.1 ) Hyperkalemia : Check serum potassium concentration during the first NEXTSTELLIS treatment cycle in females on long-term treatment with medications that may increase serum potassium concentration. ( 5.2 , 7.2 ) Hypertension : Monitor blood pressure periodically and stop use if blood pressure rises significantly. ( 5.3 ) Migraine : Discontinue if new, recurrent, persistent, or severe migraines occur.

( 5.4 ) Hormonally-Sensitive Malignancy: Discontinue NEXTSTELLIS if a hormonally-sensitive malignancy is diagnosed. ( 5.5 ) Liver Disease : Withhold or permanently discontinue for persistent or significant elevation of liver enzymes. ( 5.6 ) Glucose Tolerance and Hypertriglyceridemia : Monitor glucose in females with prediabetes or diabetes.

Consider an alternate contraceptive method for females with hypertriglyceridemia. ( 5.8 ) Gallbladder Disease and Cholestasis : Consider discontinuing NEXTSTELLIS in females with symptomatic gallbladder or cholestatic disease. ( 5.9 ) Bleeding Irregularities and Amenorrhea : May cause irregular bleeding or amenorrhea.

Evaluate for other causes if symptoms persist. ( 5.11 )

5.1Thromboembolic Disorders and Other Vascular Problems Stop NEXTSTELLIS if an arterial or venous thrombotic/thromboembolic event occurs. Stop NEXTSTELLIS if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately. Discontinue NEXTSTELLIS during prolonged immobilization.

Start NEXTSTELLIS no earlier than four weeks after delivery in females who are not breast feeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week. Before starting NEXTSTELLIS, evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy.

NEXTSTELLIS is contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases [see Contraindications (4) ] . Cardiovascular and Cerebrovascular Events Use of CHCs increases the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among females over age 40, smokers, and females with hypertension, dyslipidemia, diabetes, or obesity.

The risk increases with age, particularly in females 35 years of age and older, and with the number of cigarettes smoked. In addition to cigarettes, use of other nicotine-containing products – including cigars, smokeless tobacco, hookah tobacco, e-cigarettes, and nicotine replacement therapy – may also increase the risk of serious cardiovascular events from CHC use. Venous Thromboembolism Use of CHCs also increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism.

The rate of VTE in females using COCs has been estimated to be 3 to 9 cases per 10,000 woman-years and should be considered in the context of other female of reproductive potential subpopulations who are not taking CHCs [see Adverse Reactions (6.1) ]. Risk factors for VTEs include smoking, obesity, family history of VTE, and prolonged immobilization in addition to other factors that contraindicate use of CHCs [see Contraindications (4) ] . The presence of multiple risk factors for VTE may increase the risk synergistically.

The risk of VTE is highest during the first year of CHC use and when restarting hormonal contraception after a break of four weeks or longer. The risk of VTE returns to baseline approximately 3 months after CHC use is disc…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions with the use of COCs are discussed elsewhere in labeling: Serious cardiovascular events including venous and arterial thromboembolism [see Boxed Warning and Warnings and Precautions (5.1) ] Hyperkalemia [see Warnings and Precautions (5.2) ] Liver disease [see Warnings and Precautions (5.5) ] Most common adverse reactions (≥2%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one 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 provided reflect the experience with the use of NEXTSTELLIS in two large prospective studies, one in Europe/Russia (C301) and one in North America (C302) (N = 3,632) of NEXTSTELLIS for the prevention of pregnancy in females 16-50 years of age.

The mean duration of NEXTSTELLIS exposure was 317 and 257 days for the respective studies. The study population was 27 years of age on average, with a mean BMI of 25 kg/m 2 . The racial distribution was 83% White; 11% Black; 3% Asian; and 3% Other.

Table 4 Adverse Reactions Occurring in ≥ 2% of Females Receiving NEXTSTELLIS in Studies C301 and C302 Preferred Term (PT) Participants with Adverse Reaction – US/Canada Phase 3 trial (n [%]) (N = 2073) Represents the safety population of C302 only (US/Canada). Participants with Adverse Reaction – Two Phase 3 trials (n [%]) (N=3632) Represents the safety population of C301/C302 for DRSP/E4. Any adverse reaction Any adverse reaction equals any adverse event ≥ 2%.

1205 (58.1) 2126 (58.5) Mood disturbance Includes PTs: adjustment disorder, affective disorder, agitation, anger, anxiety, depressed mood, depression, depressive symptom, disorientation, emotional disorder, emotional distress, euphoric mood, generalized anxiety disorder, insomnia, irritability, mood altered, mood swings, nervousness, panic attack, panic disorder, performance fear, restlessness, sleep disorder, stress, suicidal ideation, tearfulness. 226 (10.9) 329 (9.1) Bleeding irregularities Includes PTs: abnormal withdrawal bleeding, amenorrhea, cervix hemorrhage uterine, coital bleeding, dysfunctional uterine bleeding, menometrorrhagia, menorrhagia, menstrual disorder, menstruation irregular, metrorrhagia, oligomenorrhea, polymenorrhea, uterine hemorrhage, vaginal hemorrhage.

201 (9.7) 393 (10.8) Breast symptoms Includes PTs: anisomastia, breast cyst, breast discoloration, breast discomfort, breast disorder, breast engorgement, breast enlargement, breast mass, breast edema, breast pain, breast swelling, breast tenderness, fibrocystic breast disease, galactorrhea, gynecomastia, mastoptosis, nipple disorder, nipple pain. 110 (5.3) 197 (5.4) Headache Includes PTs: headache, premenstrual headache, and tension headache. 100 (4.8) 227 (6.3) Dysmenorrhea Includes PTs: adnexa uteri pain, dysmenorrhea, premenstrual cramps, pelvic discomfort, pelvic pain, uterine spasm.

84 (4.1) 133 (3.7) Weight increased Includes PTs: weight increased, weight fluctuation, body mass index increased, weight loss poor, and obesity. 68 (3.3) 108 (3.0) Acne Includes PTs: acne and cystic acne. 66 (3.2) 136 (3.7) Libido decreased/lost Includes PTs: libido decreased and loss of libido.

27 (1.3) 72 (2.0) Adverse Reactions Leading to Study Discontinuation (> 1%) Of 3,632 females in two clinical studies for prevention of pregnancy in females 16-50 years of age, 9.6% discontinued due to an adverse reaction; the most frequent adverse reaction leading to discontinuation was bleeding irregularity (2.8%). Six subjects (0.17%) discontinued study participation due to new…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS CYP3A Inducers: May lead to contraceptive failure and/or increase breakthrough bleeding. Avoid concomitant use. If concomitant use is unavoidable, use an alternative or back-up contraceptive method during co-administration and up to 28 days after discontinuation of the CYP3A inducer. ( 7.1 ) See Full Prescribing Information for additional clinically significant drug interactions ( 7 ).

7.1Effects of Other Drugs on Hormonal Contraceptives Clinically significant drug interactions with other drugs that affect NEXTSTELLIS are presented in Table 5. Table 5. Clinically Significant Drug Interactions With Other Drugs that Affect NEXTSTELLIS CYP3A Inducers Clinical Effect DRSP is a CYP3A4 substrate.

Concomitant use with strong CYP3A inducers or certain moderate or weak CYP3A inducers may decrease DRSP exposure [see Clinical Pharmacology (12.3) ] , which may lead to contraceptive failure. Prevention or Management Strong CYP3A Inducers Avoid concomitant use. If concomitant use is unavoidable, use an alternative contraceptive method (e.g., intrauterine system) or backup non-hormonal contraceptive method during coadministration and up to 28 days after discontinuation of the strong CYP3A inducer.

Moderate and Weak CYP3A Inducers Use an alternative or backup contraceptive method during coadministration and up to 28 days after discontinuation of the CYP3A inducer, unless the Prescribing Information of the specific moderate or weak CYP3A inducer indicates there is no clinically significant interaction with NEXTSTELLIS. Strong CYP3A Inhibitors Clinical Effect DRSP is a CYP3A4 substrate. Concomitant use with a strong CYP3A inhibitor may increase DRSP exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions of NEXTSTELLIS, including hyperkalemia [see Warnings and Precautions (5.2) ] .

Prevention or Management Consider monitoring serum potassium concentration in patients who take a strong CYP3A4 inhibitor long-term and concomitantly with NEXTSTELLIS. Drugs that May Reduce the Absorption of NEXTSTELLIS Clinical Effect Concomitant use with drugs such as bile acid sequestrants may decrease the E4 and DRSP exposure, which may lead to contraceptive failure and/or an increase in breakthrough bleeding. Prevention or Management Separate time of administration of NEXTSTELLIS and the concomitant drug.

Refer to the concomitant drug's Prescribing Information for additional information.

7.2Effects of NEXTSTELLIS on Other Drugs Table 6 includes clinically significant drug interactions with NEXTSTELLIS that affect other drugs. Table 6. Clinically Significant Drug Interactions of NEXTSTELLIS on Other Drugs Anti-Diabetic Drugs Clinical Effect Concomitant use of NEXTSTELLIS may reduce the blood glucose lowering effect of anti-diabetic drugs [see Warnings and Precautions (5.8) and Clinical Pharmacology (12.2) .

Prevention or Management Increase frequency of glucose monitoring and increase anti-diabetic drug dosage, as needed, based on glucose levels. Drugs that may increase serum potassium concentration Clinical Effect There is a potential for an increase in serum potassium concentration in females taking NEXTSTELLIS with other drugs that may increase serum potassium concentration [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2) ]. Prevention or Management Monitor serum potassium concentration in females at increased risk for hyperkalemia.

Lamotrigine Clinical Effect Concomitant use of NEXTSTELLIS may decrease lamotrigine exposure [see Clinical Pharmacology (12.3) ] , which may reduce efficacy of lamotrigine. Prevention or Management Adjust lamotrigine dosage as recommended in its Prescribing Information based on NEXTSTELLIS initiation or discontinuation. Systemic Corticosteroids Clinical Effect Concomitant use of NEXTSTELLIS may increase the exposure of certain systemic corticosteroids, which may increase the risk of corticosteroid-related adverse reactions [ see Clinical Pharmacology…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Discontinue if pregnancy occurs. (8.1) Lactation : Advise postpartum females that NEXTSTELLIS can decrease milk production. ( 8.2 )

8.1Pregnancy Risk Summary Discontinue NEXTSTELLIS if pregnancy occurs, because there is no reason to use hormonal contraceptives during pregnancy [see Contraindications (4) ] . 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 exposure to COCs before conception or during early pregnancy. Reproductive toxicity studies performed with E4 alone have shown expected pharmacologic effects in animals, which are considered consistent with estrogen exposure.

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.

8.2Lactation Risk Summary Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well established.

When possible, advise the nursing woman to use other methods of contraception until she discontinues breast-feeding [see also Dosage and Administration (2.1) ] . The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for NEXTSTELLIS and any potential adverse effects on the breast-fed child from NEXTSTELLIS or from the underlying maternal condition. After oral administration of DRSP 3 mg/EE 30 µg, about 0.02% of the DRSP dose was excreted into the breast milk of postpartum females within 24 hours.

This results in a potential maximal daily dose of less than 1 µg DRSP in an infant.

8.4Pediatric Use Safety and efficacy of NEXTSTELLIS have been established in females of reproductive potential. The study population of C302 [see Clinical Studies (14) ] was in females of reproduction age 16-50 years of age. Use of NEXTSTELLIS before menarche is not indicated.

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

8.6Hepatic Impairment NEXTSTELLIS is contraindicated in females with hepatic impairment [see Contraindications (4) , Warnings and Precautions (5.1 , 5.3) ] . The mean exposure to drospirenone (DRSP) in females with moderate liver impairment is approximately three times higher than the exposure in females with normal liver function. NEXTSTELLIS has not been studied in females with severe hepatic impairment [see Clinical Pharmacology (12.3) ].

8.7Renal Impairment NEXTSTELLIS 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 Warnings and Precautions (5.2) , Drug Interactions (7.2) and Clinical Pharmacology (12.3) ] .

8.8Race/Ethnicity No clinically significant difference was observed between the pharmacokinetics of E4 or DRSP depending on race [see Clinical Pharmacology (12.3) ] .

8.9Body Mass Index (BMI)/Body Weight The safety and efficacy of NEXTSTELLIS in females with a BMI ≥ 35 kg/m 2 have not been adequately evaluated.

🤰 Pregnancy 108 words ▾

8.1Pregnancy Risk Summary Discontinue NEXTSTELLIS if pregnancy occurs, because there is no reason to use hormonal contraceptives during pregnancy [see Contraindications (4) ] . 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 exposure to COCs before conception or during early pregnancy. Reproductive toxicity studies performed with E4 alone have shown expected pharmacologic effects in animals, which are considered consistent with estrogen exposure.

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.

🧒 Pediatric Use 44 words ▾

8.4Pediatric Use Safety and efficacy of NEXTSTELLIS have been established in females of reproductive potential. The study population of C302 [see Clinical Studies (14) ] was in females of reproduction age 16-50 years of age. Use of NEXTSTELLIS before menarche is not indicated.

🧓 Geriatric Use 18 words ▾

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

🆘 Overdosage 73 words ▾

10 OVERDOSAGE Overdosage of CHCs may cause nausea, vomiting, and severe headaches. Individual reports of thromboembolic complications and vaginal bleeding have occurred from overdosage. Pediatric patients with unintended CHC ingestion have reported nausea and vomiting and some developed irritability and drowsiness; rare reports described vaginal bleeding.

Overdosage Management Recommendations Consider short-term prophylactic anticoagulation therapy for patients with high risk of VTE. Monitor serum potassium and sodium levels, and for evidence of metabolic acidosis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action CHCs prevent pregnancy primarily by suppressing ovulation.

12.2Pharmacodynamics Drospirenone is a spironolactone analogue with anti-mineralocorticoid and antiandrogenic activity. The estrogen in NEXTSTELLIS is estetrol, a synthetic analogue of a native estrogen present during pregnancy, that is selective for nuclear estrogen receptor-α (ER-α) and ER-β. Effect of NEXTSTELLIS on ovarian function A clinical study evaluated the effect of NEXTSTELLIS on the suppression of ovarian activity as assessed by measurement of follicle size via transvaginal ultrasound and serum hormone (progesterone and estradiol) analyses in two of the three treatment cycles (24-day active tablet period plus 4-day pill-free period).

No ovulations were observed during the study. Cardiac Electrophysiology At a dose 5 times the maximum recommended dose (i.e., supra-therapeutic dose of 15 mg DRSP /71 mg E4), NEXTSTELLIS does not prolong the QT interval to any clinically relevant extent. Drugs That Have the Potential to Increase Serum Potassium Concentration There is a potential for an increase in serum potassium concentration in females taking NEXTSTELLIS with other drugs that may increase serum potassium concentration [see Warnings and Precautions (5.2) ].

A drug-drug interaction study of DRSP 3 mg /E2 1 mg versus placebo was performed in 24 mildly hypertensive postmenopausal females taking enalapril maleate 10 mg twice daily. Potassium concentrations were obtained every other day for a total of 2 weeks in all subjects. Mean serum potassium concentrations in DRSP/E2 treatment group relative to baseline were 0.22 mEq/L higher than those in the placebo group.

Serum potassium concentrations also were measured at multiple time points over 24 hours at baseline and on Day 14. On Day 14, the ratios for serum potassium C max and AUC in the DRSP/E2 group to those in the placebo group were 0.955 (90% CI: 0.914, 0.999) and 1.010 (90% CI: 0.944, 1.08), respectively. No patient in either treatment group developed hyperkalemia (serum potassium concentrations > 5.5 mEq/L).

Other PD effects of NEXTSTELLIS Table 7 displays pharmacodynamic effects of CHCs on hemostatic, metabolic, and endocrine parameters. Table 7: Pharmacodynamics Effects of CHCs on Hemostatic, Metabolic, and Endocrine Parameters Category Direction of Change Increase Decrease No change Coagulation Factors ↑ Platelet count; factors II, VII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, and beta-thromboglobulin; fibrinogen and fibrinogen activity; plasminogen antigen and activity ↓(Accelerated) Prothrombin time, partial thromboplastin time, and platelet aggregation time ↓ Anti-factor Xa and antithrombin III, antithrombin III activity Corticosteroids ↑ Corticosteroid-binding globulin (CBG), total circulating corticosteroids - - Glucose - ↓ Glucose tolerance - Lipids ↑ ↓ Low-density lipoprotein concentration Plasma high-density lipoprotein (HDL) and HDL2 cholesterol subfraction concentration, triglyceride levels Mineralocorticoids ↑ Aldosterone Plasma proteins ↑ Concentrations of angiotensinogen/renin substrate, alpha-1 antitrypsin, ceruloplasmin - - Sex hormones ↑ Sex hormone-binding globulin (SHBG) ↓ Possible decreased free testosterone concentrations ↓ Androstenedione, progesterone, free testosterone, estradiol DHEA-S, FSH, LH,Dihydrotestosterone Thyroid hormones ↑ Thyroxin-binding globulin (TBG), total thyroid hormone levels, total T4 and T3 levels ↓ T3 resin uptake ↔ TSH, Free T4 and free T3 concentrations in females with normal thyroid function

12.3Pharmacokinetics Absorption, Distribution, Metabolism, and Excretion The pharmacokinetic properties of E4 and DRSP following administration of NEXTSTELLIS are provided in TABLE 8. Table 8. Pharmacokinetics of E4 and DRSP E4 DRSP C max = Maximum plasma concentration; AUC 0-t = Area under the plasma concentration-time curve integrated from time of administration (0) to time of last quantifiable obser…

🧬 Mechanism of Action 11 words ▾

12.1Mechanism of Action CHCs prevent pregnancy primarily by suppressing ovulation.

📦 How Supplied / Storage and Handling 133 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied NEXTSTELLIS ® (drospirenone and estetrol tablets) is available in a blister card, with 28 6-mm round, bi-convex film-coated tablets in the following order: 24 pink active film-coated tablets containing 3 mg drospirenone and 14.2 mg estetrol embossed with a drop-shaped logo on one side. 4 white inert film-coated tablets embossed with a drop-shaped logo on one side. NEXTSTELLIS ® is supplied in cartons containing 1 blister card of 28 tablets: NDC 51862-258-01.

16.2Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

16.3Disposal Dispose unused medication via a take-back option if available. Otherwise, follow FDA instructions for disposing medication in the household trash, www.fda.gov/drugdisposal. Do NOT flush down the toilet.

📦 Storage and Handling 24 words ▾

16.2Storage Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

📋 Description ~1 min read ▾

11 DESCRIPTION NEXTSTELLIS ® (drospirenone and estetrol tablets) is an oral contraceptive. It is supplied in a transparent PVC/aluminum blister card containing 28 tablets: 24 pink active tablets contain 3 mg drospirenone and 14.2 mg of estetrol on the anhydrous basis. Drospirenone is a synthetic progestin and estetrol is a synthetic estrogen.

4 white inert tablets. The chemical name for estetrol is estra-1,3,5(10)-triene-3,15α,16α,17α-tetrol monohydrate. It has a molecular formula of C 18 H 24 O 4 ∙H 2 O and a molecular weight of 322.4 g/mol, equivalent to 304.4 g/mol (anhydrous).

Estetrol has the following chemical structure: Estetrol (monohydrate) is a white to off-white crystalline solid that is poorly soluble in water and aqueous solutions. It is soluble in methanol, ethanol, sparingly soluble in acetone, and slightly soluble in ethyl acetate and acetonitrile. 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 g/mol, 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 neutral molecule with slight solubility in water. The active tablet is a 6 mm, round pink film-coated tablet which contains 3 mg of drospirenone and 15 mg of estetrol as the monohydrate, equivalent to 14.2 mg of estetrol on the anhydrous basis, and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.

Each tablet is embossed on one side with a drop-shaped logo. The pink film-coating has the following inactive ingredients: hydrogenated cottonseed oil, hydroxypropyl cellulose, hypromellose, iron oxide red, talc, and titanium dioxide. The inert tablet is a 6 mm, round white film-coated tablet which contains the inactive ingredients corn starch, lactose monohydrate, and magnesium stearate.

Each tablet is embossed on one side with a drop-shaped logo. The film-coating has the following inactive ingredients: hydrogenated cottonseed oil, hydroxypropyl cellulose, hypromellose, talc, and titanium dioxide. Chemical Structure Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved patient labeling (Patient Information and Instructions of Use). Sexually Transmitted Infections Advise females that NEXTSTELLIS does not protect against HIV infection or other sexually transmitted infections. Important Administration Instructions and Instructions for Missed Doses Instruct females to take one tablet daily by mouth at the same time every day.

Advise patients about what to do in the event that pills are missed [see Dosage and Administration (2.3) ] . Advise females starting NEXTSTELLIS to use additional nonhormonal contraception for 7 days after the first dose unless NEXTSTELLIS is started on the first day (Day 1) of menses [see Dosage and Administration (2.1) ] Advise females who miss more than two consecutive days of NEXTSTELLIS or experience vomiting or diarrhea for > 48 hours consecutively to use additional nonhormonal contraception for 7 days [see Dosage and Administration (2.3 , 2.4) ] Thromboembolic Disorders and Other Vascular Problems [see Warnings and Precautions (5.1) ] .

Advise females that there is an increased risk of arterial and/or venous thrombotic/thromboembolic events with NEXTSTELLIS and the risk of arterial and/or venous thrombotic/thromboembolism is greater in smokers and females with preexisting medical conditions including hypertension, dyslipidemia, diabetes, and obesity. Advise patients of the pertinent factors that further increase their risk and ways to diminish the risk, e.g., to stop smoking (if applicable). Advise patients to contact their healthcare professional for any signs or symptoms of arterial and/or VTE Advise patients to contact their healthcare professional if they will be immobilized for a prolonged period of time.

Hyperkalemia Advise females to contact their healthcare professional if signs or symptoms of hyperkalemia develop [see Warnings and Precautions (5.2) ]. Hypertension Advise females that NEXTSTELLIS can cause an increase in blood pressure over time. Instruct patients to contact their healthcare professional if blood pressure increases [see Warnings and Precautions (5.3) ].

Liver Disease Advise females that use of NEXTSTELLIS can cause elevated liver enzymes and can increase the risk of liver tumors. Instruct females to contact their healthcare professional for any signs or symptoms of liver disease [see Warnings and Precautions (5.5) ]. Glucose Tolerance Advise females that NEXTSTELLIS may decrease glucose tolerance.

Instruct females with diabetes and prediabetes to contact their healthcare professional for any signs or symptoms of hyperglycemia [see Warnings and Precautions (5.7) and Clinical Pharmacology (12.2) ]. Gallbladder Disease and Cholestasis Advise females that use of NEXTSTELLIS is associated with an increased risk of developing and/or worsening gallbladder disease. Instruct patients to contact their healthcare professional for any signs or symptoms of gallbladder disease [see Warnings and Precautions (5.8) ].

Bleeding Irregularities, Amenorrhea, and Pregnancy Advise females that NEXTSTELLIS can cause unscheduled bleeding and spotting, as well as amenorrhea and oligomenorrhea. Advise females to contact their health care professional if amenorrhea occurs in two or more consecutive cycles or symptoms of pregnancy occur, e.g., morning sickness or unusual breast tenderness. Instruct females to stop NEXTSTELLIS if pregnancy is confirmed during use [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1) ] .

Chloasma Advise females that NEXTSTELLIS can cause chloasma and the risk is highest in females with a history of chloasma, especially chloasma gravidarum. Instruct females to take precautions to limit UVA and UVB exposure while using NEXTSTELLIS [see Warnings and Precautions (5.14) ] . Lactation Advise postpartum females that NEXTSTELLIS may reduce breast milk production.

Advise females that this reduction is less likely to occur if breast-feeding is well est…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51862-0179-01 · Mayne 51862-0295-10 · Mayne →
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.