nextstellis provides a GOOD side-effect profile¹

% of women experiencing adverse reactions (N=3,632)^1*

Weight gain

Mood^**

9.1%

Body shot of woman holding her right breast with her left hand over her clothing.

Breast symptoms^***

5.4%

Acne¹

3.7%

Libido loss / reduction

Any adverse reaction	58.5%
Bleeding irregularities	10.8%
Headache	6.3%
Dysmenorrhea	3.7%

*Any adverse reaction equals any adverse event ≥2%¹

**Includes 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

***Includes 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

Most commonly reported adverse reactions (≥2% of patients) in the Phase III trial results¹

Preferred term	Participants with adverse  reactions: US/Canadian  Phase III trial (N=2,073), n(%)	Participants with adverse reactions: 2 Phase III trials (N=3,632), n (%)
Any adverse reaction	1,205 (58.1)	2,126 (58.5)
Mood disturbance	226 (10.9)	329 (9.1)
Bleeding irregularities	201 (9.7)	393 (10.8)
Breast symptoms	110 (5.3)	197 (5.4)
Headache	100 (4.8)	227 (6.3)
Dysmenorrhea	84 (4.1)	133 (3.7)
Weight increased	68 (3.3)	108 (3.0)
Acne	66 (3.2)	136 (3.7)
Libido decreased/lost	27 (1.3)	72 (2.0)

Any adverse reaction equals any adverse event ≥2%¹

Most common adverse reactions 

The most common adverse reactions (≥2%) in the studies were bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, increased weight, and decreased libido¹

Serious adverse reactions 

Included depression (n=36), venous thromboembolism (VTE, n=1). Six subjects (0.17%) discontinued study participation due to new onset of migraine with aura; two subjects (0.05%) discontinued due to severe migraine¹

NEXTSTELLIS delivers a well-tolerated bleeding profile^1,2

Women tend to stay with NEXTSTELLIS because of a good side-effect profile combined with a predictable bleeding profile^1,2

42%^† relative reduction in unscheduled spotting^†† and bleeding over 12 cycles^1,2

Average duration <1 day of any unscheduled spotting^†† or bleeding on average per cycle after Cycle 12²

^† Calculated as the percent reduction from Cycle 1 through Cycle 12.

^†† Spotting is any light bleeding that does not require the use of sanitary protection, including pantyliners.

Women who start, tend to stay with NEXTSTELLIS

Only 9.6% of women discontinued NEXTSTELLIS due to adverse reactions^1,§
Only 2.8% of women discontinued due to bleeding (all types)¹
0.03% discontinuation rate due to VTE³

<1%

discontinuation rate due to:¹

Acne

Libido reductions

Weight increase

Depression symptoms

Breast pain

Severe migraine

New onset migraine with aura

^§(N=3,632)

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IMPORTANT SAFETY INFORMATION FOR NEXTSTELLIS^® (drospirenone and estetrol tablets 3 mg/14.2 mg)

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.
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use NEXTSTELLIS safely and effectively. See full prescribing information for NEXTSTELLIS.
NEXTSTELLIS (drospirenone and estetrol tablets), for oral use Initial U.S. Approval: 2021

INDICATIONS AND USAGE

NEXTSTELLIS is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.

LIMITATIONS OF USE

NEXTSTELLIS may be less effective in females with a BMI ≥30 kg/m². In females with BMI ≥30 kg/m², decreasing effectiveness may be associated with increasing BMI.

DOSAGE AND ADMINISTRATION

Take one tablet by mouth at the same time every day.
Take tablets in the order directed on the blister pack.

DOSAGE FORMS AND STRENGTHS

NEXTSTELLIS consists of 28 tablets in the following order:

24 pink active tablets each containing drospirenone 3 mg and estetrol 14.2 mg
4 white inert tablets

CONTRAINDICATIONS

A high risk of arterial or venous thrombotic diseases
Current or history of a hormonally-sensitive malignancy (e.g., breast cancer)
Hepatic adenoma, hepatocellular carcinoma, acute hepatitis or decompensated cirrhosis
Co-administration with hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
Abnormal uterine bleeding that has an undiagnosed etiology
Renal impairment
Adrenal insufficiency

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.
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.
Hypertension: Monitor blood pressure periodically and stop use if blood pressure rises significantly.
Migraine: Discontinue if new, recurrent, persistent, or severe migraines occur.
Hormonally-Sensitive Malignancy: Discontinue NEXTSTELLIS if a hormonally-sensitive malignancy is diagnosed.
Liver Disease: Withhold or permanently discontinue for persistent or significant elevation of liver enzymes.
Glucose Tolerance and Hypertriglyceridemia: Monitor glucose in females with prediabetes or diabetes. Consider an alternate contraceptive method for females with hypertriglyceridemia.
Gallbladder Disease and Cholestasis: Consider discontinuing NEXTSTELLIS in females with symptomatic gallbladder or cholestatic disease.
Bleeding Irregularities and Amenorrhea: May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist.

ADVERSE REACTIONS

Most common adverse reactions (≥2%): Bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased

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.
See full Prescribing Information for additional clinically significant drug interactions.

USE IN SPECIFIC POPULATIONS

Pregnancy: Discontinue if pregnancy occurs.
Lactation: Advise postpartum females that NEXTSTELLIS can decrease milk production.

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.

See PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

BMI=body mass index; COC=combined oral contraceptive; EU=European Union; HDL=high-density lipoprotein; LDL=low-density lipoprotein; LNG=levonorgestrel.

References:

NEXTSTELLIS Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf (last accessed June 2025).
Creinin MD et al. Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results. Contraception. 2021; 104:222-228 .
Chen M et al. Tolerability and safety of the estetrol/drospirenone combined oral contraceptive: Pooled analysis of two multicenter, open-label phase 3 trials. Contraception 2022; 116:44-50.

nextstellis provides a GOOD side-effect profile1

NEXTSTELLIS delivers a well-tolerated bleeding profile1,2

Women who start, tend to stay with NEXTSTELLIS

nextstellis provides a GOOD side-effect profile¹

NEXTSTELLIS delivers a well-tolerated bleeding profile^1,2