NEXTSTELLIS®: Proven tolerability and safety in 2 Phase III studies with 3,632 patients ages 16-50 years1

Tolerability profile

NEXTSTELLIS demonstrated low rates of the side effects often associated with COCs, including acne, breast symptoms (e.g., pain, tenderness), and libido changes1

Adverse events in women receiving NEXTSTELLIS

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

Percentage of women experiencing:

Weight gain 3%

Acne 3.7%

Mood 9.1%

Libido loss/ reduction 2%

Breast symptoms 5.4%

Effect on weight

On average, women taking NEXTSTELLIS experienced less than a 1.1lb weight increase after 6 treatment cycles in the North American study2

WEIGHT CHANGE <1.1 lb (N=1,864)

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

Adverse Reactions in women receiving NEXTSTELLIS
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
  • Adverse Events include non-drug and drug-related Adverse Events3
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), and migraine (6 women [0.17%] discontinued study participation due to new onset of migraine with aura; 2 women [0.05%] discontinued due to severe migraine)1

NEXTSTELLIS demonstrated safety and was
well-tolerated

One VTE occurred in the EU/Russian trial; none were reported in the North American trial.2,4
NEXTSTELLIS VTE RATE
The rate of VTE in women taking NEXTSTELLIS was:
3.66 per 10,000 women-years.3

Likelihood of VTE in women1

Number of women with a blood clot

*Pregnancy data based on actual duration of pregnancy in the reference studies. Based on a model assumption that pregnancy is 9 months, the rate is 7 to 27 per 10,000 WY.

In the Phase III study, NEXTSTELLIS had low impact on metabolic parameters2

Measures of lipid and glucose metabolism were compared at baseline, cycle 7, and cycle 14

LIPID METABOLISM

CHOLESTEROL

  • Minimal change from baseline in cholesterol (HDL and LDL)

TRIGLYCERIDES

  • Minimal change from baseline in triglycerides

GLUCOSE METABOLISM

FASTING GLUCOSE

  • Minimal change from baseline in glucose

GLYCATED HEMOGLOBIN

  • No change from baseline in glycated hemoglobin

CARDIOVASCULAR METABOLISM

BLOOD PRESSURE

  • Minimal change from baseline in blood pressure

Women who had diabetes mellitus and vascular involvement, diabetes mellitus of >20 years’ duration, or dyslipoproteinemia requiring active treatment with anti-lipidemic agents were excluded from the study.2

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If you would like more information, or have any questions about NEXTSTELLIS, then please submit a request: for example, on our product availability, savings program, sampling, or for details on our patient support services.

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IMPORTANT SAFETY INFORMATION FOR NEXTSTELLIS®

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
1. NEXTSTELLIS [package insert]. Raleigh, NC: Mayne Pharma; April 2021.
2. Data on file. Clinical study report MIT‐Es0001‐C302. Mayne Pharma US. Raleigh, NC.
3. Electronic Code of Federal Regulations. IND safety reporting. 21 CFR §312.32. Accessed May 21, 2021. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.32
4. Data on file. Clinical study report MIT‐Es0001‐C301. Mayne Pharma US. Raleigh, NC.