Drospirenone/estetrol

What is Drospirenone/estetrol?[edit | edit source]

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

What are the uses of this medicine?[edit | edit source]

NEXTSTELLIS is a birth control pill (oral contraceptive) used by females to prevent pregnancy.

How does this medicine work?[edit | edit source]

CHCs prevent pregnancy primarily by suppressing ovulation.

Who Should Not Use this medicine ?[edit | edit source]

This medicine cannot be used in patients who:

smoke and are 35 years of age and older.
have or have had blood clots in your arms, legs, lungs, or eyes.
have a problem with your blood that makes it clot more than normal.
have certain heart valve problems or an irregular heart beat that increases your risk of having blood clots.
had a stroke.
had a heart attack.
have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessel problems.
have diabetes
with high blood pressure or kidney, eye, nerve, or blood vessel damage, or
for more than 20 years.
have certain kinds of severe migraine headaches with aura.
have liver problems, including liver tumors.
have any unexplained vaginal bleeding.
have or have had breast cancer or any cancer that is sensitive to female hormones.
have kidney disease or kidney failure.
have reduced adrenal gland function (adrenal insufficiency).
take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme "alanine aminotransferase" (ALT) in the blood.

What drug interactions can this medicine cause?[edit | edit source]

Avoid concomitant of NEXTSTELLIS with: 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.

Is this medicine FDA approved?[edit | edit source]

It was approved for use in the United States in 2021.

How should this medicine be used?[edit | edit source]

Recommended dosage

Start NEXTSTELLIS using a Day 1 start. Take one tablet by mouth at the same time every day with or without food.
Take tablets in the order directed on the blister pack.

Administration 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.

Starting NEXTSTELLIS after delivery (>20 weeks gestation)

Must not start earlier than 4 weeks after delivery (due to the increased risk of thromboembolism
Must not start earlier than 4 weeks after delivery (due to the increased risk of thromboembolism

What are the dosage forms and brand names of this medicine?[edit | edit source]

This medicine is available in fallowing doasage form: 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

This medicine is available in fallowing brand namesː

NEXTSTELLIS

What side effects can this medication cause?[edit | edit source]

The most common side effects of this medicine include:

irregular vaginal bleeding (including absence of period)
mood changes
headache
breast tenderness, pain, and discomfort
pain with your periods
acne
weight gain
decreased sex drive

QELBREE can cause serious side effects, including:

NEXTSTELLIS may cause serious side effects including:
blood clots
high potassium levels in your blood (hyperkalemia)
high blood pressure
new or worsening headaches including migraine headaches
possible cancer that is sensitive to female hormones, such as breast cancer, skin cancer (melanoma), lung cancer, and brain cancer
liver problems
changes in the sugar and fat (cholesterol and triglycerides) levels in your blood
gallbladder problems (cholestasis)
irregular or unusual vaginal bleeding
Depression
possible cancer in your cervix
swelling of your skin especially around your mouth, eyes, and in your throat (angioedema)
dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma)

What special precautions should I follow?[edit | edit source]

Stop NEXTSTELLIS if a thrombotic or thromboembolic event occurs.
Check serum potassium concentration during the first NEXTSTELLIS treatment cycle in females on long-term treatment with medications that may increase serum potassium concentration.
This medicine may cause hypertension. Monitor blood pressure periodically and stop use if blood pressure rises significantly.
Discontinue if new, recurrent, persistent, or severe migraines occur.
Discontinue NEXTSTELLIS if a hormonally-sensitive malignancy is diagnosed.
Withhold or permanently discontinue for persistent or significant elevation of liver enzymes.
Monitor glucose in females with prediabetes or diabetes. Consider an alternate contraceptive method for females with hypertriglyceridemia.
Monitor glucose in females with prediabetes or diabetes. Consider an alternate contraceptive method for females with hypertriglyceridemia.
This medicine may cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist.

What to do in case of emergency/overdose?[edit | edit source]

Symptoms of overdosage may include:

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.

Management of Overdose

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.

Can this medicine be used in pregnancy?[edit | edit source]

Discontinue NEXTSTELLIS if pregnancy occurs, because there is no reason to use hormonal contraceptives during pregnancy.

Can this medicine be used in children?[edit | edit source]

Safety and efficacy of NEXTSTELLIS have been established in females of reproductive potential only.
Use of NEXTSTELLIS before menarche is not indicated.

What are the active and inactive ingredients in this medicine?[edit | edit source]

Active ingredient: Pink tablets: drospirenone and estetrol Inactive ingredients:

Pink tablets: corn starch, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate. Film-coating: hydrogenated cottonseed oil, hydroxypropyl cellulose, hypromellose, iron oxide red, talc, and titanium dioxide.
White tablets: corn starch, lactose monohydrate, and magnesium stearate. Film coating: hydrogenated cottonseed oil, hydroxypropyl cellulose, hypromellose, talc, and titanium dioxide.

Who manufactures and distributes this medicine?[edit | edit source]

Packager: Mayne Pharma

What should I know about storage and disposal of this medication?[edit | edit source]

Store NEXTSTELLIS at room temperature between 68°F to 77°F (20°C to 25°C).
Throw away unused NEXTSTELLIS through a take-back option, if available. You may also visit www.fda.gov/drugdisposal for FDA instructions for throwing away medicine in your household trash. Do not flush NEXTSTELLIS down the toilet.
Keep NEXTSTELLIS and all medicines out of the reach of children.

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