Drospirenone/estetrol

What is Drospirenone/estetrol?

• 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?

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

How does this medicine work?

• CHCs prevent pregnancy primarily by suppressing ovulation.

Who Should Not Use this medicine ?

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?

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?

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

How should this medicine be used?

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?

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?

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?

• 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?

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?

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

Can this medicine be used in children?

• 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?

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?

Packager: Mayne Pharma

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Drospirenone/estetrol
• FDA Drospirenone/estetrol

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