Drospirenone/estetrol
(Redirected from Peri-nesta)
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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