Estellis
Generic: Drospirenone + Estetrol
Daily Dose:
Duration:
Alternatives (1)Cheaper & Alternative Brands (3 mg+14.2 mg)
Same active generic (Drospirenone + Estetrol), same form (Tablet), exact same strength (3 mg+14.2 mg)
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Estellis is indicated for use by females of reproductive potential to prevent pregnancy.
Dosage & Administration
The recommended dosage of is one tablet daily for 28 consecutive days
: one pink active tablet daily at the same time during the first 24 days followed by one white inactive tablet daily during the 4 following days.
Instruction for missed doses-
If one pink active tablet is missed
: Take the missed tablet as soon as possible and take the next tablet at the scheduled time, even if two active tablets are taken in one day. Continue taking one tablet a day until the pack is finished.
If two or more pink active tablets are missed in Week 1 or Week 2
: Take one missed tablet as soon as possible and take the tablet for the current day (that means taking two tablets in one day) and discard the other missed tablets. Continue taking one tablet a day until the pack is finished. Use additional non-hormonal contraception as back-up until pink tablets have been taken for 7 consecutive days.
If two pink active tablets are missed in Week 3
: Take one missed tablet as soon as possible and take the tablet for the current day (that means taking two tablets in one day) and discard the other missed tablets. Finish the active tablets and discard the inactive tablets in the pack. Start a new pack of tablets the next day. Use additional non-hormonal contraception as back-up until pink tablets have been taken for 7 consecutive days.
If one or more white inert tablets are missed
: Skip the missed pill days and continue taking one tablet a day until the pack is finished.
Administration recommendations after vomiting or acute Diarrhea
: If vomiting or acute diarrhea occurs within 3 to 4 hours after taking an active tablet, take the new active tablet (scheduled for the next day) as soon as possible. Take the new tablet within 12 hours of the usual time of tablet-taking if possible. If more than two tablets are missed, follow the advice concerning missed tablets, including using backup non hormonal contraception.
Contraindications
This is contraindicated in females who develop or are known to have the following conditions:
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
Side Effects & Adverse Reactions
Most common adverse reactions (≥2%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased.
Warnings & Precautions
Thromboembolic Disorders and Other Vascular Problems
: Stop LIANA 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 LIANA 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 LIANA 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 LIANA 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.