Estellis Tablet

Estellis is indicated for use by females of reproductive potential to prevent pregnancy.

Drospirenone and Estetrol tablets is an oral contraceptive.

• 24 pink active tablets: Each tablet contains Drospirenone USP 3 mg and Estetrol Monohydrate INN equivalent to Estetrol 14.2 mg. Drospirenone is a synthetic progestin and estetrol is a synthetic estrogen.
• 4 white inert tablets.

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.

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.

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

Most common adverse reactions (≥2%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased.

Discontinue this if pregnancy occurs, because there is no reason to use hormonal contraceptives during pregnancy. Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well established. When possible, advise the nursing woman to use other methods of contraception until she discontinues breast-feeding.

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.

Pediatric Use: Safety and efficacy of LIANA have been established in females of reproductive potential. Use of LIANA before menarche is not indicated.

Geriatric Use: LIANA has not been studied in postmenopausal females and is not indicated in this population.

Overdosage of CHCs may cause 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. Overdosage Management Recommendations 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.

Oral Contraceptive preparations

Store at 20°C to 25°C & frost-free place. Keep away from light. Excursions permitted to 15°C to 30°C. Keep out of the reach of children.