Liana3 mg+14.2 mg

Liana is a combined hormonal contraceptive indicated for the following use:

Established / FDA-approved use

• Prevention of pregnancy in women of reproductive potential who choose to use an oral contraceptive. This is the sole approved indication for Liana.

Liana is not indicated, and should not be relied upon, for emergency contraception, treatment of acne, or management of abnormal uterine bleeding; women with these needs should discuss appropriate alternatives with a physician.

Each active film-coated tablet of Drospirenone + Estetrol contains drospirenone 3 mg (a spirolactone-derived progestin) and estetrol (as monohydrate) 14.2 mg (a native estrogen). A typical pack contains 24 active hormone tablets followed by 4 hormone-free (placebo) tablets, taken in strict daily sequence.

Liana is a combined oral contraceptive (COC) pairing drospirenone, a progestin with anti-mineralocorticoidand anti-androgenic activity, with estetrol, an estrogen produced naturally by the fetal liver during pregnancy andnow manufactured for pharmaceutical use.

Estetrol is described as a "native estrogen" with a metabolic and receptor-binding profile that differs fromethinylestradiol used in older combined pills; it is believed to have a more selective action on estrogen receptors insome tissues (e.g., less stimulation of liver protein synthesis and breast tissue in preclinical data) with acomparatively lower impact on certain coagulation-related liver proteins. However, because estetrol is a newerestrogen, long-term comparative outcome data (particularly head-to-head thrombotic risk data against establishedCOCs) are still accumulating, and Liana should be prescribed with the same clinical vigilance as other combinedhormonal contraceptives pending more mature evidence.

Combined oral contraceptive (progestin + estrogen); hormonal contraceptive

Mechanism of Action

Drospirenone + Estetrol prevents pregnancy through the combined hormonal actions of its two components:

• Drospirenone is a progestin that suppresses the mid-cycle luteinizing hormone (LH) surge,inhibiting ovulation, and thickens cervical mucus to impede sperm penetration. It also has anti-mineralocorticoid(anti-aldosterone) activity, which can raise serum potassium, and anti-androgenic activity.
• Estetrol is a native estrogen that suppresses follicle-stimulating hormone (FSH) and contributesto ovulation inhibition and endometrial changes that reduce the likelihood of implantation, while producing atissue-selective estrogenic effect distinct from ethinylestradiol.

Together, the combination alters the cervical mucus, endometrium, and hypothalamic-pituitary-ovarian axis toachieve contraceptive efficacy.

Pharmacokinetics

Both components are absorbed orally; drospirenone is metabolized primarily via non-CYP pathways with some CYP3A4involvement, while estetrol undergoes minimal hepatic first-pass metabolism and is largely excreted via glucuronide/sulfate conjugation. Steady-state concentrations of both components are generally reached within about a week ofonce-daily dosing.

Take Liana by mouth once daily, at approximately the same time each day, in the order directed on the pack, with or without food. Swallow the tablet whole. Do not skip the hormone-free interval instructions provided by the prescriber.

Clinically Significant Interactions

• Strong CYP3A4 inducers (e.g., rifampin, certain anticonvulsants such as phenytoin, carbamazepine,and topiramate, and St. John's Wort) can lower hormone levels and reduce contraceptive efficacy of Liana; a back-upmethod or alternative contraception should be considered during and after use of these agents, per physician advice.
• Potassium-elevating drugs — ACE inhibitors, angiotensin receptor blockers (ARBs), potassium-sparingdiuretics, and chronic NSAID use — can compound the anti-mineralocorticoid (potassium-retaining) effect of thedrospirenone component of Liana and raise the risk of hyperkalemia; potassium monitoring is advised when these areco-administered, particularly in patients with renal, hepatic, or adrenal impairment (see Precautions).
• Strong CYP3A4 inhibitors (e.g., certain azole antifungals, some HIV protease inhibitors) mayincrease drospirenone exposure; clinical monitoring is advised.

Most reported side effects of Liana are mild and often diminish with continued use. Common effects include:

• Irregular or breakthrough vaginal bleeding, especially in the first few cycles
• Headache
• Breast tenderness or pain
• Nausea
• Menstrual cramping (dysmenorrhea)
• Acne
• Mood changes
• Weight fluctuation

Serious but uncommon risks include venous or arterial thromboembolic events and hyperkalemia (see Contraindicationsand Precautions); patients experiencing severe abdominal or chest pain, leg swelling/pain, sudden severe headache,visual disturbance, or shortness of breath should seek immediate medical attention.

Pregnancy

Liana is not indicated for use during pregnancy and offers no benefit once pregnancy has occurred; it should bediscontinued if pregnancy is confirmed or suspected. There is no established therapeutic use of Liana in pregnantwomen, and its use should be avoided; a physician should be consulted immediately if pregnancy occurs while takingthis medicine.

Lactation

Combined hormonal contraceptives such as Liana may reduce milk quantity and alter milk composition, particularly ifstarted before breastfeeding is well established. Liana should be used during breastfeeding only if clearly needed andafter the potential benefit is weighed against potential risk to milk supply and the infant, and only on the adviceof a physician; progestin-only or non-hormonal methods are often preferred in early lactation.

Thromboembolic Risk

Like other combined hormonal contraceptives, Liana carries an increased risk of venous and arterial thromboembolicevents (e.g., deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction), which is highest in thefirst year of use and in women with predisposing risk factors (smoking, obesity, immobilization, family history,older age). Because estetrol is a comparatively newer estrogen, the body of long-term comparative thrombotic-riskevidence against established combined contraceptives is still accumulating; available clinical trial data supportits use for contraception, but this evolving evidence base should be considered when weighing risks and benefits foran individual patient.

Hyperkalemia Risk

The anti-mineralocorticoid activity of drospirenone can raise serum potassium. Caution and potassium monitoringare advised in patients with renal, hepatic, or adrenal insufficiency, and in those taking interacting drugs (ACEinhibitors, ARBs, potassium-sparing diuretics, chronic NSAIDs) (see Interactions and Contraindications).

Other Precautions

• Discontinue promptly if signs of thromboembolism, jaundice, severe hypertension, or new-onset migraine withaura occur, and seek medical evaluation.
• Use with caution in women with a history of depression or mood disorders, as hormonal contraceptives can affect mood.
• Cigarette smoking increases the risk of serious cardiovascular events; women who smoke should be strongly advisedagainst smoking while using Liana, especially if over 35 years of age (see Contraindications).

There is limited clinical experience with overdose of Liana. Reported effects of overdose with combined hormonalcontraceptives generally include nausea, vomiting, and withdrawal bleeding in females; no specific antidote exists.If an overdose of Liana is suspected, seek immediate medical attention or contact a poison control center;treatment is supportive and symptomatic, and should only be directed by a qualified healthcare professional.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

• Renal impairment: Because drospirenone can increase serum potassium, Liana should be used withcaution in patients with mild-to-moderate renal impairment, and is contraindicated in significant renal insufficiency(see Contraindications); potassium monitoring is recommended.
• Hepatic impairment: Liana is contraindicated in patients with severe hepatic disease or hepatictumors (see Contraindications); use with caution and physician oversight in milder hepatic impairment.
• Obesity: Contraceptive efficacy may be reduced in women with a higher body mass index; overallthromboembolic risk is also elevated with obesity, so individualized risk assessment by a physician is advised.
• Elderly / postmenopausal women: Liana is not intended for use after menopause or for indicationsother than contraception in reproductive-age women.
• Adolescents: Safety and efficacy have been established in adolescents who have startedmenstruating (post-menarche); use in girls who have not yet menstruated is not appropriate.

Liana may be continued for as long as pregnancy prevention is desired and no contraindications develop. Periodic clinical review (at least annually, or sooner if risk factors change) is recommended to reassess continued suitability with the prescribing physician.

Combined hormonal contraceptive: progestin component (drospirenone, a spirolactone-derived progestin with anti-mineralocorticoid and anti-androgenic activity) plus estrogen component (estetrol, a native estrogen). Drospirenone + Estetrol belongs to the broader class of combined oral contraceptives (COCs).

Drospirenone + Estetrol inhibits ovulation via combined suppression of the LH surge and FSH, thickens cervical mucus to block sperm transport, and alters the endometrial lining to reduce the likelihood of implantation.

Liana is indicated only for women of reproductive potential who have begun menstruating (post-menarche). Safetyand efficacy have not been established in pre-menarchal girls, and Liana is not intended for use before the onsetof menstruation. In adolescents who have started menstruating, the dosing and administration are the same as foradult women; a physician should assess bone health, growth status, and appropriateness of hormonal contraceptionbefore prescribing.