Elago 200 mg Tablet, 1 strip

Elago 200 mg Tablet, 1 strip

Composition

Elago 150 mg Tablet: Each tablet contains 155.2 mg of elagolix sodium equivalent to 150 mg of elagolix INN.

Elago 200 mg Tablet: Each tablet contains 207.0 mg of elagolix sodium equivalent to 200 mg of elagolix INN.

Pharmacology

Elago is a GnRH receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration of Elago results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone.

Indications

Elago is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis.

Dosage and adminstration

Pregnancy should be excluded before starting Elago and bhstart Elago within 7 days from the onset of menses. Elago should be taken at approximately the same time each day, with or without food. Lowest effective dose, taking into account the severity of symptoms and treatment objectives.

Initial treatment with Elago 150 mg once daily up to 24 months. But in case of moderate hepatic impairment up to 6 months.

Initial treatment with Elago 200 mg twice daily up to 6 months (with coexisting dyspareunia). Treatment with Elago 200 mg should not exist more than 6 months as it may decrease bone mineral density (BMD) In case of moderate to severe hepatic impairment

Elago 200 mg is not recommended.

Contraindications

Elago is contraindicated in pregnant women because exposure to Elago early in pregnancy may increase the risk of early pregnancy loss. With known osteoporosis, it can increase the risk of further bone loss. It is also contraindicated for severe hepatic impairment and also with concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 Inhibitors (e.g., cyclosporine and gemfibrozil).

Warning and precaution

Bone Loss: Dose- and duration-dependent decreases in bone mineral density (BMD) that may not be completely reversible.

Reduced Ability to Recognize Pregnancy: Elago may alter menstrual bleeding, which may reduce the ability to recognize pregnancy. Pregnancy test should be done if suspected. Treatment should be discontinued if pregnancy is confirmed.

Suicidal Ideation and Mood Disorders: Patient must seek medical attention for suicidal ideation, suicidal behavior, new onset or worsening depression, anxiety, or other mood changes.

Hepatic Transaminase Elevations: Dose-dependent elevations in serum alanine

aminotransferase (ALT). Patients should be aware of the signs and symptoms of liver injury. Potential for Reduced Efficacy with Estrogen-Containing Contraceptives:

Non-hormonal contraception have to use during treatment and for one week after discontinuing Elago.

Side Effects

The most common side effects of Elago include: hot flashes or night sweats, headache, nausea, difficulty sleeping, absence of periods, anxiety, joint pain, depression and mood changes.

Use in pregnancy and lactation

The limited human data with the use of Elago in pregnant women are insufficient to determine whether there is a risk for major birth defects or miscarriage.

Exposure to Elago early in pregnancy may increase the risk of early pregnancy loss. Use of

Elago is contraindicated in pregnant women. Elago has to be discontinued if pregnancy occurs during treatment. There is no information on the presence of elagolix or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.

Use in child and adolescents:

No data available.

DRUG INTERACTIONS

Elagolix is a weak to moderate inducer of cytochrome P450 (CYP) 3A. Co-administration with Elago may decrease plasma concentrations of drugs that are substrates of CYP3A.

Elagolix is a weak inhibitor of CYP 2C19. Co-administration with Elago may increase plasma concentrations of drugs like omeprazole.

Elagolix is an inhibitor of efflux transporter P-glycoprotein (P-gp). Co-administration with

Elago may increase plasma concentrations of drugs like digoxin. Concomitant use of Elago and strong OATP1B1 inhibitors (e.g., cyclosporine and gemfibrozil) is also contraindicated.

OVERDOSAGE

In case of overdose, patient should be monitored for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment, as needed.

Storage

Store at 2°C to 30°C (36°F to 86°F) temperature, dry and cool place and protected from light.

Keep all medicines out of reach of children.

Packing

ELAGO 150 mg Tablet: Each Box contains 1 × 10 tablets in blister strip.

ELAGO 200 mg Tablet: Each Box contains 1 × 10 tablets in blister strip