Riliz

Dienogest

Endometriosis.

1 tab daily w/o break. May start on any day of menstrual cycle.

May be taken with or without food: Preferably taken at the same time each day, w/ some liqd as needed.

Hypersensitivity. Active venous thromboembolic disorder; past or present arterial & CV disease (eg, MI, CVA, ischemic heart disease); DM w/ vascular involvement; known or suspected sex hormone-dependent malignancies; undiagnosed abnormal vag bleeding; any ocular lesion arising from ophth vascular disease eg, partial or complete loss of vision or defect in visual fields; current or history of migraine w/ focal aura. Presence or history of severe hepatic disease as long as liver function values have not returned to normal; liver tumors (benign or malignant). Known or suspected pregnancy. Lactation.

Not to be used in combination w/ hormonal methods of contraception if contraception is desired during treatment. Advise women not to smoke. Serious uterine bleeding; uterine bleeding in women w/ adenomyosis uteri or uterine leiomyomata may be aggravated. Consider discontinuation of treatment in the event of anemia. Changes in bleeding pattern. Thoroughly investigate abnormal vag bleeding (eg, prolonged &/or heavy) by pelvic ultrasound, endometrial biopsy or hysteroscopy. Risk of stroke may be slightly enhanced in women w/ HTN. Slightly increased risk of VTE (DVT, pulmonary embolism). Discontinue use (in case of elective surgery at least 4 wk in advance) & not to resume treatment until 2 wk after complete remobilization in case of long-term immobilization. Increased risk of thromboembolism in puerperium. Stop treatment at once if there are symptoms of arterial or venous thrombotic event or suspicion thereof. Slightly increased risk of breast cancer; do regular breast exams. Adequately investigate (eg, by mammography or ultrasound) any irregularity or anomaly of breast. Consider hepatic tumor in differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal hemorrhage occur. Osteoporosis & changes in bone mineral density; perform careful risk-benefit assessment before starting treatment in patients w/ increased risk of osteoporosis. Adequate intake of Ca & vit D, whether from diet or supplements, in women of all ages. Chloasma especially in women w/ history of chloasma gravidarum; avoid exposure to sun or UV radiation in women w/ tendency to chloasma. Diabetic women, especially those w/ history of gestational DM. Patients who have history of depression; discontinue if clinically relevant depression occurs or if pre-existing depression is aggravated during treatment. Ectopic pregnancy; women w/ history of extrauterine pregnancy or impairment of tube function. W/draw therapy & treat HTN if sustained clinically significant HTN develops during use. Recurrence of cholestatic jaundice &/or pruritus which occurred 1st during pregnancy or previous use of sex steroids necessitates discontinuation of use. Persistent ovarian follicles may occur during use. Conduct complete medical history & physical & gynecological exam prior to initiation or reinstitution & repeat at least annually during use. May influence results of certain lab tests, including biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of (carrier) proteins (eg, corticosteroid binding globulin & lipid/lipoprotein fractions), parameters of carbohydrate metabolism & parameters of coagulation & fibrinolysis. Do not administer to pregnant women because there is no need to treat endometriosis during pregnancy. Not indicated in ped patients prior to menarche. Adolescents (menarche to 18 yr). Not indicated in elderly (>65 yr).

Changes in menstrual bleeding pattern eg, spotting, irregular bleeding, or amenorrhea. Headache, breast discomfort, depressed mood, & acne.

Drug metabolism may be affected w/ inducers or inhibitors of CYP3A4. Increased clearance, & plasma conc may be decreased w/ CYP3A4 inducers (eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin; oxcarbazepine, topiramate, felbamate, griseofulvin); NNRTIs (eg, nevirapine, efavirenz); St. John's wort (Hypericum perforatum). Plasma conc may be increased w/ strong & moderate CYP3A4 inhibitors eg, azole antifungals (eg, ketoconazole, itraconazole, voriconazole, fluconazole), macrolides (eg, clarithromycin, erythromycin), diltiazem, verapamil; antacids (eg, cimetidine, ranitidine); grapefruit juice. Plasma conc may be increased/decreased w/ HIV/HCV PIs (eg, ritonavir, saquinavir, indinavir, nelfinavir, boceprevir).

Oestrogens, Progesterones & Related Synthetic Drugs

G03DB08 - dienogest ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.

Rx