Origolix Tablet
Elagolix sodium
200 mg
Incepta Pharmaceuticals Ltd.
| Pack size | 10's Pack |
|---|---|
| Unite Price | 235.00 BDT |
Indications
Origolix Tablet is used for:
Indicated for the management of moderate to severe pain associated with endometriosis, Dysmenorrhea, Non-menstrual Pelvic Pain
Adult Dose
Endometriosis
Indicated for management of moderate-to-severe pain associated with endometriosis
Initiate with 150 mg once a day for up to 24 months
Hepatic impairment
Mild (Child-Pugh A): No dosage adjustment required
Moderate (Child-Pugh B): Only the 150-mg qDay regimen is recommended for women with moderate hepatic impairment, and the duration of treatment should be limited to 6 months
Severe (Child-Pugh C): Contraindicated
Child Dose
Renal Dose
Renal impairment
No dosage adjustment required with any degree of renal impairment or end-stage renal disease (including dialysis)
Administration
One tablet taken once a day AM or PM, at approximately the same time each day.
Exclude pregnancy before starting Elagolix or start Elagolix within 7 days from the onset of menses.
Take at approximately the same time each day, with or without food
Contra Indications
Pregnancy
Known osteoporosis
Severe hepatic impairment
Coadministration of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (eg, cyclosporine and gemfibrozil)
Precautions
May reduce the amount, intensity, or duration of menstrual bleeding, which may decrease the ability to recognize the occurrence of a pregnancy in a timely manner; perform pregnancy testing if pregnancy is suspected, and discontinue drug if pregnancy confirmed
Dose-dependent elevations of ALT >3x ULN occurred with elagolix; use the lowest effective dose and instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury
Suicidal behavior and mood disorders
Suicidal ideation and behavior, including 1 completed suicide, occurred in subjects treated with elagolix in the endometriosis clinical trials
Patients taking elagolix had a higher incidence of depression and mood changes compared with placebo
Patients with a history of suicidality or depression had a higher incidence of depression compared with subjects without such a history
Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits
Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate
Advise patients to seek immediate medical attention for suicidal ideation and behavior
Reevaluate the benefits and risks of continuing elagolix if such events occur
Pregnancy-Lactation
Pregnancy
Contraindicated in pregnant women
Drug exposure early in pregnancy may increase the risk of early pregnancy loss
Discontinue elagolix if pregnancy occurs during treatment
The limited human data with use in pregnant women are insufficient in determining whether there is a risk for major birth defects or miscarriage; although 2 cases of congenital malformations were reported in clinical trials with elagolix, no pattern was identified and miscarriages were reported at a similar incidence across treatment groups
Animal data
When pregnant rats and rabbits were orally dosed with elagolix during the period of organogenesis, postimplantation loss was observed in pregnant rats at doses 20 times the maximum recommended human dose (MRHD)
Spontaneous abortion and total litter loss was observed in rabbits at doses 7 and 12 times the MRHD
There were no structural abnormalities in the fetuses at exposures up to 40 and 12 times the MRHD for the rat and rabbit, respectively
Pregnancy testing
Exclude pregnancy before initiating treatment with elagolix
Perform pregnancy testing if pregnancy is suspected during treatment with elagolix
Contraception
Advise women to use effective nonhormonal contraception during treatment with elagolix and for 1 week after discontinuing elagolix
Lactation
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
There are no adequate animal data on the excretion of elagolix in milk
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for elagolix and any potential adverse effects on the breastfed child from elagolix
Interactions
Elagolix is contraindicated in women with concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine and gemfibrozil)
Combined Birth Control Pill
Elagolix has been found to increase exposure to digoxin and ethinylestradiol, whereas it has been found to decrease exposure to rosuvastatin, midazolam, norethisterone, norelgestromin, and norgestrel.
Side Effects
Side effects of Elagolix sodium :
>10%
Hot flush or night sweats (24-36%)
Headache (17-20%)
Nausea (11-16%)
1-10%
Insomnia (6-9%)
Mood altered, mood swings (5-6%)
Amenorrhea (4-7%)
Depressed mood, depression, depressive symptoms and/or tearfulness (3-6%)
Hypersensitivity reactions (5.8%)
Anxiety (3-5%)
Arthralgia (3-5%)
Mode of Action
Oral gonadotropin-releasing hormone (GnRH) receptor antagonist; inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland
Administration of elagolix 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
Note
Origolix 200 mg Tablet generic name is Elagolix sodium. Origolix 200 mg Tablet is manufactured by Incepta Pharmaceuticals Ltd.Origolix is availble in all over Bangladesh.
Mes BD drug index information on Origolix Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.