elagolix

REMS

Moderate to severe pain associated with endometriosis.

Contraindicated in:

Hypersensitivity
Osteoporosis (may ↑ risk of bone loss)
Severe hepatic impairment
Concurrent use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors
OB: Pregnancy (may ↑ risk of early pregnancy loss).

Use Cautiously in:

History of low-trauma fracture or other risk factors for osteoporosis
History of suicidal thoughts/behaviors or depression
Moderate hepatic impairment (use lower dose)
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
Rep: Women of reproductive potential
Pedi: Safety and effectiveness not established in children.

Derm: rash.

Endo: hot flush, night sweats.

GI: nausea, ↑ liver enzymes, abdominal pain, constipation, diarrhea.

GU: ↓ libido, menstrual irregularities.

Metab: ↑ weight, dyslipidemia.

MS: ↓ bone density, arthralgia.

Neuro: headache, anxiety, depression, dizziness, insomnia, mood swings, SUICIDAL THOUGHTS/BEHAVIOR.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).

Drug-Drug:

Strong OATP1B1 inhibitors, including cyclosporine and gemfibrozil may significantly ↑ levels; concurrent use contraindicated.
Estrogen-containing oral contraceptives may ↓ effectiveness; impact of progestin-containing oral contraceptives on effectiveness unknown; recommended to use nonhormonal contraceptives.
May ↑ estrogen exposure when used with estrogen-containing contraceptives, which may ↑ risk of thromboembolic events.
May ↓ levels of levonorgestrel-containing oral contraceptives , which may ↓ effectiveness.
May ↓ levels of CYP3A substrates, including midazolam.
May ↑ levels of CYP2C19 substrates, including omeprazole; consider ↓ omeprazole dose when using higher doses (>40 mg/day).
May ↑ levels of P-glycoprotein substrates, including digoxin; closely monitor digoxin levels.
Strong CYP3A inhibitors may ↑ levels; limit concurrent use with elagolix 200 mg twice daily to ≤1 mo; limit concurrent use with elagolix 150 mg once daily to ≤6 mo.
CYP3A inducers, including rifampin may ↓ levels; concurrent use with elagolix 200 mg twice daily not recommended; limit concurrent use with elagolix 150 mg once daily to ≤6 mo.
May ↓ rosuvastatin levels; consider ↑ rosuvastatin dose.

Tablets: 150 mg; 200 mg;
In combination with: estradiol/norethindrone (Oriahnn). See Appendix [not included in this PDA edition].

PO (Adults): No dyspareunia: 150 mg once daily for max duration of 24 mo; Coexisting dyspareunia: 200 mg twice daily for max duration of 6 mo.

Hepatic Impairment

PO (Adults): Moderate hepatic impairment: 150 mg once daily for max duration of 6 mo.

Competitively binds to and inhibits gonadotropin-releasing hormone receptors in the pituitary gland, causing a decrease in the release of estradiol and progesterone by the ovaries.

Therapeutic Effects:

Reduction in dysmenorrhea and nonmenstrual pelvic pain.

Therapeutic Classification: analgesics

Pharmacologic Classification: gnrh antagonist

Absorption: Rapidly absorbed.

Distribution: Unknown.

Metabolism/Excretion: Primarily metabolized in the liver via the CYP3A isoenzyme with some metabolism by the CYP2D6 and CYP2C8 isoenzymes as well as UGT. 90% of dose excreted in feces, <3% in urine.

Half-life: 4–6 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1 hr	24 hr

Instruct patient to take elagolix as directed. Take missed doses as soon as remembered if same day as missed dose, then return to regular dosing schedule; do not double doses. Advise patient to read Medication Guide before starting and with each Rx refill in case of changes.
Inform patient that elagolix may change menstrual periods (irregular bleeding or spotting, a decrease in menstrual bleeding, no bleeding at all), and make it hard to know if you are pregnant. Watch for other signs of pregnancy (breast tenderness, weight gain, nausea).
Advise patient and family to notify health care professional if signs and symptoms of mood or behavior changes (thoughts about suicide or dying, try to commit suicide, new or worse depression, new or worse anxiety, other unusual changes in behavior or mood) or liver problems (yellowing of skin or whites of eyes, dark amber-colored urine, feeling tired, nausea and vomiting, generalized swelling, right upper abdomen pain, bruising easily) occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially birth control pills.
Rep: May result in pregnancy loss if used in early pregnancy. Advise females of reproductive potential to use effective nonhormonal contraception during and for 28 days after last dose. Hormonal contraceptives may decrease effectiveness of elagolix and may increase risk of thromboembolic and vascular disorders. Advise patient to notify health care professional if pregnancy is planned or suspected, or if breastfeeding. Encourage patient to enroll in pregnancy registry to monitor outcomes of women who become pregnant while taking elagolix by calling 1-833-782-7241. Discontinue elagolix if pregnancy occurs.

NDC Code^*

0074- AbbVie Inc.
0074-0038- Orilissa 0074-0038-01- 1 BLISTER PACK in 1 CARTON (0074-0038-01) > 7 TABLET, FILM COATED in 1 BLISTER PACK

0074- AbbVie Inc.
0074-0038- Orilissa 0074-0038-07- 1 BLISTER PACK in 1 CARTON (0074-0038-07) > 7 TABLET, FILM COATED in 1 BLISTER PACK

0074- AbbVie Inc.
0074-0038- Orilissa 0074-0038-28- 4 BLISTER PACK in 1 CARTON (0074-0038-28) > 7 TABLET, FILM COATED in 1 BLISTER PACK

0074- AbbVie Inc.
0074-0039- Orilissa 0074-0039-01- 1 BLISTER PACK in 1 CARTON (0074-0039-01) > 14 TABLET, FILM COATED in 1 BLISTER PACK

0074- AbbVie Inc.
0074-0039- Orilissa 0074-0039-14- 1 BLISTER PACK in 1 CARTON (0074-0039-14) > 14 TABLET, FILM COATED in 1 BLISTER PACK

0074- AbbVie Inc.
0074-0039- Orilissa 0074-0039-56- 4 BLISTER PACK in 1 CARTON (0074-0039-56) > 14 TABLET, FILM COATED in 1 BLISTER PACK

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