Endometriosis:

Indications for ORILISSA:

Moderate to severe pain associated with endometriosis.

Limitations of Use:

Limit the duration of use based on the dose and coexisting condition.

Adult Dosage:

Exclude pregnancy prior to starting or begin within 7 days from onset of menses. Use lowest effective dose. Initiate at 150mg once daily for up to 24 months. If dyspareunia: consider initiating with 200mg twice daily for up to 6 months. Concomitant strong CYP3A inhibitors, rifampin, or if moderate hepatic impairment: limit to 150mg once daily for up to 6 months.

Children Dosage:

<18yrs: not established.

ORILISSA Contraindications:

Pregnancy. Osteoporosis. Severe hepatic impairment. Concomitant OATP 1B1 inhibitors.

ORILISSA Warnings/Precautions:

Risk of decrease in bone mineral density (BMD). Consider BMD assessment in those with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss; supplementation with calcium and Vit.D may be beneficial. History of suicidality or depression. Evaluate if new onset or worsening depression, anxiety, other mood changes occur. Evaluate if signs/symptoms of liver injury (eg, jaundice, elevated liver tests) occurs. Reduced ability to recognize pregnancy. Perform pregnancy testing if suspected; discontinue if confirmed. Advise women to use effective non-hormonal contraceptives during therapy and for 28 days after discontinuation. Nursing mothers.

ORILISSA Classification:

GnRH antagonist.

ORILISSA Interactions:

See Adults and Contraindications. May potentiate P-gp substrates (eg, digoxin; monitor), CYP2C19 substrates (eg, omeprazole; limit doses to ≤40mg daily). May antagonize CYP3A substrates. Antagonizes oral midazolam, rosuvastatin: consider increasing their doses. May be antagonized by strong CYP3A inducers (eg, rifampin). Potentiates ethinyl estradiol. Antagonizes levonorgestrel. Reduced efficacy with estrogen-containing contraceptives.

Adverse Reactions:

Hot flushes, night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions, mood changes; bone loss, elevated hepatic transaminase, change in lipid parameters or menstrual bleeding pattern.

Generic Drug Availability:

NO

How Supplied:

Tabs 150mg—28; 200mg—56

Pricing for ORILISSA

28 tablets of 150mg dose pack (Qty: 1)
Appx. price $980
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