Orili 150mg Tablet

✔️ Uses of Orili 150

Treatment of Endometriosis

✔️ Side Effects of Orili 150

• Common Side Effects:
  • Hot flushes
  • Night sweats
  • Headache
  • Nausea
  • Amenorrhea (absence of menstruation)
  • Arthralgia (joint pain)
  • Mood changes
  • Bone loss
• Rare but Serious Side Effects:
  • Insomnia
  • Anxiety
  • Elevated Hepatic Transaminase Levels: Indicators of liver dysfunction.

If you experience any severe or persistent side effects, discontinue use and consult your doctor immediately.

✔️

Adult Dosage:

• Initial Treatment:
  • 150 mg: 150 mg once daily for up to 24 months.
    • Note: For patients with moderate hepatic impairment, the duration is limited to 6 months.
  • 200 mg: 200 mg twice daily for up to 6 months, particularly for those experiencing coexisting dyspareunia.
    • Caution: Prolonged use beyond 6 months may lead to decreased bone mineral density (BMD).

Pediatric Use:

• Safety and efficacy in children and adolescents under 18 years of age have not been established.

Hepatic Impairment:

• Moderate Impairment: Elagolix 200 mg is not recommended.

Confirm pregnancy status before initiating treatment with Elagolix. Begin treatment within 7 days from the onset of menstruation.

Always follow your registered physician’s guidance regarding dosage adjustments and duration of therapy.

✔️ Competitive Binding:

Elagolix binds to GnRH receptors in the pituitary gland, blocking the natural GnRH signaling pathway.

Hormonal Suppression: This inhibition reduces the secretion of gonadotropins:

• Luteinizing Hormone (LH)
• Follicle-stimulating hormone (FSH)

Reduction of Ovarian Sex Hormones: The suppressed gonadotropins lead to a dose-dependent decrease in ovarian hormone production:

• Estradiol
• Progesterone

By reducing estradiol and progesterone levels, elagolix helps manage conditions like endometriosis, where these hormones play a role in symptom exacerbation.

✔️ Interactions

• With Other Medications:
  • Cimetidine or Probenecid: May increase Elagolix plasma concentrations.
  • CNS Depressants (e.g., Lorazepam): May enhance depressive effects on the central nervous system, leading to increased sedation.
  • P-gp Substrates (e.g., Digoxin) and CYP2C19 Substrates (e.g., Omeprazole): Dose adjustments may be necessary to prevent elevated levels.
  • CYP3A Substrates: Elagolix may antagonize these medications; consider adjusting their doses accordingly.
  • OAT1, OAT3, OCT2, MATE1, MATE2-K, UGT Inhibitors: Co-administration may increase Elagolix exposure; use with caution.
• With Food:
  • No significant interactions with food have been observed. However, alcohol consumption should be avoided as it can potentiate the impairment of motor skills and enhance the sedative effects of Elagolix.

✔️ Orili is contraindicated in the following scenarios:

• Pregnancy: Elagolix exposure early in pregnancy may increase the risk of miscarriage.
• Osteoporosis: Known osteoporosis can be exacerbated, increasing the risk of further bone loss.
• Severe Hepatic Impairment: Not recommended for use.
• Concurrent Use with Strong OATP1B1 Inhibitors: Such as cyclosporine and gemfibrozil.

✔️ Pregnancy & Lactation

• Pregnancy:
  • Limited human data are available regarding the use of Elagolix during pregnancy.
  • Animal studies indicate potential risks, including an increased likelihood of early pregnancy loss.
  • Use is contraindicated in pregnant women. If pregnancy occurs during treatment, discontinue Elagolix and consult your healthcare provider.
• Lactation:
  • It is unknown whether Elagolix or its metabolites are excreted in human breast milk.
  • Animal studies have shown transfer into milk.
  • Weigh the benefits of breastfeeding against any potential risks before continuing nursing while on Elagolix.

✔️ Precautions & Warnings

• Bone Health:
  • Elagolix may cause dose- and duration-dependent decreases in bone mineral density (BMD).
  • Regularly assess BMD in women with additional risk factors for bone loss.
• Pregnancy Recognition:
  • Altered menstrual bleeding may reduce the ability to recognize pregnancy. Perform pregnancy testing if pregnancy is suspected.
• Mental Health:
  • Monitor for suicidal ideation, suicidal behavior, depression, anxiety, or other mood changes. Seek medical attention if these symptoms occur.
• Liver Function:
  • Be aware of symptoms indicating liver injury, such as nausea, vomiting, and jaundice. Regular blood tests may be necessary to monitor liver function.
• Contraception:
  • Elagolix may reduce the efficacy of estrogen-containing contraceptives. Use non-hormonal contraception methods during treatment and for one week after discontinuation.

✔️ Storage Conditions

• Store Orili tablets in a cool, dry place away from light and moisture.
• Keep out of reach of children to prevent accidental ingestion.