Endolix 200 mg (Tablet)

Unit Price: ৳ 235.00 (1 x 10: ৳ 2,350.00)
Strip Price: ৳ 2,350.00

Medicine Details

Category Details
Generic Elagolix sodium
Company Eskayef pharmaceuticals ltd
Also available as
Endolix 150 mg tablet

Indications

  • Management of moderate to severe pain associated with endometriosis

Pharmacology

  • GnRH receptor antagonist
  • Inhibition of endogenous GnRH signaling
  • Competitive binding to GnRH receptors
  • Suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
  • Decreased blood concentrations of estradiol and progesterone

Dosage & Administration

  • Exclusion of pregnancy before starting treatment
  • Initiation within 7 days from the onset of menses
  • Initial treatment with 150 mg once daily up to 24 months
  • Initial treatment with 200 mg twice daily up to 6 months
  • Limitation of 150 mg dose to 6 months in case of moderate hepatic impairment
  • Restriction of 200 mg treatment to 6 months in coexisting dyspareunia
  • Incompatibility of 200 mg treatment with moderate to severe hepatic impairment
  • Lack of established use in children and adolescents below 18 years

Interaction

  • Potentiation of P-gp substrates
  • Limitation of doses for CYP2C19 substrates
  • Antagonism with CYP3A substrates
  • Consideration for increasing doses of oral midazolam and rosuvastatin
  • Antagonism by CYP3A inducers
  • Reduced efficacy with estrogen-containing contraceptives
  • No known food interaction

Contraindications

  • Pregnancy
  • Known osteoporosis
  • Severe hepatic impairment
  • Concomitant use of strong organic anion transporting polypeptide OATP1B1 inhibitors (e.g. cyclosporine and gemfibrozil)

Side Effects

  • Common: hot flushes, night sweats, headache, nausea, amenorrhea, arthralgia, mood changes, bone loss
  • Rare: insomnia, anxiety, elevated hepatic transaminase

Pregnancy & Lactation

  • Insufficient human data
  • Risk of early pregnancy loss
  • Use contraindicated in pregnant women
  • Discontinuation if pregnancy occurs during treatment
  • No information on presence in human milk, effects on the breastfed child, or effects on milk production

Precautions & Warnings

  • Dose and duration-dependent decreases in bone mineral density (BMD)
  • Assessment of BMD in women with additional risk factors for bone loss
  • Reduced ability to recognize pregnancy
  • Potential for altered menstrual bleeding
  • Need for testing if pregnancy is suspected
  • Discontinuation if pregnancy is confirmed
  • Advisement for seeking medical attention for suicidal ideation, mood disorders, and signs of liver injury
  • Requirement for non-hormonal contraception during and after treatment
  • No dose adjustment required in women with any degree of renal impairment or end-stage renal disease
  • No dosage adjustment required in women with mild hepatic impairment
  • Safety and effectiveness not established in patients less than 18 years of age

Use in Special Populations

  • No dose adjustment required in women with any degree of renal impairment or end-stage renal disease (including women on dialysis)
  • No dosage adjustment required in women with mild hepatic impairment
  • Safety and effectiveness not established in patients less than 18 years of age

Overdose Effects

  • Need for monitoring of signs or symptoms of adverse reactions
  • Initiation of appropriate symptomatic treatment, as needed

Therapeutic Class

  • Gonadotropin-releasing hormone (GnRH) antagonist

Storage Conditions

  • Requirement of storing in a cool & dry place
  • Protection from light & moisture
  • Necessity to keep all medicines out of reach of children

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