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Nuvista Pharma LtdProduct Description
Indication
Moderate to severe pain associated with endometriosis.
Pharmacology (Mechanism of Action)
GnRH receptor antagonist.
Blocks GnRH receptors in the pituitary gland → ↓ LH & FSH secretion → ↓ estradiol and progesterone levels.
Dosage & Administration
Before starting: Exclude pregnancy and start within 7 days of onset of menses.
150 mg once daily: Up to 24 months (moderate hepatic impairment: up to 6 months).
200 mg twice daily: Up to 6 months (especially with dyspareunia).
Not recommended: 200 mg in moderate to severe hepatic impairment.
<18 years: Safety and efficacy not established.
Drug Interactions
Increases effects of P-gp substrates (e.g., digoxin).
Increases effects of CYP2C19 substrates (e.g., omeprazole; max 40 mg/day).
May reduce effects of CYP3A substrates.
May reduce effectiveness of estrogen-containing contraceptives.
No significant food interaction.
Contraindications
Pregnancy.
Osteoporosis.
Severe hepatic impairment.
Concomitant use with strong OATP1B1 inhibitors (e.g., cyclosporine, gemfibrozil).
Side Effects
Common:
Hot flushes
Night sweats
Headache
Nausea
Amenorrhea
Arthralgia
Mood changes
Bone loss (↓ BMD)
Rare:
Insomnia
Anxiety
Elevated liver enzymes (ALT)
Pregnancy & Lactation
Contraindicated in pregnancy (may increase risk of early pregnancy loss).
Discontinue immediately if pregnancy occurs.
Safety during breastfeeding is unknown.
Precautions & Warnings
May cause bone mineral density (BMD) loss (dose & duration dependent).
Can alter menstrual bleeding, making pregnancy difficult to recognize.
Monitor for depression, anxiety, suicidal thoughts.
Monitor liver function (ALT).
Use non-hormonal contraception during treatment and for 1 week after stopping.
Special Populations
No dose adjustment in renal impairment (including dialysis).
No dose adjustment in mild hepatic impairment.
Not established in patients <18 years.
Overdose
Symptomatic and supportive treatment; monitor for adverse effects.
Therapeutic Class
Gonadotropin-Releasing Hormone (GnRH) antagonist
Storage
Store in a cool, dry place, protected from light and moisture.
Keep out of reach of children.
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