Medicine Overview
Adult Dose
| Clinical Information | Administration Information |
|---|---|
|
Indication: Heavy menstrual bleeding associated with uterine leiomyomas (Uterine Fibroids) Age: Premenopausal women |
Dose: Oral Tablet – 1 tablet (relugolix 40 mg, estradiol 1 mg, norethindrone 0.5 mg) Frequency: once daily Duration: 24 months Note: Start as early as possible after onset of menses but no later than 7 days after menses has started. |
|
Indication: Heavy menstrual bleeding associated with uterine leiomyomas (Uterine Fibroids) Condition: Hepatic impairment |
Dose: Oral Tablet – Contraindicated Note: Use of estradiol in patients with hepatic impairment is expected to increase exposure to estradiol and increase the risk of estradiol-associated adverse reactions. |
Child Dose
| Clinical Information | Administration Information |
|---|---|
|
Age: Pediatric |
Dose: No approved pediatric dosage available Note: Not recommended |
Renal Dose
| Clinical Information | Administration Information |
|---|---|
|
Condition: Renal impairment, Mild-to-severe (CrCl 15-89 mL/min) |
Dose: No dosage adjustment required Note: Estradiol, norethindrone, and end-stage renal disease not studied |
Administration
- May take with or without food
- Take at same time daily
Side Effect
- Hot flush
- hyperhidrosis
- or night sweats (10.6%)
- Increased total cholesterol 130 to Less than 160 mg/dL (9.3%)
- Abnormal uterine bleeding (6.3%)
- Alopecia (3.5%)
- Libido decreased (3.1%)
- Irritability (2-3%)
- Dyspepsia (2-3%)
- Breast cyst (2-3%)
- Depression (2.4%)
- Irritability (2.4%)
- Increased total cholesterol More than 240 mg/dL (1.7%)
- Increased total cholesterol 160 to Less than 190 mg/dL (1.5%)
- Anxiety (1.2%)
- Low trauma fractures (defined as a fall from standing height or less) (0.6%)
- Increased total cholesterol ≥190 mg/dL (0.5%)
- Uterine myoma expulsion (0.4%)
- Uterine leiomyoma (prolapse) (0.4%)
- Suicidal ideation
Drug Interaction
Drug Interaction
| Drug Name | Risk Factors |
|---|---|
|
No interactions listed
|
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Disease Interaction
Disease Interaction
| Disease Name | Risk Factors |
|---|---|
|
No specific contraindications listed
|
Monitor for general drug reactions
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Pregnancy
Pregnancy
Lactation
Special Use
Precaution
Overdose
Pharmacology
Storage
Details coming soon
Data Sources
Clinical & regulatory information on this page is compiled from the following government sources:
DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.