Rehanzil (40mg+1mg+0.5mg) Tablet

✔️ Uses of Rehanzil

• Helps reduce heavy periods caused by uterine fibroids.
• May be used to treat pain from endometriosis.

✔️ How does Rehanzil work?

• Relugolix decreases the amount of estrogen and other hormones the body makes.
• This reduction in hormones helps in reducing heavy bleeding and pain associated with uterine fibroids and endometriosis.
• Estradiol lowers the risk of bone loss caused by relugolix.
• Norethindrone helps lower the risk of cancer that can be caused by estradiol.
• The medication contains the hormones estrogen and progestin.

✔️ Side Effects of Rehanzil

The most common adverse reactions (incidence >3%): Hot flush, Hyperhidrosis or night sweats, Uterine bleeding, Alopecia, Decreased libido, increased sweating, night sweats, and menstrual period changes.

✔️ Quick Suggestions:

• Exclude pregnancy and discontinue hormonal contraceptives before initiation.
• Orally take one tablet once daily.
• In case of a missed dose, take it as soon as possible on the same day and resume regular dosing the next day.
• If using oral P-gp inhibitors, take the tablet at least 6 hours before the inhibitor.
• Safety and effectiveness in pediatric patients have not been established.

✔️ Indications

Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

✔️ Pharmacology

• Relugolix decreases the amount of estrogen and other hormones the body makes.
• This reduction in hormones helps in reducing heavy bleeding and pain associated with uterine fibroids and endometriosis.
• Estradiol lowers the risk of bone loss caused by relugolix.
• Norethindrone helps lower the risk of cancer that can be caused by estradiol.
• The medication contains the hormones estrogen and progestin.

✔️ Dosage & Administration of Rehanzil

Adult Dosage for Uterine Fibroids:

• Tablet: 40 mg/1 mg/0.5 mg
• Take 1 tablet (Relugolix 40 mg/estradiol 1 mg/norethindrone 0.5 mg) orally every day.
• Start as early as possible after the onset of menses but no later than 7 days after menses have started.

Adult Dosage for Endometriosis Pain:

• Tablet: 40 mg/1 mg/0.5 mg
• Take 1 tablet (Relugolix 40 mg/estradiol 1 mg/norethindrone 0.5 mg) orally every day.
• Start as early as possible after the onset of menses, but no later than 7 days after menses have started.

✔️ Interaction

Do Not Modify Medication Without Consultation:

• Do not start, stop, or change the dosage of any medicine without checking with your doctor, healthcare provider, or pharmacist first.

Severe Interactions:

• Relugolix-Estradiol-Norethindrone has severe interactions with specific drugs, such as mifepristone and ospemifene.

Serious Interactions:

• There are serious interactions with at least 54 other drugs.

Moderate Interactions:

• Moderate interactions exist with at least 85 other drugs.

Minor Interactions:

• Minor interactions are noted with at least 37 other drugs.

✔️ Contraindications

• Pregnancy
• Osteoporosis
• Current or history of breast cancer or other hormone-sensitive malignancies
• Hepatic impairment or disease
• Undiagnosed abnormal uterine bleeding
• Hypersensitivity to drug or its components
• High risk of arterial, venous thrombotic, or thromboembolic disorder
• Examples include women aged ≥35 years who smoke and are known to have
• Current or history of DVT or PE
• Vascular disease (eg, cerebrovascular disease, coronary artery disease, peripheral vascular disease)
• Thrombogenic valvular or thrombogenic rhythm diseases of the heart (eg, subacute bacterial endocarditis with valvular disease, atrial fibrillation)
• Inherited or acquired hyper coagulopathies
• Uncontrolled hypertension
• Headaches with focal neurological symptoms or migraine headaches with auras

✔️ Pregnancy & Lactation

• May cause early pregnancy loss; discontinue if pregnancy occurs.
• No data on the presence of relugolix or its metabolites in human milk. Detected in rat milk.

✔️ Precautions & Warnings

Thromboembolic Disorders and Vascular Events:

• Discontinue if arterial or venous thrombotic, cardiovascular, or cerebrovascular event occurs.

Bone Loss:

• Decreases in Bone Mineral Density (BMD) may not be completely reversible.

Depression, Mood Disorders, and Suicidal Ideation:

• Advise seeking medical attention for new-onset or worsening depression, anxiety, or mood changes.

Risk of Early Pregnancy Loss:

• Can cause early pregnancy loss; advise effective non-hormonal contraception.

✔️ Storage Conditions

Store in a cool and dry place, protected from light.