MYFEMBREE

1 Pregnant Women and 2 CONTRAINDICATIONS). • Limitations of Use: Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible (see 7 WARNINGS AND PRECAUTIONS). • Concomitant medications: Avoid concomitant use of MYFEMBREE with oral P-gp inhibitors.

4 Drug-Drug Interactions). 3 Pharmacokinetics). • It is recommended that the administration of MYFEMBREE be initiated as early as possible after the onset of menses but no later than 5 days after menses has started. If MYFEMBREE is initiated later in the menstrual cycle, irregular and/or heavy bleeding may initially occur.

1 Pediatrics). 2 Geriatrics). 4 Administration MYFEMBREE is to be taken at approximately the same time each day, with or without food. 3 Pharmacokinetics). Serious Warnings and Precautions • Estrogen and progestin combination products, including MYFEMBREE, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism (PE), deep vein thrombosis (DVT), stroke and myocardial infarction (MI), especially in women at increased risk for these events (see 7 WARNINGS AND PRECAUTIONS).

• MYFEMBREE is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke or women with uncontrolled hypertension (see 2 CONTRAINDICATIONS).

5 Missed Dose If a dose is missed, treatment must be taken as soon as possible the same day and then continue the next day at the usual time.

). In Phase 3 placebo-controlled clinical trials in women with heavy menstrual bleeding associated with uterine fibroids, more women experienced mild to moderate alopecia, hair loss, and hair thinning with MYFEMBREE compared to placebo.

For one MYFEMBREE-treated woman in the extension trials, For management of a suspected drug overdose, contact your regional poison control centre. Product Monograph MYFEMBREE (relugolix, estradiol, and norethindrone acetate tablets) Page 7 of 43 alopecia was a reason for discontinuing treatment.

The majority of affected women completed the study with reported hair loss ongoing. Whether the hair loss is reversible is unknown. There was no increase in alopecia, hair loss, and hair thinning observed among women with endometriosis-associated pain treated with MYFEMBREE as compared to placebo in the Phase 3 placebo-controlled clinical trials.

However, for three MYFEMBREE-treated women in the extension trial of endometriosis, alopecia was a reason for discontinuing treatment. Carbohydrate and Lipid Metabolism MYFEMBREE may decrease glucose tolerance and result in increased blood glucose concentrations.

More frequent monitoring in MYFEMBREE-treated women with prediabetes and diabetes may be necessary. Use of MYFEMBREE is associated with increases in total cholesterol and low-density lipoprotein cholesterol (LDL-C) [see 8 Adverse Reactions].

Monitor lipid levels and consider discontinuing MYFEMBREE if hypercholesterolemia or hypertriglyceridemia worsens. In women with pre-existing hypertriglyceridemia, estrogen therapy may be associated with elevations in triglycerides levels leading to pancreatitis.

, breast cancer and endometrial cancer) and in women at increased risk for hormone-sensitive malignancies (see 2 CONTRAINDICATIONS). Discontinue MYFEMBREE if a hormone-sensitive malignancy is diagnosed. Surveillance measures in accordance with standard of care, such as breast examinations and mammography are recommended.

). g. myocardial infarction, stroke, coronary heart disease, cerebrovascular accident, ischemic heart disease). • have inherited or acquired hypercoagulopathies. • have uncontrolled hypertension. • have headaches with focal neurological symptoms or migraine headaches with aura if over 35 years of age.

• smoke if over 35 years of age. 1 Pregnant Women). • use hormonal contraceptives concomitantly. • are known to have osteoporosis. • have known, suspected, or history of breast cancer or other hormone-sensitive endometrial cancer), or with increased risk for hormone-sensitive malignancies (see 7 WARNINGS AND PRECAUTIONS).

• have presence or history of liver tumours (benign or malignant), liver dysfunction, or liver disease as long as liver function values have not returned to normal (see 7 WARNINGS AND PRECAUTIONS). • have genital bleeding of unknown aetiology.

• partial or complete loss of vision from ophthalmic vascular disease. • endometrial hyperplasia. Product Monograph MYFEMBREE (relugolix, estradiol, and norethindrone acetate tablets) Page 5 of 43 • are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). 1 Pregnant Women and 2 CONTRAINDICATIONS). • Limitations of Use: Use of MYFEMBREE should be limited to 24 months due to the risk of continued bone loss which may not be reversible (see 7 WARNINGS AND PRECAUTIONS).

• Concomitant medications: Avoid concomitant use of MYFEMBREE with oral P-gp inhibitors. 4 Drug-Drug Interactions). 3 Pharmacokinetics). • It is recommended that the administration of MYFEMBREE be initiated as early as possible after the onset of menses but no later than 5 days after menses has started.

If MYFEMBREE is initiated later in the menstrual cycle, irregular and/or heavy bleeding may initially occur. 1 Pediatrics). 2 Geriatrics). 4 Administration MYFEMBREE is to be taken at approximately the same time each day, with or without food.

g. deep venous thrombosis, pulmonary embolism) (see 7 WARNINGS AND PRECAUTIONS). g. myocardial infarction, stroke, coronary heart disease, cerebrovascular accident, ischemic heart disease). • have inherited or acquired hypercoagulopathies.

• have uncontrolled hypertension. • have headaches with focal neurological symptoms or migraine headaches with aura if over 35 years of age. • smoke if over 35 years of age. 1 Pregnant Women). • use hormonal contraceptives concomitantly.

• are known to have osteoporosis. • have known, suspected, or history of breast cancer or other hormone-sensitive endometrial cancer), or with increased risk for hormone-sensitive malignancies (see 7 WARNINGS AND PRECAUTIONS). • have presence or history of liver tumours (benign or malignant), liver dysfunction, or liver disease as long as liver function values have not returned to normal (see 7 WARNINGS AND PRECAUTIONS).

• have genital bleeding of unknown aetiology. • partial or complete loss of vision from ophthalmic vascular disease. • endometrial hyperplasia. Product Monograph MYFEMBREE (relugolix, estradiol, and norethindrone acetate tablets) Page 5 of 43 • are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).