DUAVEE® Patient Counseling Information

(conjugated estrogens/bazedoxifene)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

17.1 Instructions for Patients

•
Keep DUAVEE in the original container to protect from moisture. Do not place DUAVEE in pill boxes or pill organizers.
•
If more than one blister package is dispensed to the patient, instruct them to open one foil pouch at a time.
•
Instruct patient to record the date the blister package is opened in the space provided on the blister package label. Do not use if the blister package has been open more than 60 days.
•
Instruct patient to remove only one tablet from the blister package at the time of use.

17.2 Venous Thromboembolic Events

Advise patients to immediately report to their physician any signs or symptoms related to venous thrombosis and thromboembolic events [see Warnings and Precautions (5.2)].

17.3 Abnormal Vaginal Bleeding

Inform postmenopausal women of the importance of reporting abnormal vaginal bleeding to their healthcare provider as soon as possible [see Warnings and Precautions (5.3)].

17.4 Possible Serious Adverse Reactions with Estrogen Therapy

Inform postmenopausal women of possible serious adverse reactions of estrogen therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see Warnings and Precautions (5.2, 5.3, 5.4)].

17.5 Possible Less Serious Adverse Reactions with DUAVEE

Inform postmenopausal women of possible less serious but common adverse reactions of DUAVEE therapy such as muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, throat pain, dizziness and neck pain.

17.6 Calcium and Vitamin D Intake

Advise patients to add supplemental calcium and/or vitamin D to the diet if daily intake is inadequate.

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Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

17.1 Instructions for Patients

•
Keep DUAVEE in the original container to protect from moisture. Do not place DUAVEE in pill boxes or pill organizers.
•
If more than one blister package is dispensed to the patient, instruct them to open one foil pouch at a time.
•
Instruct patient to record the date the blister package is opened in the space provided on the blister package label. Do not use if the blister package has been open more than 60 days.
•
Instruct patient to remove only one tablet from the blister package at the time of use.

17.2 Venous Thromboembolic Events

Advise patients to immediately report to their physician any signs or symptoms related to venous thrombosis and thromboembolic events [see Warnings and Precautions (5.2)].

17.3 Abnormal Vaginal Bleeding

Inform postmenopausal women of the importance of reporting abnormal vaginal bleeding to their healthcare provider as soon as possible [see Warnings and Precautions (5.3)].

17.4 Possible Serious Adverse Reactions with Estrogen Therapy

Inform postmenopausal women of possible serious adverse reactions of estrogen therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see Warnings and Precautions (5.2, 5.3, 5.4)].

17.5 Possible Less Serious Adverse Reactions with DUAVEE

Inform postmenopausal women of possible less serious but common adverse reactions of DUAVEE therapy such as muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, throat pain, dizziness and neck pain.

17.6 Calcium and Vitamin D Intake

Advise patients to add supplemental calcium and/or vitamin D to the diet if daily intake is inadequate.
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