RETACRIT™ Patient Counseling Information

(epoetin alfa-epbx)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Inform patients:

•
Of the increased risks of mortality, serious cardiovascular reactions, thromboembolic reactions, stroke, and tumor progression [see Warnings and Precautions (5.1, 5.2)].
•
To undergo regular blood pressure monitoring, adhere to prescribed anti-hypertensive regimen and follow recommended dietary restrictions.
•
To contact their healthcare provider for new-onset neurologic symptoms or change in seizure frequency.
•
Of the need to have regular laboratory tests for hemoglobin.
•
Risks are associated with benzyl alcohol in neonates, infants, pregnant women, and lactating women [see Use in Specific Populations (8.1, 8.2, 8.4)].

Instruct patients who self-administer RETACRIT of the:

•
Importance of following the Instructions for Use.
•
Dangers of reusing needles, syringes, or unused portions of single-dose vials.
•
Proper disposal of used syringes, needles, and unused vials, and of the full container.

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Health Professional Information

Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Inform patients:

•
Of the increased risks of mortality, serious cardiovascular reactions, thromboembolic reactions, stroke, and tumor progression [see Warnings and Precautions (5.1, 5.2)].
•
To undergo regular blood pressure monitoring, adhere to prescribed anti-hypertensive regimen and follow recommended dietary restrictions.
•
To contact their healthcare provider for new-onset neurologic symptoms or change in seizure frequency.
•
Of the need to have regular laboratory tests for hemoglobin.
•
Risks are associated with benzyl alcohol in neonates, infants, pregnant women, and lactating women [see Use in Specific Populations (8.1, 8.2, 8.4)].

Instruct patients who self-administer RETACRIT of the:

•
Importance of following the Instructions for Use.
•
Dangers of reusing needles, syringes, or unused portions of single-dose vials.
•
Proper disposal of used syringes, needles, and unused vials, and of the full container.
Medication Guide

Health Professional Information

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