OXBRYTA Patient Counseling Information

(voxelotor)

17 PATIENT COUNSELING INFORMATION

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

Hypersensitivity Reactions

Advise patients that serious hypersensitivity reactions including DRESS may occur, and to notify their healthcare providers if they develop generalized rash, urticaria, shortness of breath, facial swelling, swelling around their eyes, lips, or tongue, fever, fatigue, muscle and/or joint pain, swollen glands, and eosinophilia [see Warnings and Precautions (5.1)]. Inform patients that some severe hypersensitivity reactions may affect their internal organs (such as liver, kidneys, lungs) and their blood cells. Advise patients to stop OXBRYTA if a severe hypersensitivity reaction is suspected.

Breastfeeding

Advise women not to breastfeed while they are on OXBRYTA therapy [see Use in Specific Populations (8.2)].

Dosage and Administration

To avoid a dosing error from using the wrong formulation of OXBRYTA, strongly advise patients and caregivers to visually inspect the tablets to verify the correct formulation each time the prescription is filled [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)].

Advise patients to:

•
Store OXBRYTA at 20°C to 30°C (68°F to 86°F).
•
Continue taking OXBRYTA every day for as long as their physician tells them.
•
Do not take St John's wort while taking OXBRYTA.
•
Swallow OXBRYTA tablets whole. Do not cut, crush, or chew the tablets.
•
Do not swallow whole, cut, crush, or chew OXBRYTA tablets for oral suspension. Disperse OXBRYTA tablets for oral suspension in room temperature clear drink (such as drinking water, clear soda, apple juice, clear electrolyte drinks, clear flavored drinks, or clear sports drinks) before administration. The amount of liquid needed to disperse the tablets for oral suspension will depend on the dose (number of tablets prescribed) [see Dosage and Administration (2.7)].
•
Take OXBRYTA with or without food.
•
If a dose is missed or not consumed entirely, resume dosing the following day [see Dosage and Administration (2.7)].

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Health Professional Information

Patient Counseling Information

17 PATIENT COUNSELING INFORMATION

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

Hypersensitivity Reactions

Advise patients that serious hypersensitivity reactions including DRESS may occur, and to notify their healthcare providers if they develop generalized rash, urticaria, shortness of breath, facial swelling, swelling around their eyes, lips, or tongue, fever, fatigue, muscle and/or joint pain, swollen glands, and eosinophilia [see Warnings and Precautions (5.1)]. Inform patients that some severe hypersensitivity reactions may affect their internal organs (such as liver, kidneys, lungs) and their blood cells. Advise patients to stop OXBRYTA if a severe hypersensitivity reaction is suspected.

Breastfeeding

Advise women not to breastfeed while they are on OXBRYTA therapy [see Use in Specific Populations (8.2)].

Dosage and Administration

To avoid a dosing error from using the wrong formulation of OXBRYTA, strongly advise patients and caregivers to visually inspect the tablets to verify the correct formulation each time the prescription is filled [see Dosage and Administration (2) and How Supplied/Storage and Handling (16)].

Advise patients to:

•
Store OXBRYTA at 20°C to 30°C (68°F to 86°F).
•
Continue taking OXBRYTA every day for as long as their physician tells them.
•
Do not take St John's wort while taking OXBRYTA.
•
Swallow OXBRYTA tablets whole. Do not cut, crush, or chew the tablets.
•
Do not swallow whole, cut, crush, or chew OXBRYTA tablets for oral suspension. Disperse OXBRYTA tablets for oral suspension in room temperature clear drink (such as drinking water, clear soda, apple juice, clear electrolyte drinks, clear flavored drinks, or clear sports drinks) before administration. The amount of liquid needed to disperse the tablets for oral suspension will depend on the dose (number of tablets prescribed) [see Dosage and Administration (2.7)].
•
Take OXBRYTA with or without food.
•
If a dose is missed or not consumed entirely, resume dosing the following day [see Dosage and Administration (2.7)].
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