(voxelotor)

Prescribing Information
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6 ADVERSE REACTIONS

6 ADVERSE REACTIONS

The following clinically significant adverse reaction is discussed in other sections of the labeling:

•
Hypersensitivity Reactions [see Contraindications (4) and Warnings and Precautions (5.1)].

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults and Pediatric Patients 12 Years and Older

The safety of OXBRYTA was evaluated in the HOPE trial based on data from 88 patients with SCD who received OXBRYTA 1,500 mg and 91 patients who received placebo orally once daily [see Clinical Studies (14.1)]. Seventy-four patients received OXBRYTA 1,500 mg once daily for ≥24 weeks, 65 patients for ≥48 weeks, and 63 patients completed the 72-week treatment period.

In patients who received OXBRYTA 1,500 mg once daily the median age was 24 years (range:12 to 59 years); 65% female; 66% Black or African American and 23% Arab/Middle Eastern; and 65% receiving hydroxyurea at baseline.

Serious adverse reactions occurred in 3% (3/88) of patients receiving OXBRYTA 1,500 mg, which included headache, drug hypersensitivity, and pulmonary embolism occurring in 1 patient each. Permanent discontinuation due to an adverse reaction (Grades 1-4) occurred in 5% (4/88) of patients who received OXBRYTA 1,500 mg.

Dosage modifications (dose reduction or dosing interruption) due to adverse reactions occurred in 14% (12/88) of patients who received OXBRYTA 1,500 mg. The adverse reactions requiring dosage modification included rash (4.5%), diarrhea (3.4%), headache (2.3%), nausea (2.3%), abdominal pain (1.1%), and drug hypersensitivity (1.1%).

The safety profile observed in pediatric patients 12 to <17 years treated with OXBRYTA in the HOPE trial was similar to that seen in adult patients.

The most common adverse reactions occurring in ≥10% of patients treated with OXBRYTA 1,500 mg with a difference of >3% compared to placebo are summarized in Table 4.

Table 4: Adverse Reactions (≥10%) in Patients Receiving OXBRYTA with a Difference Between Arms of >3% Compared to Placebo in HOPE
Adverse Reaction*OXBRYTA
1,500 mg
(N=88)		Placebo
(N=91)
*
Adverse reactions were Grades 1 or 2 except for Grade 3 headache (2), diarrhea (1), nausea (1), rash (1), and rash generalized (3)
†
Abdominal pain (grouped PTs) includes the following PTs: abdominal pain, lower abdominal pain, and upper abdominal pain
‡
Rash (grouped PTs) includes the following PTs: rash, urticaria, generalized rash, macular rash, maculo-papular rash, pruritic rash, and papular rash

Headache

32%

25%

Diarrhea

23%

11%

Abdominal Pain†

23%

16%

Nausea

19%

10%

Rash‡

15%

11%

Pyrexia

15%

8%

Clinically relevant adverse reactions occurring in <10% of patients included:

•
Drug hypersensitivity

Pediatric Patients 4 to <12 Years

The safety of OXBRYTA in pediatric patients 4 to <12 years with SCD was evaluated in an open-label, Phase 2 study [see Clinical Studies (14.2)]. In this study, 45 patients 4 to <12 years of age received doses of OXBRYTA tablets for oral suspension based on weight at baseline. Thirty-five patients received OXBRYTA for 24 weeks and 26 patients for 48 weeks. The most common adverse reactions (>10%) reported in pediatric patients 4 to <12 years were pyrexia (36%), vomiting (33%), rash (20%), abdominal pain (18%), diarrhea (18%), and headache (18%).

The overall safety profile of OXBRYTA in pediatric patients 4 to <12 years was similar to that seen in adults and pediatric patients 12 years and older.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of OXBRYTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

•
Drug reaction with eosinophilia and systemic symptoms (DRESS), Pruritis, Angioedema (including swelling of eyelid, face edema, lip swelling, and periorbital swelling).
Medication Guide

MEDICATION GUIDE

This Patient Information has been approved by the U.S. Food and Drug Administration

Revised: 08/2023

PATIENT INFORMATION

OXBRYTA® (ox brye ta)
(voxelotor)
tablets

 

OXBRYTA® (ox brye ta)
(voxelotor)
tablets for oral suspension

What is OXBRYTA?
OXBRYTA is a prescription medicine used for the treatment of sickle cell disease in adults and children 4 years of age and older.
It is not known if OXBRYTA is safe and effective in children with sickle cell disease below 4 years of age.

Do not take OXBRYTA if you or your child have had an allergic reaction to voxelotor or any of the ingredients in OXBRYTA. See the end of this leaflet for a list of the ingredients in OXBRYTA.

Before taking OXBRYTA, tell your healthcare provider about all of your medical conditions, including if you or your child:

•
have liver problems
•
are pregnant or plan to become pregnant. It is not known if OXBRYTA can harm your unborn baby.
•
are breastfeeding or plan to breastfeed. It is not known if OXBRYTA can pass into your breastmilk and if it can harm your baby. Do not breastfeed during treatment with OXBRYTA and for at least 2 weeks after the last dose.

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how OXBRYTA works. OXBRYTA may also affect how other medicines work and may affect the results of certain blood tests. Keep a list of all your medicines and show it to your healthcare provider.

How should I take OXBRYTA?

•
Take OXBRYTA exactly as your healthcare provider tells you.
•
Do not change your dose or stop taking OXBRYTA unless your healthcare provider tells you to. Your healthcare provider may change your dose if needed.
•
Take your prescribed dose of OXBRYTA 1 time each day.
•
Take OXBRYTA with or without food.
•
OXBRYTA comes in two different dosage forms, OXBRYTA tablets and OXBRYTA tablets for oral suspension. Your healthcare provider will decide which dosage form you take based on your age, weight, and ability to swallow tablets.
o
If you take OXBRYTA tablets: Swallow each OXBRYTA tablet whole. Do not cut, crush, or chew the tablets.
o
If you take OXBRYTA tablets for oral suspension: See the detailed Instructions for Use on how to prepare and take your dose. You must mix the 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, right before taking it. Do not swallow whole, cut, crush, or chew the tablets for oral suspension.
•
Check to make sure you receive the correct dosage form of OXBRYTA each time your prescription is filled to avoid taking the wrong medicine.
•
Your healthcare provider may also prescribe a medicine called hydroxyurea during treatment with OXBRYTA.
•
If you or your child miss a dose of OXBRYTA or if the entire dose is not taken, skip that dose and return to your normal dosing schedule the next day.

What should I avoid while taking OXBRYTA?
Do not take St. John's wort during treatment with OXBRYTA.

What are the possible side effects of OXBRYTA?
OXBRYTA can cause serious side effects, including:

•
Severe skin rash and serious allergic reactions. Treatment with OXBRYTA may cause severe skin reactions and serious allergic reactions. The organs in your body may also be affected, such as your liver, kidneys or lungs, and your blood cells.
•
Stop taking OXBRYTA, and tell your healthcare provider or get emergency medical help right away if you develop any of the following signs or symptoms during treatment:
o
rash
o
hives
o
high temperature (fever)
o
swollen glands (lymph nodes)
o
trouble swallowing
o
shortness of breath (difficult breathing)
o
swelling of your face, around your eyes, lips, or tongue
o
lack of energy and tiredness (fatigue)
o
muscle or joint aches

The most common side effects of OXBRYTA include:

•
headache
•
diarrhea
•
stomach-area (abdominal) pain
•
nausea
•
rash or hives
•
fever

The most common side effects of OXBRYTA in children ages 4 to less than 12 years of age include:

•
fever
•
vomiting
•
rash
•
stomach-area (abdominal) pain
•
diarrhea
•
headache

These are not all the possible side effects of OXBRYTA.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Pfizer Inc. at 1-800-438-1985.

How should I store OXBRYTA?

•
Store OXBRYTA between 68°F to 86°F (20°C to 30°C).
•
The OXBRYTA bottle comes with a child-resistant closure.
•
The OXBRYTA bottle may contain a desiccant canister to help keep your medicine dry (protect it from moisture) and a polyester coil. Do not eat the desiccant or polyester coil.

Keep OXBRYTA and all medicines out of the reach of children.

General information about the safe and effective use of OXBRYTA.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use OXBRYTA for a condition for which it was not prescribed. Do not give OXBRYTA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about OXBRYTA that is written for health professionals.

What are the ingredients of OXBRYTA?
Active Ingredient: voxelotor
Inactive Ingredients:
OXBRYTA tablets: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The 500 mg tablet film coating contains: polyethylene glycol 3350, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide. The 300 mg tablet film coating contains: black and red iron oxide, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide.
OXBRYTA tablets for oral suspension: artificial grape flavor, colloidal silicon dioxide, croscarmellose sodium, iron oxide pigment, magnesium stearate, microcrystalline cellulose, and sucralose.

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Distributed by

Global Blood Therapeutics, Inc

A subsidiary of Pfizer Inc.

South San Francisco, CA 94080

LAB-1567-1.0

For more information, go to www.pfizer.com or call 1-800-438-1985.

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To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.