DR SHAH:

“I’m Dr. Nirmish Shah. I’m an associate professor in both medicine and pediatrics. I’m also the director of the transition program there where I care for both pediatric and adult patients.”

MUYIWA:

“My name is Muyiwa. I am 36 years old. I currently live in Durham, North Carolina by the way of Nigeria. Been here since I was a child.”

NARRATOR:

"INDICATION

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.

This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

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 the patient leaflet for a list of the ingredients in OXBRYTA.”

DR SHAH:

“It was really quite clear when Muyiwa came into the office that he was having problems.”

MUYIWA:

“I was telling Dr. Shah that I can’t do this anymore…that I don’t know what’s next.”

DR SHAH:

“And I think that really highlighted the fact that he was tired, and his hemoglobin was really low.”

DR SHAH:

“The first thing that came to mind was Oxbryta.”

DR SHAH:

“And the reason being… it’s trying to prevent hemolysis. It’s trying to improve anemia. And so that, in itself right there in trying to customize a therapy plan for Muyiwa, it was really trying to address the fact that can I get his hemoglobin higher?”

MUYIWA:

“I trust him. So, I said yes.”

DR SHAH:

“I really want to make sure the patient understands what this drug can do for them.”

DR SHAH:

“So, the side effects for Oxbryta that we discuss with all our patients are headaches, abdominal pain, nausea, diarrhea.”

DR SHAH:

“So, compliance with Oxbryta is extremely important. We need our patients to understand that they need to take this medication every single day. And to get maximal benefit, you have to take it as we direct, which is once a day.”

DR SHAH:

“So, when Muyiwa returned to clinic, his labs were pretty clear that his hemoglobin had risen.”

MUYIWA:

“It was just a joyous moment for me, knowing that my hemoglobin was going to a good place.”

DR SHAH:

“The labs in regards to hemolysis markers like bilirubin, reticulocyte count, they all had significantly improved. They all had decreased. And that was something that sustained over the months that we followed him after that.”

DR SHAH:

“It was really quite happy of a situation that he came in with a smile, which is not hard, but he came in with a swagger.”

MUYIWA:

“The fact that Oxbryta is treating sickle cell means everything”

MUYIWA:

“I still have good days and bad days, just like, you know, anybody. But I’m just thankful for what Oxbryta has done for me, and I’m very hopeful. I’m hopeful for the future.”

NARRATOR:

“IMPORTANT SAFETY INFORMATION

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.”

NARRATOR:

“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.”

NARRATOR:

“What should I avoid while taking OXBRYTA?

Do not take St. John’s wort during treatment with OXBRYTA.”

NARRATOR:

“What are the possible side effects of OXBRYTA?

OXBRYTA can cause serious side effects, including:

Serious allergic reactions. Tell your healthcare provider or get emergency medical help right away if you get:

• rash
• hives
• shortness of breath (difficult breathing)
• swelling of the face”

NARRATOR:

“The most common side effects of OXBRYTA include:

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

NARRATOR:

“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”

NARRATOR:

“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 Global Blood Therapeutics at 1-833-428-4968 (1-833-GBT-4YOU).

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