MUYIWA:

“My name is Muyiwa. I’m a father of three beautiful children and I’m married, been married for 10 years.”

DR SHAH:

“I’m Dr. Nirmish Shah. I’m an associate professor in both medicine and pediatrics.”

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.

MUYIWA:

“This man right here, I mean, my doctor, I was lucky and blessed to have him. When I first met him, it was the way he approached me, it was the way he spoke to me, like a human being.”

DR SHAH:

“I think it’s critical for the patient and the provider to have a connection. And the connection that I have with Muyiwa, as well as with as many patients as I can have, is all about communication.”

MUYIWA:

“I was telling Dr Shah that I didn’t know what steps to take next. I don’t know if you remember that story.”

DR SHAH:

“I remember it very clearly because he was a patient I thought was a really good candidate for Oxbryta.”

DR SHAH:

“I told Muyiwa I have this medication. It gets to the root cause that prevents the sickling process.”

DR SHAH:

“So when we start Oxbryta for a patient, we’re very clear about how we want to communicate all things that are happening.”

MUYIWA:

“He told me of the importance of checking in. “Hey, in two weeks, I have to know how you feel.”

DR SHAH:

“I ask my patients to come back to get their labs checked so they can see what type of difference we’ve made with the treatment with Oxbryta.”

DR SHAH:

“So, when Muyiwa came to clinic we made sure that we reviewed his labs, as I always try to do and show him where’s your hemoglobin now.”

MUYIWA:

“I know based on the way this man communicates with me in the clinic and based on the question that the number is very important. To the point that when I tell him a symptom that I’m feeling, he knows what number to check to see if this is what is wrong, or this is not what is wrong.”

MUYIWA:

“He’s very good at explaining why he’s having me take the blood work, exactly what he’s looking for, why he’s looking for it…”

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.”

MUYIWA:

“When I first started, he did tell me, “Muyiwa, be compliant. Make sure you’re compliant to this med.” Every appointment, “How many doses did you miss? Did you miss anything? Did you take it all?” You know, he makes sure that I did not miss anything.”

MUYIWA:

“The tips and trick I use to remember is one, there’s a permanent reminder on my cell phone. Every time I eat dinner, I know to use my med.”

DR SHAH:

“But even though I know you take it, I still ask.”

MUYIWA:

“Yeah, every time.”

DR SHAH:

“Every single time I ask you.”

MUYIWA:

“Every single time he asks.”

MUYIWA:

“Being able to communicate with this man, being able to talk to this man is what changed my life. Period.”

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.”