DR SCOTT:

“Hi, my name is Dr. Lametra Scott. I am the Director of Pharmacy at the Tennessee Department of Corrections, as well as the CEO of Breaking the Sickle Cell Cycle Foundation. Today, I’m going to walk you through the steps to administer Oxbryta 300 milligram tablets for oral suspension which are approved for sickle cell patients four years and older based on the child’s weight and ability to swallow tablets.”

DR SCOTT:

“Here’s what you will need to prepare the dose. A teaspoon, a small cup, phone or timer, a room temperature clear drink, like: drinking water or clear soda and the Oxbryta 300 mg tablets for oral suspension, which are light yellow, round and marked with 300 D on one side.”

DR SCOTT:

“It is very important to take Oxbryta exactly as your healthcare provider prescribes and that you don’t change the dose or stop taking Oxbryta unless your healthcare provider tells you to. Today, we are going to prepare the three tablet dose, using three teaspoons of our clear drink. Let’s get started.”

DR SCOTT:

“First, look closely at the pills to ensure that you have the correct medication. Be sure your hands are clean and dry. Then, pour your room temperature clear drink into the cup. As a reminder, we are prepping three tablets so we will need at least three teaspoons of water.”

DR SCOTT:

“Add the prescribed number of Oxbryta 300 mg tablets for oral suspension to the cup. It is important that you or your child do not cut, crush, chew or swallow these tablets.”

DR SCOTT:

“After the tablets have been added to the water, swirl the cup until the tablets break down in the drink and be careful not to spill. If any of the medicine spills, dispose of the rest of the prepared dose, clean up the spill and start again at step one. When fully mixed, the liquid will not be clear. Wait for one to five minutes before taking or giving the dose.”

DR SCOTT:

“Once you’ve waited one to five minutes, swirl the cup again. Be careful not to spill. Do not pour the medicine into another cup or container. Make sure the child who is receiving the prepared medicine is sitting upright and takes the medicine immediately.”

DR SCOTT:

“Once the child has taken the dose, add more of your clear drink to that same cup. This is to mix the leftover medicine and to make sure the full dose is taken. Swirl the cup until all the leftover medicine is mixed, and have your child drink it immediately. Repeat this step until all the medicine is taken.”

DR SCOTT:

“After taking all the medicine, your child may drink water or any other type of drink they prefer. Be sure to wash the spoon and cup with warm water and soap when you’re finished.”

DR SCOTT:

“And remember, if you ever have questions about Oxbryta or how to prepare Oxbryta 300 mg tablets for oral suspension dose correctly, you can ask your pharmacist or refer to the Oxbryta pediatric dosing card."

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.

OXBRYTA is approved under accelerated approval based on an increase in hemoglobin. Continued approval may depend on verification of clinical benefits in ongoing trials.”

NARRATOR:

“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.

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:

• 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:

NARRATOR:

“The most common side effects of OXBRYTA include:

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

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 Pfizer Inc. at 1-800-438-1985.

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