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SEPHIENCE helps reduce blood phenylalanine (Phe) levels in adults and children 1 month of age and older with Phenylketonuria (PKU).

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SEPHIENCE is a once‍-‍daily oral powder made to mix into your daily routine.

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Thomas’s SEPHIENCE story

Hear Thomas talk about his experience living with PKU, working with his healthcare team, and what SEPHIENCE has meant for him.

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My name is Thomas. I live just outside of Seattle. I work as materials management for a hospital, and I’m living with PKU. I love to you know work on boats, doing some building and restoration, I love photography, and cooking. The type of photographs I like to take are more slice of life, everyday people doing everyday life.

As a kid, food and I just had a weird relationship because to me it was always something different than what everyone else was having. Family meals there would always be a separate dish that was just for me and my sister. I mean, I was still able to connect with my sister, she also has PKU. But still I just never felt close with everyone else.

During my teenage years I just felt different. I didn’t want to feel different and I kind of started rebelling against my diet. I had trouble concentrating, a lot of brain fog, a lot of muscle spasms, and a lot of other health issues that came along with that. I would wake up in the morning, I would feel very sick, go to work and just kind of muddle through my day with not really being able to focus on anything. I got in trouble with my bosses a lot, and I just kind of felt a little bit like a failure.

The first step for me was moving to a new clinic and having a conversation with my new healthcare team about creating a plan to help me maintain a healthy lifestyle. My team had recommended SEPHIENCE to me and I was willing to try a lot of things. So I started taking SEPHIENCE and I noticed that my levels did drop to a much healthier range for myself. The feeling of seeing my Phe levels in a healthy range after about 20 years was a little overwhelming at first. I was so ecstatic and elated that I honestly had trouble showing that emotion.

So when I started taking SEPHIENCE and working with my healthcare team to introduce more protein into my diet it opened the door for having foods like eggs and peanut butter and beans. I had my first peanut butter and jelly sandwich. That first bite was very emotional.

With my PKU managed with SEPHIENCE, I don’t spend as much mental energy on it and I can concentrate more on things that I enjoy doing like photography, and boat building, and history and aviation, and everything that just brings me joy. I’m definitely considering going back to school now that Phe control is less of an issue for me.

I am sharing my personal experience, but everyone’s treatment journey is different. If I could tell my younger self, I would definitely say it gets better. To someone who hasn’t checked in with their healthcare team for a while, I would say definitely reach out. They can do a lot more for you than you might think.

I’m Thomas, and for me reducing my Phe levels with SEPHIENCE means less limits and more possibilities.

INDICATION & IMPORTANT SAFETY INFORMATION

What is SEPHIENCE?

SEPHIENCE™ (sepiapterin) is a prescription medicine used to lower blood levels of phenylalanine (Phe) in adults and children 1 month of age and older with a certain type of Phenylketonuria (PKU). SEPHIENCE is used along with a Phe-restricted diet. It is not known if SEPHIENCE is safe and effective in children younger than 1 month of age.

What is the most important information I should know about SEPHIENCE?

SEPHIENCE may cause serious side effects, including:

increased bleeding problems. SEPHIENCE may increase your risk of bleeding. Tell your healthcare provider if you develop any symptoms of bleeding including:
- bruising or red or purple skin marks
- menstrual bleeding that is heavier than normal
- bleeding longer than usual or that does not stop
low blood Phe (hypophenylalaninemia). Low blood Phe levels are common during treatment with SEPHIENCE and can be severe.

The most common side effects of SEPHIENCE include: diarrhea, headache, stomach (abdominal) pain, yellow or orange stool (feces), and throat pain.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SEPHIENCE. Call your healthcare provider for medical advice about side effects.

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

are pregnant or plan to become pregnant. It is not known if SEPHIENCE will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if SEPHIENCE passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take SEPHIENCE.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SEPHIENCE and other medicines may affect each other causing side effects. SEPHIENCE may affect the way other medicines work, and other medicines may affect how SEPHIENCE works. Especially tell your healthcare provider if you take:

a medicine that contains levodopa
an antifolate medicine
another medicine also used to lower Phe
medicines used to treat erectile dysfunction (phosphodiesterase 5 inhibitors or PDE5)

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I take or give SEPHIENCE?

Take or give SEPHIENCE exactly as your healthcare provider tells you. Your healthcare provider will tell you how much SEPHIENCE to take or give.
Your healthcare provider may change your or your child’s dose of SEPHIENCE depending on your weight and age.
Take or give SEPHIENCE 1 time each day with food. You must take or give more food after the SEPHIENCE dose.
SEPHIENCE comes as a packet containing oral powder.
- For SEPHIENCE doses less than 1,000 mg: mix SEPHIENCE oral powder with water or apple juice before giving or taking.
- For SEPHIENCE doses 1,000 mg or greater: SEPHIENCE oral powder can be mixed with water, apple juice, strawberry jam, or applesauce before taking or giving.
- See the detailed Instructions for Use that comes with SEPHIENCE for information about the correct way to prepare, take, or give a dose of SEPHIENCE oral powder.
If you or your child miss a dose of SEPHIENCE, take or give it as soon as possible. Do not take 2 doses in a day. Continue with your normal dosing schedule the following day.
During treatment with SEPHIENCE, you or your child will have regular check-ups with your healthcare provider.
Your healthcare provider will do blood tests before and during your treatment with SEPHIENCE to check your blood Phe levels.
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with SEPHIENCE if you have certain side effects.
Your healthcare provider may change your diet during treatment. Follow your healthcare provider’s instructions and do not make any changes to your diet without first talking to your healthcare provider.

To report an adverse event, please call 1‍-‍866-562-4620 or email at usmedinfo@ptcbio.com. You may also report side effects to FDA at 1‍-‍800‍-‍FDA‍-‍1088 or at www.fda.gov/medwatch.

Please see Full Prescribing Information.