Patient information: uses, side effects, how to take - Orladeyo

What is ORLADEYO?

ORLADEYO is a prescription medicine used to prevent attacks of Hereditary Angioedema (HAE) in adults and children 2 years of age and older.
ORLADEYO is not used to treat an acute HAE attack.
Do not take more than 1 dose of ORLADEYO a day because extra doses can cause heart rhythm problems.
It is not known if ORLADEYO is safe and effective to treat an acute HAE attack.
It is not known if ORLADEYO is safe and effective in children under 2 years of age.

Before you take ORLADEYO, tell your healthcare provider about all of your medical conditions, including if you:

have liver problems or kidney problems.
are pregnant or planning to become pregnant. It is not known if ORLADEYO can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if ORLADEYO passes into your breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking ORLADEYO.

Tell your healthcare provider about all of the medicines you take, including other medicines for HAE, prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking ORLADEYO with certain other medicines may affect the way other medicines work and other medicines may affect how ORLADEYO works.

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

How should I take ORLADEYO?

Take ORLADEYO exactly as your healthcare provider tells you to take it.
Take ORLADEYO with food.
ORLADEYO capsules (for adults and children ages 12 years and older): Take 1 capsule, by mouth, 1 time every day.
ORLADEYO oral pellets (for adults and children ages 2 years and older): Take 1 packet, by mouth, 1 time every day.
- Eat a meal either right before or right after you take your dose.
- Do not chew or crush the oral pellets because this will affect the film coating and result in bitter taste.
- Hold the packet with the cut line on top.
- Gently tap the packet to settle the oral pellets.
- Open the packet along the cut line.
- Take ORLADEYO oral pellets in 1 of the following ways:
  - Pour all the oral pellets in the packet directly into the mouth and swallow right away with a non-acidic liquid such as water or milk.
    or
  - Carefully sprinkle all the oral pellets in the packet over 1 tablespoon (about 15mL) of soft, non-acidic food and take right away. Food should be at or below room temperature.
    Examples of soft, non-acidic foods include pudding, mashed potatoes, creamed corn, pureed peas, pureed bananas, and pureed carrots.
- To prevent the taste-masking coating from dissolving and resulting in a bitter taste:
  - Take the oral pellets within 10 minutes of being sprinkled over food. Throw the oral pellets away if not taken within 10 minutes of sprinkling over food.
  - Do not sprinkle the oral pellets on acidic foods such as yogurt and applesauce.

What are the possible side effects of ORLADEYO?

Taking more than 1 dose of ORLADEYO a day may cause serious side effects, including:

heart rhythm problems. A heart rhythm problem called QTc interval prolongation can happen in people who take more than 1 dose of ORLADEYO a day. This condition can cause an abnormal heart beat. Do not take more than 1 dose of ORLADEYO a day.

The most common side effects of ORLADEYO include:

abdominal pain

vomiting

diarrhea

back pain

heartburn

Less common side effects include increases in liver function tests. Rarely, some people had a brief, itchy rash.

These are not all of the possible side effects of ORLADEYO. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ORLADEYO?

Store ORLADEYO at room temperature between 68ºF to 77ºF (20ºC to 25ºC).
Each carton contains a tamper evident seal. Do not use ORLADEYO if the tamper evident seal is broken or missing.

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

General information about the safe and effective use of ORLADEYO.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ORLADEYO for a condition for which it was not prescribed. Do not give ORLADEYO 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 ORLADEYO that is written for health professionals.

What are the ingredients in ORLADEYO?

ORLADEYO capsules:

Active ingredient: berotralstat dihydrochloride

Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and pregelatinized starch

ORLADEYO oral pellets:

Active ingredient: berotralstat dihydrochloride

Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and pregelatinized starch.

The oral pellets film-coating contains: butylated methacrylate copolymer, silicon dioxide, sodium lauryl sulphate, stearic acid, talc, and titanium dioxide.

Manufactured for: BioCryst Pharmaceuticals, Inc., Durham, NC 27703

ORLADEYO^®is a registered trademark of BioCryst Pharmaceuticals, Inc.

ORL:3PPI

For more information, visit www.ORLADEYO.com or call 1-833-633-2279.

Orladeyo: Uses, Side Effects and Dosage