Pediatric Psoriatic Arthritis | Otezla® (apremilast) for Pediatric
Indications
APPROVED USES Prescription Otezla®/Otezla XRTM (apremilast) is used for the treatment of:

Active Psoriatic Arthritis:

  • OTEZLA: Adult and pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with active psoriatic arthritis. Read more >
Approved Uses Prescription Otezla®/Otezla XRTM (apremilast) is used for the treatment of:

Active Psoriatic Arthritis:

  • OTEZLA: Adult and pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with active psoriatic arthritis.
  • OTEZLA XR: Adult and pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with active psoriatic arthritis.

Plaque Psoriasis:

  • OTEZLA/OTEZLA XR: Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA: Pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA XR: Pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Oral Ulcers Associated with Behçet’s Disease:

  • OTEZLA/OTEZLA XR: Adult patients with oral ulcers associated with Behçet’s Disease. Read less >

Otezla is approved for kids 6+ with active psoriatic arthritis*

*Patients must weigh at least 20 kg (44 lbs).

Otezla is the only treatment of its kind for kids and teens with psoriatic arthritis

needle-free

Otezla is a needle-free option with no initial or routine blood tests required.

Otezla® (apremilast) tablet

Otezla treats inside the body, where inflammation starts.

Think Otezla might be right for your child?

What happens the first few weeks of treatment?

We know helping someone you care for begin a new treatment can be scary.
Let’s go over what you can expect in the first few weeks so you can feel more comfortable and confident as your child gets started.

Your child can start today

No blood tests with Otezla® (apremilast)

With no initial or routine blood tests required, your child can get started on treatment right away.

No needles—Otezla is a pill.

Otezla is a pill with dosing options for children.

After completing their sample pack:

Two dose strengths of Otezla® (apremilast)

After completing their sample pack:

  • Patients prescribed Otezla and weighing more than 110 lbs, take one 30 mg pill twice daily. Patients weighing 44–110 lbs, take one 20 mg pill twice daily.
  • Patients prescribed Otezla Extended-Release and weighing more than 110 lbs: take one 75 mg pill once daily.

When your child starts on treatment, they will slowly increase their dose over the first 5 days of treatment until they reach the recommended dose. This is known as titration.†,‡

Body Weight Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & Beyond
>110
lbs
AM 10 mg 10 mg 10 mg 20 mg 20 mg 30 mg OR 75 mg
Otezla
Extended-Release
PM - 10 mg 20 mg 20 mg 30 mg 30 mg
44 lbs
to
<110 lbs
AM 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg
PM - 10 mg 20 mg 20 mg 20 mg 20 mg
 

Kids and teens with severe kidney disease will follow a different dosing schedule.

You can give Otezla or Otezla Extended-Release with or without food— whichever works best for your child. The tablet should be swallowed whole and should not be crushed, split, or chewed. Otezla should be stored below 86° F and Otezla Extended-Release should be stored between 68° F and 77° F.

When taking Otezla Extended-Release, you may sometimes see part of the tablet in your child’s stool. This is not a cause for concern, this is the outer shell of the tablet. By the time you see it, the medicine inside has already been absorbed by the body.

†Pediatric patients with severe kidney disease: for initial dosage titration, it is recommended that Otezla be titrated using only the AM schedule shown above for appropriate body weight category and that the PM doses be skipped. From day 6 on, for pediatric patients weighing more than 110 lbs, reduce dosage to 30 mg once daily. For pediatric patients weighing 44 lbs to less than 110 lbs, reduce dosage to 20 mg once daily.

‡Otezla Extended-Release is not recommended for pediatric patients with severe renal impairment.

As with any treatment, your child may experience side effects.

The safety profile of Otezla in pediatric patients was established in a clinical study of 245 moderate to severe plaque psoriasis patients 6+. The most common side effects are seen below.

Most common side effects (up to week 16) Otezla 163 patients Placebo 80 patients
Diarrhea 32 (20%) 8 (10%)
Nausea 32 (20%) 2 (3%)
Abdominal Pain 32 (20%) 8 (10%)
Vomiting 29 (18%) 2 (3%)
Headache 17 (10%) 4 (5%)
Fever 10 (6%) 1 (1%)
Common Cold 10 (6%) 3 (4%)
Upper Abdominal Pain 9 (6%) 4 (5%)

Ask your doctor about potential side effects, and be sure to let them know about any side effects that bother your child or don’t go away as they may be able to help manage it.

An Otezla prescription takes 2 easy steps to fill.

Here’s how to get started with Otezla

So, you and your doctor have decided Otezla is right for your child. Here’s what happens next.

Enroll to pay as little as $0

The Otezla Co-Pay* Program may help eligible patients with commercial insurance pay as little as $0 out of pocket for Otezla per month. Caregivers of kids and teens 18 and under can contact
Amgen® SupportPlus at 1-844-4OTEZLA (1-844-468-3952) to complete enrollment, Monday – Friday, 8 AM – 8 PM ET.

*Eligibility criteria and program maximums apply. See AmgenSupportPlus.com/copay-terms for full Terms and Conditions.

Get Otezla in 2 steps

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Enroll in the Otezla Co-Pay Program to pay as little as $0*

Call 1-844-4OTEZLA (1-844-468-3952) to complete enrollment, Monday – Friday, 8 AM – 8 PM ET.

Mail

Receive your digital co-pay card immediately by email

Co-pay card

Screenshot, save & share your co-pay card information for when your specialty pharmacy contacts you

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Don’t miss the call from your specialty pharmacy

Prescriptions

Once your doctor has given your prescription to a specialty pharmacy, they will call you to arrange delivery of Otezla

Smartphone

The ONLY way to receive your Otezla is to answer the specialty pharmacy’s call, so save them as a contact in your phone

Medication mail delivery

Your Otezla will be on its way to your door

Want tools to help you and your child as they start and stay on treatment?

Whether you are considering Otezla for your child, or they’re just beginning treatment,

Here are a few resources to help as your child starts and stays on Otezla

Patient brochure

Patient Onboarding
Brochure

Get even more information about Otezla, how it works, and getting started with treatment. All in a downloadable brochure.

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Amgen® Nurse Partners

Personalized Support

With the help from a dedicated Nurse Partner, savings offers on Otezla and more, you'll never have to do it alone.

Call 1-844-4OTEZLA (1-844-468-3952)
to enroll
Monday – Friday, 8 AM – 8 PM ET.

Amgen® Nurse Partners are not part of your treatment team and do not provide medical advice, nursing, or case management services. Patients should always consult their healthcare provider regarding medical decisions or treatment concerns.

Group 88188

Questions about Otezla?

If your child has already been
prescribed Otezla, call
1-844-4OTEZLA (1-844-468-3952)
to find out how to get started. If you’re
still considering Otezla, you can find
even more key information here.

IMPORTANT SAFETY INFORMATION

Do not take Otezla 30 mg tablets or Otezla XR 75 mg extended-release tablets if you are allergic to apremilast or to any of the ingredients in Otezla/Otezla XR

Otezla/Otezla XR can cause serious side effects, including:

  • Allergic reactions, sometimes severe. Stop using Otezla/Otezla XR and call your healthcare provider or seek emergency help right away if you develop any of the following symptoms of a serious allergic reaction: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.
  • Severe diarrhea, nausea, and vomiting, especially within the first few weeks of treatment. Use in elderly patients and the use of certain medications with Otezla/Otezla XR may increase the risk of complications from having severe diarrhea, nausea, or vomiting. Tell your doctor if any of these conditions occur.
  • Depression. In clinical studies, some patients reported depression or suicidal behavior while taking Otezla. Some patients stopped taking Otezla due to depression. Before starting Otezla/Otezla XR, tell your doctor if you have had feelings of depression, or suicidal thoughts or behavior. Be sure to tell your doctor if any of these symptoms or other mood changes develop or worsen during treatment with Otezla/Otezla XR.
  • Weight loss. Your doctor should monitor your weight regularly. If unexplained or significant weight loss occurs, your doctor will decide if you should continue taking Otezla/Otezla XR. For children 6 years of age or older, their doctor should monitor their growth (height and weight). If they are not growing or gaining weight as expected, their doctor will decide if they should continue taking Otezla/Otezla XR.

Some medicines may make Otezla/Otezla XR less effective and should not be taken with Otezla/Otezla XR. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines.

The most common side effects include diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. These are not all the possible side effects with Otezla/Otezla XR. Ask your doctor about other potential side effects. Tell your doctor about any side effect that bothers you or does not go away.

Tell your doctor if you are pregnant, planning to become pregnant or planning to breastfeed.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.

Please click here for the Full Prescribing Information for Otezla/Otezla XR.

APPROVED USES

Prescription Otezla® /Otezla XRTM (apremilast) is used for the treatment of:

Active Psoriatic Arthritis:

  • OTEZLA: Adult and pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with active psoriatic arthritis
  • OTEZLA XR: Adult and pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with active psoriatic arthritis.

Plaque Psoriasis:

  • OTEZLA/OTEZLA XR: Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA: Pediatric patients 6 years of age and older and weighing at least 20 kg (44 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
  • OTEZLA XR: Pediatric patients 6 years of age and older and weighing at least 50 kg (110 lbs) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Oral Ulcers Associated with Behçet’s Disease:

  • OTEZLA/OTEZLA XR: Adult patients with oral ulcers associated with Behçet’s Disease.

IMPORTANT SAFETY INFORMATION

Do not take Otezla 30 mg tablets or Otezla XR 75 mg extended-release tablets if you are allergic to apremilast or to any of the ingredients in Otezla/Otezla XR.

Otezla/Otezla XR can cause serious side effects, including:

  • Allergic reactions, sometimes severe. Stop using Otezla/Otezla XR and call your healthcare provider or seek emergency help right away if you develop any of the following symptoms of a serious allergic reaction: trouble breathing or swallowing, raised bumps (hives), rash or itching, swelling of the face, lips, tongue, throat or arms.