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.
- 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.
