Otezla XR

Otezla XR is used in adults and children who are 6 years old and older and weigh at least 20 kg to treat active psoriatic arthritis.

Otezla XR is also used to treat adults and children who are 6 years old and older and weigh at least 20 kg with plaque psoriasis who may also receive phototherapy or other treatments for psoriasis.

Otezla XR extended release tablet is used in children only if they are 6 years old and older and weigh at least 50 kg.

Otezla XR is also used in adults with Behçet's disease (a disease causing inflammation in blood vessels) to treat mouth ulcers.

Otezla XR may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take Otezla XR with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Doses are based on weight in children and teenagers. Your child's dose may change if the child gains or loses weight.

Keep track of your body weight while you are taking this medicine and tell your doctor about any major weight loss.

If you are taking extended-release tablets, you may notice part of the tablet shell in your stool. This is normal and will not make the medicine less effective.

Store at room temperature away from moisture and heat.

Some people have thoughts about suicide while taking Otezla XR. Tell your doctor right away if you notice any sudden changes in mood or behavior, or if you have thoughts about suicide.

You should not use Otezla XR if you are allergic to it or any of its ingredients.

Tell your doctor if you have or have ever had:

• depression or suicidal thoughts or actions; or
• kidney disease.

Some people have thoughts about suicide while taking Otezla XR. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

It is not known if Otezla XR will harm an unborn baby. However, there may be a potential risk during pregnancy. Tell your doctor if you are pregnant or think you may be pregnant.

Ask your doctor if it is safe to breastfeed while using Otezla XR.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you notice new or sudden changes in mood or behavior, including new or worsening depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Otezla XR may cause serious side effects. Call your doctor immediately if you have:

• severe diarrhea, nausea, and vomiting; or
• unexplained weight loss or slow growth in children.

Your treatment may be delayed or permanently stopped if you experience certain side effects.

Common side effects of Otezla XR may include:

• nausea, diarrhea;
• headache; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect Otezla XR, especially:

• phenobarbital or other barbiturate medicine;
• St. John's wort;
• an antibiotic--rifabutin, rifampin, rifapentine;
• cancer medicine--apalutamide, enzalutamide, mitotane;
• HIV or AIDS medicine--efavirenz, nevirapine;
• seizure medicine--carbamazepine, oxcarbazepine, phenytoin, primidone; or
• steroid medicine--dexamethasone, prednisone.

This list is not complete, and many other drugs may affect Otezla XR. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.