OTEZLA (apremilast) Tablets, 30mg

Description

What is Otezla used for?

• Plaque Psoriasis: Adult patients with plaque psoriasis who require systemic therapy or light treatment (phototherapy). Pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
• Psoriatic Arthritis: Treatment for adult patients with active psoriatic arthritis.
• Oral Ulcers Associated with Behçet’s Disease: Treatment for adult patients with oral ulcers associated with Behçet’s Disease.

Warnings

Depression: Some people have thoughts about suicide while taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor. Carefully weigh the risks and benefits of treatment in patients with a history of depression and/or suicidal thoughts or behavior.

Hypersensitivity: Cases of swelling (angioedema) and anaphylaxis have been reported. Do not use this medicine in patients with known hypersensitivity to apremilast or any of the inactive ingredients:

Otezla Weight loss: Otezla may cause weight loss. Monitor weight regularly. If clinically significant or unexpected weight loss occurs, evaluate the reason for weight loss and consider stopping this medicine.

Before taking this medicine

You should not use apremilast if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

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

Some people have thoughts about suicide while taking apremilast. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Apremilast may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of apremilast on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Apremilast is not approved for use by anyone younger than 18 years old.

How should I take apremilast?

Take apremilast exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take apremilast with or without food.

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

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

Store at room temperature, away from moisture and heat.