Apremilast

Apremilast is a prescription medication used to treat adults with active psoriatic arthritis and is also used to treat moderate to severe plaque psoriasis.

Apremilast belongs to a group of drugs called phosphodiesterase 4 (PDE4) inhibitors. The specific mechanism apremilast is not well defined at this time.

This medication comes in tablet (by mouth) form and is taken typically taken 2 times a day, with or without food. Apremilast tablets should not be crushed, split, or chewed.

Common side effects include diarrhea, nausea, and headache.

Apremilast is a prescription medication used to treat adults with active psoriatic arthritis and is also used to treat moderate to severe plaque psoriasis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Apremilast may be found in some form under the following brand names:

• Otezla

Serious side effects have been reported with apremilast. See the "Drug Precautions” section.

Common side effects of apremilast include the following:

• Diarrhea
• Nausea
• Headache
• Upper respiratory tract infection
• Vomiting
• Nasopharyngitis
• Upper abdominal pain

This is not a complete list of apremilast side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)

This is not a complete list of apremilast drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with apremilast including the following:

• Depression. Tell your healthcare provider right away if you have some or all of the following symptoms of depression.
  • Worsening of depression
  • Suicidal thoughts
  • Mood changes
• Weight Decrease. Patients treated with apremilast should have their weight monitored regularly. Tell your healthcare provider right away if you have unexplained or significant weight loss. Your healthcare provider may have to discontinue apremilast.
• Drug Interactions
  • Medications that increase the activity of the enzyme CYP3A4 such as phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, are not recommended.

Do not take apremilast if you are allergic to apremilast or to any of this medication’s ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of apremilast, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking apremilast, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to apremilast or to any of its ingredients
• have renal impairment
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Apremilast falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women given apremilast during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if apremilast or its metabolites cross into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using apremilast.

Take apremilast exactly as prescribed.

Apremilast comes in tablet form and is taken twice every day. Take apremilast with or without food

Do not chew, divide, or break apremilast tablets. Swallow tablets whole.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of apremilast at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated

• other medical conditions you have
• other medications you are taking
• your kidney function
• your age

The recommended dose of apremilast is 30 mg twice a day.

The recommended dose of apremilast in severe renal impairment is 30 mg once a day.

To reduce the risk of gastrointestinal symptoms, titrate to recommended dose of 30 mg twice daily according to the following schedule:

• Day 1: 10 mg in the morning
• Day 2: 10 mg in the morning and 10 mg in the evening
• Day 3: 10 mg in the morning and 20 mg in the evening
• Day 4: 20 mg in the morning and 20 mg in the evening
• Day 5: 20 mg in the morning and 30 mg in the evening
• Day 6 and thereafter: 30 mg twice daily

(In patients with severe renal impairment, titrate using only morning schedule listed and skip afternoon doses)

If you take too much apremilast, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If apremilast is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store apremilast tablets below 30°C (86°F).
• Keep this and all medicines out of the reach of children.