Pronunciation:

a-PRE-mi-last

Brand Names:

• Otezla

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Musculoskeletal Agent

Pharmacologic—

Phosphodiesterase Inhibitor

Uses of This Medicine:

Apremilast is used to treat active psoriatic arthritis and oral ulcers caused by Behçet's disease. It is also used to treat plaque psoriasis in patients who will receive other medicines or phototherapy (light treatment).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of apremilast in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of apremilast in the elderly. However, elderly patients are more likely to have low blood pressure (hypotension) or low blood volume (hypovolemia) caused by severe diarrhea, nausea, or vomiting, which may require caution in patients receiving apremilast.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Enzalutamide
• Fosphenytoin
• Mitotane
• Phenytoin
• Primidone
• Rifabutin
• Rifampin
• Rifapentine
• St John's Wort

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression, or history of or
• Mental illness, or history of—Use with caution. May make these conditions worse.

• Hypotension (low blood pressure) or
• Hypovolemia (low blood volume)—Use with caution. May cause side effects to become worse.

• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Take this medicine with or without food.

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

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For psoriatic arthritis, plaque psoriasis, and oral ulcers caused by Behçet's disease:
    • Adults—
      • Day 1: 10 milligrams (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 onwards: 30 mg 2 times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

Apremilast may cause severe diarrhea, nausea, or vomiting which is more likely in patients 65 years of age or older, or in patients with low blood pressure (hypotension) or low blood volume (hypovolemia). Talk to your doctor if you have concerns.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may decrease your weight. Your doctor may need to check your weight regularly during treatment with this medicine. Talk to your doctor about ways to prevent weight loss.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Changes in behavior

discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

thoughts of killing oneself

tiredness

trouble concentrating

trouble sleeping

Incidence not known

Cough

chest tightness

dizziness

fast heartbeat

fever

hives, itching, or rash

hoarseness

irritation

joint pain, stiffness, or swelling

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

swelling of the hands or feet

trouble breathing or swallowing

unusual tiredness or weakness

weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

chills

diarrhea

ear congestion

headache

loss of voice

nausea

sneezing

sore throat

stuffy or runny nose

Less common

Back pain

belching

burning, itching, pain in the hairy areas, pus at the root of the hair

decreased appetite

heartburn

indigestion

muscle aches

stomach discomfort, upset, or pain

upper abdominal or stomach pain

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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