apremilast (Oral route)

a-PRE-mi-last

Commonly used brand name(s)

In the U.S.

• Otezla

Available Dosage Forms:

• Tablet

Therapeutic Class: Musculoskeletal Agent

Pharmacologic Class: Phosphodiesterase Inhibitor

Uses For apremilast

Apremilast is used to treat active psoriatic arthritis. Psoriatic arthritis is a type of arthritis that causes pain and swelling of the joints and patches of scaly skin on some areas of the body. apremilast is also used to treat moderate to severe plaque psoriasis, which is a skin disease with red patches and white scales that do not go away.

apremilast is available only with your doctor's prescription.

Before Using apremilast

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 apremilast, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to apremilast 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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of apremilast in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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 apremilast, 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 apremilast 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

Interactions with Food/Tobacco/Alcohol

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 apremilast. 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 apremilast

Take apremilast 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 apremilast with or without food.

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

Dosing

The dose of apremilast 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 apremilast. 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 and plaque psoriasis:
    • 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 two times a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of apremilast, 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 apremilast

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

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.

apremilast 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.

apremilast may decrease your weight. Your doctor may need to check your weight regularly during treatment with apremilast. 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.

apremilast Side Effects

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

• Fast heartbeat
• fever
• hives, itching, rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• redness of the skin
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing
• 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
• cough
• diarrhea
• ear congestion
• headache
• headache, severe and throbbing
• 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.

See also: Side effects (in more detail)

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