Description
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 may benefit from receiving phototherapy (ultraviolet light treatment) or other treatment.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of apremilast in children younger than 6 years of age or weighing less than 20 kilograms (kg) to treat plaque psoriasis and in children to treat psoriatic arthritis and mouth ulcers caused by Behçet's disease. Safety and efficacy have not been established. This medicine may cause slowed growth in children.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
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, split, 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 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 in the morning and 30 mg in the evening.
- Children 6 years of age and older and weighing at least 20 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
- Weighing 50 kg or more—
- 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 onwards: 30 mg in the morning and 30 mg in the evening.
- Weighing 20 kg to less than 50 kg—
- 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 20 mg in the evening.
- Day 6 and onwards: 20 mg in the morning and 20 mg in the evening.
- Weighing 50 kg or more—
- Children younger than 6 years of age and weighing less than 20 kg—Use and dose must be determined by your doctor.
- Adults—
- For psoriatic arthritis 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 in the morning and 30 mg in the evening.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For plaque psoriasis:
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
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 genitals, 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 provider if you have concerns.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. Make sure your provider knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your provider if you have sudden or strong feelings, including 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 child's weight and height. You may need to check your child's weight and height regularly during treatment with this medicine. Talk to your child's 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
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.
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