Abilify Discmelt

In the U.S.

• Abilify
• Abilify Discmelt

Available Dosage Forms:

• Tablet
• Tablet, Disintegrating
• Solution

Therapeutic Class: Antipsychotic

This section provides information on the proper use of a number of products that contain aripiprazole. It may not be specific to Abilify Discmelt. Please read with care.

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. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

If you are using the orally disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet in your mouth. It should melt quickly. After the tablet has melted, you may swallow or take a sip of water.

Swallow the tablets whole. Do not break, crush, or chew them.

Aripiprazole may be taken with or without food. If your doctor tells you to take it a certain way, follow your doctor's instructions.

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 forms (tablets and orally disintegrating tablets):
  • For bipolar mania:
    • Adults—At first, 15 milligrams (mg) once a day. When it is given with lithium or valproate, the starting dose is 10 to 15 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
    • Children 10 years of age and older—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
    • Children younger than 10 years of age—Use and dose must be determined by your doctor.
  • For depression:
    • Adults—At first, 2 to 5 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For irritability in children with autistic disorder:
    • Children 6 to 17 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 15 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For schizophrenia:
    • Adults—At first, 10 to 15 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
    • Children 13 to 17 years of age—At first, 2 mg once a day. The dose will be gradually increased to 10 mg once a day. Your doctor may adjust your dose again as needed. However, the dose is usually not more than 30 mg per day.
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
  • For Tourette's disorder:
    • Children 6 to 18 years of age—At first, 2 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
    • Children younger than 6 years of age—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.

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:

• Difficulty with speaking
• drooling
• loss of balance control
• muscle trembling, jerking, or stiffness
• restlessness
• shuffling walk
• stiffness of the limbs
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back

• Blurred vision
• dizziness
• headache
• inability to move the eyes
• increased blinking or spasms of the eyelid
• nervousness
• pounding in the ears
• slow or fast heartbeat
• sticking out the tongue
• trouble with breathing or swallowing
• unusual facial expressions

• Convulsions
• fast heartbeat
• high fever
• high or low blood pressure
• increased sweating
• lip smacking or puckering
• loss of bladder control
• muscle spasm or jerking of all extremities
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• severe muscle stiffness
• sudden loss of consciousness
• tiredness
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs
• unusually pale skin

• Hives or welts, itching, or skin rash
• itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• redness of the skin
• tightness in the chest
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

• Bigger, dilated, or enlarged pupils (black part of the eye)
• diarrhea
• fast, pounding, or irregular heartbeat or pulse
• increased sensitivity of the eyes to light
• lack or loss of strength
• nausea
• sleepiness or unusual drowsiness
• vomiting

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:

• Acid or sour stomach
• anxiety
• belching
• blurred vision
• difficulty having a bowel movement (stool)
• dry mouth
• fear
• fever
• headache
• heartburn
• hyperventilation
• inability to sit still
• indigestion
• irritability
• lightheadedness
• need to keep moving
• nervousness
• rash
• runny nose
• shaking
• sore throat
• stomach discomfort, upset, or pain
• trouble sleeping
• weight gain

• Accidental injury
• bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• congestion
• coughing
• difficulty with moving
• dryness or soreness of the throat
• hoarseness
• increased appetite
• increased salivation
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• rapid weight gain
• sneezing
• stuffy nose
• swollen joints
• tender, swollen glands in the neck
• tingling of the hands or feet
• tremor
• unusual weight gain or loss
• voice changes

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.

• It is used to treat schizophrenia.
• It is used to treat bipolar problems.
• It is used to treat low mood (depression).
• It is used to treat certain behavior problems in patients with autism.
• It is used to treat Tourette's syndrome.
• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Feeling sleepy.
• Feeling tired or weak.
• Restlessness.
• Anxiety.
• Headache.
• Upset stomach or throwing up.
• Weight gain.
• Hard stools (constipation).
• Not able to sleep.
• Feeling more or less hungry.
• Nose and throat irritation.
• Dry mouth.
• Shakiness.
• Drooling.
• Stuffy nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Abilify Discmelt is a prescription medication used in treatment of such conditions as schizophrenia, bipolar disorder, Gilles de la Tourette's syndrome and autism. It can also be used in combination with an antidepressant to treat depression.

Abilify Discmelt belongs to a group of drugs called atypical antipsychotics. These medications work by altering the activity of certain natural substances in the brain.

This medication comes in an orally disintegrating tablet and is usually taken once a day, with or without food.

Common side effects of Abilify Discmelt include insomnia, fatigue, and an inner sense of restlessness or need to move.

Common side effects in adults include the following:

• nausea
• vomiting
• constipation
• headache
• dizziness
• an inner sense of restlessness/the need to move (akathisia)
• anxiety
• insomnia
• restlessness
• pain at injection site

Common side effects in children include the following:

• sleepiness
• headache
• vomiting
• tiredness
• increased appetite
• insomnia
• nausea
• stuffy nose
• weight gain
• uncontrolled movement (restlessness, tremor, muscle stiffness)
• pain at injection site

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

Serious side effects have been reported with Abilify Discmelt. See "Abilify Discmelt Precautions" section.

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

Monotherapy:
Initial dose: 15 mg orally once a day
Target dose: 15 mg orally once a day; may increase dose based on clinical response; dose increases, if needed should be at 2-week intervals to allow time to achieve steady state
Maximum dose: 30 mg per day

Adjunctive therapy with Lithium or Valproate:
Initial dose: 10 to 15 mg orally once a day
Target dose: 15 mg orally once a day; may increase dose based on clinical response; dose increases, if needed should be at 2-week intervals to allow time to achieve steady state
Maximum dose: 30 mg per day

Comments:
-The safety of doses greater than 30 mg per day has not been studied.
-The dose recommended for maintenance treatment is the same dose needed to stabilize patients during acute treatment; periodically reassess need for maintenance treatment.
-The oral solution and oral tablets can be substituted on a mg-per-mg basis up to the 25 mg dose level; patients receiving 30 mg tablets should receive 25 mg of the oral solution.
-Dosage adjustments are recommended in patients who are known CYP450 2D6 poor metabolizers and taking concomitant CYP450 inhibitors or inducers; see dosage adjustment section for specific adjustments.

Uses: This drug may be used as monotherapy or as an adjunct to lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar I disorder and for maintenance treatment of bipolar I disorder.

No adjustment recommended

No adjustment recommended