Fanapt Titration Pack

This medicine should NOT be used to treat behavioral problems in older adult patients who have dementia.

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 iloperidone 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 iloperidone in the elderly. However, elderly patients are more likely to have dementia or age-related liver problems, which may require caution in patients receiving iloperidone.

Pregnancy

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

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.

• Acecainide


• Ajmaline


• Amiodarone


• Arsenic Trioxide


• Astemizole


• Atazanavir


• Azimilide


• Bretylium


• Cisapride


• Clarithromycin


• Disopyramide


• Dofetilide


• Droperidol


• Gatifloxacin


• Halofantrine


• Hydroquinidine


• Ibutilide


• Indinavir


• Itraconazole


• Ketoconazole


• Levofloxacin


• Mefloquine


• Methadone


• Moxifloxacin


• Nefazodone


• Nelfinavir


• Paliperidone


• Pazopanib


• Pirmenol


• Prajmaline


• Procainamide


• Quinine


• Ritonavir


• Saquinavir


• Sematilide


• Sodium Phosphate


• Sotalol


• Tedisamil


• Telavancin


• Telithromycin


• Terfenadine


• Thioridazine


• Vardenafil


• Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fluoxetine


• Paroxetine

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:

• Alzheimer`s disease or


• Blood vessel disease or


• Bradycardia (slow heartbeat), severe or


• Dehydration or


• Heart attack, recent or history of, or


• Heart failure, history of or


• Heart rhythm problems (e.g., prolonged QT interval), or a history of or


• Hypokalemia (low potassium in the blood) or


• Hypomagnesemia (low magnesium in the blood) or


• Hypotension (low blood pressure) or


• Hypovolemia (low amount of blood) or


• Stroke, history ofa€”May cause side effects to become worse.

• Blood or bone marrow problems or


• Breast cancer, prolactin-dependent or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Hyperprolactinemia (high prolactin in the blood) or


• Neuroleptic malignant syndrome (NMS), history of or


• Seizures, history ofa€”Use with caution. May make these conditions worse.

• Liver diseasea€”Should not use in patients with this condition.

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.

You may take this medicine with or without food.

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 treatment of schizophrenia:
    
    
    
    • Adultsa€”At first, 1 milligram (mg) two times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 12 mg two times a day.
    
    
    • Childrena€”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

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation . It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you have any symptoms of heart rhythm problems, such as dizziness, feeling faint, or a fast, pounding, or irregular heartbeat.

Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

This medicine may increase the amount of sugar in your blood . Check with your doctor right away if you have increased thirst or increased urination . If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor .

This medicine may increase your weight . Your doctor may need to check your weight on a regular basis while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor .

Iloperidone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination .


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

This medicine may make it more difficult for your body to cool itself down . Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke.

Iloperidone may cause some people to be agitated, irritable, or display other abnormal behaviors. 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 cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision . Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well .

Avoid drinking alcohol while you are using this medicine.

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:

More common

• Fast, pounding, or irregular heartbeat or pulse

Less common

• Blurred vision


• Body aches or pain


• Chills


• Cold sweats


• Confusion


• Cough


• Difficult or labored breathing


• Difficulty with moving


• Difficulty with speaking


• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• Drooling


• Ear congestion


• Fever


• Headache


• Inability to sit still


• Loss of balance control


• Loss of voice


• Muscle pain or stiffness


• Muscle trembling, jerking, or stiffness


• Nasal congestion


• Need to keep moving


• Pain in the joints


• Restlessness


• Runny nose


• Shakiness in the legs, arms, hands, or feet


• Shortness of breath


• Shuffling walk


• Sneezing


• Sore throat


• Stiffness of the limbs


• Sweating


• Tightness in the chest


• Trembling or shaking of the hands or feet


• Twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs


• Uncontrolled movements, especially of the face, neck, and back


• Unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness


• Wheezing

Rare

• Abdominal or stomach fullness


• Aching or discomfort in the lower legs or sensation of crawling in the legs


• Actions that are out of control


• Aggressive or angry


• Agitation


• Anxiety


• Attack, assault, or force


• Back pain


• Black, tarry stools


• Bloody nose


• Burning while urinating


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Chest pain or discomfort


• Coma


• Confusion as to time, place, or person


• Constipation


• Convulsions


• Decrease in the amount of urine


• Decrease in the frequency of urination


• Decrease in urine volume


• Decreased awareness or responsiveness


• Decreased urination


• Decreased weight


• Depression


• Difficult or painful urination


• Difficulty in passing urine (dribbling)


• Difficulty with walking


• Dilated neck veins


• Dizziness


• Dry mouth


• Dry skin and hair


• Extreme thirst


• Extremely high fever or body temperature


• Fainting


• False beliefs that cannot be changed by facts


• Fast, shallow breathing


• Feeling cold


• Frequent urination


• Gaseous abdominal pain


• Groin pain


• Hair loss


• Hoarseness or husky voice


• Holding false beliefs that cannot be changed by fact


• Hostility


• Inability to move the eyes


• Increased blinking or spasms of the eyelid


• Increased thirst


• Irregular breathing


• Irritability


• Lightheadedness


• Loss of appetite


• Loss of bladder control


• Mimicry of speech or movements


• Mood swings


• Muscle aching or cramping


• Muscle spasms


• Muscle twitching


• Nausea or vomiting


• Nervousness


• Noisy breathing


• Noisy, rattling breathing


• Numbness or tingling in the hands, feet, or lips


• Pale, clammy skin


• Peculiar postures or movements, mannerisms, or grimacing


• Pounding, slow heartbeat


• Rapid breathing


• Rapid weight gain


• Recurrent fever


• Restlessness


• Seizures


• Severe sleepiness


• Slow movement


• Slow reflexes


• Sore throat


• Sore tongue


• Sores, ulcers, or white spots on the lips or in the mouth


• Sticking out of tongue


• Stupor


• Sunken eyes


• Swelling


• Swelling of the face, ankles, fingers, feet, or lower legs


• Swollen glands


• Swollen joints


• Swollen, tender prostate


• Talking, feeling, and acting with excitement


• Thirst


• Troubled breathing at rest


• Troubled breathing with exertion


• Uncontrolled twisting movements of the neck, trunk, arms, or legs


• Unusual bleeding or bruising


• Unusual excitement, nervousness, or restlessness


• Unusual facial expressions


• Weight gain


• Wrinkled skin


• Yellow eyes or skin

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

• Diarrhea


• Sleepiness or unusual drowsiness

Less common

• Abdominal or stomach discomfort


• Not able to ejaculate semen


• Rash


• Stuffy nose

Rare

• Absent, missed, or irregular menstrual periods


• Blindness


• Blurred vision


• Breast pain


• Burning feeling in the chest or stomach


• Burning upper abdominal pain


• Canker sores


• Continuing ringing or buzzing or other unexplained noise in the ears


• Decreased interest in sexual intercourse


• Decreased vision


• Delusions of persecution, mistrust, suspiciousness, or combativeness


• Dry eyes


• Feeling of constant movement of self or surroundings


• Hearing loss


• Inability to have or keep an erection


• Increase in blood flow to the whites of the eyes


• Increased appetite


• Increased watering of the mouth


• Indigestion


• Irregular menstruation


• Irritation or soreness of the mouth


• Longer or heavier menstrual periods


• Loss in sexual ability, desire, drive, or performance


• Loss of bowel control


• Loss of memory


• Normal menstrual bleeding occurring earlier, possibly lasting longer than expected


• Problems with memory


• Redness, swelling, or itching of the eyelids


• Sensation of spinning


• Stomach upset


• Stopping of menstrual bleeding


• Swelling of the breasts or breast soreness in both females and males


• Swelling or inflammation of the mouth


• Tenderness in the stomach area


• Uncontrolled eye movements

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.