FazaClo

Name: FazaClo

Fazaclo Overview

Fazaclo is a prescription medication used to treat the symptoms of schizophrenia. It is also used to reduce suicidal behavior in patients with schizophrenia or schizoaffective disorder.

Fazaclo is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

This medication comes in an orally disintegrating tablet (tablet that dissolves quickly in the mouth) and is taken usually one to two times a day. Do not divide or break orally disintegrating tablets. Let the tablet disintegrate in the mouth. The tablets can be allowed to disintegrate, or they may be chewed.

Common side effects of Fazaclo include sedation, tachycardia (fast heartbeat), and constipation.

Fazaclo can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Fazaclo affects you.

Fazaclo Drug Class

Fazaclo is part of the drug class:

  • Diazepines, oxazepines, thiazepines and oxepines

Fazaclo Usage

Take Fazaclo exactly as prescribed. Read the label carefully.

  • Before starting Fazaclo, your doctor will obtain your complete blood cell counts. 
  • Tablets rapidly disintegrate after placement in the mouth and may be chewed if desired. No water is needed. Can be administered with or without food 
  • Fazaclo orally disintegrating tablets should be immediately placed in the mouth after removing the tablet from the blister pack or bottle. The tablet disintegrates rapidly after placement in the mouth. The tablets can be allowed to disintegrate, or they may be chewed. They may be swallowed with saliva. No water is necessary for administration.
  • The orally disintegrating tablets in a blister pack should be left in the unopened blister until the time of use. Just prior to use, peel the foil from the blister and gently remove the orally disintegrating tablet. Do not push the tablets through the foil, because this could damage the tablet.
  • If abrupt discontinuation of Fazaclo is necessary (because of agranulocytosis or another medical condition, for example), you need to be monitored carefully for the recurrence of your medical condition's symptoms and side effects related to cholinergic rebound, such as profuse sweating, headache, nausea, vomiting and diarrhea.
  • If Fazaclo is missed for more than 2 days, do not restart Fazaclo at the same dosage. Instead, contact your physician for dosing instructions.

Fazaclo will be made available only through a special program designed to ensure the required blood monitoring in order to reduce the risk of developing agranulocytosis. Your doctor will monitor your absolute neutrophil counts (ANC). 

What is the most important information I should know about clozapine?

Call your doctor right away if you have: chest pain, trouble breathing, fluttering in your chest, signs of infection (weakness, fever, sore throat, cold or flu symptoms), or if you feel like you might pass out.

Clozapine can cause severe dizziness, slow heartbeats, fainting, or seizures. Do not take more of this medicine than recommended.

Clozapine is not approved for use in psychotic conditions related to dementia. Clozapine may increase the risk of death in older adults with dementia-related conditions.

Clozapine is available only from a certified pharmacy under a special program.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Commonly used brand name(s)

In the U.S.

  • Clozaril
  • FazaClo
  • Versacloz

Available Dosage Forms:

  • Tablet
  • Tablet, Disintegrating
  • Suspension

Therapeutic Class: Antipsychotic

Chemical Class: Dibenzodiazepine

Before Using FazaClo

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 clozapine 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 clozapine in the elderly. However, elderly patients are more likely to have constipation, trouble passing urine, uncontrolled movements, or age-related liver, kidney, or heart problems, which may require caution in patients receiving clozapine.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Amisulpride
  • Bepridil
  • Bromopride
  • Cisapride
  • Dronedarone
  • Droperidol
  • Fluconazole
  • Ketoconazole
  • Mesoridazine
  • Metoclopramide
  • Nelfinavir
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Ziprasidone

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.

  • Alfentanil
  • Alfuzosin
  • Amiodarone
  • Amitriptyline
  • Anagrelide
  • Apomorphine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bedaquiline
  • Bromazepam
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Buspirone
  • Butorphanol
  • Carbamazepine
  • Ceritinib
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Codeine
  • Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Degarelix
  • Delamanid
  • Desipramine
  • Deslorelin
  • Deutetrabenazine
  • Dihydrocodeine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Doxylamine
  • Ebastine
  • Efavirenz
  • Enoxacin
  • Enzalutamide
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Famotidine
  • Felbamate
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Flibanserin
  • Fluoxetine
  • Fluvoxamine
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Gonadorelin
  • Goserelin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Histrelin
  • Hydrocodone
  • Hydromorphone
  • Hydroquinidine
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibutilide
  • Idelalisib
  • Iloperidone
  • Imipramine
  • Itraconazole
  • Ivabradine
  • Lapatinib
  • Leuprolide
  • Levofloxacin
  • Levorphanol
  • Lithium
  • Lumacaftor
  • Lumefantrine
  • Mate
  • Mefloquine
  • Meperidine
  • Methadone
  • Methotrimeprazine
  • Metronidazole
  • Mifepristone
  • Milnacipran
  • Mitotane
  • Mizolastine
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nafarelin
  • Nalbuphine
  • Nefazodone
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Oxycodone
  • Oxymorphone
  • Paliperidone
  • Panobinostat
  • Papaverine
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Pentazocine
  • Periciazine
  • Perphenazine
  • Phenobarbital
  • Phenytoin
  • Pimavanserin
  • Pipamperone
  • Pitolisant
  • Pixantrone
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Remifentanil
  • Ribociclib
  • Rifampin
  • Risperidone
  • Ritonavir
  • Salmeterol
  • Sertindole
  • Sertraline
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Solifenacin
  • Sorafenib
  • Sotalol
  • St John's Wort
  • Sufentanil
  • Sulpiride
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tapentadol
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tiotropium
  • Tizanidine
  • Tolterodine
  • Toremifene
  • Tramadol
  • Trazodone
  • Trifluoperazine
  • Trimipramine
  • Triptorelin
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vinflunine
  • Voriconazole
  • Vorinostat
  • Zotepine
  • Zuclopenthixol

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.

  • Cimetidine

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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice
  • Tobacco

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Caffeine

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:

  • Alcohol abuse, history of or
  • Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism) or
  • Blood vessel problems (poor circulation) or
  • Dehydration or
  • Head injury, history of or
  • Heart attack, recent or history of or
  • Heart disease (eg, cardiomyopathy, myocarditis) or
  • Heart failure or
  • Heart rhythm problems (eg, arrhythmia, long QT syndrome, slow heart rate), or history of or
  • Hypokalemia (low potassium in the blood) or
  • Hypomagnesemia (low magnesium in the blood) or
  • Hypotension (low blood pressure) or
  • Hypovolemia (low blood volume) or
  • Stroke, history of—May cause side effects to become worse.
  • Bowel problems (eg, constipation) or
  • Diabetes or
  • Difficult urination or
  • Dyslipidemia (high fat in the blood) or
  • Enlarged prostate or
  • Glaucoma, narrow angle or
  • Hyperglycemia (high blood sugar) or
  • Liver disease (eg, hepatitis) or
  • Neuroleptic malignant syndrome, history of or
  • Seizures, history of—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Phenylketonuria (PKU)—The orally disintegrating tablet contains phenylalanine, which can make this condition worse.

What are some other side effects of FazaClo?

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.
  • Hard stools (constipation).
  • Dry mouth.
  • Upset stomach or throwing up.
  • Weight gain.
  • Not able to sleep.
  • Drooling.
  • Headache.

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.

Contraindications

Hypersensitivity

FazaClo is contraindicated in patients with a history of serious hypersensitivity to clozapine (e.g., photosensitivity, vasculitis, erythema multiforme, or Stevens-Johnson Syndrome) or any other component of FazaClo [see Adverse Reactions (6.2)].

Overdosage

Overdosage Experience

The most commonly reported signs and symptoms associated with clozapine overdose are: sedation, delirium, coma, tachycardia, hypotension, respiratory depression or failure; and hypersalivation. There are reports of aspiration pneumonia, cardiac arrhythmias, and seizure. Fatal overdoses have been reported with clozapine, generally at doses above 2500 mg. There have also been reports of patients recovering from overdoses well in excess of 4 g.

Management of Overdosage

For the most up-to-date information on the management of FazaClo overdosage, contact a certified Regional Poison Control Center (1-800-222-1222). Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians’ Desk Reference®, a registered trademark of PDR Network. Establish and maintain an airway; ensure adequate oxygenation and ventilation. Monitor cardiac status and vital signs. Use general symptomatic and supportive measures. There are no specific antidotes for FazaClo.

In managing overdosage, consider the possibility of multiple-drug involvement.

Clinical Studies

Treatment-Resistant Schizophrenia

The efficacy of clozapine in treatment-resistant schizophrenia was established in a multicenter, randomized, double-blind, active-controlled (chlorpromazine) study of clozapine in patients with a DSM-III diagnosis of schizophrenia who had inadequate responses to at least 3 different antipsychotics (from at least 2 different chemical classes) during the preceding 5 years. The antipsychotic trials must have been judged adequate; the antipsychotic dosages must have been equivalent to or greater than 1000 mg per day of chlorpromazine for a period of at least 6 weeks, each without significant reduction of symptoms. There must have been no period of good functioning within the preceding 5 years. Patients must have had a baseline score of at least 45 on the investigator-rated Brief Psychiatric Rating Scale (BPRS). On the 18-item BPRS, 1 indicates the absence of symptoms, and 7 indicates severe symptoms; the maximum potential total BPRS score is 126. At baseline, the mean BPRS score was 61. In addition, patients must have had a score of at least 4 on at least two of the following four individual BPRS items: conceptual disorganization, suspiciousness, hallucinatory behavior, and unusual thought content. Patients must have had a Clinical Global Impressions – Severity Scale score of at least 4 (moderately ill).

In the prospective, lead-in phase of the trial, all patients (N=305) initially received single-blind treatment with haloperidol (the mean dose was 61 mg per day) for 6 weeks. More than 80% of patients completed the 6-week trial. Patients with an inadequate response to haloperidol (n=268) were randomized to double-blind treatment with clozapine (N=126) or chlorpromazine (N=142). The maximum daily clozapine dose was 900 mg; the mean daily dose was >600 mg). The maximum daily chlorpromazine dose was 1800 mg; the mean daily dose was >1200 mg.

The primary endpoint was treatment response, predefined as a decrease in BPRS score of at least 20% and either (1) a CGI-S score of ≤3 (mildly ill), or (2) a BPRS score of ≤35, at the end of 6 weeks of treatment. Approximately 88% of patients from the clozapine and chlorpromazine groups completed the 6-week trial. At the end of six weeks, 30% of the clozapine group responded to treatment, and 4% of the chlorpromazine group responded to treatment. The difference was statistically significant (p <0.001). The mean change in total BPRS score was -16 and -5 in the clozapine and chlorpromazine group, respectively; the mean change in the 4 key BPRS item scores was -5 and -2 in the clozapine and chlorpromazine group, respectively; and the mean change in CGI-S score was -1.2 and -0.4, in the clozapine and chlorpromazine group, respectively. These changes in the clozapine group were statistically significantly greater than in the chlorpromazine group (p <0.001 in each analysis).

Recurrent Suicidal Behavior in Schizophrenia or Schizoaffective Disorder

The effectiveness of clozapine in reducing the risk of recurrent suicidal behavior was assessed in the International Suicide Prevention Trial (InterSePT™, a trademark of Novartis Pharmaceuticals Corporation). This was a prospective, randomized, open-label, active-controlled, multicenter, international, parallel-group comparison of clozapine (Clozaril®) versus olanzapine (Zyprexa®, a registered trademark of Eli Lilly and Company) in 956 patients with schizophrenia or schizoaffective disorder (DSM-IV) who were judged to be at risk for recurrent suicidal behavior. Only about one-fourth of these patients (27%) were considered resistant to standard antipsychotic drug treatment. To enter the trial, patients must have met one of the following criteria:

• They had attempted suicide within the three years prior to their baseline evaluation.

• They had been hospitalized to prevent a suicide attempt within the three years prior to their baseline evaluation.

• They demonstrated moderate-to-severe suicidal ideation with a depressive component within one week prior to their baseline evaluation.

• They demonstrated moderate-to-severe suicidal ideation accompanied by command hallucinations to do self-harm within one week prior to their baseline evaluation.

Dosing regimens for each treatment group were determined by individual investigators and were individualized by patient. Dosing was flexible, with a dose range of 200-900 mg/day for clozapine and 5-20 mg/day for olanzapine. For the 956 patients who received clozapine or olanzapine in this study, there was extensive use of concomitant psychotropics: 84% with antipsychotics, 65% with anxiolytics, 53% with antidepressants, and 28% with mood stabilizers. There was significantly greater use of concomitant psychotropic medications among the patients in the olanzapine group.

The primary efficacy measure was time to (1) a significant suicide attempt, including a completed suicide; (2) hospitalization due to imminent suicide risk, including increased level of surveillance for suicidality for patients already hospitalized; or (3) worsening of suicidality severity as demonstrated by “much worsening” or “very much worsening” from baseline in the Clinical Global Impression of Severity of Suicidality as assessed by the Blinded Psychiatrist (CGI-SS-BP) scale. A determination of whether or not a reported event met criterion 1 or 2 above was made by the Suicide Monitoring Board (SMB), a group of experts blinded to patient data.

A total of 980 patients were randomized to the study and 956 received study medication. Sixty‑two percent of the patients were diagnosed with schizophrenia, and the remainder (38%) were diagnosed with schizoaffective disorder. Only about one-fourth of the total patient population (27%) was identified as “treatment-resistant” at baseline. There were more males than females in the study (61% of all patients were male). The mean age of patients entering the study was 37 years of age (range: 18–69). Most patients were Caucasian (71%), 15% were Black, 1% were Asian, and 13% were classified as being of “other” races.

Patients treated with clozapine had a statistically significant longer delay in the time to recurrent suicidal behavior in comparison with olanzapine. This result should be interpreted only as evidence of the effectiveness of clozapine in delaying time to recurrent suicidal behavior and not a demonstration of the superior efficacy of clozapine over olanzapine.

The probability of experiencing (1) a significant suicide attempt, including a completed suicide, or (2) hospitalization because of imminent suicide risk, including increased level of surveillance for suicidality for patients already hospitalized, was lower for clozapine patients than for olanzapine patients at Week 104: clozapine 24% versus olanzapine 32%; 95% CI of the difference: 2%, 14% (Figure 1).

Figure 1: Cumulative Probability of a Significant Suicide Attempt or Hospitalization to Prevent Suicide in Patients with Schizophrenia or Schizoaffective Disorder at High Risk of Suicidality

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 12.5 mg (Bottle)

                                                                                                 12.5 mg (Bottle)

NDC No. 18860-101-10

FazaClo®

(clozapine)

Orally Disintegrating Tablets

100 Tablets                                     Rx Only

                 12.5 mg

Phenylketonurics: Contains Phenylalanine, 0.87 mg per Tablet.

Usual Adult Dosage: Consult the package insert for prescribing information.

Storage Conditions: Store at 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture.

KEEP OUT OF REACH OF CHILDREN.

Dispense: Dispensing should be contingent upon ANC results; quantities dispensed should not exceed the limits set forth in the full product labeling.

Distributed by Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304 USA.

U.S. Patent Nos. 6,024,981; 6,221,392; and 6,106,861.
FazaClo® is a registered trademark of Jazz Pharmaceuticals plc or its subsidiaries.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 mg (Bottle)

                                                                                                     100 mg (Bottle)

NDC No. 18860-104-10

FazaClo®

(clozapine)

Orally Disintegrating Tablets

100 Tablets                                     Rx Only

                 100 mg

Phenylketonurics: Contains Phenylalanine, 6.96 mg per Tablet.

Usual Adult Dosage: Consult the package insert for prescribing information.

Storage Conditions: Store at 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture.

KEEP OUT OF REACH OF CHILDREN.

Dispense: Dispensing should be contingent upon ANC results; quantities dispensed should not exceed the limits set forth in the full product labeling.

Distributed by Jazz Pharmaceuticals, Inc.
Palo Alto, CA 94304 USA.

U.S. Patent Nos. 6,024,981; 6,221,392; and 6,106,861.
FazaClo® is a registered trademark of Jazz Pharmaceuticals plc or its subsidiaries.

How should I take FazaClo?

Take FazaClo exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

FazaClo can be taken with or without food.

The FazaClo orally-disintegrating tablet can be taken without water. Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet. Use dry hands to remove the tablet and place it in your mouth. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

If your doctor has prescribed one-half of an orally-disintegrating tablet, you will need to break the tablet in half. Throw the other half away. Do not save it for later use.

FazaClo can lower blood cells that help your body fight infections, especially in women and older adults, and in people who are malnourished or have serious medical problems. This can make it easier for you to develop a serious or life-threatening infection. Your blood will need to be tested often. Your future treatments may be delayed based on the results of these tests.

If you need surgery, tell the surgeon ahead of time that you are using FazaClo. You may need to stop using the medicine for a short time.

You should not stop using FazaClo suddenly or you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.

FazaClo can have long lasting effects on your body. You may need frequent medical tests for a short time after you stop using this medicine.

Store at room temperature away from moisture and heat.

FazaClo dosing information

Usual Adult Dose for Schizophrenia:

Initial dose: 12.5 mg orally once or twice a day
Titration and Maintenance: May increase total daily dose in increments of 25 mg to 50 mg per day to a target dose of 300 mg to 450 mg per day (administered in divided doses) by the end of week 2. Subsequent dose increases can be in increments of up to 100 mg once or twice weekly.
Maximum dose: 900 mg per day

Comments:
-The absolute neutrophil count (ANC) must be 2000/mm3 or greater and WBC count 3500 mm3 or greater, prior to initiating treatment; the ANC and WBC must be monitored regularly during therapy.
-A low starting dose, gradual titration, and divided doses are necessary to minimize the risk of orthostatic hypotension, bradycardia, and syncope.
-When therapy is interrupted for 2 or more days, re-initiate with 12.5 mg once or twice a day; based on tolerability, a dose that is restarted may be increased to a previously therapeutic dose more quickly than it was for initial treatment.

Uses:
-For the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment.
-To reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder, who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state.

For the Consumer

Applies to clozapine: oral suspension, oral tablet, oral tablet disintegrating

Along with its needed effects, clozapine (the active ingredient contained in FazaClo) 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 while taking clozapine:

More common
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • shakiness in the legs, arms, hands, or feet
  • sleepiness or unusual drowsiness
  • sweating
  • trembling or shaking of the hands or feet
  • unusual tiredness or weakness
Less common
  • Anxiety
  • black, tarry stools
  • chest pain
  • chills
  • convulsions
  • cough or hoarseness
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficult or labored breathing
  • difficulty in passing urine (dribbling)
  • discouragement
  • dry mouth
  • feeling sad or empty
  • fever with or without chills
  • frequent strong or increased urge to urinate
  • general feeling of tiredness or weakness
  • headache
  • hyperventilation
  • irritability
  • lack of appetite
  • loss of bladder control
  • loss of interest or pleasure
  • lower back or side pain
  • muscle spasm or jerking of the arms or legs
  • painful or difficult urination
  • pounding in the ears
  • restlessness or need to keep moving
  • severe or continuing headache
  • shakiness and unsteady walk
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sudden jerky movements of the body
  • sudden loss of consciousness
  • swollen glands
  • throat discomfort
  • tightness in the chest
  • trouble concentrating
  • trouble sleeping
  • unsteadiness, trembling, or other problems with muscle control or coordination
Rare
  • Absence of or decrease in movement
  • change in appetite
  • dark urine
  • decreased sexual ability
  • difficult or fast breathing or sudden shortness of breath
  • increased sweating
  • increased thirst
  • increased urination
  • lip smacking or puckering
  • muscle stiffness (severe)
  • nausea
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • swelling or pain in the leg
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • unusual bleeding or bruising
  • unusually pale skin
  • vomiting
  • weakness
  • yellow eyes or skin
Incidence not known
  • Abdominal or stomach pain
  • bloating
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • clay-colored stools
  • confusion as to time, place, or person
  • constipation
  • diarrhea
  • epileptic seizure that will not stop
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • feeling, seeing, or hearing things that are not there
  • holding false beliefs that cannot be changed by fact
  • inability to move the eyes
  • increased blinking or spasms of the eyelid
  • indigestion
  • itching or skin rash
  • joint pain
  • light-colored stools
  • muscle twitching
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • rhythmic movement of the muscles
  • severe mood or mental changes
  • sticking out of the tongue
  • swelling around the eyes
  • swelling of the body or feet and ankles
  • trouble with speaking
  • unpleasant breath odor
  • unusual behavior
  • unusual excitement, nervousness, or restlessness
  • unusual facial expressions
  • unusual weight gain
  • upper right abdominal or stomach pain
  • vomiting of blood

Some side effects of clozapine 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
  • Acid or sour stomach
  • belching
  • feeling of constant movement of self or surroundings
  • heartburn
  • relaxed and calm sensation of spinning
  • sleepiness
Less common
  • Blurred or loss of vision
  • change or problem with discharge of semen
  • disturbed color perception
  • double vision
  • halos around lights
  • inability to sit still
  • increase in body movements
  • muscle ache or pain
  • muscle weakness
  • night blindness
  • nightmares
  • overbright appearance of lights
  • pain in the back, neck, or legs
  • pain in the chest below the breastbone
  • severe muscle stiffness
  • sore tongue
  • stuffy nose
  • tunnel vision
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • hives
  • increased sensitivity of the skin to sunlight
  • painful or prolonged erection of the penis
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • reddening of the skin, especially around the ears
  • severe stomach pain
  • severe sunburn
  • sores, welting, or blisters
  • swelling of the eyes, face, or inside of the nose
  • swelling of the salivary glands

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