Bruce Cozadd

Chairman and CEO

November 15, 2011

8

th

Annual Lazard Capital Markets

Healthcare Conference

Forward-Looking Statements

2

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

dependence

on

sales

of

Xyrem

®

and

Luvox

CR

®

products

and

its

ability

to

increase

sales

of

its

Xyrem;

This presentation contains forward-looking statements, including, but not limited to, statements related to Jazz

Pharmaceuticals’ growth potential and future financial performance, including 2011 financial guidance, and

statements related to the anticipated consummation of the business combination transaction between Jazz

Pharmaceuticals and Azur Pharma Public Limited Company (formerly Azur Pharma Limited), including the timing

and benefits thereof. These forward-looking statements are based on Jazz Pharmaceuticals’ current

expectations and inherently involve significant risks and uncertainties. Jazz Pharmaceuticals’ actual results and

the timing of events could differ materially from those anticipated in such forward looking statements as a result

of these risks and uncertainties, which include, without limitation, risks related to: Jazz Pharmaceuticals’

competition, including potential generic competition; Jazz Pharmaceuticals’ dependence on single source

suppliers and manufacturers; the ability of Jazz Pharmaceuticals to protect its intellectual property and defend its

patents; regulatory obligations and oversight; Jazz Pharmaceuticals’ cash flow; and Jazz Pharmaceuticals’ ability

to complete the transaction with Azur Pharma on the proposed terms and schedule and achieve the anticipated

benefits of the transaction.  These and those other applicable risks are described in more detail under the

caption “Risk Factors” and elsewhere in Jazz Pharmaceuticals’ Securities and Exchange Commission (“SEC”)

filings and reports, including in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2011 and

definitive proxy statement related to the Azur Pharma transaction. Jazz Pharmaceuticals undertakes no duty or

obligation to update any forward-looking statements contained in this presentation as a result of new information,

future events or changes in its expectations.

3

Additional Information

Additional Information and Where to Find It

           In connection with the proposed transaction between Jazz Pharmaceuticals and Azur Pharma, the companies have filed documents with

the SEC, including the filing by Jazz Pharmaceuticals of a definitive proxy statement relating to the proposed transaction and related matters,

and the filing by Azur Pharma of a registration statement on Form S-4 that includes the definitive proxy statement/prospectus relating to the

proposed transaction and related matters. The definitive proxy statement/prospectus has been mailed to Jazz Pharmaceuticals’ stockholders in

connection with the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION

STATEMENT ON FORM S-4 AND THE RELATED DEFINITIVE PROXY STATEMENT/PROSPECTUS BECAUSE THEY CONTAIN IMPORTANT

INFORMATION ABOUT JAZZ PHARMACEUTICALS, AZUR PHARMA, THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors

and security holders may obtain free copies of these documents and other related documents filed with the SEC at the SEC’s web site at

www.sec.gov, or by directing a request to Jazz Pharmaceuticals’ Investor Relations department at Jazz Pharmaceuticals, Inc., Attention: Investor

Relations, 3180 Porter Drive, Palo Alto, California 94304, to Jazz Pharmaceuticals’ Investor Relations department at 650-496-2800 or by email to

investorinfo@jazzpharma.com. Investors and security holders may obtain free copies of the documents filed with the SEC on Jazz

Pharmaceuticals’ website at www.jazzpharmaceuticals.com under the heading “Investors” and then under the heading “SEC Filings.”

           Jazz Pharmaceuticals and its directors and executive officers and Azur Pharma and its directors and executive officers may be deemed

participants in the solicitation of proxies from the stockholders of Jazz Pharmaceuticals in connection with the proposed transaction. Information

regarding the special interests of these directors and executive officers in the proposed transaction is included in the proxy statement/prospectus

described above. Additional information regarding the directors and executive officers of Jazz Pharmaceuticals is also included in Jazz

Pharmaceuticals’ proxy statement for its 2011 Annual Meeting of Stockholders, which was filed with the SEC on April 12, 2011. These documents

are available free of charge at the SEC’s web site and from Investor Relations at Jazz Pharmaceuticals as described above.

           This communication does not constitute an offer to sell, or the solicitation of an offer to sell, or the solicitation of an offer to subscribe for or

buy, any securities nor shall there be any sale, issuance or transfer of securities in any jurisdiction in which such offer, solicitation or sale would

be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

For full prescribing information refer to product websites.

Building Shareholder Value by Focusing on Patient Needs

Jazz Pharmaceuticals’

mission is to improve

patients’

lives by identifying, developing and

commercializing valuable pharmaceutical

products in focused therapeutic areas

4

5

Strategy to Build Shareholder Value

Grow Xyrem sales in

current indications

Increased focus on

achieving full potential

1

Maintain entrepreneurial, ownership culture at the company

4

Make disciplined resource allocation decisions

2

3

Acquire additional

marketed or close to

approval products

Leverage our expertise

and infrastructure

Pursue lower risk

development of

specialty products

Invest percentage

of sales longer-term

Current Business Overview

$39

$54

$97

$230-235

1

2010

2009

2008

2007

2011G

$143

$0

$25

$50

$75

$100

$175

$200

$125

$150

$225

$250

Xyrem -

Strong Sales Growth

8%

7

1.

Based on guidance provided on November 1, 2011.  The company is not updating the prior guidance and actual results may differ.

Xyrem is a Standard of Care in Narcolepsy

•

Only FDA-approved product for both cataplexy and

excessive daytime sleepiness in patients with

narcolepsy

–

Marketed in U.S. since 2002

–

Marketed in major European countries by

UCB and in Canada by Valeant

•

Currently marketed in U.S. by 110-person specialty sales force

•

Over 9,000 patients on therapy, usually in conjunction with stimulant therapy

•

Distributed

under

proprietary

Xyrem

Success

Program

®

8

The Burden of Narcolepsy

•

Affects

1

in

2000

in

US

1

–

multiple

sclerosis

and

Parkinson's

disease

2

–

>

cystic

fibrosis

3

•

Although narcolepsy is thought to affect between

125,000 and 200,000 Americans, only about

50,000

are

diagnosed

4

•

Key symptoms can be debilitating

–

Cataplexy occurs in 60%-100% of patients

–

100% experience excessive daytime sleepiness

1.

National Institute of Neurological Disorders and Stroke.  http://www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm. Accessed March 17, 2011.

2.

Narcolepsy Sleep Foundation. www.sleepfoundation.org/article/sleep-related-problems/narcolepsy-and-sleep. Accessed March 17, 2011.

3.

Zemanick et  al. J Cyst Fibros. 2010;9:1-16.

4.

American Sleep Association. http;//www.sleepassociation.org/index.php?p=aboutnarcolepsy. Accessed March 17, 2011.

9

2

-40

-30

-20

-10

0

Xyrem has Demonstrated Effect

on Two Key Symptoms of Narcolepsy

XYREM

6 g/night

(n=58)

XYREM

9 g/night

(n=47)

Placebo

(n=59)

–16%

*

–37%

*

–3%

Improvement in Epworth

Sleepiness Scale

Week 2

Week 4

Baseline

Reduction in Weekly

Cataplexy Attacks

-28%

-49%*

-69%+

10

-80

-60

-40

-20

0

Placebo (n=33)

XYREM 6 g/night (n=31)

XYREM 9 g/night (n=33)

*p<0.001 vs placebo

*p<0.05 vs placebo

+p<0.005 vs placebo

1

Most Common Adverse Events in

Controlled Studies of Xyrem

Adverse Event

1

% of Patients (N=655)

Placebo

Xyrem

Nausea

4

19

Dizziness

4

18

Headache

15

18

Vomiting

1

8

Somnolence

4

6

Urinary incontinence

4

<1

6

Nasopharyngitis

5

6

Label includes boxed warning that sodium oxybate is a central nervous system

depressant with abuse potential and should not be used with alcohol or other

CNS depressants.  See complete boxed warning at end of presentation.

11

2

3

1. Occurring

in

5%

of

XYREM

patients

and

more

frequently

than

with

placebo.

2.

Data

on

file,

Jazz

Pharmaceuticals,

Inc.

3.

XYREM

(sodium

oxybate)

PI.

4.

Generally

nocturnal

enuresis.

Update on FDA Form 483 and Related Warning Letter

•

Fully committed to accurate and timely adverse event (AE) reporting

•

After receipt of FDA Form 483 in May, immediate actions initiated to

improve AE reporting procedures:

–

Implemented additional procedures at central pharmacy

–

Strengthened AE collection and reporting systems, including revised SOPs

–

Improved training and auditing programs

•

Timely response to October FDA warning letter submitted

•

Ongoing oversight strengthened to ensure robust safety reporting

systems

12

Strong Sodium Oxybate Patent Coverage

* Listed in FDA Orange Book

13

Number

Issue Date

Expiration Date

Distribution system patent*

7,765,106

7/27/2010

6/16/2024

Distribution system patent*

7,765,107

7/27/2010

6/16/2024

Distribution system patent

7,797,171

9/14/2010

6/16/2024

Distribution system patent*

7,668,730

2/23/2010

6/16/2024

Distribution system patent*

7,895,059

2/23/2011

12/17/2022

Formulation patent*

6,780,889

8/24/1999

7/4/2020

Formulation patent*

7,262,219

8/28/2007

7/4/2020

Process patent

6,472,431

10/29/1999

12/22/2019

Method of use patent*

7,851,506

12/14/2010

12/22/2019

Overview of Manufacturing and Distribution

•

DEA drug quota needed to manufacture controlled “Schedule I”

API

•

Exclusive relationships with API supplier and finished goods

manufacturer:

–

Siegfried approved by FDA for API supply

•

Unique proprietary distribution system uses exclusive single pharmacy

•

Risk management program and unique product attributes require high

touch capabilities

14

Current Xyrem Patient Coverage Distribution*

•

Approximately 90% of insured patients

have access

•

Relatively low rates of required prior

authorizations

•

Low monthly out-of-pocket (OOP)

expenses

–

Over 70% of patients have monthly

OOP of   

$50

78%

8%

4%

1%

9%

*  Company data and MediMedia Formulary Compass: Sep/Oct 2011.

Commercial

Medicaid

Medicare Part D

Patient

Assistance

Program

Cash

15

16

•

New narcolepsy physician targets

•

Xyrem Success Program education

•

Patient services

-

Nursing program

-

Xyrem Patient Connection

-

Patient assistance programs

Increased Marketing Investment

Xyrem Growth Initiatives

Improve Market Penetration Over Time

Current Patients >9,000

Approximately 18% of 50K Diagnosed Narcolepsy Patients

17

1. National Institute of Mental Health. http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-disorders-in-america.shtml. Accessed March 3, 2008.  2. Kessler RC, et al. Arch Gen Psychiatry. 2005;62:617-627.  3. Fireman

B, et al. Am J Psychiatry. 2001;158:1904-1910.  4. Grabill K et al..Assessment of obsessive-compulsive disorder: a review.J Anxiety Disord. 2008;22(1):1-17.  5. Hales RE, et al (eds). Textbook of Psychiatry. 1999:600-610.  6. Koran LM,

et al. Am J Health Syst Pharm. 2000;57:1972-1978.

Luvox CR

®

-

Important Treatment Option for OCD

•

Indicated for obsessive compulsive

disorder (OCD)

•

OCD affects ~ 2.2 million Americans

1,2

–

Often underdiagnosed

3,4

–

Difficult to differentiate from comorbidities

5

•

Only 43% of adults newly diagnosed with OCD received adequate treatment in the

year after their first visit for OCD

6

Label includes boxed warning regarding suicidality and antidepressant drugs.

See complete boxed warning at end of presentation.

Luvox CR –

Continued Sales Growth

$30

$6

$31-33

1

2009

2008

2011G

18

$0

$5

$10

$15

$20

$25

2010

2

$18

$35

$40

$27

1.

Based on guidance provided on November 1, 2011.  The company is not updating the prior guidance and actual results may differ.

2.

Includes $2 million of revenue recorded as a result of a change in the timing of when Luvox CR revenue is recognized. The company now records sales upon shipment to distributors net of estimated returns.

19

2011 Guidance Reflects High Operating Leverage

1.

Based on guidance provided on November 1, 2011.  The company is not updating the prior guidance and actual results may differ.

2.

Includes Azur transaction related expenses of $10-11 million.

3.

Adjusted

net

income

and

adjusted

EPS

are

non-GAAP

financial

measures

that

exclude

certain

items

from

GAAP

net

income

and

GAAP

EPS.

A

reconciliation

of

adjusted

net

income to

GAAP net income and the related per share amounts is in a table included with this presentation.

2010-

A

2011-

G

1

Total Product Sales

$170M

$261 –

268M

Xyrem

$143M

$230 -

235M

Luvox CR

$27M

$31 -

33M

SG&A and R&D Combined

2

$95M

$114 –

118M

GAAP Net Income

$33M

$128 –

131M

Adjusted Net Income

3

$61M

$160 –

163M

GAAP EPS

$0.83

$2.76 –

$2.81

Adjusted EPS

3

$1.55

$3.45 –

$3.50

Strategic Transaction with

Azur Pharma

21

Strategic Benefits

•

Diversified portfolio of CNS and

women’s health products

•

Increased scale and platform

for growth

•

Resources to invest in future

pipeline and strong franchise

management opportunities

•

Stronger, enhanced

management team

Projected Financial Benefits

•

Accretive transaction

1

•

Revenues >$475M

and cash flow >$200M in

first 12 months

•

Strong balance sheet

with no debt

•

Lower combined tax rate

1

Accretion for Jazz Pharmaceuticals shareholders is on a fully-taxed adjusted EPS basis. Adjusted EPS is a non-GAAP financial measure that excludes certain items from GAAP EPS.

Compelling Strategic and Financial Benefits

Jazz

Pharmaceuticals plc

Ireland

Azur Pharma –

Compelling Fit with Jazz Pharmaceuticals

22

CNS

Women’s

Health

Net Sales (Millions)

•

Strong commercial focus and expertise

in CNS and women’s health

•

Approximately 170 employees:

–

105 people in 3 US sales forces

across pain, psychiatry and

women’s health

–

16 person medical affairs team

–

50 people in home office

(18 Dublin; 32 Philadelphia)

•

Pipeline of line extensions for clozapine

franchise

1.

Based on estimate provided on September 19, 2011.  The estimate is not being updated. 

Total Net

Sales

Estimate

$5

$24

$57

$67

$83

$95-100

1

Prialt -

for Chronic Pain

•

2010 net sales of $20M (marketed by Azur since May 2010)

•

Only

non-opioid

intrathecal

(IT)

analgesic

for

severe

chronic

pain

1

•

Compelling growth opportunity with similar characteristics to Xyrem:

–

Requires high touch sales capability with heavy clinical emphasis

–

Currently used in less than 3% of available pain market pumps (approximately 1500)

–

Limited competitive threats and multiple years of patent and other protection

•

European rights licensed to Eisai; Azur retains ROW rights

23

1. See full prescribing information on website

FazaClo –

for Treatment Resistant Schizophrenia

•

2010 net sales of $37M

•

Orally disintegrating clozapine tablets approved for management of treatment

resistant schizophrenia

1

•

Approximately 10% prescription share despite largely generic clozapine market

•

FazaClo High Dose (HD) launched September 2010

–

More than 27% switched from Low Dose (LD) as of 3Q11

–

Dosing flexibility and lower pill burden

•

Generics

filed

to

FazaClo

–

settlement

with

Teva

with

potential

launch

of

lower

dosage

product in 2Q12 and HD in 2015

•

Additional clozapine line extensions in development

24

1. See full prescribing information on website

25

•

Diversified

and

balanced

set

of

six

products

1

with 2010 net sales of $27M

•

Significant

growth

opportunity

driven

by

Elestrin

1

, a topical gel ERT therapy

•

Patents through 2022

•

Revamped Elestrin promotion model in 2010 leveraging ~ 50 sales representatives

0%

20%

40%

60%

80%

100%

2009

2010

2011E

Women’s Health Products -

Targeting a Growing Market

Elestrin

Other Women’s Health

Net Sales Contribution

1. See full prescribing information on website

26

2011 Estimated Net Sales

Stand Alone Jazz Pharmaceuticals, Inc.

Pro forma Jazz Pharmaceuticals plc

A Growing, Diversified Product Portfolio

Luvox CR

13%

Xyrem 87%

Xyrem 63%

Luvox CR

9%

Prialt 6%

Women’s

Health 10%

Other CNS

1%

FazaClo LD

8%

FazaClo HD

3%

27

Transaction Closing on Track

SEC filings and

stockholder meeting

Transaction expected

to close January 2012

Transaction subject

to customary closing

conditions and

regulatory approvals

•

Azur approval of other

necessary actions required

•

US antitrust clearance

pending

•

Transaction taxable to Jazz

Pharmaceuticals, Inc.

stockholders

•

Jazz Pharmaceuticals plc shares

to be traded on Nasdaq under

“JAZZ”

•

Azur Pharma S-4 declared

effective

•

Proxy statement/prospectus

mailed to Jazz Pharmaceuticals,

Inc. stockholders in November

•

Jazz Pharmaceuticals, Inc.

stockholder meeting on

December 12, 2011

28

Strategic Benefits

•

Diversified portfolio of CNS and

women’s health products

•

Increased scale and platform

for growth

•

Resources to invest in future

pipeline and strong franchise

management opportunities

•

Stronger, enhanced

management team

Projected Financial Benefits

•

Accretive transaction

1

•

Revenues >$475M

and cash flow >$200M in

first 12 months

•

Strong balance sheet

with no debt

•

Lower combined tax rate

1

Accretion for Jazz Pharmaceuticals shareholders is on a fully-taxed adjusted EPS basis. Adjusted EPS is a non-GAAP financial measure that excludes certain items from GAAP EPS.

Compelling Strategic and Financial Benefits

Jazz

Pharmaceuticals plc

Ireland

30

2010

Reconciliation of GAAP Net Income and EPS to Adjusted

Net Income and EPS in Financial Results and Guidance

(In millions, except per share amounts)

GAAP net income

Add:

Intangible asset amortization

Stock-based compensation expense

Non-cash interest expense and extinguishment of debt

Azur Pharma transaction related costs

Deduct:

Contract revenues

GAAP net income per diluted share (EPS)

Adjusted net income per diluted share (EPS)

Shares used in computing GAAP and adjusted net

income per diluted share amounts

Adjusted net income

Luvox CR revenue recognition timing change

(1)

$128-131M

7

13

2

$160-163

$2.76-2.81

$3.45-3.50

46-47

10-11

(1)

$33

8

8

14

$61

$0.83

$1.55

39

(1)

1.

Based on guidance provided on November 1, 2011.  The company is not updating the prior guidance and actual results may differ.

-

-

2010

2011G

1

31

Xyrem

(sodium oxybate)

Boxed Warning

Sodium oxybate is GHB, a known drug of abuse. Abuse has been associated with some important central nervous system

(CNS)

adverse

events

(including

death).

Even

at

recommended

doses,

use

has

been

associated

with

confusion,

depression

and

other

neuropsychiatric

events.

Reports

of

respiratory

depression

occurred

in

clinical

trials.

Almost

all

of

the

patients

who

received sodium oxybate during clinical trials were receiving CNS stimulants.

Important CNS adverse events associated with abuse of GHB include seizure, respiratory depression and profound decreases

in

level

of

consciousness,

with

instances

of

coma

and

death.

For

events

that

occurred

outside

of

clinical

trials,

in

people

taking

GHB

for

recreational

purposes,

the

circumstances

surrounding

the

events

are

often

unclear

(e.g.,

dose

of

GHB

taken,

the

nature and amount of alcohol or any concomitant drugs).

Xyrem

is

available

through

the

Xyrem

Success

Program,

using

a

centralized

pharmacy

1-866-XYREM88

®

(1-866-997-3688).

The

Success

Program

provides

educational

materials

to

the

prescriber

and

the

patient

explaining

the

risks

and

proper

use

of

sodium oxybate, and the required prescription form. Once it is documented that the patient has read and/or understood the

materials, the drug will be shipped to the patient. The Xyrem Success Program also recommends patient follow-up every 3

months. Physicians are expected to report all serious adverse events to the manufacturer. (See WARNINGS).

XYREM (sodium oxybate) PI

!WARNING:

Central nervous system depressant with abuse potential.

Should not be used with alcohol or other CNS depressants.

Luvox CR

(fluvoxamine maleate)

Boxed Warning

LUVOX CR (fluvoxamine maleate ) PI

Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking

and behavior (suicidality) in children, adolescents, and young adults in short-term

studies of major depressive disorder (MDD) and other psychiatric

disorders.

Anyone

considering

the

use

of

LUVOX

CR

®

(fluvoxamine

maleate)

Extended-Release Capsules or any other antidepressant in a child, adolescent,

or young adult must balance this risk with the clinical need. Short-term studies

did not show an increase in the risk of suicidality with antidepressants

compared to placebo in adults beyond age 24; there was a reduction in risk with

antidepressants

compared

to

placebo

in

adults

aged

65

and

older.

Depression

and certain other psychiatric disorders are themselves associated with

increases in the risk of suicide. Patients of all ages who are started on

antidepressant therapy should be monitored appropriately and observed closely

for clinical worsening, suicidality, or unusual changes in behavior. Families and

caregivers should be advised of the need for close observation and

communication with the prescriber. LUVOX CR Capsules are not approved for

use

in

pediatric

patients.

(See

WARNINGS:

Clinical

Worsening

and

Suicide

Risk,

PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

Prialt

(ziconotide intrathecal infusion)

Boxed Warning

Severe psychiatric symptoms and neurological impairment may occur during

treatment with PRIALT. Patients with a pre-existing history of psychosis

should not be treated with PRIALT. All patients should be monitored

frequently

for

evidence

of

cognitive

impairment,

hallucinations,

or

changes

in

mood or  consciousness. PRIALT therapy can be interrupted or discontinued

abruptly without evidence of withdrawal effects in the event of serious

neurological or psychiatric signs or symptoms

Prialt (ziconotide intrathecal infusion) PI

WARNING:

FazaClo

(clozapine)

Boxed Warning

1. AGRANULOCYTOSIS

BECAUSE OF A SIGNIFICANT RISK OF AGRANULOCYTOSIS, A POTENTIALLY LIFE-THREATENING ADVERSE EVENT,

CLOZAPINE SHOULD BE RESERVED FOR USE IN (1) THE TREATMENT OF SEVERELY ILL PATIENTS WITH

SCHIZOPHRENIA WHO FAIL TO SHOW AN ACCEPTABLE RESPONSE TO ADEQUATE COURSES OF STANDARD

ANTIPSYCHOTIC DRUG TREATMENT, OR (2) FOR REDUCING THE RISK OF RECURRENT SUICIDAL BEHAVIOR IN

PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER WHO ARE JUDGED TO BE AT RISK OF

REEXPERIENCING SUICIDAL BEHAVIOR. PATIENTS BEING TREATED WITH CLOZAPINE MUST HAVE A BASELINE

WHITE

BLOOD

CELL

(WBC)

COUNT

AND

ABSOLUTE

NEUTROPHIL

COUNT

(ANC)

BEFORE

INITIATION

OF

TREATMENT

AS WELL AS REGULAR WBC COUNTS AND ANCs DURING TREATMENT AND FOR AT LEAST 4 WEEKS

AFTER DISCONTINUATION OF TREATMENT.  (SEE WARNINGS.) CLOZAPINE IS AVAILABLE ONLY THROUGH A

DISTRIBUTION SYSTEM THAT ENSURES MONITORING OF WBC COUNTS AND ANCs ACCORDING TO THE

SCHEDULE

DESCRIBED

BELOW

PRIOR

TO

DELIVERY

OF

THE

NEXT

SUPPLY

OF

MEDICATION.

(SEE

WARNINGS.)

2. SEIZURES

SEIZURES HAVE BEEN ASSOCIATED WITH THE USE OF CLOZAPINE.  DOSE APPEARS TO BE AN IMPORTANT

PREDICTOR OF SEIZURE, WITH A GREATER LIKELIHOOD AT HIGHER CLOZAPINE DOSES.  CAUTION SHOULD BE

USED WHEN ADMINISTERING CLOZAPINE TO PATIENTS HAVING A HISTORY OF SEIZURES OR OTHER

PREDISPOSING FACTORS.  PATIENTS SHOULD BE ADVISED NOT TO ENGAGE IN ANY ACTIVITY WHERE SUDDEN

LOSS OF CONSCIOUSNESS COULD CAUSE SERIOUS RISK TO THEMSELVES OR OTHERS.  (SEE WARNINGS.)

3. MYOCARDITIS

ANALYSES OF POSTMARKETING SAFETY DATABASES SUGGEST THAT THATCLOZAPINE IS ASSOCIATED WITH AN

INCREASED RISK OF FATAL MYOCARDITIS, ESPECIALLY DURING, BUT NOT LIMITED TO, THE FIRST

MONTH

OF

THERAPY.

IN

PATIENTS

IN

WHOM

MYOCARDITIS

IS

SUSPECTED,

CLOZAPINE

TREATMENT

SHOULD

BE

PROMPTLY DISCONTINUED.  (SEE WARNINGS.)

FazaClo (clozapine) PI

WARNING:

FazaClo

(clozapine)

Boxed Warning -

continued

4. OTHER ADVERSE CARDIOVASCULAR AND RESPIRATORY EFFECTS

ORTHOSTATIC

HYPOTENSION,

WITH

OR

WITHOUT

SYNCOPE,

CAN

OCCUR

WITH

CLOZAPINE

TREATMENT.

RARELY,

COLLAPSE CAN BE PROFOUND AND BE ACCOMPANIED BY RESPIRATORY AND/OR CARDIAC ARREST. 

ORTHOSTATIC HYPOTENSION IS MORE LIKELY TO OCCUR DURING INITIAL TITRATION IN ASSOCIATION WITH RAPID

DOSE

ESCALATION.

IN

PATIENTS

WHO

HAVE

HAD

EVEN

A

BRIEF

INTERVAL

OFF

CLOZAPINE

(ie,

2

OR

MORE

DAYS

SINCE THE LAST DOSE) TREATMENT SHOULD BE STARTED WITH 12.5 MG ONCE OR TWICE DAILY.  (SEE WARNINGS

AND DOSAGE AND ADMINISTRATION.) SINCE COLLAPSE, RESPIRATORY ARREST, AND CARDIAC ARREST DURING

INITIAL TREATMENT HAS OCCURRED IN PATIENTS WHO WERE BEING ADMINISTERED BENZODIAZEPINES OR

OTHER PSYCHOTROPIC DRUGS, CAUTION IS ADVISED WHEN CLOZAPINE IS INITIATED IN PATIENTS TAKING A

BENZODIAZEPINE OR ANY OTHER PSYCHOTROPIC DRUG.  (SEE WARNINGS.)

5.

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIARELATED PSYCHOSIS

ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN

INCREASED RISK OF DEATH.  ANALYSES OF SEVENTEEN PLACEBO-CONTROLLED TRIALS (MODAL DURATION OF 10

WEEKS),

LARGELY

IN

PATIENTS

TAKING

ATYPICAL

ANTIPSYCHOTIC

DRUGS,

REVEALED

A

RISK

OF

DEATH

IN

DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7 TIMES THE RISK OF DEATH IN PLACEBO-TREATED PATIENTS. 

OVER THE COURSE OF A TYPICAL 10-WEEK CONTROLLED TRIAL, THE RATE OF DEATH IN DRUG-TREATED

PATIENTS

WAS

ABOUT

4.5%,

COMPARED

TO

A

RATE

OF

ABOUT

2.6%

IN

THE

PLACEBO

GROUP.

ALTHOUGH

THE

CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED TO BE EITHER CARDIOVASCULAR (eg, HEART

FAILURE,

SUDDEN

DEATH)

OR

INFECTIOUS

(eg,

PNEUMONIA)

IN

NATURE.

OBSERVATIONAL

STUDIES

SUGGEST

THAT, SIMILAR TO ATYPICAL ANTIPSYCHOTIC DRUGS, TREATMENT WITH CONVENTIONAL ANTIPSYCHOTIC DRUGS

MAY INCREASE MORTALITY.   THE EXTENT TO WHICH THE FINDINGS OF INCREASED MORTALITY IN

OBSERVATIONAL STUDIES MAY BE ATTRIBUTED TO THE ANTIPSYCHOTIC DRUG AS OPPOSED TO SOME

CHARACTERISTIC(S) OF THE PATIENTS IS NOT CLEAR.  FAZACLO®

(clozapine, USP) IS NOT APPROVED FOR THE

TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS.  (SEE WARNINGS.)

FazaClo (clozapine) PI