Approved Drug Label (PDF)
5
Warnings and Precautions
5.3 Risk of New
Onset Pruritus After Discontinuation of Xyzal
Newly added
subsection
Cases
of pruritus after discontinuation of XYZAL have been reported in the
postmarketing setting in patients where pruritus was not present before
initiation of XYZAL. Pruritus occurred within a few days of discontinuing XYZAL
among patients who used XYZAL long-term (e.g., few months to years). Reported
cases of pruritus were infrequent, but some were serious with patients
experiencing widespread severe pruritus [See
Adverse Reactions (6.2)]. If pruritus occurs after discontinuation of
XYZAL, symptoms may improve with restarting or tapering XYZAL.
6
Adverse Reactions
Additions and/or
revisions underlined:
The
following clinically significant adverse reactions are described elsewhere in
the labeling:
- Risk of New Onset Pruritus After Discontinuation of
XYZAL [see Warnings and Precautions
(5.3)]
6.1 Clinical
Trials Experience
Additions and/or
revisions underlined:
Because
clinical trials are conducted under widely varying conditions, adverse reaction
rates observed in the clinical trials of a drug cannot be directly compared to
rates in the clinical trials of another drug and may not reflect the rates
observed in practice.
. . .
6.2 Postmarketing
Experience
Additions and/or
revisions underlined:
In addition to the adverse reactions reported during
clinical trials and listed above, the following adverse reactions have also
been identified during postapproval use of XYZAL. Because these reactions are
reported voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
. . .
- Skin and subcutaneous tissue disorders:
angioedema, fixed drug eruption, pruritus, rash, urticaria, and new onset
pruritus within a few days after discontinuation of XYZAL, usually after
long-term use (e.g., few months to years) of XYZAL
. . .
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING
INFORMATION
Additions and/or
revisions underlined:
.
. .
Risk
of New Onset Pruritus After Discontinuation of XYZAL
Inform
patients pruritus has occurred within a few days of discontinuing XYZAL among
patients who used XYZAL long-term (e.g., few months to years). Pruritus may
improve with restarting or tapering XYZAL [see
Warnings and Precautions (5.3)]. Advise patients to seek medical advice if
pruritus occurs.
.
. .
Approved Drug Label (PDF)
8
Use in Specific Populations
8.1 Pregnancy
(PLLR
conversion, Please refer to label)
8.2 Lactation
(PLLR conversion)
Risk Summary
There are no data on the presence of
levocetirizine in human milk, the effects on the breastfed infant, or the
effects on milk production. However, cetirizine has been reported to be present
in human breast milk. In mice and beagle dogs, studies indicated that
cetirizine was excreted in milk (see
Data). When a drug is present in animal milk, it is likely the drug will be
present in human milk. The developmental and health benefits of breastfeeding
should be considered along with the mother’s clinical need for XYZAL and any
potential adverse effects on the breastfed child from XYZAL or from the
underlying maternal condition.
Data
Animal
Data
Cetirizine was detected in the milk of
mice. No adverse developmental effects on pups were seen when cetirizine was
administered orally to dams during lactation at a dose that was approximately
25 times the MRHD in adults [see Use in Specific Populations (8.1)]. Studies in
beagle dogs indicated that approximately 3% of the dose of cetirizine was
excreted in milk. The concentration of drug in animal milk does not necessarily
predict the concentration of drug in human milk.
Approved Drug Label (PDF)
6
Adverse Reactions
6.2 Post-Marketing Experience
(Additions and/or revisions are underlined)
In addition to the adverse
reactions reported during clinical trials and listed above, the following
adverse reactions have also been identified during post-approval use of XYZAL…
- Cardiac disorders: palpitations, tachycardia
- Ear and labyrinth
disorders: vertigo
- Eye disorders: blurred vision, visual disturbances
- Gastrointestinal
disorders: nausea, vomiting
- General disorders
and administration site conditions: edema
- Hepatobiliary
disorders: hepatitis
- Immune system
disorders: anaphylaxis and hypersensitivity
- Metabolism and
nutrition disorders: increased appetite
- Musculoskeletal,
connective tissues, and bone disorders: arthralgia,
myalgia
- Nervous system
disorders: dizziness, dysgeusia, febrile
seizure, movement disorders (including dystonia and oculogyric crisis),
paraesthesia, seizure (reported in subjects with and without a known
seizure disorder), tremor
- Psychiatric
disorders: aggression and agitation, depression, hallucinations,
insomnia, suicidal ideation
- Renal and urinary
disorders: dysuria, urinary retention
- Respiratory,
thoracic, and mediastinal disorders: dyspnea
- Skin and
subcutaneous tissue disorders: angioedema,
fixed drug eruption, pruritus, rash and urticaria
Besides these
reactions reported under treatment with XYZAL, other potentially severe adverse
events have been reported from the post- marketing experience with cetirizine…
Cardiac disorders: severe hypotension
Gastrointestinal disorders: cholestasis
Nervous system disorders: extrapyramidal symptoms, myoclonus, orofacial dyskinesia, tic
Pregnancy, puerperium and perinatal
conditions: stillbirth
Renal and urinary disorders: glomerulonephritis
Skin and subcutaneous tissue disorders:
acute generalized exanthematous
pustulosis (AGEP)
Approved Drug Label (PDF)
8
Use in Specific Populations
8.4 Pediatric Use
(additions
underlined)
The recommended dose of XYZAL
for the treatment of the uncomplicated skin manifestations of chronic
idiopathic urticaria in patients 6 months to 17 years of age is based on
extrapolation of efficacy from adults 18 years of age and older.
The recommended dose of XYZAL in patients 6 months
to 2 years of age for the treatment of the symptoms of perennial
allergic rhinitis and 6 months to 11 years of age with chronic
idiopathic urticariais based on cross-study comparisons of the systemic
exposure of XYZAL in adults and pediatric patients and on the safety profile of
XYZAL in both adult and pediatric patients at doses equal to or higher than the
recommended dose for patients 6 months to 11 years of age.
…
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