Approved Drug Label (PDF)
8
Use in Specific Populations
Lactation
(PLLR conversion.
Please refer to label for complete information.)
Pregnancy
(PLLR conversion.
Please refer to label for complete information.)
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT COUNSELING INFORMATION
(Newly added
information)
Pregnancy Registry
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed
to INTUNIV
during pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise breastfeeding mothers to monitor infants exposed to guanfacine through breastmilk for sedation, lethargy
and poor feeding [see Use in Specific Populations
(8.2)].
Patient Information
(Newly added
information)
There is a pregnancy registry for females
who are exposed
to ADHD medications, including INTUNIV, during pregnancy. The purpose of the registry
is to collect information about the health of females exposed to INTUNIV
and their baby.
If you or your child becomes pregnant during treatment with INTUNIV, talk to your healthcare provider
about registering
with the National
Pregnancy Registry of ADHD medications at 1-866-961-2388.
Approved Drug Label (PDF)
5
Warnings and Precautions
5.4 Rebound Hypertension
(Newly added subsection)
In post marketing
experience, abrupt discontinuation of INTUNIV® has resulted in clinically
significant and persistent rebound hypertension above baseline levels and
increases in heart rate. Hypertensive encephalopathy has also been reported in
association with rebound hypertension with both INTUNIV® and immediate release
guanfacine. In these cases, high-dosage guanfacine
was discontinued; concomitant stimulant use was also reported, which may
potentially increase hypertensive response upon abrupt discontinuation of
guanfacine. Children commonly have gastrointestinal illnesses that lead to
vomiting, and a resulting inability to take medications, so they may be
especially at risk for rebound hypertension.
To minimize the
risk of rebound hypertension upon discontinuation, the total daily dose of
INTUNIV® should be tapered in decrements of no more than 1 mg every 3 to 7
days. Blood pressure and heart rate should be monitored when reducing the dose
or discontinuing INTUNIV®. If abrupt discontinuation occurs (especially with
concomitant stimulant use), patients should be closely followed for rebound
hypertension.
6
Adverse Reactions
(Additions and/or revisions are underlined)
The following
serious adverse reactions are described elsewhere in the labeling:
6.1 Clinical Trials Experience
(Additions and/or revisions are underlined)
Discontinuation
of Treatment
Blood pressure
and pulse may increase above baseline values following discontinuation of
INTUNIV®. In five studies of
children and adolescents, increases in mean systolic and diastolic
blood pressure averaging approximately 3 mmHg and increases in heart
rate averaging 5 beats per minute above original baseline were observed
upon discontinuation with tapering of INTUNIV. In a maintenance of efficacy
study, increases in blood pressure and heart rate above baseline slowly
diminished over the follow up period, which ranged between 3 and 26
weeks post final dose; the estimated average time to return to baseline was
between six and twelve months. In this study, the increases in blood
pressure and pulse were not considered serious or associated with adverse
events. However, individuals may have larger increases than reflected by the
mean changes.
In postmarketing
experience, following abrupt discontinuation of INTUNIV®, rebound hypertension
and hypertensive encephalopathy have been reported.
6.2 Postmarketing Experience
(Additions and/or revisions are underlined)
Less frequent,
possibly guanfacine-related events observed in the post-marketing study and/or
reported spontaneously, not included in section 6.1, include:
Cardiovascular: palpitations, tachycardia, rebound
hypertension, hypertensive encephalopathy
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Dosing and
Administration
…
Advise patients
not to abruptly discontinue INTUNIV® as abrupt discontinuation can result in
clinically significant rebound hypertension. Concomitant stimulant use and
abrupt discontinuation of Intuniv may increase this hypertensive response. Instruct patients on how to properly taper
the dose to minimize the risk of rebound hypertension.
Patient Information
(Additions and/or revisions are underlined)
What should I tell my doctor before taking
INTUNIV®?
Before you take INTUNIV®,
tell your doctor if you:
How should I take INTUNIV®?
Try
not to miss your dose of INTUNIV®. If you miss a dose of INTUNIV®, take the
next dose at your regular time. If you miss 2 or more doses, talk to your
doctor, as you may need to restart INTUNIV® with a lower dose.
- Do
not take a double dose to make up for a missed dose.
What should I avoid while taking INTUNIV®?
- Do
not suddenly stop INTUNIV. Tell your healthcare provider if you have been
vomiting and cannot take INTUNIV, you may be at risk for rebound hypertension.
What are the possible side effects of
INTUNIV®?
INTUNIV® may cause serious side effects
including:
- increased
blood pressure and heart rate after suddenly stopping INTUNIV (rebound
hypertension). Suddenly stopping INTUNIV can cause increased blood pressure and
heart rate and other withdrawal symptoms such as headache, confusion,
nervousness, agitation, and tremors. If these symptoms continue to get worse
and are left untreated, it could lead to a very serious condition including
very high blood pressure, feeling very sleepy or tired, severe headache,
vomiting, vision problems, seizures.
Other
(Dear Health Care Provider Letter added; please refer to label)
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