injectable suspension: 39 mg, 78 mg, 117 mg, 156 mg, 234 mg
name: paliperidone (pal ee PER i done)
class: Second generation antipsychotic (SGA), atypical antipsychotic
All FDA black box
warnings are at the end of this fact sheet. Please review
before taking this medication.
is Invega® and what does it treat?
medication that works in the brain to treat schizophrenia and
schizoaffective disorder. It is also known as a second generation
antipsychotic (SGA) or atypical antipsychotic. Paliperidone
rebalances dopamine and serotonin to improve thinking, mood, and
disorder is an illness that includes abnormal moods (elevated and/or
depressed) and psychosis.
of schizophrenia/psychosis include:
- imagined voices or images that seem real
- beliefs that are not true (e.g., other people are reading your
thinking or trouble organizing your thoughts and making sense
desire to be around other people
mood – feeling sad, empty, or tearful
worthless, guilty, hopeless, or helpless
of interest or pleasure in normal activities
and eat more or less than usual (for most people it is less)
energy, trouble concentrating, or thoughts of death (suicidal
agitation (ânervous energy’)
retardation (feeling like you are moving in slow motion)
irritable or âhighâ
increased self esteem
like you don’t need to sleep
the need to continue to talk
like your thoughts are too quick (racing thoughts)
involved in activities that are risky or could have bad consequences
(e.g. excessive spending)
may help some or all of these symptoms.
medication sheet will focus primarily on schizophrenia. You can find
more information about schizoaffective disorder at http://www2.nami.org/Template.cfm?Section=By_Illness.
is the most important information I should know about Invega®?
requires long-term treatment. Do not stop taking paliperidone, even
when you feel better.
your healthcare provider can determine the length of paliperidone
treatment that is right for you.
doses of paliperidone may increase your risk for a relapse in your
not stop taking paliperidone or change your dose without talking to
with your healthcare provider first.
paliperidone to work properly, it should be taken everyday as ordered
by your healthcare provider.
there specific concerns about Invega® and
you are planning on becoming pregnant, notify your healthcare
provider to best manage your medications. People living with
schizophrenia who wish to become pregnant face important decisions.
This is a complex decision since untreated schizophrenia has risks to
the fetus, as well as the mother. It is important to discuss the
risks and benefits of treatment with your doctor and caregivers.
is advised with breastfeeding since paliperidone does pass into
should I discuss with my healthcare provider before taking Invega®?
of your condition that bother you the most
you have thoughts of suicide or harming yourself
you have taken in the past for your condition, whether they were
effective or caused any adverse effects
you ever had muscle stiffness, shaking, tardive dyskinesia,
neuroleptic malignant syndrome, or weight gain caused by a
you experience side effects from your medications, discuss them with
your provider. Some side effects may pass with time, but others may
require changes in the medication.
psychiatric or medical problems you have, such as heart rhythm
problems, long QT syndrome, heart attacks, diabetes, high
cholesterol, or seizures
you have a family history of diabetes or heart disease
other medications you are currently taking (including over the
counter products, herbal and nutritional supplements) and any
medication allergies you have
non-medication treatment you are receiving, such as talk therapy or
substance abuse treatment. Your provider can explain how these
different treatments work with the medication.
you are pregnant, plan to become pregnant, or are breast-feeding
you smoke, drink alcohol, or use illegal drugs
should I take Invega®?
tablets are usually taken 1 time per day with or without food.
patients begin at a low dose of medicine and the dose is increased
slowly over several weeks.
dose of the tablets usually ranges from 3 mg to 12 mg. The dose of
the injection usually ranges from 78 mg to 234 mg. Only
your healthcare provider can determine the correct dose for you.
tablets should be swallowed whole. They should not be chewed,
crushed, or broken.
a calendar, pillbox, alarm clock, or cell phone alert to help you
remember to take your medication. You may also ask a family
member a friend to remind you or check in with you to be sure you are
taking your medication.
long-acting injection form of paliperidone is administered twice in
the first 8 days of treatment, then every 4 weeks. Your healthcare
provider will administer these injections.
happens if I miss a dose of Invega®?
you miss a dose of paliperidone,
take it as soon as you remember, unless it is closer to the time of
your next dose. Discuss this with your healthcare provider. Do not
double your next dose or take more than what is prescribed.
should I avoid while taking Invega®?
drinking alcohol or using illegal drugs while you are taking
They may decrease the benefits (e.g. worsen your confusion) and
increase adverse effects (e.g. sedation) of the medication.
happens if I overdose with Invega®?
an overdose occurs call your doctor or 911. You may need urgent
medical care. You may also contact the poison control center at
specific treatment to reverse the effects of paliperidone does not
are possible side effects of Invega®?
blood pressure, feeling dizzy and increased heart rate, especially
when standing up
sleepiness, headache, constipation, and appetite increases are also
common and more likely in children than in adults.
may increase the blood levels of a hormone called prolactin. Side
effects of increased prolactin levels include females losing their
period, production of breast milk and males losing their sex drive or
possibly experiencing erectile problems. Long term (months or years)
of elevated prolactin can lead to osteoporosis, or increased risk of
people may develop muscle related side effects while taking
The technical terms for these are âextrapyramidal effectsâ (EPS)
and âtardive dyskinesiaâ (TD). Symptoms of EPS include
restlessness, tremor, and stiffness. TD symptoms include slow or
jerky movements that one cannot control, often starting in the mouth
with tongue rolling or chewing movements.
generation antipsychotics (SGAs) increase the risk of weight gain,
high blood sugar, and high cholesterol. This is also known as
metabolic syndrome. Your healthcare provider may ask you for a blood
sample to check your cholesterol, blood sugar, and hemoglobin A1c (a
measure of blood sugar over time) while you take this medication.
have been linked with higher risk of death, strokes, and transient
ischemic attacks (TIAs) in elderly people with behavior problems due
antipsychotics have been associated with the risk of sudden cardiac
death due to an arrhythmia (irregular heart beat). To minimize this
risk, antipsychotic medications should be used in the smallest
effective dose when the benefits outweigh the risks. Your doctor may
order an EKG to monitor for irregular heart beat.
malignant syndrome is a rare, life threatening adverse effect of
antipsychotics which occurs in <1% of patients. Symptoms include
confusion, fever, extreme muscle stiffness, and sweating. If any of
these symptoms occur, contact your healthcare provider immediately.
there any risks of taking Invega® for long periods of time?
dyskinesia (TD) is a side effect that develops with prolonged use of
antipsychotics. Medications such as paliperidone have been shown to
have a lower risk of TD compared to older antipsychotics, such as
Haldol® (haloperidol). If you develop symptoms of TD, such as grimacing,
sucking, and smacking of lips, or other movements that you cannot
control, contact your healthcare provider immediately. All patients
taking either first or second generation antipsychotics should have
an Abnormal Involuntary Movement Scale (AIMS) completed regularly by
their healthcare provider to monitor for TD.
generation antipsychotics (SGAs) increase the risk of diabetes,
weight gain, high cholesterol, and high triglycerides. (See âSerious
Side Effectsâ section for monitoring recommendations.)
other medications may interact with Invega®?
may block the effects of agents used to treat Parkinson’s disease
such as levodopa (Sinemet®),
bromocriptine, pramipexole (Mirapex®),
may lower your blood pressure. Medications used to lower blood
pressure may increase this effect and increase your risk of falling.
is an example of this type of medication.
following medications may increase the risk of heart problems when
used with paliperidone.
and ziprasidone (Geodon®).
(heart rhythm medications), including procainamide, quinidine,
and sotalol (Betapace®).
following medications may increase the levels and effects of paliperidone: divalproex sodium
following medications may decrease the levels and effects of paliperidone: carbamazepine (Tegretol®,
long does it take for Invega® to
is very important to tell your doctor how you feel things are going
during the first few weeks after
you start taking paliperidone. It will
probably take several weeks to see big enough changes in your
symptoms to decide if paliperidone is the
right medication for you.
treatment is generally needed lifelong for persons with
schizophrenia. Your doctor can best discuss the duration of treatment
you need based on your symptoms and illness.
disorganized thinking, and delusions may improve in the first 1-2
these symptoms do not completely go away
and desire to be around other people can take at least 1-2 weeks to
continue to get better the longer you take paliperidone
may take 2-3 months before you get the full benefit of paliperidone
of Psychiatric and Neurologic Pharmacists
of FDA Black Box Warnings
Mortality in Elderly Patients with Dementia Related Psychosis
first generation (typical) and second generation (atypical)
antipsychotics are associated with an increased risk of mortality in
elderly patients when used for dementia related psychosis.
there were multiple causes of death in studies, most deaths appeared
to be due to cardiovascular causes (e.g. sudden cardiac death) or
infection (e.g. pneumonia).
are not indicated for the treatment of dementia-related psychosis.