- Orally disintegrating
sublingual tablets: 5 mg, 10 mg
name: asenapine (a
SEN a peen)
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 Saphris® and what does it treat?
is a medication that works in the brain to treat schizophrenia. It
is also known as a second generation antipsychotic (SGA) or atypical
rebalances dopamine and serotonin to improve thinking, mood, and
of schizophrenia 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
may help some or all of these symptoms.
is also FDA approved for the following indications:
medication sheet will focus primarily on schizophrenia. You can find
more information about bipolar disorders at http://www2.nami.org/Template.cfm?Section=By_Illness.
is the most important information I should know about Saphris®?
requires long-term treatment. Do not stop taking asenapine, even
when you feel better.
your healthcare provider can determine the length of asenapine
treatment that is right for you.
doses of asenapine may increase your risk for a relapse in your
not stop taking asenapine or change your dose without talking to with
your healthcare provider first.
asenapine to work properly, it should be taken everyday as ordered by
your healthcare provider.
there specific concerns about Saphris® 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 not recommended in women who are taking asenapine. It is not
known if asenapine passes into breast milk.
should I discuss with my healthcare provider before taking Saphris®?
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 Saphris®?
is usually taken 2 times per day day. Do not eat or drink for 10
minutes after taking asenapine.
patients begin at a low dose of medicine and the dose is increased
slowly over several weeks.
dose usually ranges from 5 mg to 10 mg. Only
your healthcare provider can determine the correct dose for you.
disintegrating tablets must remain in their original packaging. Open
the package with clean dry hands before each dose. Do not try to put
tablets in a pillbox if you take the orally disintegrating tablets.
sublingual tablets will dissolve within seconds when placed under
your tongue. It should not be swallowed.
a calendar, 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
happens if I miss a dose of Saphris®?
you miss a dose of asenapine,
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 Saphris®?
drinking alcohol or using illegal drugs while you are taking
asenapine. They may decrease the benefits (e.g. worsen your
confusion) and increase adverse effects (e.g. sedation) of the
happens if I overdose with Saphris®?
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 asenapine does not
are possible side effects of Saphris®?
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 asenapine
The technical terms for these are â€śextrapyramidal effectsâ€ť (EPS)
and â€śtardive dyskinesiaâ€ť (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 Saphris® for long periods of time?
dyskinesia (TD) is a side effect that develops with prolonged use of
antipsychotics. Medications such as asenapine 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 â€śSerious
Side Effectsâ€ť section for monitoring recommendations.)
other medications may interact with Saphris®?
may block the effects of agents used to treat Parkinson’s disease
such as levodopa/carbidopa (Sinemet®),
bromocriptine, pramipexole (Mirapex®),
following medications may increase the risk of heart problems when
used with asenapine:
and ziprasidone (Geodon®).
(heart rhythm medications), including procainamide, quinidine,
and sotalol (Betapace®).
following medications may increase the levels and effects of asenapine: fluvoxamine
and ciprofloxacin (Cipro®).
long does it take for Saphris® to
is very important to tell your doctor how you feel things are going
during the first few weeks after
you start taking asenapine. It will
probably take several weeks to see big enough changes in your
symptoms to decide if asenapine 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 asenapine
may take 2-3 months before you get the full benefit of asenapine
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.