IMPORTANT SAFETY INFORMATION FOR KYNMOBI (apomorphine HCI)
SUBLINGUAL FILM
Do not take KYNMOBI if you are taking certain medicines to treat
nausea called 5HT3 antagonists, including ondansetron, granisetron,
dolasetron, palonosetron, and alosetron. People taking ondansetron
together with apomorphine, the active ingredient in KYNMOBI, have had
very low blood pressure and lost consciousness or "blacked out."
Do not use KYNMOBI if you are allergic to apomorphine hydrochloride or
to any of the ingredients in KYNMOBI. KYNMOBI also contains a sulfite
called sodium metabisulfite. Sulfites can cause severe,
life‐threatening allergic reactions in some people. An allergy to
sulfites is not the same as an allergy to sulfa. People with asthma
are more likely to be allergic to sulfites. Call your healthcare
provider if you have hives, itching, rash, swelling of the lips,
tongue and mouth, redness of your face (flushing), throat tightness,
trouble breathing or swallowing.
Before starting KYNMOBI, tell your healthcare provider:
About all of your medical conditions, including if you:
-
have difficulty staying awake during the daytime
-
have liver problems
-
have dizziness
-
have kidney problems
-
have fainting spells
-
have heart problems
-
have low blood pressure
-
have had a stroke or other brain problems
-
have asthma
-
have a mental problem called a major psychotic disorder
-
are allergic to any medicines containing sulfites
-
drink alcohol
-
are pregnant or plan to become pregnant. It is not known if KYNMOBI
will harm your unborn baby
-
are breastfeeding or plan to breastfeed. It is not known if KYNMOBI
passes into your breast milk. You and your healthcare provider
should decide if you will take KYNMOBI or breastfeed.
Tell your healthcare provider about all the medicines you take,
including:
- prescription medicines
- over-the-counter medicines
- vitamins
- herbal supplements
KYNMOBI may affect the way other medicines work, and other medicines
can affect how KYNMOBI works. Taking KYNMOBI with other medicines may
cause serious side effects.
If you take nitroglycerin under your tongue (sublingual) while using
KYNMOBI, your blood pressure may decrease and cause dizziness. You
should lie down before and after taking sublingual nitroglycerin.
KYNMOBI can cause serious side effects, including:
- nausea and vomiting. Nausea is a common side effect of
KYNMOBI.
Nausea and vomiting can happen with KYNMOBI. Your healthcare
provider may prescribe a medicine called an antiemetic, such as
trimethobenzamide to help prevent nausea and vomiting. If
trimethobenzamide is prescribed, talk to your healthcare provider
about how long you should remain on this medicine.
- sleepiness or falling asleep during the day. Sleepiness is a
serious, and common side effect of KYNMOBI.
Some people treated with KYNMOBI may get sleepy during the day or
fall asleep without warning while doing everyday activities such as
talking, eating, or driving a car.
- dizziness. Dizziness is a serious, and common side effect of
KYNMOBI.
KYNMOBI may lower blood pressure and cause dizziness. Dizziness can
happen when KYNMOBI treatment is started or when the KYNMOBI dose is
increased. Do not get up too fast from sitting or after lying down,
especially if you have been sitting or lying down for a long period
of time.
- mouth (oral) irritation. Mouth (oral) irritation is a common side
effect of KYNMOBI.
You should call your healthcare provider if you develop any of these
signs or symptoms.
- redness
- mouth sores (ulceration)
- dryness of the mouth, lips or tongue
- swelling
- pain
- pain with swallowing
- falls. The changes that can happen with PD, and the effects
of some PD medicines, can increase the risk of falling. KYNMOBI may
also increase your risk of falling.
- hallucinations or psychotic-like behavior. KYNMOBI may cause
or make psychotic-like behavior worse including hallucinations
(seeing or hearing things that are not real), confusion, excessive
suspicion, aggressive behavior, agitation, delusional beliefs
(believing things that are not real), and disorganized thinking.
- strong (intense) urges. Some people with PD have reported new
or strong uncontrollable urges to gamble, increased sexual urges,
increased urges to spend money (compulsive shopping), and other
intense urges, while taking PD medicines, including KYNMOBI. If you
or your family members notice that you have strong urges, talk to
your healthcare provider. The strong urges may go away if your
KYNMOBI dose is lowered or stopped.
- high fever and confusion. KYNMOBI may cause a problem that
can happen in people who suddenly lower their dose, stop using, or
change their dose of KYNMOBI. Symptoms include:
- very high fever
- confusion
- stiff muscles
- changes in breathing and heartbeat
Do not stop taking KYNMOBI or change your dose unless you are
told to do so by your healthcare provider.
- heart problems. If you have shortness of breath, fast
heartbeat, chest pain, or feel like you are going to pass out
(faint) while taking KYNMOBI, call your healthcare provider or get
emergency help right away.
- tissue changes (fibrotic complications). Some people have had
changes in the tissues of their pelvis, lungs, and heart valves when
taking medicines called nonergot derived dopamine agonists like
KYNMOBI.
- prolonged painful erections (priapism). KYNMOBI may cause
prolonged, painful erections in some people. If you have a prolonged
and painful erection, you should call your healthcare provider or go
to the nearest hospital emergency room right away.
The most common side effects of KYNMOBI include:
- nausea
- dizziness
- sleepiness
- mouth swelling, pain, or sores
INDICATION
KYNMOBI™ (apomorphine HCl) sublingual film is a prescription medicine
used to treat short-term (acute), intermittent “off” episodes in
people with Parkinson’s disease (PD).
You are encouraged to report negative side effects of prescription
drugs to the FDA.
Visit
www.fda.gov/medwatch
or call 1-800-FDA-1088.
For more information, please see the KYNMOBI
Patient Information,
full Prescribing Information, and
Instructions for Use.
