Description
Apomorphine sublingual film is used to treat short-term (acute), intermittent “off” episodes in patients with Parkinson’s disease. By improving muscle control and reducing stiffness, this medicine allows more normal movements of the body as the symptoms of the disease are reduced.
This medicine is available only with your doctor's prescription.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of apomorphine sublingual film in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of apomorphine sublingual film in the elderly. However, elderly patients are more likely to have serious unwanted effects (eg, confusion, hallucination, heart or blood vessel problems, falls, stomach or bowel problems, lung or breathing problems) and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients using this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alosetron
- Bepridil
- Cisapride
- Dolasetron
- Dronedarone
- Granisetron
- Levoketoconazole
- Mesoridazine
- Ondansetron
- Palonosetron
- Piperaquine
- Saquinavir
- Sparfloxacin
- Sulpiride
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Adagrasib
- Alfuzosin
- Alizapride
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Benperidol
- Bromopride
- Bromperidol
- Buprenorphine
- Ceritinib
- Chloroquine
- Chlorpromazine
- Chlorprothixene
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Delamanid
- Desipramine
- Deutetrabenazine
- Dexmedetomidine
- Disopyramide
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Nitroglycerin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to sulfites, history or
- Asthma—Apomorphine sublingual film contains a sulfite which can trigger attacks in patients with this condition.
- Bradycardia (slow heartbeat) or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Kidney disease, severe (eg, end-stage kidney disease) or
- Liver disease, severe—Use with caution. May increase risk for more side effects.
- Heart or blood vessel disease, history of or
- Heart rhythm problems (eg, QT prolongation) or
- Hypotension (low blood pressure) or history of or
- Mental illness (eg, psychosis) or
- Trouble sleeping—Use with caution. May make these conditions worse.
- Kidney disease, mild or moderate or
- Liver disease, mild or moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed. Do not stop taking your medicine or change your dose unless ordered by your doctor. It is also important to not start taking other medicines for your Parkinson's disease without first talking with your doctor.
This medicine usually comes with patient information leaflet. Read the instructions carefully and make sure you understand them before taking this medicine. If you have any questions, ask your doctor.
To use the sublingual film:
- Drink water before using this medicine to moisten your mouth.
- Place the film under your tongue. Do not cut, chew, or swallow it.
- Keep the film in place for about 3 minutes until it completely dissolves. Do not talk or swallow your saliva while the film is dissolving.
Your doctor may also give you other medicines (eg, trimethobenzamide) if needed, 3 days before starting, or during treatment with this medicine and for up to 2 months to prevent nausea and vomiting.
Do not use more than 1 dose of this medicine to treat an "off" episode. Do not use more than 5 doses of this medicine per day.
If you are also using sublingual nitroglycerin, lie down before and after taking it.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For sublingual dosage form (films):
- For "off" episodes in Parkinson's disease:
- Adults—At first, 10 milligrams (mg) placed under the tongue as needed. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 30 mg per day.
- Children—Use and dose must be determined by your doctor.
- For "off" episodes in Parkinson's disease:
Missed Dose
Call your doctor or pharmacist for instructions.
Do not take another dose of this medicine less than 2 hours after the last dose.
Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep this medicine in the foil pouch until you are ready to use it.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not take this medicine together with alosetron (Lotronex®), dolasetron (Anzemet®), granisetron (Kytril®, Sancuso®), ondansetron (Ondisolv®, Zofran®), or palonosetron (Aloxi®).
Do not change your dose or stop using this medicine without first checking with your doctor. Stopping this medicine suddenly may cause fever, confusion, or severe muscle stiffness.
Call your doctor if your symptoms do not improve or if they get worse.
This medicine may make you dizzy or drowsy, or cause trouble with controlling body movements, which may lead to falls. It may also cause you to fall asleep without warning. This could happen while you are driving, eating, or talking. Tell your doctor right away if this happens. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Standing up slowly from a sitting or lying position can help prevent getting dizzy.
This medicine may cause serious allergic reactions, which an be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
This medicine can cause swelling or inflammation of the mouth. Talk to your doctor if you have any concerns.
Some people who have used this medicine had unusual changes in their mood or behavior. Talk with your doctor right away if you start seeing, hearing, or feeling things that are not there, or start having unusual urges, such as gambling urges, binge or compulsive eating, compulsive shopping, or sexual urges while using this medicine.
Check with your doctor right away if you have back, leg, or stomach pains, bleeding gums, chills, dark urine, difficulty breathing, fever, general body swelling, headache, loss of appetite, nausea or vomiting, nosebleeds, pale skin, sore throat, unusual tiredness or weakness, or yellowing of the eyes or skin. These may be symptoms of a blood problem called hemolytic anemia.
This medicine may also increase your risk of having serious heart and blood vessel problems such as chest pain or heart attack. Check with your doctor right away if you start having chest pain or discomfort, pain or discomfort in the arms, jaw, back or neck, trouble breathing, nausea, sweating, or vomiting.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.
This medicine may increase your risk for fibrotic complications (tissue changes in the pelvis, lungs, and heart valves). Check with your doctor right away if you have fever, general feeling of illness, loss of appetite, lower stomach or back pain, cough, or trouble breathing.
If you experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with apomorphine may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Chest tightness
- falls
- fast heartbeat
- fever
- hives, itching, skin rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- redness of the skin
- sleepiness or unusual drowsiness
- swelling of the eyelids, face, lips, hands, or feet
- trouble with breathing or swallowing
- unusual tiredness or weakness
Less common
- Blurred vision
- confusion
- dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
- false beliefs that cannot be changed by facts
- seeing, hearing, or feeling things that are not there
- sweating
Incidence not known
- Back, leg, or stomach pains
- bleeding gums
- chills
- dark urine
- general body swelling
- headache
- loss of appetite
- nausea
- nosebleeds
- pale skin
- sore throat
- vomiting
- yellowing of the eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Dry mouth
- irritation, redness, numbness, swelling, or soreness of the mouth
- runny nose
- tearing of the skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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