Gocovri

Gocovri is a prescription medicine containing amantadine.

Gocovri is used to treat dyskinesia (sudden uncontrolled movements) in people with Parkinson's disease who are treated with levodopa or levodopa plus other medicines that increase the effects of dopamine in the brain.

Gocovri is also used with the medicines levodopa and carbidopa in people with Parkinson’s disease who are having “off” episodes.

Gocovri may also be used for purposes not listed in this medication guide.

Take Gocovri exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take Gocovri with or without food. You may need to take this medicine only at bedtime. Follow your doctor's instructions.

Swallow the capsule whole and do not crush, chew, or break it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Call your doctor if your symptoms do not improve, or if you have a fever with a headache, cough, skin rash, or other new symptoms.

If you take Gocovri for Parkinson symptoms: You should not stop using this medicine suddenly or your condition may become worse. Stopping suddenly may also cause unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Gocovri.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

You should not use Gocovri if you received a nasal flu vaccine in the past 14 days.

Do not receive a nasal flu vaccine while taking Gocovri, and for at least 48 hours after your last dose.

You should not use Gocovri if you are allergic to amantadine, or if:

• you have severe kidney disease; or
• you have received a "live" nasal flu vaccine (FluMist) within the past 14 days.

Tell your doctor if you have ever had:

• kidney disease;
• daytime drowsiness (caused by a sleep disorder or taking certain medicines);
• congestive heart failure;
• eczema;
• glaucoma;
• liver disease;
• a seizure;
• low blood pressure, fainting spells;
• alcoholism or drug addiction; or
• mental illness, psychosis, or suicidal thoughts or actions.

People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.

It is not known whether Gocovri will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breast-feed while using Gocovri.

Get emergency medical help if you have signs of an allergic reaction to Gocovri: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• extreme drowsiness, falling asleep suddenly even after feeling alert;
• a light-headed feeling, like you might pass out;
• shortness of breath (even with mild exertion), swelling in your hands or feet;
• painful or difficult urination;
• depression, agitation, aggression, behavior changes, hallucinations, thoughts of hurting yourself;
• a seizure; or
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking Gocovri. Talk with your doctor if this occurs.

Side effects may be more likely in older adults.

Common Gocovri side effects may include:

• dizziness, falls;
• dry mouth;
• swelling in your legs or feet;
• nausea, constipation; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Parkinson's Disease Extended-release (ER) capsules: Initial dose: 137 mg orally once a day for 1 week, then 274 mg orally once a day; doses should be taken at bedtime. Take orally once a day at bedtime with or without food -Swallow whole; do not crush, chew, or divide capsules -If unable to swallow whole, may open the capsule and sprinkle the entire contents on a small amount of soft food and swallow immediately without chewing. -Concomitant use with alcohol is not recommended as it may result in dose-dumping.

Renal Dose Adjustments: Extended-release capsules: -Mild renal impairment (CrCl 60 to 89 mL/min/1.73 m2): No adjustment recommended -Moderate renal impairment (CrCl 30 to 59 mL/min/1.73 m2): Initial dose: 68.5 mg orally once a day at bedtime; increase after 1 week to 137 mg/day if needed -Severe renal impairment (CrCl 15 to 29 mL/min/1.73 m2): 68.5 mg orally once a day at bedtime -ESRD: Contraindicated Note: extended-release tablets and extended-release capsules have different release profiles; they are not interchangeable.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Call your doctor if you miss several doses in a row.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Gocovri can be fatal.

Overdose symptoms may include confusion, agitation, behavior changes, hallucinations, severe headache or pounding in your ears, muscle stiffness, problems with balance or walking, trouble breathing, fast heartbeats, or seizure.

Do not drink alcohol. Dangerous side effects could occur.

Avoid driving or operating machinery until you know how Gocovri will affect you. Amantadine may impair your thinking or reactions. Some people taking Gocovri have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with amantadine can increase your risk of unpleasant side effects.

Using Gocovri with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

• glaucoma medication; or
• medicine that contains sodium bicarbonate (such as Alka-Seltzer).

This list is not complete. Other drugs may interact with amantadine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.