Gocovri

For all uses of this medicine:

• Tell all of your health care providers that you take Gocovri. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Heat stroke has happened in people taking Gocovri. Be careful in hot weather and during physical activity.
• Talk with your doctor before getting a flu vaccine after taking this medicine. Talk with your doctor before you take Gocovri if you have just gotten a flu vaccine.
• Avoid drinking alcohol while taking this medicine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• If you have kidney problems, talk with your doctor. Your dose may need to be changed based on how well your kidneys work. Deaths have happened in people with kidney problems whose dose was too high for their kidney function.
• Deadly overdoses have happened with Gocovri in adults and children. Keep away from children. Do not take more than you were told. If this drug is taken by accident, call your poison control center or get medical care right away.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Gocovri while you are pregnant.

Parkinson's disease:

• Do not stop taking this medicine all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop Gocovri (amantadine extended-release capsules), you will want to slowly stop it as ordered by your doctor.
• The chance of a type of skin cancer called melanoma may be raised in people with Parkinson's disease. It is not known if this medicine may also raise the chance. Have skin exams while you take Gocovri. Talk with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Gocovri or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Gocovri (amantadine extended-release capsules). This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Gocovri contains amantadine in an extended release formulation. The active ingredient in Gocovri is amantadine hydrochloride.

The chemical name for amantadine hydrochloride is tricyclo [3.3.1.1 3,7] decan-1-amine, hydrochloride or 1-adamantanamine hydrochloride with the following structural formula:

The molecular formula is C10H17N•HCl and the molecular weight is 187.71 (g/mol). Amantadine hydrochloride is a white crystalline powder and is non-hygroscopic, practically insoluble in ether, sparingly soluble in methylene chloride, soluble in chloroform, and freely soluble in water, ethanol, and methanol.

Gocovri capsules are for oral use. Each capsule contains 68.5 mg or 137 mg amantadine (as 85 mg or 170 mg amantadine hydrochloride, respectively). Capsules also contain the following inactive ingredients: copovidone, ethylcellulose, hypromellose, magnesium stearate, medium-chain triglycerides, microcrystalline cellulose, povidone, and talc in a hard gelatin capsule.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Animal studies designed to evaluate the carcinogenic potential of amantadine have not been conducted.

Mutagenesis

Amantadine was negative for genotoxicity in in vitro (Ames and mammalian cell [Chinese Hamster ovary and human peripheral blood lymphocytes]) assays in the presence or absence of metabolic activation and in an in vivo mouse bone marrow micronucleus assay.

Impairment of Fertility

The effects of amantadine on fertility have not been adequately tested in a study in animals conducted according to current standards. In a reproduction study reported in the literature, oral administration of amantadine to male and female rats at a dose of 32 mg/kg/day resulted in impaired fertility. The no-effect dose for adverse effects on fertility (10 mg/kg/day) is less than the recommended human dose of 274 mg/day on a mg/m2 basis.

How Supplied

Gocovri is supplied as extended release capsules in the following configurations:

The 68.5 mg capsule is a white opaque size #2 capsule, with black printing of ‘ADAMAS’ on front and ‘85’ on back of the cap and three black bands printed on body of capsule.

• 60 count bottles      NDC# 70482-085-60

The 137 mg capsule is a light blue opaque size #0 capsule, with black printing of ‘ADAMAS’ on front and ‘170’ on back of the cap and three black bands printed on body of capsule.

• 60 count bottles      NDC# 70482-170-60

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Applies to amantadine: oral capsule, oral capsule liquid filled, oral solution, oral syrup, oral tablet

Along with its needed effects, amantadine (the active ingredient contained in Gocovri) 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 while taking amantadine:

• Blurred vision
• confusion
• difficult urination
• dizziness or lightheadedness
• fainting
• seeing, hearing, or feeling things that are not there
• swelling of the hands, feet, or lower legs

• Convulsions (seizures)
• decreased vision or any change in vision
• difficulty in coordination
• fever, chills, or sore throat
• increased blood pressure
• increase in body movements
• irritation and swelling of the eye
• loss of memory
• mental depression
• severe mood or mental changes
• skin rash
• slurred speech
• thoughts of suicide or attempts at suicide
• unexplained shortness of breath

Some side effects of amantadine 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:

• Agitation, anxiety, or nervousness
• difficulty concentrating
• headache
• irritability
• loss of appetite
• nausea
• purplish red, net-like, or blotchy spots on the skin
• trouble in sleeping or nightmares

• Constipation
• decrease in sexual desire
• diarrhea
• drowsiness
• dryness of the mouth, nose, and throat
• false sense of well-being
• vomiting
• unusual tiredness or weakness

You should not use amantadine if you are allergic to it, or if you have received a "live" nasal flu vaccine (FluMist) within the past 14 days.

To make sure amantadine is safe for you, tell your doctor if you have ever had:

• daytime drowsiness (caused by a sleep disorder or taking certain medicines);

• a seizure;

• fluid retention, congestive heart failure;

• liver or kidney disease;

• low blood pressure, fainting spells;

• eczema;

• glaucoma;

• 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 this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Amantadine can pass into breast milk, but effects on the nursing baby are not known. This medicine may also affect breast milk production. You should not breast-feed while using this medicine.

Amantadine is not approved for influenza in a child younger than 1 year old. Gocovri is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

If you take amantadine to treat influenza A, start taking the medicine within 24 to 48 hours after flu symptoms begin. Keep taking amantadine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

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

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

To make swallowing easier, you may open the capsule 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 amantadine for Parkinson symptoms: You should not stop using amantadine suddenly or your condition may become worse. Stopping suddenly may also cause unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

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

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amantadine 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 receive a nasal flu vaccine while using amantadine, and for at least 48 hours after your last dose. The vaccine may not work as well during this time, and may not fully protect you from disease.

Do not drink alcohol. Dangerous side effects could occur.

Avoid driving or operating machinery until you know how this medicine will affect you. Amantadine may impair your thinking or reactions. Some people taking amantadine 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 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.