Nuvigil (Armodafinil)

Brand Name

Nuvigil

Generic Name

Armodafinil

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FDA approval date: June 15, 2007

Form: Tablet

What is Nuvigil (Armodafinil)?

Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea , narcolepsy, or shift work disorder . Limitations of Use In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.

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Brand Information

Nuvigil (Armodafinil)

1INDICATIONS AND USAGE

NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).

Limitations of Use

In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.

2DOSAGE FORMS AND STRENGTHS

50 mg – round, white to off-white tablet with
150 mg – oval, white to off-white tablet with
200 mg – rounded, rectangular, white to off-white tablet with
250 mg – oval, white to off-white tablet with

3CONTRAINDICATIONS

NUVIGIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients

4ADVERSE REACTIONS

The following serious adverse reactions are described below and elsewhere in the labeling:

Serious Dermatologic Reactions
Drug Reaction with Eosinophilia and System Symptoms (DRESS)/Multiorgan Hypersensitivity
Angioedema and Anaphylaxis Reactions
Persistent Sleepiness
Psychiatric Symptoms
Effects on Ability to Drive and Use Machinery
Cardiovascular Events

4.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

NUVIGIL has been evaluated for safety in over 1,100 patients with excessive sleepiness associated with OSA, SWD, and narcolepsy.

Most Common Adverse Reactions

In the placebo-controlled clinical trials, the most common adverse reactions (≥5%) associated with the use of NUVIGIL more frequently than in placebo-treated patients were headache, nausea, dizziness, and insomnia. The adverse reaction profile was similar across the studies.

Table 1presents the adverse reactions that occurred at a rate of 1% or more and were more frequent in NUVIGIL-treated patients than in placebo-treated patients in the placebo-controlled clinical trials.

Dose-Dependent Adverse Reactions

In the placebo-controlled clinical trials which compared doses of 150 mg/day and 250 mg/day of NUVIGIL and placebo, the following adverse reactions were dose-related: headache, rash, depression, dry mouth, insomnia, and nausea. See Table 2for additional information.

Adverse Reactions Resulting in Discontinuation of Treatment

In placebo-controlled clinical trials, 44 of the 645 patients (7%) who received NUVIGIL discontinued due to an adverse reaction compared to 16 of the 445 (4%) of patients that received placebo. The most frequent reason for discontinuation was headache (1%).

Laboratory Abnormalities

Clinical chemistry, hematology, and urinalysis parameters were monitored in the studies. Mean plasma levels of gamma glutamyltransferase (GGT) and alkaline phosphatase (AP) were found to be higher following administration of NUVIGIL, but not placebo. Few patients, however, had GGT or AP elevations outside of the normal range. No differences were apparent in alanine aminotransferase (ALT), aspartate aminotransferase (AST), total protein, albumin, or total bilirubin, although there were rare cases of isolated elevations of AST and/or ALT. A single case of mild pancytopenia was observed after 35 days of treatment and resolved with drug discontinuation. A small mean decrease from baseline in serum uric acid compared to placebo was seen in clinical trials. The clinical significance of this finding is unknown.

4.2Postmarketing Experience

The following adverse reactions have been identified during post approval use of NUVIGIL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders:Mouth Sores (including mouth blistering and ulceration)

5DRUG INTERACTIONS

Effects of NUVIGIL on CYP3A4/5 Substrates

The clearance of drugs that are substrates for CYP3A4/5 (e.g., steroidal contraceptives, cyclosporine, midazolam, and triazolam) may be increased by NUVIGIL via induction of metabolic enzymes, which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when these drugs are used concomitantly with NUVIGIL

The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients taking steroidal contraceptives (e.g., ethinyl estradiol) when treated concomitantly with NUVIGIL and for one month after discontinuation of NUVIGIL treatment.

Blood levels of cyclosporine may be reduced when used with NUVIGIL. Monitoring of circulating cyclosporine concentrations and appropriate dosage adjustment for cyclosporine should be considered when used concomitantly with NUVIGIL.

Effects of NUVIGIL on CYP2C19 Substrates

Elimination of drugs that are substrates for CYP2C19 (e.g., phenytoin, diazepam, propranolol, omeprazole, and clomipramine) may be prolonged by NUVIGIL via inhibition of metabolic enzymes, with resultant higher systemic exposure. Dose reduction of these drugs may be required when these drugs are used concomitantly with NUVIGIL.

Warfarin

More frequent monitoring of prothrombin times/INR should be considered whenever NUVIGIL is coadministered with warfarin

Monoamine Oxidase (MAO) Inhibitors

Caution should be used when concomitantly administering MAO inhibitors and NUVIGIL.

6OVERDOSAGE

Fatal overdoses involving modafinil alone or involving NUVIGIL or modafinil in combination with other drugs have been reported in the postmarketing setting. Symptoms most often accompanying NUVIGIL or modafinil overdose, alone or in combination with other drugs, have included anxiety, dyspnea, insomnia; central nervous system symptoms such as restlessness, disorientation, confusion, excitation and hallucination; digestive changes such as nausea and diarrhea; and cardiovascular changes such as tachycardia, bradycardia, hypertension, and chest pain.

No specific antidote exists for the toxic effects of a NUVIGIL overdose. Such overdoses should be managed with primarily supportive care, including cardiovascular monitoring.

7DESCRIPTION

NUVIGIL (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2-[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C

The chemical structure is:

Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol.

NUVIGIL tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.

8PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Serious Dermatologic Reactions

Advise patients and caregivers about the risk of potentially fatal serious skin reactions. Educate patients about the signs and symptoms that may signal a serious skin reaction. Instruct patients to discontinue NUVIGIL and consult with their healthcare provider immediately if a skin reaction such as rash, mouth sores, blisters, or peeling skin occurs during treatment with NUVIGIL

DRESS/Multi-organ Hypersensitivity

Instruct patients that a fever associated with signs of other organ system involvement (e.g., rash, lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately

Angioedema and Anaphylactic Reactions

Advise patients of life-threatening symptoms suggesting anaphylaxis or angioedema (such as hives, difficulty in swallowing or breathing, hoarseness, or swelling of the face, eyes, lips, or tongue) that can occur with NUVIGIL. Instruct them to discontinue NUVIGIL and immediately report these symptoms to their healthcare provider

Wakefulness

Advise patients that treatment with NUVIGIL will not eliminate their abnormal tendency to fall asleep. Advise patients that they should not alter their previous behavior with regard to potentially dangerous activities (e.g., driving, operating machinery) or other activities requiring appropriate levels of wakefulness, until and unless treatment with NUVIGIL has been shown to produce levels of wakefulness that permit such activities. Advise patients that NUVIGIL is not a replacement for sleep.

Continuing Previously Prescribed Treatments

Inform patients that it may be critical that they continue to take their previously prescribed treatments (e.g., patients with OSA receiving CPAP should continue to do so).

Psychiatric Symptoms

Advise patients to stop taking NUVIGIL and contact their physician right away if they experience, depression, anxiety, or signs of psychosis or mania.

Pregnancy

Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to NUVIGIL during pregnancy

Females of Reproductive Potential

Caution females regarding the potential increased risk of pregnancy when using hormonal contraceptives (including depot or implantable contraceptives) with NUVIGIL and advise females who are using a hormonal method of contraception to use an additional barrier method or an alternative non-hormonal method of contraception during treatment with NUVIGIL and for one month after discontinuation of NUVIGIL.

Concomitant Medication

Advise patients to inform their physician if they are taking, or plan to take, any prescription or over‑the‑counter drugs, because of the potential for interactions between NUVIGIL and other drugs.

Alcohol

Advise patients that the use of NUVIGIL in combination with alcohol has not been studied. Advise patients that it is prudent to avoid alcohol while taking NUVIGIL.

Dispense with Medication Guide available at

9MEDICATION GUIDE

NUVIGIL (nu-vij-el)(armodafinil)tablets, for oral use, C-IV

Medication Guide available at https://www.apotex.com/products/us/mg.asp

Read this Medication Guide before you start taking NUVIGIL and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

What is the most important information I should know about NUVIGIL?

NUVIGIL is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep NUVIGIL in a safe place to prevent misuse and abuse. Selling or giving away NUVIGIL may harm others, and is against the law.Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.

NUVIGIL may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells. Any of these may need to be treated in a hospital and may be life-threatening.

Stop taking NUVIGIL and call your doctor right away or get emergency help if you have any of these symptoms:

skin rash, hives, sores in your mouth, or your skin blisters and peels
swelling of your face, eyes, lips, tongue, or throat
trouble swallowing, breathing, or hoarseness
fever, shortness of breath, swelling of the legs, yellowing of the skin or whites of theeyes, or dark urine.

If you have a severe rash with NUVIGIL, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.

NUVIGIL is not approved for use in children for any medical condition.

It is not known if NUVIGIL is safe and effective in children under the age of 18.

What is NUVIGIL?

NUVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:

narcolepsy
obstructive sleep apnea (OSA). NUVIGIL is used with other medical treatments for this sleep disorder NUVIGIL does not take the place of using your CPAP machine or other treatments that your doctor has prescribed for this condition. It is important that you continue to use these treatments as prescribed by your doctor.
shift work disorder (SWD)

Do not take NUVIGIL:

are allergic to any of its ingredients. See the end of this Medication Guide for a complete list of ingredients in NUVIGIL.
have had a rash or allergic reaction to either armodafinil (NUVIGIL) or modafinil (PROVIGIL®). These medicines are very similar.

Before you take NUVIGIL, tell your doctor about all of your medical conditions, including if you:

have a history of mental health problems, including psychosis
have heart problems or had a heart attack
have high blood pressure. Your blood pressure may need to be checked more often while taking NUVIGIL.
have liver or kidney problemshave a history of drug or alcohol abuse or addiction
are pregnant or planning to become pregnant. It is not known if NUVIGIL will harm your unborn baby.
are breastfeeding. It is not known if NUVIGIL passes into your milk. Talk to your doctor about the best way to feed your baby if you take NUVIGIL.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. NUVIGIL and many other medicines can interact with each other, sometimes causing side effects. NUVIGIL may affect the way other medicines work, and other medicines may affect how NUVIGIL works. Your dose of NUVIGIL or certain other medicines may need to be changed. Especially, tell your doctor if you use or take:

a hormonal birth control method, such as birth control pills, shots, implants, patches, vaginal rings, and intrauterine devices (IUDs). Hormonal birth control methods may not work while you take NUVIGIL. Women who use one of these methods of birth control may have a higher chance for getting pregnant while taking NUVIGIL, and for 1 month after stopping NUVIGIL. You should use effective birth control while taking NUVIGIL and for 1 month after your final dose. Talk to your doctor about birth control choices that are right for you while taking NUVIGIL.

Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. Your doctor or pharmacist will tell you if it is safe to take NUVIGIL and other medicines together. Do not start any new medicines with NUVIGIL unless your doctor has told you it is okay.

How should I take NUVIGIL?

Take NUVIGIL exactly as prescribed by your doctor. Your doctor will prescribe the dose of NUVIGIL that is right for you. Do not change your dose of NUVIGIL without talking to your doctor.
Your doctor will tell you the right time of day to take NUVIGIL.
Do not change the time of day you take NUVIGIL unless you have talked to your doctor. If you take NUVIGIL too close to your bedtime, you may find it harder to go to sleep.
You can take NUVIGIL with or without food.
If you take more than your prescribed dose or if you take an overdose of NUVIGIL, call your doctor or poison control center right away.

Symptoms of an overdose of NUVIGIL may include:

Trouble sleeping
Confusion
Feeling excited
Nausea and diarrhea
Chest pain
Anxiety
Restlessness
Feeling disoriented
Hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
A fast or slow heartbeat
Increased blood pressure
Shortness of breath

What should I avoid while taking NUVIGIL?

Do not drive a car or do other dangerous activities until you know how NUVIGIL affects you. People with sleep disorders should always be careful about doing things that could be dangerous. Do not change your daily habits until your doctor tells you it is okay.
You should avoid drinking alcohol. It is not known how drinking alcohol will affect you when taking NUVIGIL.

What are the possible side effects of NUVIGIL?

NUVIGIL may cause serious side effects.Stop taking NUVIGIL and call your doctor right away or get emergency help if you get any of the following:

a serious rash or serious allergic reaction. (See “What is the most important information I should know about NUVIGIL?”)
mental (psychiatric) symptoms, including:
depression

hearing, seeing, feeling, or sensing things that are not really there (hallucinations)

thoughts of suicide