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NUVIGIL (ARMODAFINIL) TABLETS: WARNINGS

Angioedema and Anaphylactoid Reactions

One serious case of angioedema and one case of hypersensitivity (with rash, dysphagia, and bronchospasm), were observed among 1,595 patients treated with Armodafinil (Nuvigil) tablets. Patients should be advised to discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness).

Multi-organ Hypersensitivity Reactions

Multi-organ hypersensitivity reactions, including at least one fatality in postmarketing experience, have occurred in close temporal association (median time to detection 13 days: range 4-33) to the initiation of modafinil. A similar risk of multi-organ hypersensitivity reactions with armodafinil cannot be ruled out.

Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening. There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions associated with modafinil. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement. Other associated manifestations included hepatitis, myocarditis, liver function test abnormalities, hematological abnormalities (e.g., leukopenia, eosinophilia, thrombocytopenia), pruritus, and asthenia. Because multi-organ hypersensitivity is variable in its expression, other organ system symptoms and signs, not noted here, may occur.

If a multi-organ hypersensitivity reaction is suspected, Nuvigil (Armodafinil) should be discontinued. Although there are no case reports to indicate cross-sensitivity with other drugs that produce this syndrome, the experience with drugs associated with multi-organ hypersensitivity would indicate this to be a possibility.

Persistent Sleepiness

Patients with abnormal levels of sleepiness who take Nuvigil should be advised that their level of wakefulness may not return to normal. Patients with excessive sleepiness, including those taking Armodafinil (Nuvigil), should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity. Prescribers should also be aware that patients may not acknowledge sleepiness or drowsiness until directly questioned about drowsiness or sleepiness during specific activities.

Psychiatric Symptoms

Psychiatric adverse experiences have been reported in patients treated with modafinil. Modafinil and Armodafinil (Nuvigil) are very closely related. Therefore, the incidence and type of psychiatric symptoms associated with armodafinil are expected to be similar to the incidence and type of these events with modafinil. Postmarketing adverse events associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization. Many, but not all, patients had a prior psychiatric history. One healthy male volunteer developed ideas of reference, paranoid delusions, and auditory hallucinations in association with multiple daily 600 mg doses of modafinil and sleep deprivation. There was no evidence of psychosis 36 hours after drug discontinuation.

In the controlled trial Nuvigil database, anxiety, agitation, nervousness, and irritability were reasons for treatment discontinuation more often in patients on Nuvigil (Armodafinil) tablets compared to placebo (Nuvigil 1.2% and placebo 0.3%). In the Nuvigil controlled studies, depression was also a reason for treatment discontinuation more often in patients on Armodafinil (Nuvigil) tablets compared to placebo (Nuvigil 0.6% and placebo 0.2%). Two cases of suicide ideation were observed in clinical trials. Caution should be exercised when this medication is given to patients with a history of psychosis, depression, or mania. If psychiatric symptoms develop in association with Nuvigil administration, consider discontinuing this drug.

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