DOCSLIB.ORG

(Research Base)* Study Co

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text

Load more

ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY ALLIANCE A221101 A PHASE III RANDOMIZED, DOUBLE-BLIND PLACEBO CONTROLLED STUDY OF ARMODAFINIL (NUVIGIL®) TO REDUCE CANCER-RELATED FATIGUE IN PATIENTS WITH HIGH GRADE GLIOMA Study Chairs: Alyx B. Porter Umphrey, M.D. (Research Base)* Study Co-chairs: Statisticians: Drug Availability Drug Company Supplied: Armodafinil (Exempt IND 116927) *Investigator having NCI responsibility for this protocol √Study contributor(s) not responsible for patient care. ClinicalTrials.gov Identifier: NCT01781468 Participating NCTN Organizations Alliance/Alliance for Clinical Trials in Oncology (lead) ECOG ACRIN/ ECOG-ACRIN Medical Research Foundation, Inc NRG/NRG Oncology Foundation, Inc SWOG/SWOG NCI Version Date: 9/24/2018 Update #7 1 Alliance A221101 Cancer Trials Support Unit (CTSU) Address and Contact Information For regulatory requirements: For patient enrollments: For study data submission Regulatory documentation must be Please refer to the patient Legacy NCCTG sites will submitted to the CTSU via the enrollment section of the submit electronic CRFs via: Regulatory Submission Portal. protocol for instructions on NCCTG Remote Data Entry Regulatory Submission Portal: (Sign using the Oncology Patient System. in at , and select Enrollment Network (OPEN) the Regulatory Submission sub-tab which can be accessed at Sites not previously affiliated under the Regulatory tab.) with NCCTG will submit or paper CRFs to: Institutions with patients waiting that . are unable to use the Portal should alert the CTSU Regulatory Office Contact the CTSU Help Desk immediately at to with any OPEN-related receive further instruction and questions at support. Contact the CTSU Regulatory Help Do not submit study data or Desk at for forms to CTSU Data regulatory assistance. Operations. Do not copy the CTSU on data submissions. The most current version of the study protocol and all supporting documents must be downloaded from the protocol-specific Web page of the CTSU Member Web site located at . Access to the CTSU members’ website is managed through the Cancer Therapy and Evaluation Program - Identity and Access Management (CTEP-IAM) registration system and requires user log on with CTEP-IAM username and password. Permission to view and download this protocol and its supporting documents is restricted and is based on person and site roster assignment housed in the CTSU RSS. For clinical questions (i.e. patient eligibility or treatment-related) see the Protocol Contacts, Page 3. For non-clinical questions (i.e. unrelated to patient eligibility, treatment, or clinical data submission) contact the CTSU Help Desk by phone or e-mail: CTSU General Information Line – , or . All calls and correspondence will be triaged to the appropriate CTSU representative. The CTSU Web site is located at . NCI Version Date: 9/24/2018 Update #7 2 Alliance A221101 Protocol Resources Data Manager Protocol Coordinator Expedited Adverse Event Reporting OPEN (Oncology Patient Enrollment Network) A221101 Nursing Contacts Protocol-related questions may be directed as follows: Questions Contact (via email) Questions regarding patient eligibility, treatment, Study Chair, Nursing Contact, Protocol and dose modification: Coordinator, and (where applicable) Data Manager Questions related to data submission or patient Data Manager follow-up: Questions regarding the protocol document and Protocol Coordinator model informed consent: Alliance Regulatory Inbox Questions related to IRB review Questions regarding CTEP-AERS reporting: Alliance Pharmacovigilance Inbox NCI Version Date: 9/24/2018 Update #7 3 Alliance A221101 Schema Randomization Armodafinil Placebo Armodafinil 150mg q.d. x 8 weeks q.d.x 8 weeks 250mg q.d. x 8 weeks Off Study Unacceptable adverse events or patient refusal at any time Off Study Cycle 1 length = 4 weeks Cycle 2 length = 4 weeks NOTE: Cycle is a data management tool to facilitate consistent remote data entry. Generic name: Armodafinil Generic name: Placebo Brand name(s): Nuvigil® Brand name(s): Alliance Abbreviation: Alliance Abbreviation: Availability: Alliance Research Base pharmacy Availability: Alliance Research Base pharmacy NCI Version Date: 9/24/2018 Update #7 4 Alliance A221101 Table of Contents 1.0 INTRODUCTION ........................................................................................................................... 7 1.1 Background .................................................................................................................................................. 7 1.2 Evidence-Based Interventions ...................................................................................................................... 9 1.3 Mechanisms of Newer Psychostimulants and Rationale for Armodafinil (Nuvigil) .................................. 12 1.4 Study rationale ........................................................................................................................................... 14 2.0 GOALS........................................................................................................................................... 14 2.1 Primary ....................................................................................................................................................... 14 2.2 Secondary ................................................................................................................................................... 14 3.0 PATIENT ELIGIBILITY ............................................................................................................ 15 3.1 Inclusion Criteria ........................................................................................................................................ 15 3.2 Exclusion Criteria ...................................................................................................................................... 15 4.0 TEST SCHEDULE ....................................................................................................................... 18 4.1 Neurocognitive Testing .............................................................................................................................. 19 5.0 STRATIFICATION FACTORS .................................................................................................. 22 5.1 Concomitant Chemotherapy: Yes vs. No .................................................................................................. 22 5.2 Age: < 60 vs. ≥60 ...................................................................................................................................... 22 5.3 Corticosteroid use: Yes vs. No .................................................................................................................. 22 5.4 Gender: Male vs. Female .......................................................................................................................... 22 6.0 REGISTRATION/RANDOMIZATION PROCEDURES ........................................................ 22 6.1 Registration Requirements ......................................................................................................................... 22 6.2 CTEP Registration Procedures ................................................................................................................... 22 6.3 Site Registration Requirements – IRB Approval ....................................................................................... 23 6.4 Patient Randomization ............................................................................................................................... 25 6.5 Procedures for Double-Blinding the Treatment Assignment ..................................................................... 26 7.0 PROTOCOL TREATMENT ...................................................................................................... 28 7.1 Treatment Schedule .................................................................................................................................... 28 7.2 Unblinding Procedures ............................................................................................................................... 28 8.0 DOSAGE MODIFICATION BASED ON ADVERSE EVENTS ............................................. 29 9.0 ANCILLARY TREATMENT/SUPPORTIVE CARE ............................................................... 29 10.0 ADVERSE EVENT (AE) REPORTING AND MONITORING .............................................. 29 10.1 Routine Adverse Event Reporting .............................................................................................................. 29 10.2 CTCAE Routine Study Reporting Requirements ....................................................................................... 30 10.3 Expedited adverse event reporting (CTEP-AERS) .................................................................................... 30 10.4 Contact Information for NCI Safety Reporting .......................................................................................... 33 10.5 Other Required Expedited Reporting ......................................................................................................... 34 10.6 Adverse events to be graded at each evaluation. ........................................................................................ 34 11.0 TREATMENT EVALUATION ................................................................................................... 34 11.1 Patient Self-Report Measures
Recommended publications
  • Modafinil Tablets

    Modafinil Tablets

    PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PrAURO-MODAFINIL Modafinil Tablets 100 mg House Standard Central Nervous System Stimulant Auro Pharma Inc. 3700 Steeles Avenue West, Suite # 402 Date of Revision: Woodbridge, ON, L4L 8K8, August 8, 2019. CANADA Submission Control Number: 230314 Page 1 of 41 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION .................................................................... 3 INDICATIONS AND CLINICAL USE .......................................................................... 3 CONTRAINDICATIONS ............................................................................................... 4 WARNINGS AND PRECAUTIONS .............................................................................. 4 ADVERSE REACTIONS .............................................................................................. 12 DRUG INTERACTIONS .............................................................................................. 16 DOSAGE AND ADMINISTRATION .......................................................................... 19 OVERDOSAGE ............................................................................................................ 21 ACTION AND CLINICAL PHARMACOLOGY ........................................................ 21 STORAGE AND STABILITY ...................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING
  • These Highlights Do Not Include All the Information Needed to Use PROVIGIL Safely and Effectively

    These Highlights Do Not Include All the Information Needed to Use PROVIGIL Safely and Effectively

    PROVIGIL- modafinil tablet Bryant Ranch Prepack ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PROVIGIL safely and effectively. See full prescribing information for PROVIGIL. PROVIGIL® (modafinil) tablets, for oral use, C-IV Initial U.S. Approval: 1998 INDICATIONS AND USAGE PROVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). (1) Limitations of Use In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. DOSAGE AND ADMINISTRATION The recommended dosage of PROVIGIL for each indication is as follows: • Narcolepsy or OSA: 200 mg once a day in the morning. (2.1) • SWD: 200 mg once a day, taken approximately one hour prior to start of the work shift. (2.2) • Severe Hepatic Impairment: reduce dose to half the recommended dose. (2.3, 12.3) • Geriatric Patients: consider lower dose. (2.4, 12.3) DOSAGE FORMS AND STRENGTHS Tablets: 100 mg and 200 mg. (3) CONTRAINDICATIONS PROVIGIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil. (4) WARNINGS AND PRECAUTIONS • Serious Rash, including Stevens-Johnson Syndrome: Discontinue PROVIGIL at the first sign of rash, unless the rash is clearly not drug-related. (5.1) • Angioedema and Anaphylaxis Reactions: If suspected, discontinue PROVIGIL. (5.2) • Multi-organ Hypersensitivity Reactions: If suspected, discontinue PROVIGIL. (5.3) • Persistent Sleepiness: Assess patients frequently for degree of sleepiness and, if appropriate, advise patients to avoid driving or engaging in any other potentially dangerous activity. (5.4) • Psychiatric Symptoms: Use caution in patients with a history of psychosis, depression, or mania.
  • Modafinil: a Review of Neurochemical Actions and Effects on Cognition

    Modafinil: a Review of Neurochemical Actions and Effects on Cognition

    Neuropsychopharmacology (2008) 33, 1477–1502 & 2008 Nature Publishing Group All rights reserved 0893-133X/08 $30.00 www.neuropsychopharmacology.org Perspective Modafinil: A Review of Neurochemical Actions and Effects on Cognition ,1 1 Michael J Minzenberg* and Cameron S Carter 1Imaging Research Center, Davis School of Medicine, UC-Davis Health System, University of California, Sacramento, CA, USA Modafinil (2-[(Diphenylmethyl) sulfinyl] acetamide, Provigil) is an FDA-approved medication with wake-promoting properties. Pre-clinical studies of modafinil suggest a complex profile of neurochemical and behavioral effects, distinct from those of amphetamine. In addition, modafinil shows initial promise for a variety of off-label indications in psychiatry, including treatment-resistant depression, attention- deficit/hyperactivity disorder, and schizophrenia. Cognitive dysfunction may be a particularly important emerging treatment target for modafinil, across these and other neuropsychiatric disorders. We aimed to comprehensively review the empirical literature on neurochemical actions of modafinil, and effects on cognition in animal models, healthy adult humans, and clinical populations. We searched PubMed with the search term ‘modafinil’ and reviewed all English-language articles for neurochemical, neurophysiological, cognitive, or information-processing experimental measures. We additionally summarized the pharmacokinetic profile of modafinil and clinical efficacy in psychiatric patients. Modafinil exhibits robust effects on catecholamines, serotonin, glutamate, gamma amino-butyric acid, orexin, and histamine systems in the brain. Many of these effects may be secondary to catecholamine effects, with some selectivity for cortical over subcortical sites of action. In addition, modafinil (at well-tolerated doses) improves function in several cognitive domains, including working memory and episodic memory, and other processes dependent on prefrontal cortex and cognitive control.
  • PROVIGIL® (Modafinil) Tablets [C-IV] Rx Only

    PROVIGIL® (Modafinil) Tablets [C-IV] Rx Only

    PI + MG October 2010 PROVIGIL® (modafinil) Tablets [C-IV] Rx Only DESCRIPTION PROVIGIL (modafinil) is a wakefulness-promoting agent for oral administration. Modafinil is a racemic compound. The chemical name for modafinil is 2-[(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is: OO CH S CH2 CNH2 Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets contain 100 mg or 200 mg of modafinil and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate. CLINICAL PHARMACOLOGY Mechanism of Action and Pharmacology The precise mechanism(s) through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions similar to sympathomimetic agents like amphetamine and methylphenidate, although the pharmacologic profile is not identical to that of sympathomimetic amines. Modafinil has weak to negligible interactions with receptors for norepinephrine, serotonin, dopamine, GABA, adenosine, histamine-3, melatonin, and benzodiazepines. Modafinil also does not inhibit the activities of MAO-B or phosphodiesterases II-V. 1 PI + MG October 2010 Modafinil-induced wakefulness can be attenuated by the α1-adrenergic receptor antagonist prazosin; however, modafinil is inactive in other in vitro assay systems known to be responsive to α-adrenergic agonists, such as the rat vas deferens preparation. Modafinil is not a direct- or indirect-acting dopamine receptor agonist. However, in vitro, modafinil binds to the dopamine transporter and inhibits dopamine reuptake. This activity has been associated in vivo with increased extracellular dopamine levels in some brain regions of animals.
  • A Critical Review of Properties of Modafinil and Analytical, Bio Analytical Methods for Its Determination

    A Critical Review of Properties of Modafinil and Analytical, Bio Analytical Methods for Its Determination

    Critical Reviews in Analytical Chemistry ISSN: 1040-8347 (Print) 1547-6510 (Online) Journal homepage: http://www.tandfonline.com/loi/batc20 A Critical Review of Properties of Modafinil and Analytical, Bio Analytical Methods for Its Determination B. Ramachandra To cite this article: B. Ramachandra (2016): A Critical Review of Properties of Modafinil and Analytical, Bio Analytical Methods for Its Determination, Critical Reviews in Analytical Chemistry, DOI: 10.1080/10408347.2016.1153948 To link to this article: http://dx.doi.org/10.1080/10408347.2016.1153948 Accepted author version posted online: 23 Feb 2016. Submit your article to this journal Article views: 10 View related articles Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=batc20 Download by: [RMIT University] Date: 01 March 2016, At: 20:24 ACCEPTED MANUSCRIPT A Critical Review of Properties of Modafinil and Analytical, Bio Analytical Methods for Its Determination B. Ramachandra1,* 1Government Degree College, Rajampeta-516115, Kadapa Dist, Andhra Pradesh, India. *Correspondence to: B. Ramachandra, Government Degree College, Rajampeta-516115, Kadapa Dist, Andhra Pradesh, India Phone No: +91-9492753765 E-mail: [email protected] Abstract Modafinil is a synthetic molecule used for the treatment of narcolepsy. Narcolepsy is a neurological disorder, due to which people experience frequent excessive daytime sleepiness. Nevertheless, there are some concerns about modafnil quality control. The modafinil enantiomers are both biologically active. However, it has been reported that the pharmacological properties of the both enantiomers are different and that the S-enantiomer is eliminated three times faster than the R-enantiomer. Therefore, most of the pharmaceutical companies have shifted to produce of armodafinil (R- enantiomer) instead of the racemate.
  • Product Monograph Mar-Modafinil

    Product Monograph Mar-Modafinil

    PRODUCT MONOGRAPH PrMAR-MODAFINIL Modafinil tablets, USP 100mg Central Nervous System Stimulant Marcan Pharmaceuticals Inc., DATE OF PREPARATION: 77-Auriga Drive, Unit # 4 November 9, 2017 Ottawa, Ontario K2E7Z7 Control# 210834 1 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................................... 3 INDICATIONS AND CLINICAL USE .................................................................................................... 3 CONTRAINDICATIONS .......................................................................................................................... 4 WARNINGS AND PRECAUTIONS ........................................................................................................ 4 ADVERSE REACTIONS ........................................................................................................................ 12 DRUG INTERACTIONS ......................................................................................................................... 16 DOSAGE AND ADMINISTRATION .................................................................................................... 19 OVERDOSAGE ....................................................................................................................................... 21 ACTION AND CLINICAL PHARMACOLOGY ..................................................................................
  • (And Dosage Form) PROVIGIL 100 (Tablets) COMPO

    (And Dosage Form) PROVIGIL 100 (Tablets) COMPO

    PACKAGE INSERT – PROVIGIL® 100 (Tablets) SCHEDULING STATUS S5 PROPRIETARY NAME (and dosage form) PROVIGIL 100 (Tablets) COMPOSITION Each tablet contains 100 mg modafinil. PHARMACOLOGICAL CLASSIFICATION A 1.1 Central analeptics PHARMACOLOGICAL ACTION Pharmacodynamics The mechanism(s) through which modafinil promotes wakefulness is unknown. Modafinil has wake-promoting actions like sympathomimetic agents including amphetamine and methylphenidate, although the pharmacological profile is not identical to that of sympathomimetic amines. At pharmacologically relevant concentrations, modafinil does not bind to most potentially relevant receptors for sleep/wake regulation, including those for norepinephrine, serotonin, dopamine, GABA, adenosine, histamine-3, melatonin, or benzodiazepines. Modafinil also does not inhibit the activities of MAO-B or phosphodiesterases II-V. Modafinil is not a direct- or indirect-acting dopamine receptor agonist and is inactive in several in vivo pre-clinical models capable of detecting enhanced dopaminergic activity. In vitro, modafinil binds to the dopamine reuptake site and causes an increase in extra-cellular dopamine, but no increase in dopamine release. In a pre-clinical model the wakefulness induced by amphetamine, but not modafinil, is antagonised by the dopamine receptor Page 1 of 17 antagonist haloperidol. Modafinil does not appear to be a direct or indirect 1-adrenergic agonist. Although modafinil-induced wakefulness can be attenuated by the 1-adrenergic receptor antagonist, prazosin, in assay systems known to be responsive to -adrenergic agonists, modafinil has no activity. Modafinil does not display sympathomimetic activity in the rat vas deferens preparations (agonist-stimulated or electrically stimulated) nor does it increase the formation of the adrenergic receptor-mediated second messenger phosphatidyl inositol in in vitro models.
  • Decentralised Procedure Public Assessment Report Modafinil

    Decentralised Procedure Public Assessment Report Modafinil

    Bundesinstitut für Arzneimittel und Medizinprodukte Decentralised Procedure Public Assessment Report Modafinil Efarmes 100 mg Tabletten Modafinil Runiam 100 mg Tabletten Modafinil DE/H/2481, 2508/001/DC Applicant: Efarmes S.A.U., Spain Reference Member State DE The BfArM is a Federal Institute within the portfolio of the Federal Ministry of Health. 1/7 Public AR TABLE OF CONTENTS I. INTRODUCTION......................................................................................................................... 4 II. EXECUTIVE SUMMARY....................................................................................................... 4 II.1 Problem statement..................................................................................................................... 4 II.2 About the product ..................................................................................................................... 4 II.3 General comments on the submitted dossier .......................................................................... 4 II.4 General comments on compliance with GMP, GLP, GCP and agreed ethical principles..4 III. SCIENTIFIC OVERVIEW AND DISCUSSION ................................................................... 5 III.1 Quality aspects....................................................................................................................... 5 III.2 Nonclinical aspects ................................................................................................................ 5 III.3 Clinical aspects
  • Modafinil: Expanded Options for the Treatment of Excessive Sleepiness

    Modafinil: Expanded Options for the Treatment of Excessive Sleepiness

    For reprint orders, please contact: [email protected] DRUG EVALUATION Modafinil: expanded options for the treatment of excessive sleepiness Jonathan RL Schwartz Modafinil is an oral wake-promoting agent, initially approved in December 1998 for the Integris Sleep Disorders treatment of excessive sleepiness associated with narcolepsy. Based on the results of Center of Oklahoma, Integris Southwest and additional randomized, placebo-controlled studies, the indication for modafinil was Baptist Medical Centers, expanded in January 2004 to include excessive sleepiness associated with obstructive sleep 4200 S. Douglas, apnea/hypopnea syndrome and shift work sleep disorder. Modafinil represents a safer Suite 313, Oklahoma City, OK 73109, USA alternative to CNS stimulants for the treatment of excessive sleepiness and it has become Tel: +1 405 636 1111 the most widely prescribed agent for excessive sleepiness associated with narcolepsy over Fax: +1 405 636 7995 the past 5 years. This article summarizes the key studies on modafinil, outlining the unique E-mail: SchwJR@integris- health.com pharmacologic profile, efficacy and safety. Modafinil is a unique wake-promoting medica- licensing rights to modafinil were bought by US tion that is chemically and pharmacologically pharmaceutical company Cephalon Inc., which distinct from CNS stimulants such as ampheta- subsequently purchased Lafon. mine and methylphenidate. Modafinil was first The precise mechanism of action of modafinil approved by the US Food and Drug Adminis- remains unknown. It was
  • PRODUCT MONOGRAPH Prmar-MODAFINIL

    PRODUCT MONOGRAPH Prmar-MODAFINIL

    PRODUCT MONOGRAPH PrMAR-MODAFINIL Modafinil tablets, USP 100mg Central Nervous System Stimulant Marcan Pharmaceuticals Inc. Date of Revision: 2 Gurdwara Road, Suite #112, October 3, 2019 Ottawa, Ontario K2E 1A2 Control # 232052 1 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................................... 3 INDICATIONS AND CLINICAL USE .................................................................................................... 3 CONTRAINDICATIONS .......................................................................................................................... 4 WARNINGS AND PRECAUTIONS ........................................................................................................ 4 ADVERSE REACTIONS ........................................................................................................................ 11 DRUG INTERACTIONS ........................................................................................................................ 15 DOSAGE AND ADMINISTRATION .................................................................................................... 18 OVERDOSAGE ....................................................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ..................................................................................
  • PROVIGIL Safely and Effectively

    PROVIGIL Safely and Effectively

    HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use • Angioedema and Anaphylaxis Reactions: If suspected, discontinue PROVIGIL safely and effectively. See full prescribing information for PROVIGIL. (5.2) PROVIGIL. • Multi-organ Hypersensitivity Reactions: If suspected, discontinue PROVIGIL. (5.3) ® PROVIGIL (modafinil) tablets, for oral use, C-IV • Persistent Sleepiness: Assess patients frequently for degree of sleepiness Initial U.S. Approval: 1998 and, if appropriate, advise patients to avoid driving or engaging in any other potentially dangerous activity. (5.4) ----------------------------INDICATIONS AND USAGE--------------------------- • Psychiatric Symptoms: Use caution in patients with a history of psychosis, PROVIGIL is indicated to improve wakefulness in adult patients with depression, or mania. Consider discontinuing PROVIGIL if psychiatric excessive sleepiness associated with narcolepsy, obstructive sleep apnea symptoms develop. (5.5) (OSA), or shift work disorder (SWD). (1) • Known Cardiovascular Disease: Consider increased monitoring. (5.7) Limitations of Use ------------------------------ADVERSE REACTIONS------------------------------­ In OSA, PROVIGIL is indicated to treat excessive sleepiness and not as Most common adverse reactions (≥5%): headache, nausea, nervousness, treatment for the underlying obstruction. rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia. (6.1) ----------------------DOSAGE AND ADMINISTRATION----------------------­ To report SUSPECTED ADVERSE REACTIONS, contact Teva The recommended dosage of PROVIGIL for each indication is as follows: Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or • Narcolepsy or OSA: 200 mg once a day in the morning. (2.1) www.fda.gov/medwatch. • SWD: 200 mg once a day, taken approximately one hour prior to start of the work shift. (2.2) ------------------------------DRUG INTERACTIONS------------------------------­ • Severe Hepatic Impairment: reduce dose to half the recommended dose.
  • Auspar Attachment 1: Product Information for Nuvigil

    Auspar Attachment 1: Product Information for Nuvigil

    Attachment 1: Product information for AusPAR Nuvigil Teva Pharmaceuticals Australia Pty Ltd PM-2014-01922-1-1 Final 26 May 2016. This Product Information was approved at the time this AusPAR was published. NUVIGIL® armodafinil PRODUCT INFORMATION NAME OF THE MEDICINE NUVIGIL® (armodafinil) is a wakefulness-promoting agent for oral administration. Armodafinil is the (R)-enantiomer of modafinil (MODAVIGIL®) 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 C15H15NO2S and the molecular weight is 273.35. The chemical structure is: The CAS registry number is 112111-43-0. DESCRIPTION Armodafinil exists in multiple crystalline forms. Form 1, which is used in NUVIGIL®, is the least soluble form of armodafinil and is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone and soluble in methanol. At least 90% of the armodafinil particles used in NUVIGIL® have a diameter of less than 200 microns. NUVIGIL® tablets contain 50, 150 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised maize starch. PHARMACOLOGY Pharmacodynamics The mechanism(s) through which armodafinil promotes wakefulness is unknown. Armodafinil [(R)- modafinil)] has pharmacological properties similar to those of modafinil [a mixture of (R)- and (S)- modafinil] to the extent tested in animal and in vitro studies. The (R)- and (S)-enantiomers have similar pharmacological actions in animals. Armodafinil and modafinil have wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although their pharmacologic profile is not identical to that of the sympathomimetic amines.