RIZAFILM
Generic: RIZATRIPTAN BENZOATE
Basic Information
Manufacturer
Gensco Laboratories LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
fa32794e-d26d-e0bf-e053-6294a90abb0e
Indications & Usage
1 INDICATIONS AND USAGE RizaFilm™ is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age.
Limitations of Use RizaFilm should only be used where a clear diagnosis of migraine has been established.
If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks.
RizaFilm is not indicated for the preventive treatment of migraine.
Safety and effectiveness of RizaFilm have not been established for cluster headache.
RizaFilm is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1) Limitations of Use : Use only after a clear diagnosis of migraine has been established (1) Not indicated for the preventive treatment of migraine (1) Not indicated for the treatment of cluster headache (1)
Limitations of Use RizaFilm should only be used where a clear diagnosis of migraine has been established.
If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks.
RizaFilm is not indicated for the preventive treatment of migraine.
Safety and effectiveness of RizaFilm have not been established for cluster headache.
RizaFilm is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1) Limitations of Use : Use only after a clear diagnosis of migraine has been established (1) Not indicated for the preventive treatment of migraine (1) Not indicated for the treatment of cluster headache (1)
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see Warnings and Precautions (5.1) ].
Arrhythmias [see Warnings and Precautions (5.2) ].
Chest and or Throat, Neck and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.3) ].
Cerebrovascular Events [see Warnings and Precautions (5.4) ].
Other Vasospasm Reactions [see Warnings and Precautions (5.5) ].
Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] Medication Overuse Headache [see Warnings and Precautions (5.7) ].
Serotonin Syndrome [see Warnings and Precautions (5.8) ].
Increase in Blood Pressure [see Warnings and Precautions (5.9) ].
The most common adverse reactions in adults were (incidence ≥5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation, dizziness, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gensco Pharma at 1-866-608-6284 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The studies described below were conducted with rizatriptan benzoate tablets; adverse reactions with RizaFilm are expected to be similar to rizatriptan benzoate tablets.
Adults Incidence in Controlled Clinical Trials Adverse reactions to rizatriptan benzoate were assessed in controlled clinical trials that included over 3700 adult patients who received single or multiple doses of rizatriptan benzoate tablets.
The most common adverse reactions during treatment with rizatriptan benzoate (≥5% in either treatment group and greater than placebo) were asthenia/fatigue, somnolence, pain/pressure sensation, dizziness, and nausea.
Table 1 lists the adverse reactions (incidence ≥2% and greater than placebo) after a single dose of rizatriptan benzoate in adults.
Table 1: Incidence (≥2% and Greater than Placebo) of Adverse Reactions After a Single Dose of Rizatriptan Benzoate Tablets or Placebo in Adults % of Patients Adverse Reactions Rizatriptan Benzoate 5 mg (N=977) % Rizatriptan Benzoate 10 mg (N=1167) % Placebo (N=627) % Atypical Sensations 4 5 4 Paresthesia 3 4 <2 Pain and other Pressure Sensations 6 9 3 Chest Pain: tightness/pressure and/or heaviness <2 3 1 Pain, location unspecified 3 3 <2 Neck/throat/jaw: pain/tightness/pressure <2 2 1 Regional Pain: tightness/pressure and/or heaviness <1 2 0 Digestive 9 13 8 Nausea 4 6 4 Dry Mouth 3 3 1 Neurological 14 20 11 Dizziness 4 9 5 Somnolence 4 8 4 Headache <2 2 <1 Other Asthenia/fatigue 4 7 2 The frequencies of adverse reactions in clinical trials did not increase when up to three doses were taken within 24 hours.
Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis, oral contraceptives, or analgesics.
The incidences of adverse reactions were not affected by age or gender.
There were insufficient data to assess the impact of race on the incidence of adverse reactions.
Other Events Observed in Association with the Administration of Rizatriptan Benzoate in Adults In the following section, the frequencies of less commonly reported adverse events are presented that were not reported in other sections of the labeling.
Because the reports include events observed in open studies, the role of rizatriptan benzoate in their causation cannot be reliably determined.
Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided.
Event frequencies are calculated as the number of patients who used rizatriptan benzoate and reported an event divided by the total number of patients exposed to rizatriptan benzoate (N=3716).
All reported events occurred at an incidence ≥1%, or are believed to be reasonably associated with the use of the drug.
Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those defined as those occurring in at least (>)1/100 patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.
General: Infrequent was facial edema.
Rare were syncope and edema/swelling.
Atypical Sensations: Frequent were warm sensations.
Cardiovascular: Frequent was palpitation.
Infrequent were tachycardia, cold extremities, and bradycardia.
Digestive: Frequent were diarrhea and vomiting.
Infrequent were dyspepsia, tongue edema and abdominal distention.
Musculoskeletal: Infrequent were muscle weakness, stiffness, myalgia and muscle cramp/spasm.
Neurological/Psychiatric: Frequent were hypoesthesia, euphoria and tremor.
Infrequent were vertigo, insomnia, confusion/disorientation, gait abnormality, memory impairment, and agitation.
Respiratory: Frequent was dyspnea.
Infrequent was pharyngeal edema.
Special Senses: Infrequent were blurred vision and tinnitus.
Rare was eye swelling.
Skin and Skin Appendage: Frequent was flushing.
Infrequent were sweating, pruritus, rash, and urticaria.
Rare was erythema, hot flashes.
Pediatric Patients 6 to 17 Years of Age Incidence in Controlled Clinical Trials in Pediatric Patients Adverse reactions to rizatriptan benzoate orally disintegrating tablets were assessed in a controlled clinical trial for the acute treatment of migraine (Study 7) that included a total of 1382 pediatric patients (including those 6-17 years of age), of which 977 (72%) were administered at least one dose of study treatment (rizatriptan benzoate orally disintegrating tablets and/or placebo) [see Clinical Studies (14.2) ].
The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received rizatriptan benzoate tablets to those who received placebo.
The adverse reaction pattern in pediatric patients is expected to be similar to that in adults.
Other Events Observed in Association with the Administration of Rizatriptan Benzoate Orally Disintegrating Tablets in Pediatric Patients In the following section, the frequencies of less commonly reported adverse events are presented.
Because the reports include events observed in open studies, the role of rizatriptan benzoate orally disintegrating tablets in their causation cannot be reliably determined.
Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided.
Event frequencies are calculated as the number of pediatric patients (including those 6 to 17 years of age) who used rizatriptan benzoate orally disintegrating tablets and reported an event divided by the total number of patients exposed to rizatriptan benzoate orally disintegrating tablets (N=1068).
All reported events occurred at an incidence ≥1%, or are believed to be reasonably associated with the use of the drug.
Events are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in (>)1/100 pediatric patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 pediatric patients, and rare adverse experiences are those occurring in fewer than 1/1000 patients.
General: Frequent was fatigue.
Ear and labyrinth disorders : Infrequent was hypoacusis.
Gastrointestinal disorders: Frequent was abdominal discomfort.
Nervous system disorders: Infrequent were coordination abnormal, disturbance in attention, and presyncope.
Psychiatric disorders: Infrequent was hallucination.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of rizatriptan.
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.
Neurological/Psychiatric: Seizure.
General: Allergic conditions including anaphylaxis/anaphylactoid reaction, angioedema, wheezing, and toxic epidermal necrolysis [see Contraindications (4) ].
Special Senses: Dysgeusia.
Arrhythmias [see Warnings and Precautions (5.2) ].
Chest and or Throat, Neck and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.3) ].
Cerebrovascular Events [see Warnings and Precautions (5.4) ].
Other Vasospasm Reactions [see Warnings and Precautions (5.5) ].
Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] Medication Overuse Headache [see Warnings and Precautions (5.7) ].
Serotonin Syndrome [see Warnings and Precautions (5.8) ].
Increase in Blood Pressure [see Warnings and Precautions (5.9) ].
The most common adverse reactions in adults were (incidence ≥5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation, dizziness, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gensco Pharma at 1-866-608-6284 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The studies described below were conducted with rizatriptan benzoate tablets; adverse reactions with RizaFilm are expected to be similar to rizatriptan benzoate tablets.
Adults Incidence in Controlled Clinical Trials Adverse reactions to rizatriptan benzoate were assessed in controlled clinical trials that included over 3700 adult patients who received single or multiple doses of rizatriptan benzoate tablets.
The most common adverse reactions during treatment with rizatriptan benzoate (≥5% in either treatment group and greater than placebo) were asthenia/fatigue, somnolence, pain/pressure sensation, dizziness, and nausea.
Table 1 lists the adverse reactions (incidence ≥2% and greater than placebo) after a single dose of rizatriptan benzoate in adults.
Table 1: Incidence (≥2% and Greater than Placebo) of Adverse Reactions After a Single Dose of Rizatriptan Benzoate Tablets or Placebo in Adults % of Patients Adverse Reactions Rizatriptan Benzoate 5 mg (N=977) % Rizatriptan Benzoate 10 mg (N=1167) % Placebo (N=627) % Atypical Sensations 4 5 4 Paresthesia 3 4 <2 Pain and other Pressure Sensations 6 9 3 Chest Pain: tightness/pressure and/or heaviness <2 3 1 Pain, location unspecified 3 3 <2 Neck/throat/jaw: pain/tightness/pressure <2 2 1 Regional Pain: tightness/pressure and/or heaviness <1 2 0 Digestive 9 13 8 Nausea 4 6 4 Dry Mouth 3 3 1 Neurological 14 20 11 Dizziness 4 9 5 Somnolence 4 8 4 Headache <2 2 <1 Other Asthenia/fatigue 4 7 2 The frequencies of adverse reactions in clinical trials did not increase when up to three doses were taken within 24 hours.
Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis, oral contraceptives, or analgesics.
The incidences of adverse reactions were not affected by age or gender.
There were insufficient data to assess the impact of race on the incidence of adverse reactions.
Other Events Observed in Association with the Administration of Rizatriptan Benzoate in Adults In the following section, the frequencies of less commonly reported adverse events are presented that were not reported in other sections of the labeling.
Because the reports include events observed in open studies, the role of rizatriptan benzoate in their causation cannot be reliably determined.
Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided.
Event frequencies are calculated as the number of patients who used rizatriptan benzoate and reported an event divided by the total number of patients exposed to rizatriptan benzoate (N=3716).
All reported events occurred at an incidence ≥1%, or are believed to be reasonably associated with the use of the drug.
Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those defined as those occurring in at least (>)1/100 patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.
General: Infrequent was facial edema.
Rare were syncope and edema/swelling.
Atypical Sensations: Frequent were warm sensations.
Cardiovascular: Frequent was palpitation.
Infrequent were tachycardia, cold extremities, and bradycardia.
Digestive: Frequent were diarrhea and vomiting.
Infrequent were dyspepsia, tongue edema and abdominal distention.
Musculoskeletal: Infrequent were muscle weakness, stiffness, myalgia and muscle cramp/spasm.
Neurological/Psychiatric: Frequent were hypoesthesia, euphoria and tremor.
Infrequent were vertigo, insomnia, confusion/disorientation, gait abnormality, memory impairment, and agitation.
Respiratory: Frequent was dyspnea.
Infrequent was pharyngeal edema.
Special Senses: Infrequent were blurred vision and tinnitus.
Rare was eye swelling.
Skin and Skin Appendage: Frequent was flushing.
Infrequent were sweating, pruritus, rash, and urticaria.
Rare was erythema, hot flashes.
Pediatric Patients 6 to 17 Years of Age Incidence in Controlled Clinical Trials in Pediatric Patients Adverse reactions to rizatriptan benzoate orally disintegrating tablets were assessed in a controlled clinical trial for the acute treatment of migraine (Study 7) that included a total of 1382 pediatric patients (including those 6-17 years of age), of which 977 (72%) were administered at least one dose of study treatment (rizatriptan benzoate orally disintegrating tablets and/or placebo) [see Clinical Studies (14.2) ].
The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received rizatriptan benzoate tablets to those who received placebo.
The adverse reaction pattern in pediatric patients is expected to be similar to that in adults.
Other Events Observed in Association with the Administration of Rizatriptan Benzoate Orally Disintegrating Tablets in Pediatric Patients In the following section, the frequencies of less commonly reported adverse events are presented.
Because the reports include events observed in open studies, the role of rizatriptan benzoate orally disintegrating tablets in their causation cannot be reliably determined.
Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided.
Event frequencies are calculated as the number of pediatric patients (including those 6 to 17 years of age) who used rizatriptan benzoate orally disintegrating tablets and reported an event divided by the total number of patients exposed to rizatriptan benzoate orally disintegrating tablets (N=1068).
All reported events occurred at an incidence ≥1%, or are believed to be reasonably associated with the use of the drug.
Events are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in (>)1/100 pediatric patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 pediatric patients, and rare adverse experiences are those occurring in fewer than 1/1000 patients.
General: Frequent was fatigue.
Ear and labyrinth disorders : Infrequent was hypoacusis.
Gastrointestinal disorders: Frequent was abdominal discomfort.
Nervous system disorders: Infrequent were coordination abnormal, disturbance in attention, and presyncope.
Psychiatric disorders: Infrequent was hallucination.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of rizatriptan.
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.
Neurological/Psychiatric: Seizure.
General: Allergic conditions including anaphylaxis/anaphylactoid reaction, angioedema, wheezing, and toxic epidermal necrolysis [see Contraindications (4) ].
Special Senses: Dysgeusia.