rizafilm
Rizafilm (Rizatriptan Benzoate) is a serotonin-1b and serotonin-1d receptor agonist used to treat Migraine Disorders.
Rizatriptan Benzoate · by Gensco
Available as a generic: Rizatriptan Benzoate
Key facts
- Active ingredient
- Rizatriptan Benzoate
- Form
- Film
- Strength
- Rizatriptan Benzoate EQ 10MG Base · Rizatriptan Benzoate EQ 5MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- migraine disorders
- Manufacturer
- Gensco
- Half-life
- about 2 to 3 hours (how long it stays in your system)
- FDA application
- NDA205394
What is Rizafilm?
From the FDA label:RizaFilm contains rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist. Rizatriptan benzoate is described chemically as: N,N -dimethyl-5-(1 H -1,2,4-triazol-1-ylmethyl)-1 H- indole-3-ethanamine monobenzoate and its structural formula is: Its empirical formula is C 15 H 19 N 5 •C 7 H 6 O 2 , representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25°C. RizaFilm oral film is available for oral administration in a 5 mg and 10 mg strength (equivalent to 7.265 mg and 14.53 mg rizatriptan benzoate respectively). Each oral film contains the following inactive ingredients: ammonium glycyrrhizate, butylated hydroxytoluene, copovidone, cupric chloride, ethylcellulose, FD&C Blue No. 1, hydroxypropyl cellulose, isopropyl alcohol, levomenthol, methyl ethyl ketone, sodium acetate, sucralose, titanium dioxide, and triacetin. structure
How to use
RizaFilm is administered on the tongue (2.1) Adults: 10 mg single dose; separate repeat doses by at least two hours; maximum cumulative dosage in a 24-hour period is 30 mg (2.1) Pediatric patients 6 to 17 years of age: 5 mg single dose in patients less than 40 kg (88 lb); 10 mg single dose in patients 40 kg (88 lb) or more. (2.2) 2.1 Dosing Information in Adults The recommended dose of RizaFilm in adults is 10 mg administered on the tongue. The maximum cumulative dose that may be given in 24 hours is 30 mg, with doses separated by at least 2 hours. The safety of treating, on average, more than four headaches in a 30-day period has not been established. 2.2 Dosing Information in Pediatric Patients (6 to 17 Years of Age) Dosing in pediatric patients is based on the patient's body weight. The recommended dose of RizaFilm is 5 mg in patients weighing less than 40 kg (88 lb), and 10 mg in patients weighing 40 kg (88 lb) or more administered on the tongue. The efficacy and safety of treatment with more than one dose of RizaFilm within 24 hours in pediatric patients 6 to 17 years of age have not been established. 2.3 Administration of RizaFilm Oral Films For RizaFilm oral films, administration with liquid is not necessary. Oral films are packaged individually in child-resistant aluminum pouches with a tear notch. To open the pouch, fold on the dotted line and tear open at the notch.…
Side effects
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…
Warnings
Important safety information
Myocardial ischemia, myocardial infarction, and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors (5.1) Arrhythmias: Discontinue dosing if occurs (5.2) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness; Generally not associated with myocardial ischemia; Evaluate patients at high risk (5.3) Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occurs (5.4) Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs (5.5) Hypersensitivity Reactions: angioedema and anaphylaxis have occurred (5.6) Medication overuse headache: Detoxification may be necessary (5.7) Serotonin syndrome: Discontinue dosing if occurs (5.8) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina RizaFilm should not be given to patients with ischemic or vasospastic coronary artery disease. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of rizatriptan benzoate. Some of these reactions occurred in patients without known coronary artery disease (CAD). 5-HT1 agonists, including RizaFilm may cause coronary artery vasospasm (Prinzmetal's Angina), even in patients without a history of CAD. Perform a cardiovascular evaluation in triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) before receiving RizaFilm. If there is evidence of CAD or coronary artery vasospasm, RizaFilm is contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first RizaFilm dose in a medically supervised setting and performing an electrocardiogram (ECG) immediately following RizaFilm administration. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of RizaFilm. 5.2 Arrhythmias Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue RizaFilm if these disturbances occur. RizaFilm is contraindicated in patients with Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorder. 5.3 Chest, Throat, Neck, and/or Jaw Pain/Tightness/Pressure Sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck, and jaw commonly occur after treatment with rizatriptan, the active moiety in RizaFilm, and are usually noncardiac in origin. However, perform a cardiac evaluation if these patients are at a high cardiac risk. The use of RizaFilm is contraindicated in patients with CAD and those with Prinzmetal's variant angina. 5.4 Cerebrovascular Events Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred in patients treated with 5-HT1 agonists, and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the 5-HT1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack). Discontinue RizaFilm if a cerebrovascular event occurs. Before treating headaches in patients not previously diagnosed with migraine or in patients who present with atypical symptoms, exclude other potentially serious neurological conditions. RizaFilm is contraindicated in patients with a history of stroke or transient ischemic attack. 5.5 Other Vasospasm Reactions 5-HT 1 agonists, including RizaFilm, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud’s syndrome. In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HT 1 agonist, rule out the suspected vasospasm reaction before receiving additional RizaFilm doses. Transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT 1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT 1 agonists has not been clearly established. 5.6 Hypersensitivity Reactions Hypersensitivity reactions, including angioedema and anaphylaxis, have occurred in patients receiving rizatriptan, the active moiety in RizaFilm. Such reactions can be life-threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. RizaFilm is contraindicated in patients with a history of hypersensitivity reaction to rizatriptan. 5.7 Medication Overuse Headache Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in the frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary. 5.8 Serotonin Syndrome Serotonin syndrome may occur with triptans, including RizaFilm, particularly during coadministration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see Drug Interactions (7.5) ]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms can occur within minutes to hours of receiving a new or a greater dose of a serotonergic medication. RizaFilm treatment should be discontinued if serotonin syndrome is suspected [see Drug Interactions (7.4) and Patient Counseling Information (17) ]. 5.9 Increase in Blood Pressure Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients with and without a history of hypertension receiving 5-HT1 agonists, including rizatriptan benzoate. In healthy young adult male and female patients who received maximal doses of rizatriptan benzoate (10 mg every 2 hours for 3 doses), slight increases in blood pressure (approximately 2-3 mmHg) were observed. RizaFilm is contraindicated in patients with uncontrolled hypertension [see Contraindications (4) ].
Who should not take Rizafilm
RizaFilm is contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [ see Warnings and Precautions (5.1) ]. Coronary artery vasospasm including Prinzmetal's angina[ see Warnings and Precautions (5.1) ]. Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2) ] History of stroke or transient ischemic attack (TIA) [ see Warnings and Precautions (5.4) ]. Peripheral vascular disease (PVD) [ see Warnings and Precautions (5.5) ]. Ischemic bowel disease [ see Warnings and Precautions (5.5) ]. Uncontrolled hypertension [ see Warnings and Precautions (5.9) ]. Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) [ see Drug Interactions (7.2 and 7.3) ]. Hemiplegic or basilar migraine. Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor [see Drug Interactions (7.5) and Clinical Pharmacology (12.3) ] Concurrent administration of propranolol [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ] Hypersensitivity to rizatriptan or any ingredients in RizaFilm (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.6) ] History of ischemic heart disease or coronary artery vasospasm (4) History of stroke or transient ischemic attack (4) Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders (4) Peripheral vascular disease (4) Ischemic bowel disease (4) Uncontrolled hypertension (4) Recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan), or of an ergotamine-containing medication (4) Hemiplegic or basilar migraine (4) MAO-A inhibitor used in the past 2 weeks (4) Co-administration with propranolol (4) Hypersensitivity to rizatriptan or any of the ingredients of RizaFilm (4)
Overdose — what happens if you take too much
No overdoses of rizatriptan benzoate were reported during clinical trials in adults. Some adult patients who received 40 mg of rizatriptan benzoate either in a single dose or as two doses with a 2-hour interdose interval had dizziness and somnolence. In a clinical pharmacology study in which 12 adult subjects received rizatriptan benzoate, at total cumulative doses of 80 mg (given within four hours), two of the subjects experienced syncope, dizziness, bradycardia including third degree AV block, vomiting, and/or incontinence. In the long-term, open label study, involving 606 treated pediatric migraineurs 12 to 17 years of age (of which 432 were treated for at least 12 months), 151 patients (25%) took two 10-mg doses of Rizatriptan Benzoate Orally Disintegrating Tablets within a 24-hour period. Adverse reactions for 3 of these patients included abdominal discomfort, fatigue, and dyspnea. In addition, based on the pharmacology of rizatriptan benzoate, hypertension or myocardial ischemia could occur after overdosage. Gastrointestinal decontamination, (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with RizaFilm. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed. The effects of hemo- or peritoneal dialysis on serum concentrations of…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
7.1 Propranolol Because propranolol increases the exposure of rizatriptan and dosage adjustment is not possible with RizaFilm, concomitant use of RizaFilm with propranolol is contraindicated [see Contraindications (4) and Clinical Pharmacology (12.3) ] . 7.2 Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and RizaFilm within 24 hours is contraindicated [ see Contraindications (4) ]. 7.3 Other 5-HT 1 Agonists Because their vasospastic effects may be additive, co-administration of RizaFilm and other 5-HT 1 agonists within 24 hours of each other is contraindicated [ see Contraindications (4) ]. 7.4 SSRIs/SNRIs and Serotonin Syndrome Cases of serotonin syndrome have been reported during co-administration of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.7) ] . 7.5 Monoamine Oxidase Inhibitors Because of an increase in the systemic exposure of rizatriptan and its metabolite, RizaFilm is contraindicated in patients taking MAO-A inhibitors and non-selective MAO inhibitors [see Contraindications (4) and Clinical Pharmacology (12.3) ] . Drug Interactions Monoamine Oxidase Inhibitors: In a drug interaction study, when rizatriptan benzoate 10 mg tablets were administered to subjects (n=12) receiving concomitant therapy with the selective, reversible MAO-A inhibitor, moclobemide 150 mg three times a day, there were mean increases in rizatriptan AUC and C max of 119% and 41%, respectively; and the AUC of the active N-monodesmethyl metabolite of rizatriptan was increased more than 400%. The interaction would be expected to be greater with irreversible MAO inhibitors [see Contraindications (4) and Drug Interactions (7.5) ]. No pharmacokinetic interaction is anticipated in patients receiving selective MAO-B inhibitors. Propranolol: In a study of concurrent administration of propranolol 240 mg/day and a single dose of rizatriptan 10 mg in healthy adult subjects (n=11), mean plasma AUC for rizatriptan was increased by 70%, and a four-fold increase was observed in one subject [see Contraindications (4) and Drug Interactions (7.1) ]. The AUC of the active N-monodesmethyl metabolite of rizatriptan was not affected by propranolol. Nadolol/Metoprolol: In a drug interactions study, effects of multiple doses of nadolol 80 mg or metoprolol 100 mg every 12 hours on the pharmacokinetics of a single dose of 10 mg rizatriptan were evaluated in healthy subjects (n=12). No pharmacokinetic interactions were observed. Paroxetine: In a study of the interaction between the selective serotonin reuptake inhibitor (SSRI) paroxetine 20 mg/day for two weeks and a single dose of rizatriptan benzoate tablet 10 mg in healthy subjects (n=12), neither the plasma concentrations of rizatriptan nor its safety profile were affected by paroxetine [see Warnings and Precautions (5.7) , Drug Interactions (7.4) , and Patient Counseling Information (17) ]. Oral Contraceptives: In a study of concurrent administration of an oral contraceptive during 6 days of administration of rizatriptan (10-30 mg/day) in healthy female volunteers (n=18), rizatriptan did not affect plasma concentrations of ethinyl estradiol or norethindrone.
How long does Rizatriptan Benzoate stay in your body?
The elimination half-life of rizatriptan benzoate is about 2 to 3 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label states the plasma half-life of rizatriptan averages 2-3 hours in both males and females. Rizatriptan has one active metabolite, N-monodesmethyl-rizatriptan, but it does not outlast the parent drug: plasma levels are only about 14% of the parent's and the label says it "is eliminated at a similar rate," so it does not meaningfully extend how long the drug stays in the body. Half-life is not restated for special populations, but exposure (AUC) shifts: it was unchanged in mild-to-moderate renal impairment (CrCl 10-60 mL/min/1.73 m2) and about 44% higher in hemodialysis patients (CrCl <2 mL/min/1.73 m2); it was similar in mild hepatic impairment and about 30% higher in moderate hepatic impairment from alcoholic cirrhosis. Pharmacokinetics in healthy adults aged 65-77 were similar to those in adults aged 18-45, so age alone does not change it. AUC is about 30% higher in females than males. There is no extended-release rizatriptan; MAXALT-MLT orally disintegrating tablets have similar bioavailability and peak levels to regular tablets, only slower absorption (Tmax delayed). Two interactions raise exposure sharply: propranolol increased rizatriptan AUC by 70%, and an MAO-A inhibitor increased rizatriptan AUC 119% and the active metabolite's AUC by more than 400%.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: MAXALT (rizatriptan benzoate) tablets / MAXALT-MLT orally disintegrating tablets — FDA prescribing information, Clinical Pharmacology (Pharmacokinetics).
Drug class
How this class works, per Triptans - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Rizafilm ranks — best-rated serotonin-1b and serotonin-1d receptor agonist for:
Dosage forms
Film
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Rizafilm treat?
- Rizafilm (Rizatriptan Benzoate) may be used to treat migraine disorders, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Rizafilm work?
- Rizafilm is a serotonin-1b and serotonin-1d receptor agonist. These migraine drugs (triptans) switch on serotonin 5-HT1B/1D receptors: they tighten the dilated blood vessels around the brain and quiet the trigeminal nerve pathway, blocking the release of pain-signaling molecules that drive a migraine attack.
- Is there a coupon or discount for Rizafilm?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Rizafilm. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Rizafilm?
- Rizafilm is marketed by Gensco. You can see Gensco's full profile, rating, and other products on pharmaranks.
- Is Rizafilm a brand-name or generic drug?
- Rizafilm is a brand-name product with the active ingredient Rizatriptan Benzoate. Lower-cost generic equivalents containing Rizatriptan Benzoate are available — ask your pharmacist.
- Is Rizafilm available over the counter?
- No. Rizafilm is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Rizafilm come in?
- Rizafilm is currently marketed as film, per the FDA's National Drug Code Directory.
- What class of drug is Rizafilm?
- Rizafilm is classified as serotonin-1b and serotonin-1d receptor agonist, per the FDA's Established Pharmacologic Class.
- Is Rizafilm FDA-registered?
- Rizafilm is on record with the U.S. FDA under application number NDA205394. You can verify this on its official FDA label.
- Is Rizafilm safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Rizafilm. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Rizafilm?
- Rizafilm's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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