The Product
In milligrams, this is one dose of Tosymra for a migraine patient
10 mg
*it 1/2 the dose of most generic sumatriptan nasal sprays and 8X faster
*generic nasal sumatriptan comes in 5mg and 20mg doses
The indication in which the FDA granted for Tosymra use
Seratonin 5-HT receptor agonist indicated for the acute treatment of migraine with or without aura in adults
The maximum amount of Tosymra units a patient should administer in 24 hours
3
Drugs containing this peptide have reported vasospastic reactions. Because of this patients must wait 24 hours between dosing it and Tosymra
Ergot-containing drugs, Ergotamines
This 42 year old female migraine patient administered a dose of another triptan nasal spray (Zomig) one hour ago and now is planning to take Tosymra
Not Okay
Contraindication of another 5 HT receptor agonist within 24 hours or and ergotamine
The items in one carton of Tosymra
6 Tosymra Doses, PI & Instructions for Use
The most common adverse events with sumatriptan injection equal or greater than 5% as occurred in 2 placebo controlled clinical trials
Most common adverse reactions (≥5% and > placebo) were injection site reactions, tingling, dizziness/vertigo, warm/hot sensation, burning sensation, feeling of heaviness, pressure sensation, flushing, feeling of tightness, and numbness/ paresthesia
This is the product Tosymra is bioequivalent to
4mg subcutaneous Injection
These are activities to avoid while taking Tosymra
TOSYMRA can cause dizziness, weakness, or drowsiness. If you have these symptoms, do not drive a car, use machinery, or do anything where you need to be alert
Taking Tosymra during pregnancy
Not Okay
This is how Tosymra is supplied
10 mg nasal spray, single, ready-to-use, single dose, disposable unit
6 units to a carton
Acute migraine drugs may lead to this condition if used in excess of 10 days or more per month
Medication overuse headache
This is how fast 13% of patients may experience pain relief
10 min
*At 2 hours 57% of patients
Which of these is not a contraindication of Tosymra:
1. Cardiac accessory conduction pathway disorders 2. Severe hepatic impairment (impaired liver function) 3. Severe arteriosclerosis (kidney disease)
3. Severe arteriosclerosis (kidney disease)
A 17 year old that is turning 18 in two days, has a current migraine and comes to the clinic asking for Tosymra
Not Okay
This novel ingredient is used in Tosymra to enhance drug absorption across the nasal mucosa.
Intravail
History of Stroke, History of coronary artery disease and use of MAO-A inhibitors are contraindications for Tosymra. These two types of headaches are also contraindicated
Hemiplegic and basilar
Hemiplegic migraine is a rare and serious. Many of its symptoms mimic those common to stroke
Migraine with brainstem aura or MBA (formerly known as basilar migraines) are headaches that start in the lower part of the brain, called the brainstem. They cause symptoms such as dizziness, double vision, and lack of coordination
Following nasal administration of 10 mg TOSYMRA in 73 healthy subjects, this percentage is the the relative bioavailability of TOSYMRA following 4 mg subcutaneous injection of sumatriptan
87%
This is the maximum cumulative dose is a 24 hour period
30 mg
Mike is a patient that is also on an anti-depressant. He has used oral sumatriptan in the past and his provider is aware of his medication history.
Okay
These are the three limitations of use for Tosyrma
• Use only if 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)
These are the medicaitons that patients should tell your provider they are taking before taking Tosymra
Tell your healthcare provider about all the medicines you take, including prescription and over‑the-counter medicines, vitamins, and herbal supplements. TOSYMRA and certain other medicines can affect each other, causing serious side effects. Especially tell your healthcare provider if you take anti-depressant medicines called: • selective serotonin reuptake inhibitors (SSRIs) • serotonin norepinephrine reuptake inhibitors (SNRIs) • tricyclic antidepressants (TCAs) • monoamine oxidase inhibitors (MAOIs)
This number reflects the percentage of patients that reported local irritative symptoms in a 6 month open label study. This includes application site reaction, dysgeusia and throat irritation
46%
These are the ingredients of Tosyrma
Active ingredient: Sumatriptan
Inactive ingredients: citric acid monohydrate, n‑Dodecyl beta‑D-maltoside (Intravail), potassium phosphate monobasic, sodium chloride, and sodium phosphate dibasic anhydrous in water for injection.
This patient called the clinic after taking a dose of Tosymra and wanted to know when they could re-dose if they had no pain relief. The provider talked to the patient and approved a second dose after one hour
Okay
When counseling a patient on Tosymra a provider should inform of all but which:
1. Caution patients to avoid spraying the contents of the device in their eyes
2. Treatment with TOSYMRA may cause sensory and motor neuropathy and Angelman syndrome
3. Inform patients that they may experience local irritation of their nose, mouth, and throat; and changes in taste
2. Treatment with TOSYMRA may cause sensory and motor neuropathy and Angelman syndrome
This syndrome causes changes in color or sensation in fingers and toes and could be a serious side effect of taking Tosymra
Raynaud's Syndrome
The AE reporting phone number
1-855-899-9180 USL or
1-800- FDA-1088
This is the mechanism of action for Tosymra
Sumatriptan binds with high affinity to human cloned 5‑HT1B/1D receptors
A patient stored their Tosymra in the refrigerator
Not Okay