Sumatriptan nasal spray is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use:

• Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan nasal spray, reconsider the diagnosis of migraine before Sumatriptan nasal spray is administered to treat any subsequent attacks.
• Sumatriptan is not indicated for the prevention of migraine attacks.
• Safety and effectiveness of sumatriptan nasal spray have not been established for cluster headache.

The recommended adult dose of sumatriptan nasal spray for the acute treatment of migraine is 5 mg, 10 mg, or 20 mg. The 20 mg dose may provide a greater effect than the 5 mg and 10 mg doses, but may have a greater risk of adverse reactions [see Clinical Studies (14)] .

The 5 mg and 20 mg doses are given as a single spray in 1 nostril. The 10 mg dose may be achieved by the administration of a single 5 mg dose in each nostril.

If the migraine has not resolved by 2 hours after taking sumatriptan nasal spray or returns after a transient improvement, 1 additional dose may be administered at least 2 hours after the first dose. The maximum daily dose is 40 mg in a 24 hour period.

The safety of treating an average of more than 4 headaches in a 30 day period has not been established.

Unit dose nasal spray devices containing 20 mg sumatriptan.

Sumatriptan nasal spray is contraindicated in patients with:

• Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or 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, transient ischemic attack (TIA), or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke [see Warnings and Precautions (5.4)]
• Peripheral vascular disease [see Warnings and Precautions (5.5)]
• Ischemic bowel disease [see Warnings and Precautions (5.5)]
• Uncontrolled hypertension [see Warnings and Precautions (5.8)]
• Recent use (i.e., within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-hydroxytryptamine 1 (5-HT 1) agonist [see Drug Interactions (7.1, 7.3)]
• Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)]
• Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) [see Warnings and Precautions (5.10)]
• Severe hepatic impairment [see Clinical Pharmacology (12.3)]

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

• Myocardial ischemia, myocardial infarction, and Prinzmetal’s angina [see Warnings and Precautions (5.1)]
• Arrhythmias [see Warnings and Precautions (5.2)]
• Chest, 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)]
• Medication overuse headache [see Warnings and Precautions (5.6)]
• Serotonin syndrome [see Warnings and Precautions (5.7)]
• Increase in blood pressure [see Warnings and Precautions (5.8)]
• Local irritation [see Warnings and Precautions (5.9)]
• Hypersensitivity reactions [see Contraindications (4) and Warnings and Precautions (5.10)]
• Seizures [see Warnings and Precautions (5.11)]

In clinical trials, the highest single doses of sumatriptan nasal spray administered without significant reactions were 40 mg to 12 volunteers and 40 mg to 85 subjects with migraine, which is twice the highest single recommended dose. In addition, 12 volunteers were administered a total daily dose of 60 mg (20 mg 3 times daily) for 3.5 days without significant adverse reactions.

Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.

The elimination half‑life of sumatriptan is approximately 2 hours [see Clinical Pharmacology (12.3)] , and therefore monitoring of patients after overdose with sumatriptan nasal spray should continue for at least 10 hours or while symptoms or signs persist.

It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of sumatriptan.

Sumatriptan nasal spray contains sumatriptan, a selective 5-HT 1B/1D receptor agonist. Sumatriptan is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide, and it has the following structure:

The empirical formula is C 14H 21N 3O 2S, representing a molecular weight of 295.4. Sumatriptan is a white to off-white powder that is very slightly soluble in water and in saline.

Each sumatriptan nasal spray contains 20 mg of sumatriptan in a 100-MicroL unit dose aqueous buffered solution containing monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, and water for injection USP. The pH of the solution is approximately 5.5. The osmolality of the solution is 372 or 742 mOsmol for the 5 and 20 mg sumatriptan nasal spray, respectively.

The efficacy of sumatriptan nasal spray in the acute treatment of migraine headaches was demonstrated in 8, randomized, double-blind, placebo-controlled trials, of which 5 used the recommended dosing regimen and used the marketed formulation. Patients enrolled in these 5 trials were predominately female (86%) and Caucasian (95%), with a mean age of 41 years (range of 18 to 65 years). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction in headache severity from moderate or severe pain to mild or no pain, was assessed up to 2 hours after dosing. Associated symptoms such as nausea, photophobia, and phonophobia were also assessed. Maintenance of response was assessed for up to 24 hours postdose. A second dose of sumatriptan nasal spray or other medication was allowed 2 to 24 hours after the initial treatment for recurrent headache. The frequency and time to use of these additional treatments were also determined. In all trials, doses of 10 and 20 mg were compared with placebo in the treatment of 1 to 3 migraine attacks. Patients received doses as a single spray into 1 nostril. In 2 trials, a 5 mg dose was also evaluated.

In all 5 trials utilizing the market formulation and recommended dosage regimen, the percentage of patients achieving headache response 2 hours after treatment was significantly greater among patients receiving sumatriptan nasal spray at all doses (with one exception) compared with those who received placebo. In 4 of the 5 trials, there was a statistically significant greater percentage of patients with headache response at 2 hours in the 20 mg group when compared with the lower dose groups (5 and 10 mg). There were no statistically significant differences between the 5 and 10 mg dose groups in any trial. The results from the 5 controlled clinical trials are summarized in Table 2. Note that, in general, comparisons of results obtained in trials conducted under different conditions by different investigators with different samples of patients are ordinarily unreliable for purposes of quantitative comparison.

aP<0.05 in comparison with placebo.

bP<0.05 in comparison with 10 mg.

cP<0.05 in comparison with 5 mg.

dData are for attack 1 only of multi-attack trial for comparison.

The estimated probability of achieving an initial headache response over the 2 hours following treatment is depicted in Figure 1.

Figure 1. Estimated Probability of Achieving Initial Headache Response within 120 Minutes a

aThe figure shows the probability over time of obtaining headache response (no or mild pain) following treatment with intranasal sumatriptan. The averages displayed are based on pooled data from the 5 clinical controlled trials providing evidence of efficacy. Kaplan-Meier plot with patients not achieving response within 120 minutes censored to 120 minutes.

For patients with migraine-associated nausea, photophobia, and phonophobia at baseline, there was a lower incidence of these symptoms at 2 hours following administration of sumatriptan nasal spray compared with placebo.

Two to 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain relief in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2.

Figure 2. The Estimated Probability of Patients Taking a Second Dose or Other Medication for Migraine Over the 24 Hours Following the Initial Dose of Study Treatment a

aKaplan-Meier plot based on data obtained in the 3 clinical controlled trials providing evidence of efficacy with patients not using additional treatments censored to 24 hours. Plot also includes patients who had no response to the initial dose. No remedication was allowed within 2 hours postdose.

There is evidence that doses above 20 mg do not provide a greater effect than 20 mg. There was no evidence to suggest that treatment with sumatriptan was associated with an increase in the severity of recurrent headaches. The efficacy of sumatriptan nasal spray was unaffected by presence of aura; duration of headache prior to treatment; gender, age, or weight of the subject; or concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants). There were insufficient data to assess the impact of race on efficacy.

Sumatriptan nasal spray, 20 mg ( NDC 71921-170-61) is supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 20 mg of sumatriptan.

Store between 2°C and 30°C (36°F and 86°F). Protect from light.

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal’s Angina, Other Vasospasm-Related Events, Arrhythmias, and Cerebrovascular Events: Inform patients that sumatriptan nasal spray may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, irregular heartbeat, significant rise in blood pressure, weakness, and slurring of speech and should ask for medical advice if any indicative sign or symptoms are observed. Apprise patients of the importance of this follow-up [see Warnings and Precautions (5.1, 5.2, 5.4, 5.5, 5.8)] .

Anaphylactic/Anaphylactoid Reactions: Inform patients that anaphylactic/anaphylactoid reactions have occurred in patients receiving sumatriptan nasal spray. 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 [see Contraindications (4) and Warnings and Precautions (5.10)] .

Concomitant use with other Triptans or Ergot Medications: Inform patients that use of sumatriptan nasal spray within 24 hours of another triptan or an ergot-type medication (including dihydroergotamine or methysergide) is contraindicated [see Contraindications (4) and Drug Interactions (7.1, 7.3)] .

Serotonin Syndrome: Caution patients about the risk of serotonin syndrome with the use of sumatriptan nasal spray or other triptans, particularly during combined use with SSRIs, SNRIs, TCAs, and MAO inhibitors [see Warnings and Precautions (5.7) and Drug Interactions (7.4)].

Medication Overuse Headache: Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see Warnings and Precautions (5.6)] .

Pregnancy: Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to become pregnant  [see Use in Specific Populations (8.1)] .

Lactation: Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed  [see Use in Specific Populations (8.2)] .

Ability to Perform Complex Tasks: Treatment with sumatriptan nasal spray may cause somnolence and dizziness; instruct patients to evaluate their ability to perform complex tasks after administration of sumatriptan nasal spray.

Local Irritation: Inform patients that they may experience local irritation of their nose and throat. The symptoms will generally resolve in less than 2 hours.

How to Use sumatriptan nasal spray: Provide patients instruction on the proper use of sumatriptan nasal spray. Caution patients to avoid spraying the contents of the device in their eyes.

Manufactured for Florida Pharmaceutical Products, LLC

by Novocol Pharmaceutical of Canada, Inc.

25 Wolseley Court,

Cambridge, Ontario.

N1R 6X3 Canada

Made in Canada.

Rev. 02/2021 (2079-0)

Patient Information

Sumatriptan nasal spray

(soo” ma trip’ tan)

Read this Patient Information before you start using sumatriptan nasal spray and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is the most important information I should know about sumatriptan nasal spray?

Sumatriptan nasal spray can cause serious side effects, including:

Heart attack and other heart problems. Heart problems may lead to death.

Stop taking sumatriptan nasal spray and get emergency medical help right away if you have any of the following symptoms of a heart attack:

• discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
• severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
• pain or discomfort in your arms, back, neck, jaw, or stomach
• shortness of breath with or without chest discomfort
• breaking out in a cold sweat
• nausea or vomiting
• feeling lightheaded

Sumatriptan nasal spray is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. You have a higher risk for heart disease if you:

• have high blood pressure
• have high cholesterol levels
• smoke
• are overweight
• have diabetes
• have a family history of heart disease

What is sumatriptan nasal spray?

Sumatriptan nasal spray is a prescription medicine used to treat acute migraine headaches with or without aura in adults.

Sumatriptan nasal spray is not used to treat other types of headaches such as hemiplegic (that make you unable to move on one side of your body) or basilar (rare form of migraine with aura) migraines.

Sumatriptan nasal spray is not used to prevent or decrease the number of migraine headaches you have.

It is not known if sumatriptan nasal spray is safe and effective to treat cluster headaches.

It is not known if sumatriptan nasal spray is safe and effective in children under 18 years of age.

Do not use sumatriptan nasal spray if you have:

• heart problems or a history of heart problems
• narrowing of blood vessels to your legs, arms, stomach, or kidneys (peripheral vascular disease)
• uncontrolled high blood pressure
• severe liver problems
• hemiplegic migraines or basilar migraines. If you are not sure if you have these types of migraines, ask your healthcare provider.
• had a stroke, transient ischemic attacks (TIAs), or problems with your blood circulation
• taken any of the following medicines in the last 24 hours:
  • almotriptan (AXERT ®)
  • eletriptan (RELPAX ®)
  • frovatriptan (FROVA ®)
  • naratriptan (AMERGE ®)
  • rizatriptan (MAXALT ®, MAXALT-MLT ®)
  • sumatriptan (IMITREX ®)
  • sumatriptan and naproxen (TREXIMET ®)
  • ergotamines (CAFERGOT ®, ERGOMAR ®, MIGERGOT ®)
  • dihydroergotamine (D.H.E. 45 ®, MIGRANAL ®)
    Ask your healthcare provider if you are not sure if your medicine is listed above.
• an allergy to sumatriptan or any of the ingredients in sumatriptan nasal spray. See the end of this leaflet for a complete list of ingredients in sumatriptan nasal spray.

What should I tell my healthcare provider before using sumatriptan nasal spray?

Before you use sumatriptan nasal spray, tell your healthcare provider about all of your medical conditions, including if you:

• have high blood pressure
• have high cholesterol
• have diabetes
• smoke
• are overweight
• have heart problems or family history of heart problems or stroke
• have kidney problems
• have liver problems
• have had epilepsy or seizures
• are not using effective birth control
• are pregnant or plan to become pregnant while taking sumatriptan nasal spray. It is not known if sumatriptan nasal spray can harm your unborn baby.
• are breastfeeding or plan to breastfeed. Sumatriptan passes into your breast milk. It is not known if this can harm your baby. Talk with your healthcare provider about the best way to feed your baby if you use sumatriptan nasal spray.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Sumatriptan nasal spray and certain other medicines can affect each other, causing serious side effects.

Especially tell your healthcare provider if you take antidepressant medicines called:

• selective serotonin reuptake inhibitors (SSRIs)
• serotonin norepinephrine reuptake inhibitors (SNRIs)
• tricyclic antidepressants (TCAs)
• monoamine oxidase inhibitors (MAOIs)

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I use sumatriptan nasal spray?

• Certain people should use their first dose of sumatriptan nasal spray in their healthcare provider’s office or in another medical setting. Ask your healthcare provider if you should use your first dose in a medical setting.
• Use sumatriptan nasal spray exactly as your healthcare provider tells you to use it.
• Your healthcare provider may change your dose. Do not change your dose without first talking with your healthcare provider.
• If you do not get any relief after your first nasal spray, do not use a second nasal spray without first talking with your healthcare provider.
• If your headache comes back after the first nasal spray or you only get some relief from your headache, you can use a second nasal spray 2 hours after the first nasal spray.
• Do not use more than 40 mg of sumatriptan nasal spray in a 24 hour period.
• It is not known how using sumatriptan nasal spray for a long time affects the nose and throat.
• If you use too much sumatriptan nasal spray, call your healthcare provider or go to the nearest hospital emergency room right away.
• You should write down when you have headaches and when you use sumatriptan nasal spray so you can talk with your healthcare provider about how sumatriptan nasal spray is working for you.

What should I avoid while using sumatriptan nasal spray?

Sumatriptan nasal spray 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.

What are the possible side effects of sumatriptan nasal spray?

Sumatriptan nasal spray may cause serious side effects. See “What is the most important information I should know about sumatriptan nasal spray?”

These serious side effects include:

• changes in color or sensation in your fingers and toes (Raynaud’s syndrome)
• stomach and intestinal problems (gastrointestinal and colonic ischemic events). Symptoms of gastrointestinal and colonic ischemic events include:
  • sudden or severe stomach pain
  • stomach pain after meals
  • weight loss
  • nausea or vomiting
  • constipation or diarrhea
  • bloody diarrhea
  • fever
• problems with blood circulation to your legs and feet (peripheral vascular ischemia). Symptoms of peripheral vascular ischemia include:
  • cramping and pain in your legs or hips
  • feeling of heaviness or tightness in your leg muscles
  • burning or aching pain in your feet or toes while resting
  • numbness, tingling, or weakness in your legs
  • cold feeling or color changes in 1 or both legs or feet
• medication overuse headaches. Some people who use too many sumatriptan nasal sprays may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with sumatriptan nasal spray
• serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using sumatriptan nasal spray, especially if sumatriptan nasal spray is used with anti-depressant medicines called SSRIs or SNRIs.
  
  Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
  • mental changes such as seeing things that are not there (hallucinations), agitation, or coma
  • fast heartbeat
  • changes in blood pressure
  • high body temperature
  • tight muscles
  • trouble walking
• local irritation. Some people who use Sumatriptan nasal spray may have irritation of their throat and nose. Symptoms of local irritation of the throat and nose include: burning, numbness, tingling sensation, nasal discharge, pain or soreness.
• Hives (itchy bumps); swelling of your tongue, mouth, or throat.
• Seizures have happened in people taking sumatriptan nasal spray who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take sumatriptan nasal spray.

The most common side effects of sumatriptan nasal spray include:

• unusual or bad taste in your mouth
• nausea
• vomiting
• dizziness
• warm, hot, burning feeling

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of sumatriptan nasal spray. 

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store sumatriptan nasal spray?

• Store between 2°C and 30°C (36°F and 86°F).
• Store your medicine away from light.

Keep sumatriptan nasal spray and all medicines out of the reach of children.

General information about the safe and effective use of sumatriptan nasal spray.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use sumatriptan nasal spray for a condition for which it was not prescribed. Do not give sumatriptan nasal spray to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about sumatriptan nasal spray. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about sumatriptan nasal spray that is written for healthcare professionals.

For more information, call Florida Pharmaceutical Products, LLC at 1-800-315-0985

What are the ingredients in sumatriptan nasal spray?

Active ingredient: sumatriptan

Inactive ingredients: monobasic potassium phosphate NF, anhydrous dibasic sodium phosphate USP, sulfuric acid NF, sodium hydroxide NF, and water for injection USP.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Brands listed are trademarks of their respective owners.  The makers of these brands are not affiliated with and do not endorse Florida Pharmaceutical Products, LLC or its products.

Manufactured for Florida Pharmaceutical Products, LLC

by Novocol Pharmaceutical of Canada, Inc.

25 Wolseley Court,

Cambridge, Ontario.

N1R 6X3

Canada

Made in Canada.

Rev. 02/2021

Sumatriptan nasal spray

(soo” ma trip’ tan)

For use in the nose only. Do not spray in your eyes.

	Step 1. Remove the sumatriptan nasal spray unit from the aluminum pouch (see Figure A). Do not remove the unit until you are ready to use. The unit contains only 1 spray. Do not test before use.
Figure A
	Step 2. While sitting down, gently blow your nose to clear your nasal passages (see Figure B).
Figure B
	Step 3. Keeping your head in an upright position, gently close 1 nostril with your index finger and breathe out gently through your mouth (see Figure C).
Figure C
Figure D	Step 4. With your other hand, hold the container with your thumb supporting the container at the bottom, and your index and middle fingers on either side of the nozzle (see Figure D). Insert the nozzle into your open nostril about ½ inch. Do not press the plunger yet.
Figure E	Step 5. Keep your head upright and close your mouth. While gently taking a breath in through your nose, press the plunger firmly to release the dose of sumatriptan nasal spray (see Figure E).
Figure F	Step 6. Keep your head level and remove the nozzle from your nostril. While holding your head level, gently breathe in through your nose and out through your mouth for 10 to 20 seconds (see Figure F). Do not breathe in deeply.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for Florida Pharmaceutical Products, LLC

by Novocol Pharmaceutical of Canada, Inc..

25 Wolseley Court,

Cambridge, Ontario.

N1R 6X3

Canada

Made in Canada.

Rev. 02/2021 (2667-0)

NDC 71921-170-61

R x Only

Sumatriptan Nasal Spray, USP

20 mg

0.1 mL per unit

For Intranasal Use Only

Each unit dose nasal spray contains 20 mg of sumatriptan.

1 Spray per unit.

Do not test before use.

6 Nasal Spray Units

FPP Rx

Florida Pharmaceutical Products, LLC