Sumatriptan Nasal Spray Patient Information

PATIENT INFORMATION
Sumatriptan
(soo ma TRIP tan)
Nasal Spray, USP

Read this Patient Information before you start using sumatriptan nasal spray, USP 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, USP?

Sumatriptan can cause serious side effects, including:

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

Stop taking sumatriptan nasal spray, USP 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, USP 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, USP?

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

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

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

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

Do not use sumatriptan nasal spray, USP 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 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, USP. See the end of this leaflet for a complete list of ingredients in sumatriptan nasal spray, USP.

Before you use sumatriptan nasal spray, USP, 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. It is not known if sumatriptan nasal spray, USP 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, USP.

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

Sumatriptan 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, USP?

Certain people should use their first dose of sumatriptan nasal spray, USP 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, USP 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, USP in a 24-hour period.
It is not known how using sumatriptan nasal spray, USP for a long time affects the nose and throat.
If you use too much sumatriptan nasal spray, USP, 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, USP so you can talk with your healthcare provider about how sumatriptan nasal spray, USP is working for you.

What should I avoid while using sumatriptan nasal spray, USP?

Sumatriptan nasal spray, USP 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, USP?

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

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
  - fever
  - nausea or vomiting
  - constipation or diarrhea
  - bloody diarrhea
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, USP.
serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using sumatriptan, especially if sumatriptan nasal spray, USP 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, USP 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. Seizures have happened in people taking sumatriptan nasal spray, USP who have never had seizures before. Talk with your healthcare provider about your chance of having seizures while you take sumatriptan nasal spray, USP.

The most common side effects of sumatriptan nasal spray, USP 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, USP.

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, USP?

Store sumatriptan nasal spray, USP between 36°F to 86°F (2°C to 30°C).
Store your medicine away from light.

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

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

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use sumatriptan nasal spray, USP for a condition for which it was not prescribed. Do not give sumatriptan nasal spray, USP 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, USP. 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, USP that is written for healthcare professionals.

For more information, contact Lannett Company, Inc. at 1-844-834-0530.

What are the ingredients in sumatriptan nasal spray, USP?

Active ingredient: sumatriptan

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

IMITREX and AMERGE are registered trademarks of the GSK group of companies. The other brands listed are trademarks of their respective owners and are not owned by or licensed to Lannett Company, Inc. The makers of these brands are not affiliated with and do not endorse Lannett Company, Inc. or its products.

Manufactured by:
Lannett Company, Inc.
Philadelphia, PA 19136

Manufactured by:
Summit Biosciences, Inc.
Lexington, KY 40511

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

INSTRUCTIONS FOR USE
Sumatriptan Nasal Spray, USP
(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 plastic pack (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

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.

NOTE: Plunger color may vary

Figure D

Step 5. Keep your head upright and close your mouth. While gently taking a breath in through your nose, press the plunger firmly, straight up toward the nozzle, in one rapid motion to release the dose of Sumatriptan Nasal Spray (see Figure E). The plunger may feel stiff and you may hear a click.

Figure E

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.

Figure F

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