Epinephrine Injection

Auvi-Q®
(epinephrine) Injection
Auto-Injector
For allergic emergencies (anaphylaxis)

Read this Patient Information Leaflet before you have to use Auvi-Q and each time you get a refill. There may be new information. You should know how to use Auvi-Q before you have an allergic emergency. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Auvi-Q?

1. Always carry Auvi-Q with you because you may not know when a life-threatening allergic reaction (anaphylactic reaction) may happen. Talk to your doctor if you need additional units to keep at work, school, etc. An anaphylactic reaction is a life-threatening allergic reaction that can happen within minutes and can be caused by stinging and biting insects (bees, wasps, hornets, and mosquitoes), allergy shots, foods, medicines, exercise, or other unknown causes. Follow your healthcare provider’s instructions on when to use Auvi-Q if you have the symptoms of an anaphylactic reaction, which may include the symptoms listed below:
   • trouble breathing
   • wheezing
   • hoarseness (changes in the way your voice sounds)
   • hives (raised reddened rash that may itch)
   • severe itching
   • swelling of your face, lips, mouth or tongue
   • skin rash, redness, or swelling
   • fast heartbeat
   • weak pulse
   • feeling very anxious
   • confusion
   • stomach pain
   • losing control of urine or bowel movements
   • dizziness or fainting
2. Tell your family members and others where you keep Auvi-Q and how to use it before you need it.
   You may be unable to speak in an allergic emergency.
3. Get medical attention immediately after using Auvi-Q. If you have a serious allergic reaction, you
   may need more medicine.

What is Auvi-Q?

Auvi-Q is a prescription medicine used to treat life-threatening allergic reactions including anaphylaxis in people who are at risk for or have a history of serious allergic reactions.

Auvi-Q is for immediate self (or caregiver) administration and does not take the place of emergency medical care. You should get emergency medical help right away after using Auvi-Q.

It is not known if Auvi-Q is safe and effective in children who weigh less than 33 pounds (15 kg).

What should I tell my healthcare provider before using Auvi-Q?
Before you use Auvi-Q, tell your healthcare provider if you:

• have heart problems or high blood pressure
• have diabetes
• have thyroid problems
• have history of depression
• have Parkinson’s disease
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Auvi-Q will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Auvi-Q passes into your breast milk.

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

Auvi-Q and other medicines may affect each other, causing side effects. Auvi-Q may affect the way other medicines work, and other medicines may affect how Auvi-Q works.

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

How should I use Auvi-Q?

• Each Auvi-Q contains only 1 dose of medicine.
• Auvi-Q should only be injected into the muscle of your outer thigh. It can be injected through your clothing, if needed.
• Read the Instructions for Use at the end of this Patient Information Leaflet for information about the right way to use Auvi-Q.
• Use Auvi-Q exactly as your healthcare provider tells you to use it.
• An Auvi-Q Trainer with a separate Trainer Instructions for Use leaflet is included with Auvi-Q. Additional training resources are available at www.auvi-q.com.
  • Practice with the Auvi-Q Trainer before an allergic emergency happens to make sure you are able to safely use the real Auvi-Q in an emergency.
  • The Auvi-Q Trainer does not contain a needle or medicine and can be reused to practice your injection.

What are the possible side effects of Auvi-Q?

Auvi-Q may cause serious side effects.

• Auvi-Q should only be injected into your outer thigh. Do not inject Auvi-Q into your:
  • veins
  • buttocks
  • fingers, toes, hands or feet

  If you accidentally inject Auvi-Q into any other part of your body, go to the nearest hospital emergency room right away. Tell the healthcare provider where on your body you received the accidental injection.

  • Rarely, patients who use Auvi-Q may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site:
    • redness that does not go away
    • swelling
    • tenderness
    • the area feels warm to the touch
  • If you inject a young child with Auvi-Q, hold their leg firmly in place before and during the injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg of a young child during an injection.
• If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use Auvi-Q. Talk to your healthcare provider about all your medical conditions.

Common side effects of Auvi-Q include:

• fast, irregular, or ‘pounding’ heart beat
• sweating
• shakiness
• headache
• paleness
• feelings of over excitement, nervousness, or anxiety
• weakness
• dizziness
• nausea and vomiting
• breathing problems

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

These are not all of the possible side effects of Auvi-Q. For more information, ask your healthcare provider or pharmacist.

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 Auvi-Q?

• Store Auvi-Q at 68° to 77°F (20° to 25°C).
• Do NOT expose to extreme heat or cold. For example, do NOT store in your vehicle’s glove box.
  Do not store Auvi-Q in the refrigerator or freeze.
• Examine contents in the viewing window periodically. Solution should be clear. If the solution is discolored (pinkish color or darker than slightly yellow), cloudy or contains solid particles, replace the unit.
• Your Auvi-Q has an expiration date. Replace it before the expiration date.
• Keep Auvi-Q in the outer case it comes in to protect it from light.

Keep Auvi-Q and all medicines out of the reach of children.

General information about the safe and effective use of Auvi-Q:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Auvi-Q for a condition for which it was not prescribed. Do not give Auvi-Q to other people, even if they have an allergic reaction or the same symptoms that you have. It may harm them.

This Patient Information Leaflet summarizes the most important information about Auvi-Q. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Auvi-Q that is written for health professionals.

For more information and video instructions on the use of Auvi-Q, go to www.auvi-q.com or call 1- 844-828-8472.

What are the ingredients in Auvi-Q?

Active ingredient: epinephrine.
Inactive Ingredients: sodium chloride, sodium bisulfite, hydrochloric acid, and water.

Auvi-Q does not contain latex.

Instructions for Use

Read these Instructions for Use carefully before you need to use your Auvi-Q. Before you use Auvi- Q, make sure your healthcare provider shows you the right way to use it. If you have any questions, ask your healthcare provider.

If you are administering Auvi-Q to a young child, hold the leg firmly in place and limit movement prior to and while administering an injection.

Automated Voice Instructions

Auvi-Q contains an electronic voice instruction system to help guide you through each step of your injection. If the voice instructions do not work for any reason, use Auvi-Q as instructed in these Instructions for Use. It will still work during an allergic reaction emergency.

How to use your Auvi-Q

Figure A

1. Pull Auvi-Q from the outer case. See Figure B.
   Do not go to step 2 until you are ready to use Auvi-Q. If you are not ready to use Auvi-Q, put it back in the outer case.

   Figure B.
   

2. Pull off Red safety guard. See Figure C.
   To reduce the chance of an accidental injection, do not touch the black base of the auto-injector, which is where the needle comes out. If an accidental injection happens, get medical help right away.

   Note: The red safety guard is made to fit tight. Pull firmly to remove.

   Figure C.
   

3. Place black end of Auvi-Q against the middle of the outer thigh (through clothing, if needed), then press firmly, and hold in place for 5 seconds . See Figure D.

   Only inject into the middle of the outer thigh. Do not inject into any other part of the body.

   If you are administering Auvi-Q to a young child, hold the leg firmly in place while administering an injection.

   Note: Auvi-Q makes a distinct sound (click and hiss) when you press it against your outer thigh. This is normal and indicates Auvi-Q is working correctly. Do not pull Auvi-Q away from your leg when you hear the click and hiss sound.

   The needle automatically retracts after the injection is complete, so the needle will not be visible after the injection. Auvi-Q includes a 5-second countdown after it is activated, then the voice instruction will indicate the injection is complete, Auvi-Q will beep, and the lights will blink red.

   Figure D.
   

4. Get emergency medical help right away.
   

   Replace the outer case and talk to your healthcare provider about the right way to throw away your Auvi-Q.

   Ask your healthcare provider for an Auvi-Q prescription refill.
   After the use of Auvi-Q:

   • The black base will lock into place.
   • The voice instruction system will say Auvi-Q has been used and the lights will blink red.
   • The red safety guard cannot be replaced.
   • The viewing window will no longer be clear.
   • It is normal for some medicine to remain in your Auvi-Q after you have received your dose of medicine.
   • Talk to your healthcare provider about the right way to throw away your Auvi-Q.
   • Auvi-Q is a single-use injectable device. Once Auvi-Q has been used, any medicine that remains in the auto-injector cannot be reused.

Until you throw away your used Auvi-Q, the electronic voice instruction system will remind you that it has been used when the outer case is removed.

If you will be administering Auvi-Q to a young child, ask your healthcare provider to show you how to properly hold the leg in place while administering a dose.

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

Auvi-Q®
TRAINER

Trainer Instructions for Use

Important:

The Auvi-Q Trainer Does Not contain a needle or medicine.

In cas e of an allergic emergency, us e the real Auvi-Q and not the gray Trainer. Always carry your real Auvi-Q with you in cas e of an allergic emergency.

Important Information about the Auvi-Q Trainer:

Inside your Auvi-Q Trainer are:

• batteries
• a speaker that will make a beeping sound and that produces electronic voice instructions
• red and green blinking lights

The Auvi-Q Trainer batteries are made to last long enough for you to practice 1 time each day for 2 years. If your Auvi-Q Trainer does not work properly call your healthcare provider for a new Trainer.

What is the Auvi-Q Trainer?

• The Auvi-Q Trainer does not contain a needle or medicine and can be reused to practice your injection.
• Practice with the Auvi-Q Trainer before an allergic emergency happens to make sure you are able to safely use the real Auvi-Q in an emergency.

Your Auvi-Q Trainer

In case of an allergic emergency, use the real Auvi-Q and not the gray Trainer.

Who should practice using the Auvi-Q Trainer?

Anyone who may need to help you with Auvi-Q in case of an allergic emergency:

• You
• Caregivers
• Family
• Friends
• Co-workers
• Teachers
• Child Care or Day Care Workers

Have them practice using the Trainer and review the Patient Information Leaflet included in the packaging with each prescription of Auvi-Q.

For more information and video instructions on the use of Auvi-Q, go to www.auviq. com or call 1-844-828-8472.

Practicing with the Auvi-Q Trainer

Practice with the Auvi-Q Trainer before an allergic emergency happens to make sure you are able to safely use the real Auvi-Q in an emergency.

• You should practice daily for the first week after you receive your Auvi-Q Trainer to help you feel comfortable using Auvi-Q quickly and safely. Even when you are comfortable using the Trainer, continue to practice using it often.

How to Use the Trainer

How the Auvi-Q Trainer works

Although the Trainer does not have a needle and contains no medicine, it works the same way as the real Auvi-Q.

As with the real Auvi-Q, the Auvi-Q Trainer contains an electronic voice instruction system to help guide you through each step of your injection. If the voice instructions do not work for the Auvi-Q Trainer for any reason, you can still use the Auvi-Q Trainer as instructed in this leaflet to practice.

The Auvi-Q Trainer has the same blinking red and green lights as the real Auvi-Q.

As with the real Auvi-Q, if practicing with a young child, hold the child’s leg firmly in place while using the Auvi-Q Trainer.

Ask your healthcare provider to show you how to properly hold the leg to practice so that you will be prepared before an allergic emergency happens

Storage:

• Store the Auvi-Q Trainer at room temperature; the Auvi-Q Trainer should not be used at temperatures less than 50ºF (10°C) or greater than 104°F (40°C).
• Store the Auvi-Q Trainer in its outer case.
• Keep the Auvi-Q Trainer away from dirt, chemicals, and water.

Disposal:

The Auvi-Q Trainer contains electronics and lithium coin cell batteries, and should be disposed of in the correct manner. Follow your State and local environmental regulations for disposal.

For California Only: This product uses batteries containing Perchlorate Material - special handling may apply. See www.dts c.ca.gov/hazardous was te/perchlorate

Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis caused by unknown substances or triggered by exercise.

epinephrine is available only with your doctor's prescription.

Use epinephrine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

If you are using epinephrine at home, make sure you or any of your family members understand exactly how to give them. Also, tell your doctor if you or your caregiver has severe arthritis of the hands. If you have any questions about this, check with your doctor.

epinephrine is injected into the muscle of your outer thigh only. Do not inject epinephrine into a vein, into the muscle of your buttocks, or into your fingers, toes, hands, or feet. To do so, may increase the chance of having serious side effects.

epinephrine comes with patient information and instructions leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

epinephrine comes in 2 forms:an autoinjector syringe and needle kit or a prefilled syringe. This contains the correct dose of medicine your doctor has prescribed.

epinephrine comes with an autoinjector trainer and a separate trainer instructions for use. Be sure to practice first with your autoinjector trainer before an allergy emergency happens to make sure you are ready to use the real Adrenaclick®, EpiPen®, or EpiPen Jr® autoinjector in an actual emergency. The autoinjector trainer has a grey color (for EpiPen® or EpiPen Jr®) or beige color (for Adrenaclick®) and does not contain any medicine or needle.

Do not remove the blue safety release (EpiPen® or EpiPen Jr®) or the gray end caps (Adrenaclick®) on the autoinjector until you are ready to use it. Do not put your thumb, fingers, or hand over the orange (EpiPen® or EpiPen Jr®) or red (Adrenaclick®) tip of the autoinjector or over the needle of the Symjepi® prefilled syringe. This is to avoid an accidental injection.

If you use the Symjepi® prefilled syringe:

• Do not remove the needle cap until you are ready to use it.
• Slowly inject the syringe into the thigh while sitting down.
• Push the plunger all the way down until you hear a "clicking" sound. Hold it for 2 seconds.
• Remove the syringe and massage the area for 10 seconds.
• Call your medical provider right away after injection.

You may need to use more than one injection if your allergic reaction does not get better after the first shot. If more than 2 injections are needed for 1 reaction, however, those should be given only under medical supervision.

If you are using the epinephrine injection in a child, make sure to hold his leg firmly in place and limit movement before and during an injection.

Carry epinephrine with you at all times for emergency use in case you have a severe allergic reaction.

Check the injection kits regularly to make sure that the liquid has not changed its color. It should be clear and colorless. Do not use epinephrine if the liquid has changed its color (pinkish or brown in color), has become cloudy, or if there are particles in it.

Do not reuse the remaining portion of the medicine that is left in the autoinjector or prefilled syringe. Throw away the autoinjector or prefilled syringe after you have used it.

Dosing

The dose of epinephrine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of epinephrine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For allergic reactions:
    • Adults and children weighing more than 30 kilograms (kg)—0.3 milligram (mg) injected under the skin or into the muscle of your thigh.
    • Children weighing 15 to 30 kg—0.15 mg injected under the skin or into the muscle of your thigh.
    • Children weighing less than 15 kg—Use and dose must be determined by your doctor.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the injection kits at room temperature, away from heat, moisture, and direct light. Do not store the medicine in the refrigerator or freezer, or into your vehicle's glove box.

Keep the autoinjector or prefilled syringe in its carrier tube or case to protect from damage. However, this tube or case is not waterproof. If you accidentally drop it, check for damage or leakage.

Before using epinephrine, tell your doctor if any past use of this medicine caused an allergic reaction to get worse.

To make sure epinephrine injection is safe for you, tell your doctor if you have:

• heart disease or high blood pressure;

• asthma;

• Parkinson's disease;

• depression or mental illness;

• a thyroid or adrenal gland disorder; or

• diabetes (you may need to adjust your dose of insulin or other diabetes medication after using epinephrine injection).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether epinephrine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In an emergency situation it may not be possible to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medication.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Epinephrine is injected into the muscle of your outer thigh. In an emergency, this injection can be given through your clothing.

Your medicine may also come with a "trainer pen." The trainer pen contains no medicine and no needle. It is only for non-emergency use to practice giving yourself an epinephrine injection. Do not use a trainer pen to treat an allergic reaction.

The auto-injector device is a disposable single-use system that comes with patient instructions for safe and effective use. Do not inject this medicine if you do not understand these instructions.

Do not remove the safety cap until you are ready to use the auto-injector. Never put your fingers over the injector tip when removing the safety cap or after the safety cap has been removed.

To use an epinephrine auto-injector:

• Form a fist around the auto-injector with the tip pointing down. Pull off the safety cap.

• Place the tip against the fleshy portion of your outer thigh. You may give the injection directly through your clothing.

• Push the auto-injector firmly against your thigh to release the needle that injects the dose of epinephrine. Hold the auto-injector in place for 10 seconds after activation.

• Remove the auto-injector from your thigh and massage the area gently. Carefully re-insert the used device needle-first into the carrying tube. Re-cap the tube and take it with you to the emergency room so that anyone who treats you will know how much epinephrine you have received.

• Use an auto-injector only one time. Do not try to reinsert an auto-injector a second time if the needle has come out of your skin before the full 10 seconds. If the needle is bent from the first use, it may cause serious injury to your skin.

Seek emergency medical attention after any use of epinephrine to treat a severe allergic reaction. The effects of epinephrine may wear off after 10 or 20 minutes. You will need to receive further treatment and observation.

Do not use epinephrine injection if it has changed colors or has particles in it, or if the expiration date on the label has passed. Call your pharmacist for a new prescription.

Store at room temperature away from moisture, heat, and light. Do not refrigerate or freeze this medication, and do not store it in a car.

EPINEPHRINE
Injection, USP 
1 mg/10 mL (0.1 mg/mL) 
Abboject™ Syringe
Fliptop Vial
Protect solution from light;
do not use the Injection if its color is
pinkish or darker than slightly yellow
or if it contains a precipitate.

Epinephrine Injection, USP is a sterile, nonpyrogenic solution administered parenterally by the intravenous or intracardiac (left ventricular chamber) routes, or via endotracheal tube into the bronchial tree.

Each milliliter (mL) contains epinephrine 0.1 mg; sodium chloride 8.16 mg; sodium metabisulfite added 0.46 mg; citric acid, anhydrous 2 mg and sodium citrate, dihydrate 0.6 mg added as buffers. May contain additional citric acid and/or sodium citrate for pH adjustment. pH 3.3 (2.2 to 5.0). Epinephrine Injection, USP is oxygen sensitive.

The solution contains no bacteriostat or antimicrobial agent and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded.

Epinephrine Injection, USP is a parenteral adrenergic (sympathomimetic) agent and cardiac stimulant.

The drug belongs to the group of endogenous compounds known as catecholamines.

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Epinephrine, USP is chemically designated 4-[1-hydroxy-2-(methylamino) ethyl]-1, 2 benzenediol, a white, microcrystalline powder. With acids, it forms salts that are freely soluble in water. Epinephrine has the following structural formula:

The solution should be protected from light. Do not use the injection if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Do not administer unless solution is clear and seal is intact.

Discard unused portion.

Although epinephrine can produce ventricular fibrillation, its actions in restoring electrical activity in asystole and in enhancing defibrillation of the fibrillating ventricle are well documented. The drug, however, should be used with caution in patients with ventricular fibrillation.

In patients with prefibrillatory rhythm, intravenous epinephrine must be used judiciously with extreme caution because of its excitatory action on the heart. Since the myocardium is sensitized to this action of the drug by many anesthetic agents, epinephrine may convert asystole to ventricular fibrillation if used in the treatment of anesthetic cardiac accidents.

Epinephrine should be used cautiously in patients with hyperthyroidism, hypertension and cardiac arrhythmias. All vasopressors should be used cautiously in patients taking monoamine oxidase (MAO) inhibitors.

Epinephrine should not be administered concomitantly with other sympathomimetic drugs (such as isoproterenol) because of possible additive effects and increased toxicity. Combined effects may induce serious cardiac arrhythmias. They may be administered alternately when the preceding effect of other such drug has subsided.

Administration of epinephrine to patients receiving cyclopropane or halogenated hydrocarbon general anesthetics such as halothane which sensitize the myocardium, may induce cardiac arrhythmia. (See CONTRAINDICATIONS). When encountered, such arrhythmias may respond to administration of a beta-adrenergic blocking drug. Epinephrine also should be used cautiously with other drugs (e.g., digitalis, glycosides) that sensitize the myocardium to the actions of sympathomimetic drugs.

Diuretic agents may decrease vascular response to pressor drugs such as epinephrine.

Epinephrine may antagonize the neuron blockade produced by guanethidine resulting in decreased antihypertensive effect and requiring increased dosage of the latter.

Pregnancy Category C. Animal reproduction studies have not been conducted with epinephrine. It is also not known whether epinephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Epinephrine should be given to a pregnant woman only if clearly needed.

Labor and Delivery. Parenteral administration of epinephrine if used to support blood pressure during low or other spinal anesthesia for delivery can cause acceleration of fetal heart rate and should not be used in obstetrics when maternal blood pressure exceeds 130/80. (See CONTRAINDICATIONS).

Transient and minor side effects of anxiety, headache, fear and palpitations occur with systemic therapeutic doses, especially in hyperthyroid individuals. Adverse effects such as cardiac arrhythmias and excessive rise in blood pressure may also occur with therapeutic doses or inadvertent overdosage. Other adverse reactions include cerebral hemorrhage, hemiplegia, subarachnoid hemorrhage, anginal pain in patients with angina pectoris, anxiety, restlessness, throbbing headache, tremor, weakness, dizziness, pallor and respiratory difficulty.

This medication is used in emergencies to treat very serious allergic reactions to insect stings/bites, foods, drugs, or other substances. Epinephrine acts quickly to improve breathing, stimulate the heart, raise a dropping blood pressure, reverse hives, and reduce swelling of the face, lips, and throat.

How to use Epinephrine Auto-Injector

Keep this product near you at all times. (See also Storage section).

Different brands of this medication have different directions for preparing and using the injector. Learn how to properly inject this medication in advance so you will be prepared when you actually need to use it. Also teach a family member or caregiver what to do if you cannot inject the medication yourself. For children, make sure to hold their leg in place before and during the injection of the medication to prevent injuries from occurring. Read the Patient Information Leaflet provided by your pharmacist before you have to use epinephrine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

The effects of this medication are rapid but not long-lasting. After injecting epinephrine, get medical help right away. Tell the healthcare professional that you have given yourself an injection of epinephrine. Avoid injecting this medication into your hands, feet, buttocks, or areas of your body other than the thigh. If this occurs, tell the healthcare professional right away. Discard the injector properly.

The solution in this product should be clear. Check this product visually for particles or discoloration from time to time. If it has turned cloudy or pink/brown in color, do not use the product. Obtain a new supply.

Fast/pounding heartbeat, nervousness, sweating, nausea, vomiting, trouble breathing, headache, dizziness, anxiety, shakiness, or pale skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: irregular heartbeat, signs of infection at the injection site (such as redness that doesn't go away, warmth, swelling, or pain).

Get medical help right away if you have any very serious side effects, including: chest pain, fainting, vision changes, seizures, confusion.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.