Description

EVZIO (naloxone hydrochloride injection, USP) is a pre-filled, single-use auto-injector. EVZIO is not made with natural rubber latex. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride with the following structure:

Naloxone hydrochloride occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkali; slightly soluble in alcohol; practically insoluble in ether and in chloroform.

Each 0.4 mL of EVZIO contains 2 mg naloxone hydrochloride, 3.34 mg of sodium chloride, hydrochloric acid to adjust pH, and water for injection. The pH range is 3.0 to 4.5.

 Mechanism of Action

Naloxone hydrochloride is an opioid antagonist that antagonizes opioid effects by competing for the same receptor sites.

Naloxone hydrochloride reverses the effects of opioids, including respiratory depression, sedation, and hypotension. Also, it can reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.

Before taking Evzio, tell your doctor:

• If you are allergic to Evzio; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Evzio with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Evzio?

• Tell all of your health care providers that you take Evzio. This includes your doctors, nurses, pharmacists, and dentists.
• If you are addicted to pain drugs and are given Evzio, you may have signs of withdrawal. Talk with your doctor.
• In infants younger than 4 weeks old who have been getting opioid drugs on a regular basis, sudden withdrawal may be life-threatening if not treated right away. Get medical help right away if your child has a seizure, is crying more than normal, or has increased reflexes.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• If Evzio is used during pregnancy, it may cause withdrawal in the unborn baby. A doctor will need to check on the unborn baby after Evzio is used.

How is Evzio best taken?

Use Evzio as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle or into the fatty part of the skin.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Be sure you know how to use before an emergency happens. Read the package insert and instructions for use that come with Evzio. If you have any questions about how to use Evzio, talk with the doctor or pharmacist.
• Someone else may have to give Evzio. Be sure others know where Evzio is stored and how to give it if needed.
• Jab straight into the outer thigh as you have been told. This medicine may be given through clothes if needed. Inject and hold for as long as you were told.
• Do not use Evzio if the solution changes color, is cloudy, or has particles. Get a new one.
• Each auto-injector has only 1 dose. If another dose is needed, you will need to use a second auto-injector.
• After using Evzio, overdose symptoms may go away and come back. It is important to get medical help right away after using Evzio.
• Do not use if Evzio is out of date. Get a new one.

What do I do if I miss a dose?

• Get medical help right away.

What are the side effects of Evzio that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Seizures.
• Shortness of breath.
• Chest pain or pressure.
• Fast or abnormal heartbeat.
• A burning, numbness, or tingling feeling that is not normal.
• Feeling agitated.
• Mood changes.
• Hallucinations (seeing or hearing things that are not there).
• Shakiness.
• Sweating a lot.

What are some other side effects of Evzio?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Dizziness.
• Irritation where the shot is given.
• Hot flashes.
• Flushing.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Evzio?

• Store at room temperature. Do not freeze.
• Store in the case you were given.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL -CARTON LABEL