Adrenaclick

Due to the lack of randomized, controlled clinical trials of epinephrine for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of epinephrine is difficult to determine. Adverse reactions reported in observational trials, case reports, and studies are listed below.

Common adverse reactions to systemically administered epinephrine include anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache, and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism [see WARNINGS AND PRECAUTIONS].

Arrhythmias, including fatal ventricular fibrillation, have been reported, particularly in patients with underlying cardiac disease or those receiving certain drugs [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease [see WARNINGS AND PRECAUTIONS].

Angina may occur in patients with coronary artery disease [see WARNINGS AND PRECAUTIONS].

Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area [see WARNINGS AND PRECAUTIONS].

Adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.

Lacerations, bent needles, and embedded needles have been reported when Adrenaclick has been injected into the thigh of young children who are uncooperative and kick or move during an injection [see WARNINGS AND PRECAUTIONS].

Injection into the buttock has resulted in cases of gas gangrene [see WARNINGS AND PRECAUTIONS].

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported following epinephrine injection in the thigh [see WARNINGS AND PRECAUTIONS].

In the U.S.

• Adrenaclick
• Adrenalin
• Adrenalin Chloride
• Auvi-Q
• Epipen
• Epipen Jr
• Symjepi
• Twinject

Available Dosage Forms:

• Injectable
• Solution

Therapeutic Class: Anaphylaxis Agent

Pharmacologic Class: Adrenergic

Chemical Class: Alkylarylamine

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.

This medicine is available only with your doctor's prescription.

• Injection, 0.3 mg/0.3 mL epinephrine injection, USP, pre-filled auto-injector
• Injection, 0.15 mg/0.15 mL epinephrine injection, USP, pre-filled auto-injector

Pregnancy

Teratogenic Effects: Pregnancy Category C.

There are no adequate and well controlled studies of the acute effect of epinephrine in pregnant women.

Epinephrine was teratogenic in rabbits, mice and hamsters. Epinephrine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus (fetal anoxia, spontaneous abortion, or both).

Epinephrine has been shown to have teratogenic effects when administered subcutaneously in rabbits at approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal dose of 1.2 mg/kg/day for two to three days), in mice at approximately 7 times the maximum daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal subcutaneous dose of 1 mg/kg/day for 10 days), and in hamsters at approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day for 4 days).

These effects were not seen in mice at approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days).

Nursing Mothers

It is not known whether epinephrine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Adrenaclick is administered to a nursing woman.

Pediatric Use

Adrenaclick may be administered to pediatric patients at a dosage appropriate to body weight [see Dosage and Administration (2)]. Clinical experience with the use of epinephrine suggests that the adverse reactions seen in children are similar in nature and extent to those both expected and reported in adults. Since the dose of epinephrine delivered from Adrenaclick is fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.

Geriatric Use

Clinical studies for the treatment of anaphylaxis have not been performed in subjects aged 65 and over to determine whether they respond differently from younger subjects. However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. Therefore, Adrenaclick should be administered with caution in elderly individuals, who may be at greater risk for developing adverse reactions after epinephrine administration [see Warnings and Precautions (5.5 ) and Overdosage (10)].

Adrenaclick® (a-dren-a-click)

(epinephrine injection, USP) Auto-Injector

For allergic emergencies (anaphylaxis)

Read these Instructions for Use carefully before you use Adrenaclick. Before you need to use your Adrenaclick, make sure your healthcare provider shows you the right way to use it. Parents, caregivers, and others who may be in a position to administer Adrenaclick auto-injector should also understand how to use it well. If you have any questions, ask your healthcare provider.

Your Adrenaclick auto-injector

STEP 1. Prepare Adrenaclick for injection

• Remove Adrenaclick from its protective carrying case.
• Pull off blue end caps; you will now see a red tip. Grasp the auto-injector in your fist with the red tip pointing downward. See Figure A.

Note:

• The needle comes out of the red tip.
• To avoid an accidental injection, never put your thumb, fingers, or hand over the red tip. If an accidental injection happens, get medical help right away.

Figure A

STEP 2. Administer Adrenaclick

• If you are administering Adrenaclick to a young child, hold the leg firmly in place and limit movement prior to and while administering an injection.
• Put the red tip against the middle of the outer thigh (upper leg) at a 90° angle (perpendicular) to the thigh.
• Press down hard and hold firmly against the thigh for approximately 10 seconds to deliver the medicine. See Figure B.

• Only inject into the middle of the outer thigh. Do not inject into any other part of the body.
• Remove Adrenaclick from the thigh.
• Massage the area for 10 seconds.
• Check the red tip. The injection is complete and you have received the correct dose of the medicine if you see the needle sticking out of the red tip. If you do not see the needle repeat Step 2.

STEP 3. Get emergency medical help right away. You may need further medical attention. You may need to use a second Adrenaclick auto-injector if symptoms continue or recur.

STEP 4. After use / Disposal

Carefully cover the needle with the carrying case.

• Lay the labeled half of the carrying case cover down on a flat surface. Use one hand to carefully slide the end of the auto-injector, needle first, into the labeled carrying case cover. See Figure C.

Figure C

• After the needle is inside the labeled cover, push the unlabeled half of the carrying case cover firmly over the non-needle end of the auto-injector. See Figure D.

Figure D

• Take your used Adrenaclick auto-injector with you when you go to see a healthcare provider.
• Tell the healthcare provider that you have received an injection of epinephrine. Show the healthcare provider where you received the injection.
• Give your used Adrenaclick auto-injector to the healthcare provider for inspection and proper disposal.
• Ask for a refill, if needed.

Note:

• Adrenaclick is a single-use injectable device that delivers a fixed dose of epinephrine. The auto-injector cannot be reused. Do not attempt to reuse Adrenaclick after the device has been activated. It is normal for most of the medicine to remain in the auto-injector after the dose is injected. The correct dose has been administered if you see the needle sticking out of the red tip.
• A separate Adrenaclick Trainer is available. The Adrenaclick Trainer has a beige color. The beige Adrenaclick Trainer contains no medicine and no needle. Practice with your Adrenaclick Trainer, but always carry your real Adrenaclick auto-injector in case of an allergic emergency.
• If you will be administering Adrenaclick to a young child, ask your healthcare provider to show you how to properly hold the leg in place while administering a dose.
• Do not try to take the Adrenaclick auto-injector apart.

For more information and video instructions on the use of Adrenaclick, go to www.Adrenaclick.com or call 1-888-894-6528.

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

05/2016

© 2014 Amedra Pharmaceuticals LLC, Horsham, PA. All rights reserved.

Manufactured for and Distributed by:
Amedra Pharmaceuticals LLC
Horsham, PA 19044

51007-07

PRINCIPAL DISPLAY PANEL - 0.15 mg CASE LABEL

TWIST OPPOSITE SIDE AND PULL TO OPEN

Adrenaclick®
(epinephrine injection, USP) auto-injector
0.15 mg

PRINCIPAL DISPLAY PANEL - 0.15 mg WRAP LABEL
Amedra Pharmaceuticals
Adrenaclick® (epinephrine injection, USP) auto-injector
0.15 mg

PRINCIPAL DISPLAY PANEL - 0.15 mg CARTON

Rx Only

Contains TWO Adrenaclick® 0.15 mg Auto-Injectors

Two-Pack
NDC 52054-803-02

Adrenaclick®
(epinephrine injection, USP) auto-injector
0.15 mg

For Subcutaneous or
Intramuscular Use Only

For Allergic Emergencies (Anaphylaxis)

Distributed by:
Amedra Pharmaceuticals LLC
Horsham, PA 19044

PRINCIPAL DISPLAY PANEL - 0.3 mg CASE LABEL

TWIST OPPOSITE SIDE AND PULL TO OPEN

Adrenaclick®
(epinephrine injection, USP) auto-injector
0.3 mg

PRINCIPAL DISPLAY PANEL - 0.3 mg WRAP LABEL
Amedra Pharmaceuticals
Adrenaclick® (epinephrine injection, USP) auto-injector
0.3 mg

Wrap Label

PRINCIPAL DISPLAY PANEL - 0.3 mg CARTON

Rx Only

Contains TWO Adrenaclick® 0.3 mg Auto-Injectors

Two-Pack
NDC 52054-804-02

Adrenaclick®
(epinephrine injection, USP) auto-injector
0.3 mg

For Subcutaneous or
Intramuscular Use Only

For Allergic Emergencies (Anaphylaxis)

Distributed by:
Amedra Pharmaceuticals LLC
Horsham, PA 19044

Frequency Not Defined

Angina

Anxiety

Apprehensiveness

Cardiac arrhythmias

Dizziness

Dyspnea

Flushing

Headache

Hypertension

Nausea

Nervousness

Pallor

Palpitations

Respiratory difficulties

Restlessness

Stress cardiomyopathy

Sweating

Tachycardia

Tremor

Vasoconstriction

Vomiting

Weakness

Postmarketing Reports

Necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene)

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

High IV doses may reduce milk production and milk letdown. Studies in non-nursing subjects and women with hyperprolactinemia who received an IV infusion of this drug demonstrated decreased serum prolactin concentrations. Animal studies indicate that intra-arterial administration can decrease serum oxytocin and inhibit milk ejection. However, due to its poor oral bioavailability and short half-life, any amount of this drug present in milk is unlikely to affect the infant.

Caution is recommended; according to some experts, use is not recommended. Excreted into human milk: Yes Comments: The effects in the nursing infant are unknown.