Epipen

Anaphylaxis is a life-threatening reaction and requires immediate medical attention. Check with your doctor right away, or go to an emergency room as soon as possible, even if you feel better after using this medicine.

Tell your doctor if you develop symptoms of an infection (such as redness that does not go away, swelling, warmth, or tenderness) at the injection site.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Do not inject this medicine into your buttocks. Epinephrine may not work as well and may cause gas gangrene. Check with your doctor or go to the hospital emergency room right away to get additional treatment.

Do not inject this medicine into your hands or feet. There is already less blood flow to the hands and feet, and epinephrine could make that worse and cause damage to these tissues. If you accidentally inject epinephrine into your hands or feet, check with your doctor or go to the hospital emergency room right away.

This medicine may worsen the condition of patients with heart disease or heart rhythm problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or weight gain. You might also feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• If you have an allergy to epinephrine or any other part of EpiPen (epinephrine auto-injector and prefilled syringe).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This is not a list of all drugs or health problems that interact with this medicine.

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 EpiPen with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about EpiPen, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about EpiPen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using EpiPen.

Review Date: October 4, 2017

 Emergency Treatment

EpiPen and EpiPen Jr are intended for immediate administration as emergency supportive therapy and are not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Indications and Usage (1), Dosage and Administration (2) and Patient Counseling Information (17)].

 Injection-Related Complications

EpiPen and EpiPen Jr should only be injected into the anterolateral aspect of the thigh [see Dosage and Administration (2) and Patient Counseling Information (17)].

• Do not inject intravenously. Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to sharp rise in blood pressure. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration. • Do not inject into buttock. Injection into the buttock may not provide effective treatment of anaphylaxis. Advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis. Additionally, injection into the buttock has been associated with Clostridial infections (gas gangrene). Cleansing with alcohol does not kill bacterial spores, and therefore, does not lower this risk. • Do not inject into digits, hands or feet. Since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area. Advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection. Treatment of such inadvertent administration should consist of vasodilation, in addition to further appropriate treatment of anaphylaxis [see Adverse Reactions (6)]. • Hold leg firmly during injection. Lacerations, bent needles, and embedded needles have been reported when EpiPen and EpiPen Jr have been injected into the thigh of young children who are uncooperative and kick or move during an injection. To minimize the risk of injection related injury when administering EpiPen to young children, instruct caregivers to hold the child’s leg firmly in place and limit movement prior to and during injection.

Serious Infections at the Injection Site

Rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene), have been reported at the injection site following epinephrine injection for anaphylaxis. Clostridium spores can be present on the skin and introduced into the deep tissue with subcutaneous or intramuscular injection. While cleansing with alcohol may reduce presence of bacteria on the skin, alcohol cleansing does not kill Clostridium spores. To decrease the risk of Clostridium infection, do not inject EpiPen into the buttock [see Warnings and Precautions (5.2)]. Advise patients to seek medical care if they develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness, at the epinephrine injection site.

 Allergic Reactions Associated with Sulfite

The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.

Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium metabisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons.

The alternatives to using epinephrine in a life-threatening situation may not be satisfactory.

 Disease Interactions

Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, and/or any other person who might be in a position to administer EpiPen or EpiPen Jr to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used.

• Patients with Heart Disease

Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery or organic heart disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias [see Drug Interactions (7) and Adverse Reactions (6)].

• Other Patients and Diseases

Epinephrine should be administered with caution to patients with hyperthyroidism, diabetes, elderly individuals, and pregnant women. Patients with Parkinson’s disease may notice a temporary worsening of symptoms.

EpiPen is an injection containing epinephrine, a chemical that narrows blood vessels and opens airways in the lungs. These effects can reverse severe low blood pressure, wheezing, severe skin itching, hives, and other symptoms of an allergic reaction.

EpiPen is used to treat severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens. Epinephrine is also used to treat exercise-induced anaphylaxis.

Epinephrine auto-injectors such as EpiPen and EpiPen Jr. may be kept on hand for self-injection by a person with a history of an severe allergic reaction.

EpiPen may also be used for purposes not listed in this medication guide.

EpiPen is used to treat severe allergic reactions (anaphylaxis).

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

Before using EpiPen a second time, tell your doctor if your first injection caused a serious side effect such as increased breathing difficulty, or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Before using EpiPen a second time, call your doctor if your first injection caused a side effect such as increased breathing difficulty, or dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Call your doctor at once if you notice pain, swelling, warmth, redness, or other signs of infection around the area where you gave an injection.

Common EpiPen side effects may include:

• sweating;

• nausea and vomiting;

• pale skin;

• feeling short of breath;

• dizziness;

• weakness or tremors;

• headache; or

• feeling nervous or anxious.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to epinephrine: injection injectable, injection solution

Along with its needed effects, epinephrine (the active ingredient contained in EpiPen) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking epinephrine:

Incidence not known

• Abnormal or decreased touch sensation
• anxiety
• arm, back, or jaw pain
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• cold, pale, or bluish color of the skin of the fingers or toes
• dizziness
• fainting
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• fear or nervousness
• headache
• nausea or vomiting
• numbness, tingling, or pain in the fingers
• paleness of the skin
• pounding in the ears
• restlessness
• shakiness in the legs, arms, hands, or feet
• stroke
• sweating
• trembling or shaking of the hands or feet
• troubled breathing
• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur while taking epinephrine:

Symptoms of overdose

• Agitation
• coldness of the skin
• coma
• confusion
• decreased awareness or responsiveness
• decreased urine output
• depression
• drowsiness
• hostility
• irritability
• lightheadedness, dizziness, fainting
• muscle twitching
• rapid weight gain
• rapid, deep breathing
• seizures
• severe sleepiness
• stomach cramps
• swelling of the face, ankles, or hands
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Applies to epinephrine: compounding powder, inhalation aerosol, inhalation solution, injectable kit, injectable solution, intravenous solution, subcutaneous suspension

General

Due to the lack of randomized, controlled clinical trials for the treatment of anaphylaxis, the true incidence of adverse reactions associated with the systemic use of this drug is difficult to determine. The most commonly reported adverse reactions include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.[Ref]

Cardiovascular

Frequency not reported: Tachycardia, supraventricular tachycardia, ventricular arrhythmias, myocardial ischemia, myocardial infarction, limb/peripheral ischemia, palpitations, angina, arrhythmias, hypertension, vasoconstriction, ventricular ectopy, ventricular fibrillation, cold extremities, electrocardiogram changes, stress cardiomyopathy[Ref]

Nervous system

Frequency not reported: Headache, paresthesia, tremor, stroke, central nervous system bleeding, dizziness, cerebral hemorrhage, memory impaired, lightheadedness, psychomotor agitation, tingling, Parkinsonism aggravated, syncope, convulsions, subarachnoid hemorrhage, hemiplegia[Ref]

Psychiatric

Frequency not reported: Nervousness, excitability, anxiety, apprehension, restlessness, disorientation, panic, hallucinations, psychosis, fear, sleeplessness/insomnia, tenseness, confusion, irritability[Ref]

Local

Frequency not reported: Extravasation, injection site pallor, coldness at injection site, hypoesthesia at injection site, injury at injection site, local ischemic necrosis[Ref]

Dermatologic

Frequency not reported: Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation, necrotizing fasciitis, flushing/redness of skin and face, hyperhidrosis[Ref]

Metabolic

Frequency not reported: Hypoglycemia, hyperglycemia, insulin resistance, hypokalemia, lactic acidosis, insulin secretion inhibited, metabolic acidosis, anorexia[Ref]

Respiratory

Frequency not reported: Pulmonary edema, rales, respiratory difficulty, dyspnea, bronchospasm, hypoxia of mucosa[Ref]

Renal

Frequency not reported: Renal insufficiency[Ref]

Hypersensitivity

Hypersensitivity side effects have been extremely unusual. Contact dermatitis has been associated with ocularly applied epinephrine (the active ingredient contained in EpiPen) These reactions have typically presented with lid edema and a thick yellow discharge.

Gastrointestinal

Frequency not reported: Nausea, vomiting, bowel necrosis, hypersalivation[Ref]

Genitourinary

Frequency not reported: Urinary retention, difficult micturition[Ref]

Hematologic

Frequency not reported: Thrombocytosis[Ref]

Musculoskeletal

Frequency not reported: Myonecrosis[Ref]

Other

Frequency not reported: Chest pain, weakness, gas gangrene, asthenia[Ref]

Ocular

Frequency not reported: Corneal endothelial damage[Ref]

Endocrine

Frequency not reported: Growth hormone secretion stimulated[Ref]

Some side effects of EpiPen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.