Symjepi

SYMJEPI- epinephrine injection, solution
USWM, LLC

1 INDICATIONS AND USAGE

SYMJEPI is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitoes), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis.

SYMJEPI is intended for immediate administration in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.

Anaphylactic reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing, dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.

SYMJEPI is intended for immediate administration as emergency supportive therapy only and is not a substitute for immediate medical care.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage According to Patient Body Weight

• Patients greater than or equal to 30 kg (approximately 66 pounds or more): 0.3 mg
• Patients 15 kg to 30 kg (33 pounds to 66 pounds): 0.15 mg.

2.2 Administration Instructions

• Inject the single-dose SYMJEPI intramuscularly or subcutaneously into the anterolateral aspect of the thigh with the needle facing downwards. It can be injected through clothing if necessary. Do not inject intravenously, and do not inject into buttocks, into digits, hands and feet [see Warnings and Precautions (5.2)].
• Instruct caregivers of young children who are prescribed SYMJEPI and who may be uncooperative and kick or move during an injection to hold the leg firmly in place and limit movement prior to and during an injection [see Warnings and Precautions (5.2)].
• Each SYMJEPI is a single dose of epinephrine injection for single use. Since the doses of epinephrine delivered from SYMJEPI are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary.
• With severe persistent anaphylaxis, repeat injections with an additional SYMJEPI may be necessary. More than two sequential doses of epinephrine should only be administered under direct medical supervision [see Warnings and Precautions (5.1)].
• Ensure that the patient or caregiver is instructed and understands the indications and use of this product. A health care provider should review the patient instructions for SYMJEPI, in detail, with the patient or caregiver. Patients and/or any other person who might be in a position to administer an epinephrine injection should be advised of the proper site for injection and given appropriate instructions about imbedding the needle before transferring the thumb to the syringe plunger [see Instructions for Use].
• The epinephrine solution in the syringe should be inspected visually for particulate matter and discoloration.

3 DOSAGE FORMS AND STRENGTHS

• Injection: 0.3 mg (0.3 mg/0.3 mL), clear and colorless solution in single-dose, pre-filled syringe for manual injection
• Injection: 0.15 mg (0.15 mg/0.3 mL), clear and colorless solution in single-dose, pre-filled syringe for manual injection

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Emergency Treatment

SYMJEPI is intended for immediate administration as emergency supportive therapy and is 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), Patient Counseling Information (17)].

5.2 Injection-related Complications

SYMJEPI should only be injected into the anterolateral aspect of the thigh [see Dosage and Administration (2.2), 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 gas gangrene. Cleansing with alcohol does not kill bacterial spores and therefore, does not lower the 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

To minimize the risk of injection related injury when administering SYMJEPI to young children, hold child’s leg firmly in place and limit movement prior to and during injection.

5.3 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 SYMJEPI 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.

5.4 Allergic Reactions Associated with Sulfite

The presence of a sulfite in this product should not deter administration of the drug for the 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.

5.5 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 SYMJEPI 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), 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.