Symjepi

Symjepi is a prescription medication used along with emergency medical treatment to treat life-threatening allergic reactions caused by insect bites or stings, foods, medications, latex, and other causes. Symjepi belongs to the class of medications called alpha- and beta-adrenergic agonists (sympathomimetic agents). These work by relaxing the muscles in the airways and by narrowing the blood vessels.

This medication comes in a single dose (one time) pre-filled automatic injection device containing a solution (liquid) to inject intramuscularly (into a muscle) or subcutaneously (under the skin).

Common side effects of Symjepi include swelling, warmth, or tenderness at the site of injection, anxiety, and restlessness.

Symjepi is a prescription medication indicated in the emergency treatment of allergic reactions including anaphylaxis (a severe, potentially life-threatening allergic reaction) in people who weigh 66 pounds (30 kg) or more and are at risk for or have a history of serious allergic emergencies.

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

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Symjepi. See the “Symjepi Precautions” section.

Common side effects of Symjepi include the following:

• skin redness, swelling, warmth, or tenderness at the site of injection
• fast, irregular or “pounding” heartbeat
• sweating
• headache
• weakness
• shakiness
• paleness
• feelings of over-excitement, nervousness or anxiety
• dizziness
• nausea and vomiting
• breathing problems

This is not a complete list of Symjepi side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• monoamine oxidase inhibitors such as
  • isocarboxazid (Marplan)
  • phenelzine (Nardil)
  • tranylcypromine (Parnate)
  • selegiline (Emsam, Eldepryl, Zelapar)
  • rasagiline (Azilect)
• levothyroxine sodium (Synthroid)
• some antihistamines such as chlorpheniramine (Aller-chlor), tripelennamine (Vaginex), and diphenhydramine (Benadryl)
• beta-adrenergic blocking drugs such as propranolol (Inderal)
• alpha-adrenergic blocking drugs such as phentolamine (Regitine)
• ergot alkaloids such as bromocriptine (Parlodel)

This is not a complete list of Symjepi drug interactions. Ask your doctor or pharmacist for more information.

Symjepi is used as emergency supportive therapy and is not intended as a substitute for immediate medical care. Seek immediate medical or hospital care when using Symjepi. More than two consecutive doses of Symjepi should only be given under direct medical supervision. 

Serious side effects have been reported with Symjepi including the following: 

• Injection-related problems. Symjepi should only be injected into the middle of the outer thigh. Hold the leg firmly during injection and limit movement prior to it to minimize the risk of injection-related injury.
  • Do not inject intravenously (into a vein). When injected into a vein, epinephrine may cause cerebral hemorrhage (stroke) due to a sharp rise in blood pressure.
  • Do not inject into the buttock. Injection into buttock may not provide effective treatment of anaphylaxis. Also, it might cause gas gangrene (bacterial infection).
  • Do not inject into digits, hands or feet. Injection into the digits, hands or feet may result in loss of blood flow to that area.
• Serious infections at the injection site. Symjepi injections may cause serious skin and soft tissue infections, including necrotizing fasciitis and gas gangrene. Do not inject Symjepi into buttock as it increases the risk of serious skin and soft tissue infections. Seek medical care if you develop signs or symptoms of infection, such as persistent redness, warmth, swelling, or tenderness.
• Allergic reactions associated with sulfite. Metabisulfite is one of the ingredients of Symjepi and can cause serious allergy or other emergency situation when given to sulfite-sensitive patients. 
• Disease interactions. Symjepi should be administered with caution to patients with
  • heart disease including cardiac arrhythmias (heart rhythm abnormalities), coronary artery disease (damage of heart's major blood vessels), and/or high blood pressure. 
  • hyperthyroidism (high thyroid hormone levels)
  • diabetes (high blood sugar levels)
  • parkinson's disease (a disorder of nervous system that causes movement problems)
• Symjepi should be administered with caution to elderly and pregnant patients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Symjepi there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Symjepi, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Symjepi or to any of its ingredients
• have heart problems or high blood pressure
• have diabetes
• have thyroid problems
• have asthma
• have a history of depression
• have Parkinson’s disease
• are pregnant or plan to become pregnant. It is not known if Symjepi will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Symjepi passes into your breast milk.

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

Tell your doctor if you are pregnant or plan to become pregnant. 

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known if Symjepi crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Symjepi.

Take Symjepi exactly as prescribed. 

This medication comes in a single-dose (one time) pre-filled automatic injection device containing a solution (liquid) to inject subcutaneously (under the skin).

The Sympeji prefilled syringe (0.3 mg) is for patients who weigh 66 pounds or more (30 kilograms or more).

Inject Symjepi intramuscularly (into a muscle) or subcutaneously (under the skin)  into the middle of the outer thigh with the needle facing downwards. It can be injected through clothing if necessary.

Inspect Symjepi solution in the syringe for particulate matter (particles) and discoloration before use.

Before you need to use your syringe 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 Symjepi should also understand how to use it. If you have questions, ask your healthcare provider.

Use this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Symjepi is 0.3mg (0.3mL) as a single dose injected intramuscularly (into a muscle) or subcutaneously (under the skin) into the middle of the outer thigh.

More than two consecutive doses of Symjepi should only be administered under direct medical supervision.

It is unlikely to experience overdose with a single use of Symjepi. However, if an overdose is suspected, seek emergency medical attention.

• Store Symjepi at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect from light.
• Do not expose to extreme cold or heat. For example, do not store in your vehicle’s glove box and do not store in the refrigerator or freezer.
• Examine the contents in the clear window of your prefilled syringe periodically. The solution should be clear. If the solution is discolored (pinkish or brown color), is cloudy, or contains solid particles, replace the unit.
• Always keep your Symjepi prefilled syringe in the carrier case to protect it from damage. The carrier case is not waterproof.
• The needle cap helps to prevent accidental injection. Do not remove the needle cap until you need to use Symjepi.
• Your Symjepi has an expiration date. Replace it before the expiration date.