Twinject (Injection)

Epinephrine injection is used for emergency treatment of severe allergic reactions (including anaphylaxis) caused by insect bites or stings, medicines, foods, or other substances. It is also used to treat anaphylaxis that is caused by unknown substances or triggered by exercise.

Epinephrine injection is also used to raise blood pressure in adult patients who have hypotension (low blood pressure) and septic shock.

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

Anaphylaxis is a severe reaction that can be life-threatening and needs immediate medical help. Contact your doctor right away, or go to the emergency room as soon as you can, even if you start to feel better after using this medicine.

Inform your doctor if you notice any signs of an infection (for example, redness that doesn’t go away, swelling, warmth, or tenderness) at the injection site.

This medicine may change your blood sugar levels. If you see a difference in your blood or urine sugar tests, or if you have any questions, talk to your doctor.

Do not inject this medicine into your buttocks. Epinephrine may not work as effectively and could lead to gas gangrene. Contact your doctor or go to the hospital emergency room immediately for further treatment.

Do not inject this medicine into your hands or feet. There is already less blood flow to these areas, and epinephrine could worsen this and cause tissue damage. If you accidentally inject epinephrine into your hands or feet, contact your doctor or go to the hospital emergency room right away.

This medicine may make conditions worse for patients with heart disease or heart rhythm issues. Contact your doctor immediately if you experience chest pain or tightness, reduced urine output, dilated neck veins, extreme tiredness, irregular heartbeat, swelling in the face, fingers, feet, or lower legs, trouble breathing, or weight gain. You might also feel dizzy or faint, or have a fast, pounding, or uneven heartbeat.

This medicine may cause pulmonary edema (fluid in the lungs). Contact your doctor immediately if you have chest pain, difficulty breathing, fast or noisy breathing, blue lips and fingernails, pale skin, increased sweating, coughing that sometimes produces pink frothy sputum, or swelling in the legs and ankles.

Contact your doctor right away if you notice bloody urine, a decrease in how often or how much urine you produce, higher blood pressure, increased thirst, loss of appetite, pain in your lower back or side, nausea, swelling in the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be signs of a serious kidney issue.

Do not take other medicines unless you have talked about them with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine versus the benefits it may provide. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare provider know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies so far have not shown any specific problems in children that would affect the use of epinephrine injection. However, safety and effectiveness have not been established for children weighing less than 15 kilograms (kg) using Symjepi™ or for children using Adrenalin® to treat low blood pressure due to septic shock.

Geriatric

Studies have not shown any specific problems in elderly patients that would affect the use of Auvi-Q® injection. However, older adults may be more likely to experience side effects, which could require caution when using this medicine.

Studies have not been conducted on how age affects the use of Adrenalin®, Epipen®, or Symjepi™ in elderly patients. However, older adults may be more sensitive to the effects of this medicine and more likely to have side effects, which could require caution.

There is no information available on how age affects the use of epinephrine injection in older patients. However, older adults are more likely to have age-related heart issues, which may require caution when using epinephrine injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together. In other cases, two different medicines may be used together, even if an interaction might happen. In those cases, your doctor may adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important for your healthcare provider to know if you are taking any of the following medicines. The interactions listed below have been chosen based on their potential significance and are not necessarily exhaustive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medicine or change some of the other medicines you take.

• Dihydroergotamine
• Isocarboxazid
• Linezolid
• Phenelzine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Benperidol
• Bromperidol
• Bucindolol
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dibenzepin
• Digoxin
• Dilevalol
• Dixyrazine
• Doxepin
• Droperidol
• Entacapone
• Ergonovine
• Fexofenadine
• Fluphenazine
• Furazolidone
• Haloperidol
• Halothane
• Imipramine
• Iobenguane I 123
• Iproniazid
• Levalbuterol
• Levobunolol
• Lofepramine
• Loxapine
• Melitracen
• Melperone
• Methdilazine
• Methotrimeprazine
• Methylene Blue
• Methylergonovine
• Metipranolol
• Metopimazine
• Milnacipran
• Moperone
• Nadolol
• Nialamide
• Nortriptyline
• Opicapone
• Opipramol
• Oxprenolol
• Penbutolol
• Perazine
• Periciazine
• Perphenazine
• Pindolol
• Pipamperone
• Piperazine
• Pipotiazine
• Practolol
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propiomazine
• Propranolol
• Protriptyline
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• Terfenadine
• Tertatolol
• Thiethylperazine
• Thioproperazine
• Thioridazine
• Tianeptine
• Timolol
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimipramine
• Zavegepant

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medicines might be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Labetalol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Angina pectoris (severe chest pain) or
• Asthma or
• Blood vessel problems or
• History of depression or
• Diabetes or
• Heart attack or
• Heart disease (e.g., cardiomyopathy, coronary artery disease, organic heart disease) or
• Heart rhythm problems (e.g., arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Kidney disease or
• Parkinson's disease—Use with caution. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you may need medical attention.

Check with your doctor right away if you have any of the following side effects:

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, tightness, heaviness, or discomfort
• cold, pale, or bluish color of the skin of the fingers or toes
• confusion
• difficulty in speaking
• dizziness
• double vision
• fainting
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• headache
• inability to move the arms, legs, or facial muscles
• inability to speak
• nausea
• numbness, tingling, or pain in the fingers
• paleness of the skin
• pounding in the ears
• restlessness
• shakiness in the legs, arms, hands, or feet
• slow speech
• sweating
• trembling or shaking of the hands or feet
• trouble breathing
• unusual tiredness or weakness
• vomiting

Get emergency help right away if you have any of the following symptoms of overdose:

Symptoms of overdose

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

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

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

Available Dosage Forms:

• Solution

Therapeutic Class: Anaphylaxis Agent

Pharmacologic Class: Sympathomimetic

Chemical Class: Alkylarylamine

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

A nurse or other trained health professional will give you this medicine in a medical facility to treat hypotension with septic shock. It is given through a needle placed into one of your veins.

If you are using this medicine at home, make sure you or any of your family members understand exactly how to give them. Also, tell your doctor if you or your caregiver has severe arthritis of the hands. If you have any questions about this, check with your doctor.

This medicine is injected under the skin or into the muscle of your outer thigh only. Do not inject this medicine into a vein, into the muscle of your buttocks, or into your fingers, toes, hands, or feet. To do so, may increase the chance of having serious side effects.

This medicine comes with patient information and instructions leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor or pharmacist if you have any questions.

This medicine comes in 3 forms:an autoinjector syringe and needle kit, a prefilled syringe, or a vial. This contains the correct dose of medicine your doctor has prescribed.

This medicine comes with an autoinjector trainer and a separate trainer instructions for use. Be sure to practice first with your autoinjector trainer before an allergy emergency happens to make sure you are ready to use the real Auvi-Q®, Adrenaclick®, EpiPen®, or EpiPen Jr® autoinjector in an actual emergency. The autoinjector trainer has a grey color (for Auvi-Q®, EpiPen® or EpiPen Jr®) or beige color (for Adrenaclick®) and does not contain any medicine or needle.

Inspect the autoinjector from time to time before needing it to ensure the blue safety release (EpiPen® or EpiPen Jr®) is not raised and that the autoinjector can be easily remove from the carrier tube.

Do not remove the blue safety release (EpiPen® or EpiPen Jr®), the gray end caps (Adrenaclick®), or the red safety guard (Auvi-Q®) on the autoinjector until you are ready to use it. Do not put your thumb, fingers, or hand over the black base (Auvi-Q®), orange (EpiPen® or EpiPen Jr®), or red (Adrenaclick®) tip of the autoinjector or over the needle of the Symjepi® prefilled syringe. This is to avoid an accidental injection.

If you are about to use the autoinjector, pull up straight the blue safety release (EpiPen® or EpiPen Jr®) with one hand and hold the pen with the other hand. Do not flip the blue safety release off using the thumb or by pulling it sideways, or by bending and twisting it. This may activate the device by accident (a "click is heard, the orange needle is extended, and the window is blocked), making it unusable in case of an emergency. Push the needle end (orange end of the autoinjector) firmly against the outer thigh until it "clicks". This signals that the injection has started. The autoinjector needs to stay in place for a minimum of 3 seconds following activation.

If you use the Symjepi™ prefilled syringe:

• Do not remove the needle cap until you are ready to use it.
• Slowly inject the syringe into the thigh while sitting down.
• Push the plunger all the way down until you hear a "clicking" sound. Hold it for 2 seconds.
• Remove the syringe and massage the area for 10 seconds.
• Call your medical provider right away after injection.
• You may inject the medicine through your clothing, if you need to.

You may need to use more than one injection if your allergic reaction does not get better after the first shot. If more than 2 injections are needed for 1 reaction, however, those should be given only under medical supervision.

If you are using the epinephrine injection in a child, make sure to hold his leg firmly in place and limit movement before and during an injection.

Carry this medicine with you at all times for emergency use in case you have a severe allergic reaction.

Check the injection kits regularly to make sure that the liquid has not changed its color. It should be clear and colorless. Do not use this medicine if the liquid has changed its color (pinkish or brown in color), has become cloudy, or if there are particles in it.

Do not reuse the remaining portion of the medicine that is left in the autoinjector, prefilled syringe, or vial. Throw away the autoinjector, prefilled syringe, or vial after you have used it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution):For allergic reactions: Adrenaclick®, Auvi-q®, Epipen®, Epipen Jr®, Twinject®: Adults and children weighing 30 kilograms (kg) or more—0.3 milligram (mg) injected under the skin or into the muscle of your thigh. Children weighing 15 to 30 kg—0.15 mg injected under the skin or into the muscle of your thigh. Children weighing 7.5 to 15 kg—0.1 mg injected under the skin or into the muscle of your thigh. Children weighing less than 7.5 kg—Use and dose must be determined by your doctor. Adrenalin®: Adults and children weighing 30 kilograms (kg) or more—0.3 to 0.5 milligram (mg) injected under the skin or into the muscle of your thigh. You may repeat the injection every 5 to 10 minutes as needed. Children weighing less than 30 kg—Dose is based on body weight and must be determined by your doctor. The dose is 0.01 mg per kg of body weight injected under the skin or into the muscle of your thigh. You may repeat the injection every 5 to 10 minutes as needed. However, the dose is usually not more than 0.3 mg per injection. Symjepi™: Adults and children weighing 30 kilograms (kg) or more—0.3 milligrams (mg) injected under the skin or into the muscle of your thigh. Children weighing 15 to 30 kg—0.15 mg injected under the skin or into the muscle of your thigh. Children weighing less than 15 kg—Use and dose must be determined by your doctor.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the injection kits at room temperature, away from heat, moisture, and direct light. Do not store the medicine in the refrigerator or freezer, or into your vehicle's glove box.

Keep the autoinjector or prefilled syringe in its carrier tube or case to protect from damage. However, this tube or case is not waterproof. If you accidentally drop it, check for damage or leakage.

Throw away expired, unwanted, or unused EpiPen® or EpiPen Jr® in an FDA-cleared sharps container. Do not throw it away in the trash bin.

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