Twinject

• Shionogi Inc.

• Verus Pharmaceuticals

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of epinephrine injection in children.

Geriatric

No information is available on the relationship of age to the effects of epinephrine injection in geriatric patients. However, elderly patients are more likely to have age-related heart disease which may require caution in patients receiving epinephrine injection.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amitriptyline
• Amoxapine
• Bucindolol
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Digoxin
• Dilevalol
• Dothiepin
• Doxepin
• Entacapone
• Halothane
• Imipramine
• Iobenguane I 123
• Levalbuterol
• Levobunolol
• Lofepramine
• Metipranolol
• Nadolol
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Pindolol
• Propranolol
• Protriptyline
• Rasagiline
• Sotalol
• Tertatolol
• Timolol
• Trimipramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Labetalol

Interactions with Food/Tobacco/Alcohol

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina pectoris (severe chest pain) or
• Asthma or
• Blood vessel problems or
• Depression, history of or
• Diabetes or
• Heart attack or
• Heart disease (eg, coronary artery disease, organic heart disease) or
• Heart rhythm problems (eg, arrhythmia) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Parkinson's disease—Use with caution. May make these conditions worse.

Along with its needed effects, a medicine 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:

• 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:

• 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

Other side effects not listed may also occur 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.

• If you have an allergy to epinephrine or any other part of Twinject (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 Twinject with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not give into the fingers, hands, or feet. Doing so may lead to lower blood flow in these areas. If Twinject is given on accident, get medical help right away.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Twinject while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Shortness of breath.
• Feeling very tired or weak.
• Rarely, infections have happened where this medicine was given. Sometimes, these infections can be very bad. Call your doctor right away if you have signs of an infection like redness that does not go away, warmth, swelling, or tenderness.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Nervous and excitable.
• Shakiness.
• Upset stomach or throwing up.
• Anxiety.
• Restlessness.
• Feeling tired or weak.
• Sweating a lot.
• Pale skin.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• 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 Twinject, 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 Twinject. 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 Twinject.

Review Date: October 4, 2017

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