Mylan Specialty

Mylan Specialty, a subsidiary of Mylan Inc. (NASDAQ: MYL), is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, life-threatening allergic reactions and psychiatric disorders.

EpiPen® (epinephrine) 2-Pak and EpiPen Jr® (epinephrine)
2-Pak

EpiPen® (epinephrine) 0.3 mg and EpiPen Jr® (epinephrine) 0.15 mg Auto-Injectors are for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise, or unknown triggers; and for people who are at increased risk for these reactions. EpiPen and EpiPen Jr are intended for immediate self administration as emergency supportive therapy only. Seek immediate emergency medical treatment after use.

Please see full Prescribing Information. 
Please see the full Patient Insert.


Important Safety Information
EpiPen Auto-Injectors contain a single dose of epinephrine, which you inject into your outer thigh. DO NOT INJECT INTO YOUR VEIN, BUTTOCK, FINGERS, TOES, HANDS OR FEET. In case of accidental injection, please seek immediate medical treatment. Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms.

Tell your doctor if you have certain medical conditions such as asthma, depression, thyroid disease, Parkinson’s disease, diabetes, high blood pressure and heart disease, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Be sure to also tell your doctor all the medicines you take, especially medicines for asthma. If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you take the EpiPen or EpiPen Jr Auto-Injector.

The most common side effects may include increase in heart rate, stronger or irregular heartbeat, sweating, nausea and vomiting, difficulty breathing, paleness, dizziness, weakness or shakiness, headache, apprehension, nervousness or anxiety. These side effects usually go away quickly, especially if you rest.

Talk to your healthcare professional to see if EpiPen or EpiPen Jr Auto-Injector is right for you.

Perforomist® (formoterol fumarate) Inhalation Solution

PERFOROMIST® (formoterol fumarate) Inhalation Solution is used for the long-term treatment of chronic obstructive pulmonary disease (COPD) including chronic inflammation of the lungs (bronchitis) and emphysema. It is only to be used with a jet nebulizer and is taken twice daily (morning and evening).

Important Limitations for Use:

  • PERFOROMIST should not be used as a rescue medication
  • PERFOROMIST is not indicated to treat asthma. The safety and effectiveness of PERFOROMIST Inhalation Solution in asthma has not been established.

Please see full Prescribing Information, including Boxed Warning and Medication Guide.

WARNING: ASTHMA-RELATED DEATH
PERFOROMIST Inhalation Solution belongs to a class of drugs called long-acting beta2-agonists (LABA). People with asthma who take LABA such as PERFOROMIST Inhalation Solution have an increased risk of death from asthma problems. Do not use PERFOROMIST Inhalation Solution if you have asthma without using a long-term asthma control medicine.


IMPORTANT SAFETY INFORMATION

Warnings and Precautions

PERFOROMIST Inhalation Solution should not be used instead of rescue inhaler or nebulized medicine for the treatment of acute symptoms. Extra doses of PERFOROMIST Inhalation Solution should not be used for that purpose since overuse can cause serious heart problems, including death. Acute or sudden symptoms should be treated with an inhaled short-acting beta2-agonist.

Seek immediate medical attention if:

  • your symptoms quickly worsen despite recommended doses of PERFOROMIST Inhalation Solution
  • PERFOROMIST Inhalation Solution treatment becomes less effective
  • you need more inhalations of a short-acting beta2-agonist (rescue inhaler or nebulized medicine) than usual.

Do not use PERFOROMIST Inhalation Solution with other LABA medicines for any reason.

Co-existing Conditions
The use of PERFOROMIST Inhalation Solution with certain health conditions or with certain medications can cause serious side effects. Tell your health care professional about all of your health conditions, including if you:

  • have heart problems
  • have high blood pressure
  • have diabetes
  • have seizures
  • have thyroid problems
  • have liver problems
  • are pregnant or planning to become pregnant. It is not known if PERFOROMIST Inhalation Solution can harm an unborn baby.
  • are breastfeeding. It is not known if PERFOROMIST Inhalation Solution passes into breast milk and if it can harm your baby.

Drug Interactions
It is important to inform your healthcare professional of all prescription or over the counter medications you are taking including: beta-blockers, some antidepressants (tricyclic and MAO inhibitors), steroids, diuretics, xanthine derivatives (e.g. theophylline), as well as vitamins and herbal supplements. PERFOROMIST Inhalation Solution and certain medicines may interact with each other and cause serious side effects.

Immediate allergic reactions may occur after taking PERFOROMIST Inhalation Solution, including anaphylactic reactions, hives, generalized swelling including the airway, rash, and bronchospasm.

Side Effects
The most common side effects reported in patients taking PERFOROMIST Inhalation Solution were diarrhea, nausea, nasopharyngitis, dry mouth, dizziness, and insomnia. Serious side effects may include sudden shortness of breath, serious allergic reactions, chest pain, increased or decreased blood pressure, a fast and irregular heartbeat, low blood potassium, high blood sugar, and high blood acid.

How to Use PERFOROMIST Inhalation Solution
Use PERFOROMIST Inhalation Solution exactly as directed by your health care professional. Do not stop using PERFOROMIST Inhalation Solution or other medicines to control or treat your COPD unless told to do so by your health care professional because your symptoms might get worse. Your health care professional will change your medicines as needed.

EMSAM® (selegiline transdermal system)

EMSAM® (selegiline transdermal system) is a skin patch used to treat major depressive disorder.

Please see full Prescribing Information, including Boxed Warning.

Please see Medication Guide.

Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, teens, and young adults. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. EMSAM is not approved for use in children under 18
.


IMPORTANT SAFETY INFORMATION

What is the most important information I should know about EMSAM?
  • Antidepressants may increase suicidal thoughts or actions in children, teenagers and young adults
  • Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is very important when an antidepressant is started or when the dose is changed
  • Call a healthcare provider right away to report any new or sudden changes in mood, behavior, thoughts, or feelings
  • EMSAM Transdermal System is not approved for use in patients under 18 years of age


Call a healthcare provider right away if you or someone you care for have any of the following symptoms, especially if they are new, worse, or worry you:
Thoughts about suicide or dying; attempts to commit suicide; new or worse depression, anxiety or irritability; feeling very agitated or restless; panic attacks; trouble sleeping; acting aggressive, being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood.
1. Do not eat or drink foods and beverages with high amounts of a substance called tyramine while on EMSAM 9 mg/24 hr or 12 mg/24 hr, and for 2 weeks after stopping these doses. Ask your healthcare professional or see the Medication Guide for a complete list of foods and drinks that must be avoided. EMSAM at any dose should not be used in children under 12 even when used with dietary modifications.
― Consuming tyramine-rich foods and beverages can lead to a sudden, large increase in blood pressure called "hypertensive crisis." This is a serious medical condition that may be life-threatening. Seek immediate medical care if you experience any of these symptoms: sudden severe headache, nausea, stiff neck, vomiting, a fast or slow heartbeat or a change in the way your heart beats (palpitations), tight chest pain, a lot of sweating, confusion, dilated pupils, and sensitivity to light
2. Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Tell all of your healthcare professionals that you are using EMSAM.
  • Due to the potential for serious and life-threatening side effects, do not use the following medicines while using EMSAM at any dose, and for 2 weeks after stopping EMSAM:
― Other medicines to treat depression (antidepressants) including other MAOI medicines; medicines which contain selegiline (such as Eldepryl®); St. John’s Wort; narcotic pain medicines that contain meperidine e.g., Demerol®; pain medicines tramadol, methadone, or propoxyphene; medicines containing carbamazepine e.g., Tegretol® a seizure medicine and oxcarbazepine, e.g., Trileptal® a seizure medicine; cold/ cough preparations, decongestants, over-the-counter diet pills or herbal weight-loss products containing pseudoephedrine, phenylephrine, phenylpropanolamine, dextromethorphan, or ephedrine; herbal or dietary supplements that contain tyramine; Flexeril® (cyclobenzaprine), a medicine used to treat muscle spasms; amphetamines (stimulants or “uppers”); and BuSpar® (buspirone), an anxiety medicine
Some of these medicines will have to be stopped for 1 week (or more) before you can start using EMSAM

What should I tell my doctor before starting EMSAM Transdermal System?
  • Tell your healthcare professional about any medical conditions, including if you:
    • Have or had manic episodes (a mental condition that causes "high" moods)
    • Have any heart problems
    • Have or had seizures (convulsions or "fits")
    • Tend to get dizzy or faint
    • Are planning to have surgery
    • Are or intend to become pregnant
    • Are breast-feeding


    What are the possible side effects of EMSAM Transdermal System?
    • EMSAM may worsen your depression, give you suicidal thoughts, or cause unusual changes in behavior. Call your healthcare professional right away if you feel worse with EMSAM
    • EMSAM may cause mania or hypomania in people who have a history of mania
    • EMSAM may cause low blood pressure. Lie down if you feel dizzy, faint, or lightheaded and change positions gradually
    • The most common side effect of EMSAM is a skin irritation where the patch is placed. Other common side effects with EMSAM include: headache, difficulty sleeping, diarrhea, dry mouth


    How should I use EMSAM Transdermal System?
    • Use EMSAM exactly as prescribed and do not stop or change treatment (even if you start to feel better) without talking to your health care professional
    • Use only one patch at a time and change the patch once a day (every 24 hours). If you use more than one EMSAM patch at a time, remove the patches right away and call your doctor or Poison Control at 1-800-222-1222
    General advice about EMSAM Transdermal System
    • Avoid exposing the EMSAM application site to direct heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight
    • Do not drive or operate hazardous
    • machinery until you know how EMSAM affects you as EMSAM can reduce your judgment, ability to think, or coordination. Avoid drinking alcohol while using EMSAM
    • Do not use EMSAM if you are allergic to anything in EMSAM. See the Medication Guide for a complete list of ingredients in EMSAM
    • If you have any questions about your health or medicines, talk to your health care professional

EpiPen®, EpiPen Jr®, EpiPen 2-Pak®, and EpiPen Jr 2-Pak® are registered trademarks of Mylan Inc. licensed exclusively to its wholly-owned subsidiary, Mylan Specialty L.P. Perforomist® is a registered trademark of Mylan Inc. licensed exclusively to its wholly-owned subsidiary, Mylan Specialty L.P. EMSAM® is a registered trademark of Somerset Pharmaceuticals, Inc.

MYS12-9032/EPI554815-01