What to Do If an Adverse Event or
Side Effect Occurs

Some people using prescription medicines may experience an adverse event or side effects at one time or another. The harm caused by adverse events may depend on how you respond to them when they occur. To minimize the potential impact, it's important to follow some basic safety guidelines.

Be aware of the side effects a medicine may cause.

When you're familiar with a medicine's possible side effects, you're more likely to realize that a symptom you're experiencing may be related to that medicine. The known side effects of a medicine are listed in the Package Insert or Prescribing Information. They are also in the Medication Guide if the medicine has a guide. In the Prescribing Information, they are included under sections labeled "WARNINGS and PRECAUTIONS," "CONTRAINDICATIONS," "ADVERSE REACTIONS" and "BOXED Warnings" When your doctor gives you a prescription, ask what side effects you should be most concerned about and what you should do if you experience any of them.

Know in advance what to do if you experience an adverse reaction to a medicine.

Many medications come with specific advice on what you should do if you experience specific symptoms while using that medicine. The advice may be to continue using the medicine but call your doctor, or to stop taking the medicine and call your doctor. Other symptoms may require immediate medical attention because they could mean you are having a serious or life-threatening reaction to the medicine. That's why it is vitally important to learn about a medicine before you start taking it and to keep information about the medicine in a place where you can quickly find it.

Keep a written record of all symptoms you experience when taking a medication.

It will make it much easier to remember details and share them later with your physician. You don't need to be sure that the symptoms you record were caused by one of your medicines. Write everything down and let your doctor determine which symptoms may or may not be side effects. If side effects are a problem, your doctor may consider trying a lower dose of the medicine or recommend a different medicine or therapy for your condition.

Report Adverse Events

Amgen wants you to report any adverse event or adverse reaction (or side effect) whether or not the event is caused by the medicine. An adverse event is any health problem that occurs while you are taking a medicine or some other form of therapy. It is important to understand an event may occur even after you have stopped taking the medicine. An adverse event can be a sign, symptom, or disease that may be associated with the use of a medicine such as:

• A worsening of a condition
• An event occurring from a medication error; for example, taking the wrong medication or the wrong amount of the medication or taking too much of the medicine
• An event related to stopping the medication; for example, a new symptom appears
• A medication doesn't work as it should

It is very important to report any adverse events that may be associated with the use of an Amgen medicine to Amgen's Medical Information Department. You do not need to be certain that the event was caused by a medicine to report it. Other information which should also be reported to Amgen's Medical Information Department, include:

• Use or exposure to an Amgen medicine if pregnant and/or breastfeeding
• A pregnancy where the fetus may have been exposed to an Amgen medicine
• A pregnancy in a woman whose sexual partner took, or is taking, an Amgen medicine
• An infant who has been breastfed or who may have been exposed to an Amgen medicine
• Any complaint about an Amgen medicine regarding a problem with the manufacturing, packaging, or handling of the medicine or its packaging

If there is a possibility that a medicine was responsible for an adverse event, it should be reported to the FDA's MedWatch system.  Visit http://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-332-1088.