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How to Read a Package Insert

August 14, 2018

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Table of Contents


Introduction

When you are starting or thinking of starting a new HIV drug, your health care provider will discuss some basic information with you. When you get the prescription filled, you usually receive additional written information. This may be just a brief summary provided by the pharmacy, or you may receive a very detailed "package insert" filled with information provided by the drug manufacturer and approved by the US Food and Drug Administration (FDA).

Each country or region has its own agency that regulates drugs and provides the information that consumers (users) receive with their prescriptions. In India, it is the Central Drugs Standard Control Organization (CDSCO), which is commonly referred to as the Drugs Controller General (DCG). In Europe, it is the European Medicines Agency (EMA), where the package insert is known as the patient information leaflet (PIL).

Package inserts (also known as Prescribing Information) are available for all prescription medications approved by the FDA. Similar information is available for nonprescription medicines and for some herbal medicines and dietary supplements as well.

The package insert can usually be found online on the drug manufacturer's web site and is also available in a reference book called the Physicians' Desk Reference (PDR), which you may be able to find at your local library or can access online at PDR.net.


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What Is in the Package Insert

The information in a package insert is written in technical language. It is usually very long and can be difficult to understand. It is a good idea to look through it, because it lists important information about the drug. If you have any questions, ask your health care provider or pharmacist. You can also ask an educator at your local AIDS service organization.

The package insert follows a standard format for every drug. After some identifying information, such as the drug's brand name, generic name, and year when the drug was first approved by the FDA, the following sections appear:

  1. Highlights of Prescribing Information
  2. Indications and Usage
  3. Dosage and Administration
  4. Dosage Forms and Strengths
  5. Contraindications
  6. Warnings and Precautions
  7. Adverse Reactions
  8. Drug Interactions
  9. Use in Specific Populations
  10. Overdosage
  11. Description
  12. Clinical Pharmacology
  13. Nonclinical Toxicology
  14. Clinical Studies
  15. References
  16. How Supplied/Storage and Handling
  17. Patient Counseling Information

Package inserts for some HIV drugs begin with "Boxed Warnings," which highlight especially serious (often life-threatening) side effects that have been reported but are rare.

The package insert will most often use the generic name of the drug (the scientific name for its main ingredient or ingredients). Patients usually know a drug by its brand name (the name under which it is sold), so this can be confusing. Also note that a drug's brand name may be different in different countries. For the US, check our HIV Drug Chart/Overview, which lists each drug by brand and generic names, if you have questions. A quick search online using whatever name you have should also bring up the drug's other names (e.g., if what you have is the generic name, most websites that mention that drug will also list its brand name and possible abbreviations).

While there is no specific section of the package insert dedicated solely to women, information that applies to women (for example, indications for use in pregnant or breastfeeding women, dosing adjustments by weight, drug interactions with birth control pills or hormone replacement therapy) may be found in various sections throughout the package insert.

Here is what you can expect to find in each section:


Highlights of Prescribing Information

This first section is a brief summary of the information that is most important for readers to know. It refers readers to the appropriate section(s) in the package insert for additional, more detailed information.


Indications and Usage

This section lists the uses (indications) for which the drug has been approved by the FDA. All HIV drugs are indicated for use in combination with other approved HIV drugs, unless the HIV drug is already a combination pill (e.g., Atripla). This section will also state if the drug can be used by patients who have taken HIV drugs before, by patients who have never taken HIV drugs, or by both. It may say what class of drug this is and what other HIV drugs should or should not be taken with it. A detailed description of the clinical studies for this drug will follow and will often include graphs and charts.


Dosage and Administration

This section gives the recommended dosages (doses) of the medicine and may tell you if the drug should be taken with or without food. If the medicine is indicated for more than one use (e.g., to treat HIV and hepatitis B), you may see separate sections for each use. There may also be separate information about dosages for women above and below a certain weight, children, older people, or those with certain medical problems.


Dosage Forms and Strengths

This section describes the drug's color and form (e.g., capsule, ointment). It also lists the strength or amount of medication in that form. Several different strengths and form descriptions may be listed for the same drug.


Contraindications

This section describes situations when the drug should be used with caution or not at all. These are called contraindications. For instance, a medicine should not be prescribed for someone who has had an allergic reaction (hypersensitivity) to the same medication or one that is similar, or for someone who is taking another medicine that interacts with it in a harmful way.

This section also may warn health care providers not to prescribe the medicine for people with certain medical conditions because they are at greater risk of dangerous side effects. If you have a serious medical condition, this is the place to find out whether it is likely to cause a problem if you take this medicine.

This is also the reasoning behind why it is important that you not share your medications with others. Your medication may be harmful to someone else if they have a medical condition that you do not know about.


Warnings and Precautions

This section discusses serious side effects that may occur in people who take this medicine. It does not mean that every side effect will happen to you, but it is important that you pay attention to these warnings, so you will recognize any symptoms that could suggest a serious problem.

If especially severe or life-threatening problems have been found, there may be a "Boxed Warning" on the first page of the package insert. As the name suggests, this information is clearly shown using capital letters surrounded by a black box, so it will not be overlooked.

Before you start taking an HIV drug with warnings that might affect you, your health care provider will probably explain what the warnings mean and tell you what you should watch for so that any problems can be caught early. Call your provider or pharmacist right away if you ever have a question or concern about a warning or symptoms you experience when taking the drug.


Adverse Reactions

This section lists all the side effects that were reported in people who took this medicine while it was being tested. Side effects, also called adverse reactions, are effects that are different from what the drug was developed to do. These effects are usually grouped according to the body system affected (e.g., liver, skin, stomach), the group of people tested (e.g., adults, children), and perhaps also by how many people reported having each side effect.

This list of "adverse events" can look frightening because it includes so many problems, ranging from minor to life-threatening. Remember that this section lists everything that happened to hundreds or thousands of people (and sometimes also animals when the drug was in the early phases of testing). You may experience some of the side effects on the list, or none at all. Even the effects listed as being most frequent do not affect everyone who takes the medicine.

Again, you may not experience any of the side effects mentioned. This is very important. It is equally important to tell your health care provider about any symptoms you experience since beginning the new drug.

Your health care provider probably will mention some of the side effects that you should watch for, but every person is different, and it is impossible to tell in advance what you will experience. If you tend to have problems with one body system (such as your skin or stomach), you may be particularly interested in seeing how many people had problems in that area. Many side effects that are troublesome during the first days or weeks that you take the medicine may disappear later.

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This article was provided by The Well Project. Visit The Well Project's Web site to learn more about their resources and initiatives for women living with HIV. The Well Project shares its content with TheBody.com to ensure all people have access to the highest quality treatment information available. The Well Project receives no advertising revenue from TheBody.com or the advertisers on this site. No advertiser on this site has any editorial input into The Well Project's content.
 

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