When you are considering or starting a new HIV medicine, your doctor 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 U.S. Food and Drug Administration (FDA).

Such package inserts 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, or drug label, 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 can probably find at your local library, or visit the website at http://www.pdr.net/login/Login.aspx.

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 as it contains important information about the drug. If you have any questions, ask your doctor, pharmacist or a treatment educator at your local AIDS service organization.

The package insert follows a standard format for every medication. After some identifying information such as the brand name and generic name of the product, the following sections appear:

• Description
• Microbiology and Clinical Pharmacology
• Indications and Usage
• Contraindications
• Warnings
• Precautions
• Adverse Reactions
• Overdosage
• Dosage and Administration
• How Supplied

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

The package insert will most often use the generic name of the drug. Patients usually know a drug by its brand name, so this can be confusing. Please refer to our HIV Dug Overview chart, which lists each drug by brand and generic names if you have questions.

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

This section gives the chemical name of the drug and a diagram of its chemical make up. It tells whether it is in tablet form, capsules, liquid, or powder, and how it should be given – by mouth or by injection. It also lists all inactive ingredients such as fillers, artificial colors, or flavorings. If you have food sensitivities, this is where you can check if there are ingredients that may cause you problems.

For most people who are not health care professionals, a lot of the information in this section is difficult to understand. Don’t worry if you don’t understand every word!  

Basically, this section tells how the medicine works in the body to fight HIV. It also tells whether studies in different groups of people found any differences in how it works for treatment-experienced patients (patients who have taken HIV drugs before), treatment-naïve patients (those who have never taken HIV drugs before), women, children, and elderly people.

While there is no specific section of the package insert dedicated solely to women, information pertaining 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.

.If you have a special problem like kidney or liver disease, this is one of the sections your doctor will consult while deciding whether to prescribe this type of medicine for you, and if so, how much to give.

This section lists the uses (indications) for which the drug has been FDA-approved. All HIV drugs are indicated for use in combination with other approved HIV drugs.

This section will also state if the drug can be used in treatment experienced patients, treatment naïve patients, or 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.

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's similar, or for someone who is taking another medicine that interacts with it in a harmful way.

This section also may warn doctors 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 disorder, this is the place to find out whether it's likely to cause a problem if you take this medicine.

This section discusses serious side effects that may occur in people who take this medicine. If especially severe or life-threatening problems have been found, there may be a "Box Warning" on the first page of the package insert. As the name suggests, this information is clearly displayed using capital letters surrounded by a black box so it will not be overlooked.

You should pay attention to these warnings so you will recognize any symptoms that could suggest a serious problem, but you should not be overly alarmed. It is unlikely that you will experience any of the conditions covered by Box Warnings.

Before you start taking a HIV drug with Warnings that might affect you, your doctor is likely to explain what the Warnings mean and tell you what you should watch for so that any problems can be caught early. Call your doctor or pharmacist right away if you ever have a question or concern about a warning or symptoms you experience when taking the drug.

The Precautions section tells how to use the medication most safely and effectively. It alerts the doctor about types of patients who need close observation and offers guidelines about any laboratory tests that should be performed before the medicine is taken or during the time it is in use (e.g. lab tests to monitor lipid levels or liver enzymes).

One of the most important parts of this section lists Drug Interactions—the effects that this medicine may have on other prescription or over-the-counter medicines you may be taking. This section also might warn that you shouldn't take this medicine with a particular food or other product (such as an antacid).

It's a good idea to look through this section to see if it lists any medicines or other products that you use regularly. Be sure your doctor knows about all the medications you are taking (including over-the-counter, prescription, street drugs, and herbs), even if you only use them occasionally.

The Precautions section also may tell what is known about the use of this medicine by nursing or pregnant mothers, children ("Pediatric Use"), and older people ("Geriatric Use"). Sometimes it may just say that not enough information is available. This does not mean that it is unsafe in these groups of people, just that not enough research studies have been done.

This section lists all the side effects that were reported in people who took this medicine while it was being tested. These effects are usually grouped according to the body system affected and perhaps also by how many people reported each one.

It can be hard to sort out which of the side effects on these lists you really need to be concerned about. You probably shouldn't be bothered about ones listed as rare or infrequent unless they're also discussed in the Warnings. Even "frequent" ones may have happened only a little more often in the people who took the medicine than in the people who took a placebo (commonly called a sugar pill) instead. If you tend to have problems with one body system (such as your lungs or digestion), you may be particularly interested in seeing how many people had problems in that area.

These lists of "adverse events" can look frightening because they include so many problems, ranging from minor to life-threatening. The thing to remember is that this section lists everything that happened to hundreds or thousands of people (and sometimes also animals) regardless of whether it actually had any connection to the medicine. 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. Your doctor 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. Many side effects that are troublesome during the first days or weeks that you take the medicine may disappear later.

This section tells what the results of a large overdose of the medicine are likely to be and how they should be treated. This kind of information is mainly useful to medical personnel. If you suspect an overdose of medication, you should contact a poison control center or emergency room right away.

This section gives the recommended dosages of the medicine and may advise 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. Separate information also may be given about dosages for women above and below a certain weight, children, older people, or those with certain medical problems.

This section lists all the available forms of this medicine, including tablets or capsules of various doses and perhaps liquids, and powder. Each one is described by color, shape, and markings, so you can be sure of which one you are taking. When reading the package insert for Fuzeon (an HIV drug which is injected into the body), this section will take about how to reconstitute, or mix, the powdered drug with sterile water.

This section also gives storage instructions. This is where you find out whether to keep the drug in the refrigerator or not. It also tells whether pills may be damaged from heat, light, or moisture. Usually there's a recommendation against leaving the medicine out in temperatures over 30ºC (86ºF), for instance.  So, if you pick up your prescription from the pharmacy on a hot day, don't leave it in the car while you run other errands!

The package insert is a good source of information to be used in addition to instructions your doctor or nurse may have given you. It's a good idea to review the package insert for any new medicine and to look at it again if anything about your health changes. If it raises any questions in your mind, contact your doctor or nurse for an explanation.