HIV and AIDS--Medicines to Help You (FDA)

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HIV stands for Human Immunodeficiency Virus. HIV is the virus that causes AIDS. A person with HIV is called HIV positive (HIV+).

HIV makes it hard for your body to fight off sickness. There are cells in your blood called "CD4 cells" or "T cells". These cells help protect your body from disease. HIV kills these cells. A person with HIV does not have as many of these cells as a healthy person.

There is hope.

There are drugs that can treat HIV and help people live longer. These medicines help to keep the virus from building up in your body. These drugs do not stop you from spreading HIV. You can still give the disease to someone else.

People with HIV may need to take 3 or more different medicines every day. You and your doctor will decide which ones are right for you. It is important that you take your HIV medicines every day. Do not stop taking your medicines without talking to your doctor. Over time, you can get very sick if you do not take your medicines.

Use this guide to help you talk to your doctor about the HIV medicines you are taking. This guide provides some basic facts about the HIV medicines that have been approved by the FDA.

There are many things you can do to help improve your health.

Work closely with your doctor to monitor your health.
Take your medicine.
Eat a healthy, balanced diet.
Quit smoking and using illegal drugs.
Get regular exercise.

Women and HIV

Women from all backgrounds and cultures can get HIV. However, increasing numbers of African American and Latino women have HIV.

Learn the facts about women and HIV. Educate yourself to help you live longer. Educate yourself so that you can teach other women how to prevent HIV and AIDS.

Did you know?

Most women get HIV from having unprotected sex with men.
A woman can pass HIV to her baby during pregnancy, labor, or delivery.
A woman can also pass HIV to her baby during breastfeeding.
A pregnant woman can take medicine to lower the chance of giving her baby HIV. Pregnant women should talk to their doctor about the pros and cons of taking medicines for HIV. Some anti-HIV medicines should not be taken during pregnancy because they can cause birth defects.
Babies born to women with HIV may need to take anti-HIV medicines after birth to lower the chance that they will get HIV. Talk to your doctor about the best way to treat your baby.
Women who are HIV positive should get regular pap smears and exams to test them for other health problems.
Women with HIV are more likely to have:
- Vaginal yeast infections
- Other infections such bacterial vaginosis
- Pelvic Inflammatory Disease (PID)
- Sexually Transmitted Infections like gonorrhea or HPV
- Changes in the cervix that may lead to cervical cancer

Anti-HIV Medicines

The main drug treatment for people with HIV is Highly Active Antiretroviral Therapy (also called HAART). HAART drugs help to slow the growth of HIV in your body.

HAART is made up of different kinds of medicines:

1. Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

2. Nonnucleoside Reverse Transcriptase Inhibitors (NNRTIs)

3. Protease Inhibitors

4. Fusion Inhibitors

5. Integrase Inhibitors

6. Entry Inhibitors

7. Combination Drugs

The seven different groups of HAART drugs are listed on the next few pages. The brand names and generic names are listed for each drug.

Risks and Side Effects

The drugs used to treat HIV can sometimes cause side effects. Side effects may be different depending on the person and the kind of medicine. Some people have no side effects. Others can have very bad side effects.

Tell your doctor about any side effects you are having. Do not stop taking your medicine without talking to your doctor. Your doctor may tell you tips to help you cope with the side effects. The doctor may also decide to have you take different drugs.

This guide does not give the specific side effects or warnings for each HAART drug. Check the drug label and ask your doctor for the side effects and warnings for the HIV medicines you are taking.

Information about specific drugs can also be found on the FDA Web site at: www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm²

Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Brand Name	Generic Name Other Names
Combivir	Lamivudine and Zidovudine
Emtriva	Emtricitabine FTC
Epivir	Lamivudine 3TC
Epzicom	Abacavir and Lamivudine
Hivid	Zalcitabine Dideoxycytidine, ddC
Retrovir	Zidovudine, AZT, Azidothymidine, ZDV
Trizivir	Abacavir, Zidovudine and Lamivudine
Truvada	Tenofovir Disoproxil and Emtricitabine
Videx	Didanosine , ddl, Dideoxyinosine
Videx EC	Enteric Coated Didanosine
Viread	Tenofovir Disoproxil Fumarate, TDF
Zerit	Stavudine d4T
Ziagen	Abacavir, Sulfate, ABC
For more information about the risks and side effects for each drug, check Drugs@FDA.³

Nucleoside Reverse Transcriptase Inhibitors: What You Should Know

This guide does not give the specific side effects or warnings for each drug. Check the drug label and ask your doctor for the side effects and warnings for the HIV medicines you are taking.

Warnings

Women should not breastfeed while taking these medicines.
These medicines may cause lactic acidosis (too much acid in the blood).
These medicines may cause serious liver or pancreas problems.
People with liver problems including hepatitis and people with kidney problems should talk to their doctor before taking these medicines.
In some cases, people taking HIV medicines notice changes in body fat (like extra fat in the neck or upper back or loss of fat in the face or arms).

Warning Signs

Call your doctor right away if you have any of these signs:

Upset stomach
Vomiting
Feeling very weak or tired
Problems Breathing
Weakness in arms and legs
Tingling, numbness, or pain in feet or hands
Skin or eyes look yellow
Pain in the upper stomach area

Common Side Effects

Trouble sleeping
Headache
Feeling tired
Upset stomach
Mild nausea
Vomiting
Diarrhea
Dizziness
Do not feel like eating

Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Brand Name	Generic Name Other Names
Intelence	Etravirine
Rescriptor	Delavirdine DLV
Sustiva	Efavirenz EFV
Viramune	Nevirapine NVP
For more information about the risks and side effects for each drug, check Drugs@FDA.⁴

Non-Nucleoside Reverse Transcriptase Inhibitors: What You Should Know

This guide does not give the specific side effects or warnings for each drug. Check the drug label and ask your doctor for the side effects and warnings for the HIV medicines you are taking.

Warnings

Women should not breastfeed while taking these medicines.
These medicines may cause serious liver problems or severe skin rashes.
People with liver problems including hepatitis and people with kidney problems should talk to their doctor before taking these medicines.
Women with CD4 counts higher than 250 should talk to their doctor about the risks of taking Viramune (Nevirapine).
In some cases, people taking HIV medicines notice changes in body fat (like extra fat in the neck or upper back or loss of fat in the face or arms).

Warning Signs

Call your doctor right away if you have any of these signs:

Flu-like symptoms
Feeling tired
Do not feel like eating
Dark urine (looks like tea)
Pale stools
Upset stomach/ nausea
Jaundice (skin or eyes look yellow)
Pain, aches, or sensitivity to touch on right side below your ribs

Also call your doctor right away if you have a severe rash along with blisters, swelling, pink eye, fever, muscle/ joint pain, or mouth sores.

Common Side Effects

Skin rash
Upset stomach
Dizziness
Problems concentrating
Feeling tired
Vomiting
Trouble sleeping
Headache
Diarrhea
Strange dreams

Protease Inhibitors

Brand Name	Generic Name Other Names
Agenerase	Amprenavir APV
Aptivus	Tipranavir TPV
Crixivan	Indinavir IDV, MK-639
Fortovase	Saquinavir (no longer marketed)
Invirase	Saquinavir Mesylate SQV
Kaletra	Lopinavir and Ritonavir LPV/RTV
Lexiva	Fosamprenavir Calcium FOS-APV
Norvir	Ritonavir RTV
Prezista	Darunavir
Reyataz	Atazanavir Sulfate ATV
Viracept	Nelfinavir Mesylate NFV
For more information about the risks and side effects for each drug, check Drugs@FDA.⁵

Protease Inhibitors: What You Should Know

This guide does not give the specific side effects or warnings for each drug. Check the drug label and ask your doctor for the side effects and warnings for the HIV medicines you are taking.

Warnings

Women taking birth control pills need to use another birth control method.
Tell your doctor about all medicines that you are taking. Protease Inhibitors may cause serious health problems or death if mixed with other medicines.
These medicines may cause serious liver problems.
These medicines may cause increased bleeding in people with hemophilia.
These medicines may make diabetes worse or cause people to get diabetes.
Some people taking protease inhibitors notice large increases in their cholesterol.
In some cases, people taking HIV medicines notice changes in body fat (like extra fat in the neck or upper back or loss of fat in the face or arms).
Women should not breastfeed while taking these medicines.

Warning Signs

Call your doctor if you have any of these signs:

Serious skin rash
Feeling very weak or tired
Unusual muscle pain
Trouble breathing
Stomach pain with nausea and vomiting

Common Side Effects

Rash
Diarrhea
Nausea (Upset Stomach)
Vomiting
Feeling Tired
Headache

Fusion Inhibitors

Brand Name	Generic Name Other Names
Fuzeon This medicine is a shot.	Enfuvirtide T-20
For more information about the risks and side effects for each drug, check Drugs@FDA.⁶

Fusion Inhibitors: What You Should Know

This guide does not give the specific side effects or warnings for each drug. Check the drug label and ask your doctor for the side effects and warnings for the HIV medicines you are taking.

Warnings

People taking Fuzeon with other HIV medicines may be more likely to get pneumonia. Tell your doctor if you have a cough, fever, or trouble breathing.
Women should not breastfeed while taking Fuzeon.
In some cases, people taking HIV medicines notice changes in body fat (like extra fat in the neck or upper back or loss of fat in the face or arms).

Warning Signs

Fuzeon may cause serious allergic reactions. Call your doctor right away if you have any of these signs.

Trouble breathing
Fever with vomiting and a skin rash
Blood in urine
Swelling of the feet

Common Side Effects

Itching, redness, pain, bumps or swelling where the shot is given
Pain and numbness in feet or legs
Problems sleeping
Depression
Weakness or loss of strength
Muscle pain
Constipation

Multi-Class Combination Drugs

Brand Name	Generic Name
Atripla	Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate
For more information about the risks and side effects for each drug, check Drugs@FDA.⁷

Combination Drugs: What You Should Know

This guide does not give the specific side effects or warnings for each drug. Check the drug label and ask your doctor for the side effects and warnings for the HIV medicines you are taking.

Warnings

Atripla may cause lactic acidosis (too much acid in the blood).
Atripla may cause serious liver problems.
People who have kidney or liver problems including Hepatitis B should talk to their doctor before using this medicine.
People who have ever had seizures and people taking medicines for seizure should talk to their doctor before using this medicine.
People who have ever had mental illness and people with bone problems should talk to their doctor before using this medicine
Women should not get pregnant or breast feed while taking Atripla.
Women taking birth control pills need to use another birth control method.
In some cases, people taking HIV medicines notice changes in body fat (like extra fat in the neck or upper back or loss of fat in the face or arms).

Warning Signs

Call your doctor right away if you have any of these signs:

Feeling very weak or tired
Unusual muscle pain
Trouble breathing
Stomach pain with nausea and vomiting
Feeling dizzy or lightheaded
Dark urine
Light colored stools
Loss of appetite for several days
Upset stomach (nausea)
Stomach pain
Jaundice (skin or eyes look yellow)

Common Side Effects

Dizziness
Headache
Trouble sleeping
Feeling drowsy
Problems concentrating
Unusual dreams

Integrase Inhibitors

Brand Name	Generic Name
Isentress	Raltegravir
For more information about the risks and side effects for each drug, check Drugs@FDA.⁸

Integrase Inhibitors: What You Should Know

This guide does not give all of the specific side effects or warnings for each drug. Check the drug label and ask your doctor for the side effects and warnings for the HIV medicines you are taking.

Women who are pregnant or plan to become pregnant should talk to their doctor before taking Isentress (Raltegravir).
Women should not breastfeed while taking Isentress (Raltegravir).
Tell your doctor if you have any allergies before you start taking Isentress (Raltegravir).
In some cases, people taking HIV medicines notice changes in body fat (like extra fat in the neck or upper back or loss of fat in the face or arms).

Warning Signs

You should also see your doctor right away if you have any of these signs:

Unexplained muscle pain, tenderness or weakness
Signs of an infection

Common Side Effects

Diarrhea
Nausea
Headache

Entry Inhibitors

Brand Name	Generic Name
Selzentry	Maraviroc
For more information about the risks and side effects for each drug, check Drugs@FDA.⁹

Entry Inhibitors: What You Should Know

Warnings

People with liver problems including Hepatitis B or C should talk to their doctor before taking Selzentry (Maraviroc).
People with kidney problems or heart problems should talk to their doctor before taking Selzentry (Maraviroc).
Tell your doctor if you are taking high blood pressure medicines or if you have low blood pressure.
Do not drive a car or use heavy machinery if you feel dizzy while taking Selzentry (Maraviroc).
Tell your doctor if you have any allergies before you start taking Selzentry (Maraviroc).
Women should not breastfeed while taking Selzentry (Maraviroc).
In some cases, people taking HIV medicines notice changes in body fat (like extra fat in the neck or upper back or loss of fat in the face or arms).

Warning Signs

Selzentry may cause serious liver problems. Call your doctor right away if you have any of these signs:

Itchy rash on your body
Skin or eyes look yellow
Dark (tea- colored) urine
Vomiting and stomach pain

You should also see your doctor right away if you have any of these signs:

Nausea
Flu-like symptoms
Fatigue

Serious Side Effects

Possible chance of infection or cancer

Common Side Effects

Cough
Fever
Colds
Rash
Muscle and Joint Pain
Stomach Pain
Dizziness

Important Questions to Ask Your Doctor

What drugs am I taking?
What are the side effects of taking these drugs?
What do I do if I start having bad side effects?
What other prescription drugs should I avoid while taking my HIV medicines?
What herbs (like St. John's Wort) or over-the-counter medicines should I avoid?
When should I take each drug?
Should I take my medicines with food?
How should I keep my medicines when I go out of town?
How long can I stay on this regimen?

Ask your doctor to tell you what you should know about your HIV medicines. Write down the important facts in the space below.

My Regimen:

It is important that you take your HIV medicines exactly as your doctor tells you. Do not skip a pill. The medicines may not work correctly if you skip a pill.

Here are some tips to help you remember when to take your HIV medicines.

Use a schedule or planner
Set the alarm on your watch or clock
Find a friend to remind you
Use a pillbox to help you organize your pills

My Medicine Schedule

Time	Drug Name	Dose (How many Pills)	Notes
6:30	XXX (example)	1 Pill	Take with food

To Learn More

FDA Office of Special Health Issues
FDA HIV/AIDS Info
Web: www.fda.gov/oashi/aids/virals.html¹⁰

AIDSinfo
US Department of Health and Human Services
Web: www.aidsinfo.nih.gov¹¹
Phone: 1-800-448-0440
TTY/TTD: 888-480-3739

CDC
US Department of Health and Human Services
Web: www.cdc.gov/hiv/¹²
Phone: 1-800-232-4636
TTY/TTD: 1-888-232-6348

This information reflects FDA's current analysis of data available to FDA concerning these products. FDA intends to update this sheet when additional information or analyses become available.

For the most recent information about each drug, check Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/