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Microsoft word - 2012-11-08-tdf-gs-033-cln.doc
(tenofovir disoproxil fumarate)
tablets and oral powder
Read this Patient Information before you start taking VIREAD and each time you
get a refill. There may be new information. This information does not take the
place of talking with your healthcare provider about your medical condition or your
treatment. What is the most important information I should know about VIREAD? VIREAD can cause serious side effects, including:
1. Build-up of an acid in your blood (lactic acidosis).
Lactic acidosis can
happen in some people who take VIREAD. Lactic acidosis
is a serious medical
emergency that can lead to death.
Lactic acidosis can be hard to identify early, because the symptoms could seem
like symptoms of other health problems. Call your healthcare provider right
away if you get the following symptoms which could be signs of lactic
• feeling very weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have stomach pain with
• nausea (feel sick to your stomach) • vomiting
• feel cold, especially in your arms and legs
• feel dizzy or lightheaded
• have a fast or irregular heartbeat 2. Severe liver problems.
Severe liver problems can happen in people who
take VIREAD or similar medicines. In some cases these liver problems can lead
to death. Your liver may become large (hepatomegaly) and you may develop
fat in your liver (steatosis) when you take VIREAD. Call your healthcare provider right away if you have any of the following
symptoms of liver problems:
• Your skin or the white part of your eyes turns yellow (jaundice).
• dark “tea-colored” urine
• light-colored bowel movements (stools)
• loss of appetite for several days or longer
You may be more likely to get lactic acidosis or severe liver problems if you
are female, very overweight (obese), or have been taking VIREAD for a
3. Worsening of your Hepatitis B infection.
Your hepatitis B Virus (HBV)
infection may become worse (flare-up) if you take VIREAD and then stop it. A
“flare-up” is when your HBV infection suddenly returns in a worse way than
• Do not let your VIREAD run out. Refill your prescription or talk to your
healthcare provider before your VIREAD is all gone.
• Do not stop taking VIREAD without first talking to your healthcare provider.
• If you stop taking VIREAD, your healthcare provider will need to check your
health often and do blood tests regularly to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after
4. Talk to your doctor about taking an HIV test before starting treatment
with VIREAD for chronic hepatitis B. You should also get a test for
HBV if you are taking VIREAD for treatment of HIV.
What is VIREAD?
VIREAD is a prescription medicine used:
with other antiviral medicines to treat Human Immunodeficiency Virus-1
(HIV-1) in people 2 years of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
• When used with other HIV medicines, VIREAD may reduce the amount
of HIV in your blood (called “viral load”). VIREAD may also help to increase the number of CD4 (T) cells in your blood which help fight off other infections. Reducing the amount of HIV and increasing the CD4 (T) cell count may improve your immune system. This may reduce your risk of death or infections that can happen when your immune system is weak (opportunistic infections).
• VIREAD does not cure HIV infection or AIDS.
VIREAD may still develop infections or other conditions associated with HIV infection.
• You must stay on continuous HIV therapy to control infection and
• It is very important that you stay under the care of your healthcare
• It is not known if VIREAD is safe and effective for the treatment of
HIV-1 infection in children under the age of 2 years.
to treat chronic (long-lasting) hepatitis B virus (HBV) in people 12 years of
• VIREAD will not cure HBV. • VIREAD may lower the amount of HBV in your body. • VIREAD may improve the condition of your liver. • The long-term effects of taking VIREAD for treatment of chronic
• It is not known if VIREAD is safe and effective for treatment of chronic
hepatitis B in children under the age of 12 years.
What should I tell my healthcare provider before taking VIREAD?
Before you take VIREAD, tell your healthcare provider if you:
• have liver problems, including hepatitis B (HBV) infection.
• have kidney problems.
• have bone problems.
• have any other medical conditions, including HIV infection.
• are pregnant or plan to become pregnant. It is not known if VIREAD will harm
your unborn baby.
There is a pregnancy registry for women who take
antiviral medicines during pregnancy. Its purpose is to collect information about
the health of you and your baby. Talk to your healthcare provider about how
you can take part in this registry.
• are breastfeeding or plan to breastfeed. Do not breastfeed if you are taking
Tenofovir passes into your breast milk. You should not breastfeed
because of the risk of passing HIV to your baby. Talk to your healthcare
provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take,
prescription and non-prescription medicines, vitamins and herbal supplements.
VIREAD may affect the way other medicines work, and other medicines may affect
how VIREAD works. Do not take VIREAD if you also take:
• other medicines that contain tenofovir (ATRIPLA®, COMPLERA®, STRIBILD™,
• adefovir (HEPSERA®) Especially tell your healthcare provider if you take the following medications. The dose of these other medications may need to be changed. • didanosine (VIDEX, VIDEX EC) • atazanavir (REYATAZ) • lopinavir with ritonavir (KALETRA) Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.
How should I take VIREAD?
• See “What is the most important information I should know about VIREAD?”
• Take VIREAD exactly as your healthcare provider tells you to take it.
• Take VIREAD at the same time every day.
• For adults and children 12 years of age and older, the usual dose of VIREAD is
• If you are an adult with kidney problems, your healthcare provider may tell you
• Adults and children 12 years of age and older who are unable to swallow VIREAD
tablets whole may take 7½ scoops of VIREAD oral powder.
• For children 2 to 12 years of age, your healthcare provider will prescribe the
right dose of VIREAD oral powder or tablets based on your child’s body weight.
• Tell your healthcare provider if your child has problems with swallowing tablets. • See the “Instructions for Use” section at the end of this Patient Information
leaflet for information about the right way to measure and take VIREAD oral powder.
• Take VIREAD tablets by mouth, with or without food. • Do not miss a dose of VIREAD. If you miss a dose of VIREAD, take the missed
dose as soon as you remember. If it is almost time for your next dose of
VIREAD, do not take the missed dose. Take the next dose of VIREAD at your regular time.
• If you take too much VIREAD, call your local poison control center or go right
away to the nearest hospital emergency room.
What are the possible side effects of VIREAD?
VIREAD may cause serious side effects, including:
• See “What is the most important information I should know about
• New or worse kidney problems, including kidney failure,
can happen in
some people who take VIREAD. Your healthcare provider should do blood tests to check your kidneys before you start treatment with VIREAD. If you have had
kidney problems in the past or need to take another medicine that can cause kidney problems, your healthcare provider may need to do blood tests to check your kidneys during your treatment with VIREAD.
• Bone problems
can happen in some people who take VIREAD. Bone problems
include bone pain, softening or thinning (which may lead to fractures). Your
healthcare provider may need to do additional tests to check your bones.
• Changes in body fat
can happen in some people who take antiviral medicines.
These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss
of fat from the legs, arms, and face may also happen. The cause and long-term health effects of these conditions are not known.
• Changes in your immune system (Immune Reconstitution Syndrome)
can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new symptoms after starting your HIV medicine.
The most common side effects in all people who take VIREAD are:
In some people with advanced HBV-infection, other common side effects may include:
• sleeping problems • itching • vomiting • dizziness • fever
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of VIREAD. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects
to FDA at 1-800-FDA-1088. How should I store VIREAD?
• Store VIREAD tablets or oral powder at room temperature between 68 °F to 77
• Keep VIREAD in the original container.
• Do not use VIREAD if the seal over the bottle opening is broken or missing.
• Keep the bottle tightly closed. Keep VIREAD and all medicines out of the reach of children.
General information about VIREAD:
Medicines are sometimes prescribed for purposes other than those listed in a
Patient Information leaflet. Do not use VIREAD for a condition for which it was not
prescribed. Do not give VIREAD to other people, even if they have the same condition you have. It may harm them.
Avoid doing things that can spread HIV-1 or HBV infection to others.
• Do not share or re-use needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them,
like toothbrushes and razor blades.
• Do not have any kind of sex without protection.
Always practice safe sex
by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood.
A vaccine is available to protect people at risk for becoming infected with HBV. You
can ask your healthcare provider for information about this vaccine. This leaflet summarizes the most important information about VIREAD. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about VIREAD that is written for health professionals. For more information, go to www.viread.com or call Gilead Sciences, Inc. at 1-800-
GILEAD-5 (1-800-445-3235). What are the ingredients in VIREAD?
tenofovir disoproxil fumarate Inactive Ingredients:
VIREAD tablets: croscarmellose sodium, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, and pregelatinized starch.
VIREAD Oral Powder: mannitol, hydroxypropyl cellulose, ethylcellulose, and silicon
dioxide. Tablet Coating:
VIREAD tablets 300 mg: Opadry II Y–30–10671–A, which contains FD&C blue #2
aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and
VIREAD tablets 150, 200 and 250 mg: Opadry II 32K-18425, which contains
hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. Instructions for Use of VIREAD oral powder
Read the Instructions for Use below before you give VIREAD oral powder. Be sure
you can understand and follow them. If you have any questions, ask your
healthcare provider or pharmacist. Important information
• VIREAD oral powder comes in a box that has a bottle of VIREAD and a dosing
• Only use the dosing scoop to measure VIREAD oral powder.
• Only mix VIREAD oral powder with soft foods
that can be swallowed
without chewing. Examples of soft foods you can use are: applesauce, baby
• Do not mix VIREAD oral powder with liquid
. The powder may float to
• Give the entire dose right away after mixing
to avoid a bad taste.
How do I prepare and give VIREAD oral powder?
1. Wash and dry your hands. 2. Measure ¼ to ½ cup of soft food into a cup or bowl. 3. To open a new bottle of powder, press down on the bottle lid and turn to
remove (see picture on the top of the bottle cap). Peel off the foil.
4. Measure the number of scoops prescribed by your healthcare provider.
• Fill the dosing scoop to the top. • Use the flat edge of clean knife to make the powder even with the top
• Fill the dosing scoop up to the “½ line” on the side (see Figure C).
5. Sprinkle the VIREAD oral powder on the soft food. Stir with a spoon until well
mixed. Give the entire dose right away after mixing
to avoid a bad
6. Close the bottle of VIREAD tightly. 7. Wash and dry the dosing scoop. Do not store the dosing scoop in the bottle.
See the section “How should I store VIREAD?” for information about how to store
This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured for and distributed by: Gilead Sciences, Inc. Foster City, CA 94404 Revised November 2012 COMPLERA, EMTRIVA, GSI, HEPSERA, STRIBILD, TRUVADA, and VIREAD are trademarks or registered trademarks of Gilead Sciences, Inc., or its related
companies. ATRIPLA is a registered trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. All other trademarks herein are the property of their respective owners. 21-356-GS-033
2.1 Recommended Dose in Adults and Pediatric Patients 12 Years of Age and Older (35 kg or more)
Safety and efficacy of VIREAD in patients younger than 12 years of age have not been established.
2.3 Dose Adjustment for Renal Impairment in Adults
5.1 Lactic Acidosis/Severe Hepatomegaly with Steatosis
5.2 Exacerbation of Hepatitis after Discontinuation of Treatment
5.3 New Onset or Worsening Renal Impairment
5.4 Coadministration with Other Products
5.5 Patients Coinfected with HIV-1 and HBV
5.6 Decreases in Bone Mineral Density
5.8 Immune Reconstitution Syndrome
6.1 Adverse Reactions from Clinical Trials Experience
7.4 Drugs Affecting Renal Function
8.6 Patients with Impaired Renal Function
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14.1 Clinical Efficacy in Adults with HIV-1 Infection
14.2 Clinical Efficacy in Adults with Chronic Hepatitis B
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information and Instructions for Use).
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