Emtriva: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• EMTRIVA is a type of medicine called an HIV (human immunodeficiency virus) nucleotide analog reverse transcriptase inhibitor (NRTI).
• EMTRIVA is always used in combination with other anti-HIV medicines to treat people with HIV infection.
• EMTRIVA is for adults age 18 and older. EMTRIVA has not been studied fully in children under age 18 or adults over age 65.

What it does:

• EMTRIVA helps to block HIV reverse transcriptase (enzyme) that is needed for HIV to multiply. EMTRIVA lowers the amount of HIV in the blood (viral load).
• EMTRIVA does not cure HIV infection or AIDS. The long-term effects of EMTRIVA are not known at this time. People taking EMTRIVA may still get opportunistic infections or other conditions that happen with HIV infection. Opportunistic infections are infections that develop because the immune system is weak.
• EMTRIVA may also help increase the number of T cells called CD4 cells which are important to your immune system.

• EMTRIVA does not lower your chance of passing HIV to other people through sexual contact, sharing needles, or being exposed to your blood. For your health and the health of others it is important to always practice safe sex by using a latex or polyurethane condom or other barrier to lower the chance of sexual

  • contact with semen, vaginal secretions, or blood. Never use or share dirty needles.

When it should not be used:

• Do not take EMTRIVA if you are allergic to EMTRIVA or any of its ingredients (See: What the important nonmedicinal ingredients are).

What the medicinal ingredient is:

Emtricitabine

What the important nonmedicinal ingredients are:

Crospovidone, magnesium stearate, microcrystalline cellulose and povidone.

Capsule shell contains gelatin.

What dosage forms it comes in:

EMTRIVA is available as capsules. Each capsule contains 200 mg of emtricitabine and inactive ingredients. EMTRIVA capsules have a blue cap and white body, printed with “200 mg” in black on the cap and “GILEAD” and the corporate logo in black on the body.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Some people who have taken nucleoside analog medications like EMTRIVA have developed a serious condition called lactic acidosis (build up of acid in the blood) and a condition called hepatoxicity (serious liver problems), with hepatomegaly (liver enlargement) and steatosis (fat in the liver). Fatal cases have been reported. Lactic acidosis is a medical emergency and must be treated in the hospital.

If you have hepatitis B virus infection (inflammation of the liver), you may have a “flare-up” of hepatitis B, in which the disease suddenly returns in a worse way than before if you stop taking EMTRIVA. Your doctor will monitor your condition for several months after stopping EMTRIVA if you have both HIV and HBV infection. EMTRIVA is not approved for the treatment of Hepatitis B Virus infection.

BEFORE you use EMTRIVA talk to your doctor or pharmacist if:

• You are pregnant or planning to become pregnant: Pregnant mothers should not take EMTRIVA unless specifically directed by the doctor. If you take EMTRIVA while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.

• Your are breastfeeding or planning to breastfeed: Do not breastfeed if you are taking EMTRIVA or have HIV. Emtricitabine passes to your baby in your breast milk. You should not breastfeed because of the risk of passing HIV to your baby. Talk to your doctor about the best way to feed your baby.
• You have other medical conditions: Let your doctor know if you have other medical conditions, especially hepatitis (inflammation of the liver), and kidney problems.
• You are taking other medicines: Some medicines can interact when taken together, including prescription and non-prescription medicines and dietary supplements.

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, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Grave's disease (which affects the thyroid gland), Guillain-Barre syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling or fatigue, or any new symptoms, contact your doctor right away.

INTERACTIONS WITH THIS MEDICATION

Let your doctor know if you are taking any other medications.

Do not take EMTRIVA with other medications containing emtricitabine such as TRUVADA^®, ATRIPLA^®, COMPLERA^® or STRIBILD^® or other medications containing lamivudine such as Combivir^®, 3TC^®, Heptovir^®, Kivexa^® or Trizivir^®. because these medicines contain the same or similar active ingredients

PROPER USE OF THIS MEDICATION

Stay under a doctor’s care when taking EMTRIVA.

Missed Dose

• If you miss a dose of EMTRIVA, take it as soon as possible and then take your next scheduled dose at its regular time.
• Do not double the next dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects of EMTRIVA are Headache, Diarrhea, Nausea, Rash, Vomiting, Sleeplessness and Cough. Other side effects include Skin discoloration.

Changes in body fat have been seen in patients taking antiretroviral therapy. These changes may include increased amount of fat in the upper back and neck (‘buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen.

This is not a complete list of side effects. For any unexpected effects while taking EMTRIVA, contact your doctor or pharmacist.

HOW TO STORE IT

• Keep EMTRIVA and all other medications out of reach of children.
• EMTRIVA should be stored at 15–30 C.
• Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

__________________________________________

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701C

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the Medeffect Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, please contact your health professional. The Canada Vigilance program does not provide medical advice.

MORE INFORMATION

This document plus the full Product Monograph, prepared for health professionals can be found at:

www.gilead.ca

or requested by contacting the sponsor, Gilead Sciences, Inc., at:

1–866–207–4267

Last revised: September 2013

Gilead Sciences, Inc.

Foster City, CA 94404

USA

Gilead Sciences Canada, Inc.

Mississauga L5N 2W3

Canada

COMPLERA, STRIBILD, TRUVADA, VIREAD and EMTRIVA are 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 referenced herein are the property of their owners.

2013 Gilead Sciences, Inc.

GS9427–G0701–29–007