Vitekta: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

VITEKTA contains the active substance elvitegravir.

VITEKTA is a prescription medicine used in the treatment of Human Immunodeficiency Virus-1 (HIV) infection in adults.

VITEKTA must be taken with other anti-HIV medicines, including one of the following:

• atazanavir (REYATAZ ) with ritonavir (NORVIR^®);
• darunavir (PREZISTA ) with ritonavir (NORVIR^®);
• fosamprenavir (TELZIR ^®) with ritonavir (NORVIR );
• lopinavir/ritonavir (KALETRA ); or
• tipranavir (APTIVUS^®) with ritonavir (NORVIR ).

Your doctor will tell you which of these medicines to take with VITEKTA.

The safety and effect of VITEKTA has not been established in children under age 18.

What it does:

The HIV virus produces an enzyme called HIV integrase. This enzyme helps the virus to multiply in the cells in your body. VITEKTA stops this enzyme working and reduces the amount of HIV in the blood (viral load).

HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infection. After a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops.

VITEKTA may help increase the count of CD4+ (T) white blood cells that help fight off other infections. Lowering the amount of HIV in the blood and increasing the CD4+ (T) lowers the chance of deaths or getting infections that happen when your immune system is weak (opportunistic infections).

VITEKTA does not cure HIV infection or AIDS. The long-term effects of VITEKTA are not known at this time. People taking VITEKTA 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. Some of these conditions are pneumonia, herpes virus infections, and Mycobacterium avium complex (MAC) infections. It is very important that you see your doctor regularly while taking VITEKTA.

VITEKTA has not been shown to reduce the risk of passing HIV to others through sexual contact or blood contamination. Continue to practice safe sex. Use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood. Do not re-use or share needles.

When it should not be used:

Do not take VITEKTA if:

• you are allergic to VITEKTA or any of its ingredients. The medicinal ingredient is elvitegravir (see: What the important nonmedicinal ingredients in VITEKTA are).

What the medicinal ingredients are:

elvitegravir

What the important nonmedicinal ingredients are:

lactose monohydrate, microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, hydroxypropyl cellulose, and magnesium stearate. The tablets are film-coated with a coating material containing indigo carmine (FD&C blue #2) aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.

What dosage forms it comes in:

IMPORTANT: PLEASE READ

VITEKTA is available as tablets. VITEKTA tablets are for oral administration. Each tablet contains 85 or 150 mg of elvitegravir as active ingredient. VITEKTA 85 mg tablets are green, pentagon-shaped, film-coated tablet of dimensions 8.9 mm x 8.7 mm, debossed with “GSI” on one side of the tablet and “85” on the other side of the tablet. VITEKTA 150 mg tablets are green, triangle-shaped, film-coated tablet of dimensions 10.9 mm x 10.5 mm, debossed with “GSI” on one side of the tablet and “150” on the other side of the tablet. Each bottle contains 30 tablets and is closed with a child-resistant closure.

WARNINGS AND PRECAUTIONS

BEFORE you use VITEKTA (elvitegravir) talk to your doctor or pharmacist:

If you are pregnant or plan to become pregnant: It is not known if VITEKTA can harm your unborn child.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. This registry collects information about your health and your baby’s health. If you become pregnant while taking VITEKTA, talk with your doctor about taking part in this registry.

If you are breast-feeding or plan to breast-feed: Do not breast-feed if you have HIV because of the chance of passing the HIV virus to your baby. It is not known if VITEKTA can pass through your breast milk and harm your baby. If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby.

If you have other medical conditions: Let your doctor know if you have other medical conditions, especially liver problems (including hepatitis B or C virus infection).

If you are taking other medicines: VITEKTA may change the effect of other medicines and may cause side effects that can be serious or life-threatening. Other medicines can make the amount of VITEKTA in your body too low to help control your HIV infection and the virus in your body may become resistant to VITEKTA. For some medicines, your healthcare provider may need to change the amount of medicine you take or monitor your therapy more closely. As well, some medicines can interact when taken together, including prescription and non-prescription medicines, herbal products and dietary supplements (see INTERACTIONS WITH THIS MEDICATION).

INTERACTIONS WITH THIS MEDICATION

If you are taking VITEKTA, you should not take:

• Cobicistat TYBOST™-boosted protease inhibitors.
• Other medicines that contain elvitegravir (STRIBILD^®).

Also tell your doctor if you take:

• An antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or after you take VITEKTA.
• Didanosine (VIDEX^®, VIDEX EC^®). Take didanosine at least 1 hour before or 2 hours after VITEKTA.
• efavirenz, nevirapine, teleprevir, boceprevir
• anticonvulsants (e.g. cabamazepine (Tegretol^®), phenobarbital, phenytoin (Dilantin^®)
• hormonal contraceptives (e.g. norgestimate/ethinyl estradiol)
• antimycobacterial (rifampin (Rifadin^®, Rifamate^®*, Rifater^®, Rofact^®), rifabutin)
• dexamethasone, modafinil, bosentan
• St. John's Wort (Hypericum perforatum)

These are not all the medicines that may cause problems if you take VITEKTA. Be sure to tell your doctor about all the medicines you take.

Keep a complete list of all the prescription and nonprescription medicines as well as any herbal medicines that you are taking, how much you take and how often you take them. Make a new list when medicines or herbal medicines are added or stopped, or if the dose changes. Give copies of this list to all your doctors and pharmacists every time you visit them or fill a prescription. This will give your doctor a complete picture of the medicines you use. Then he or she can decide the best approach for the situation.

PROPER USE OF THIS MEDICATION

Together with your doctor, you need to decide whether VITEKTA is right for you.

Stay under a doctor’s care when taking VITEKTA. Do not change your treatment or stop treatment without first talking with your doctor.

Take VITEKTA every day exactly as your doctor prescribed it. Follow the directions from your doctor, exactly as written on the label. Set up a dosing schedule and follow it carefully.

When your VITEKTA supply starts to run low, get more from your doctor or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. If VITEKTA is not taken regularly, as prescribed, the virus may develop resistance to VITEKTA and become harder to treat.

Only take medicine that has been prescribed specifically for you. Do not give VITEKTA to others or take medicine prescribed for someone else.

Do not use if seal over bottle opening is broken or missing.

Usual Adult Dose:

VITEKTA is not indicated for use in pediatric patients < 18 years of age.

You must always take VITEKTA with one of the following:

• Atazanavir (REYATAZ^®) and ritonavir (NORVIR^®)
• Darunavir (PREZISTA^®) and ritonavir
• Fosamprenavir (TELZIR ^®) and ritonavir
• Lopinavir/ritonavir (KALETRA^®)
• Tipranvir (APTIVUS^®) and ritonavir
• If you are taking VITEKTA with atazanavir (REYATAZ^®) and ritonavir (NORVIR^®) or lopinavir/ritonavir (KALETRA^®), the recommended dose of VITEKTA is one 85 mg tablet orally (by mouth) once a day.
• If you are taking VITEKTA with darunavir (PREZISTA^®) and ritonavir (NORVIR^®) , fosamprenavir (TELZIR ^®) and ritonavir or tipranavir (APTIVUS^®) and ritonavir, the recommended dose of VITEKTA is one 150 mg tablet orally (by mouth) once a day.
• Swallow with plenty of water.

• Take VITEKTA with food. Taking VITEKTA with food helps get the right amount of medicine in your body.

Overdosage:

Missed Dose:

It is important that you do not miss any doses. If you miss a dose of VITEKTA, take the missed dose as soon as possible with food. Then take your next dose as usual with your other HIV medicines. If it is almost time for your next dose of VITEKTA, do not take the missed dose. Wait and take your next dose with food at your usual time with your other HIV medicines. Do not take a double dose to make up for a missed dose. Call your doctor or pharmacist if you are not sure what to do.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects of VITEKTA are:

• Diarrhea
• nausea
• vomiting
• headache
• abdominal pain
• tiredness muscle and joint pain
• back pain

Additional side effects may include:

• back pain
• depression
• trouble sleeping
• rash

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.

For more information on the side effects of of the co-administered anti-HIV medicines see the Consumer Information Leaflets for these products.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of VITEKTA. If you have questions about side effects, ask your doctor, nurse, or pharmacist. You should report any new or continuing symptoms to your doctor right away. Your doctor may be able to help you manage these side effects.

HOW TO STORE IT

• Keep VITEKTA and all other medications out of reach of children.
• VITEKTA should be stored at 15–30 °C (59–86 °F). It should remain stable until the expiration date printed on the label.
• Do not keep your medicine in places that are too hot or cold.
• 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.
• Keep VITEKTA in its original container and keep the container tightly closed.

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

This document plus the full Product Monograph, prepared for health professionals can be found at: www.gilead.ca or by contacting the sponsor, Gilead Sciences Canada, Inc., at: 1-866-207-4267

Prepared: August 23, 2013

Gilead Sciences, LLC

Foster City, CA 94404

USA

Gilead Sciences Canada, Inc.

Mississauga, ON L5N 2W3

VITEKTA, TYBOST, STRIBILD are trademarks or registered trademarks of Gilead Sciences, Inc. or its related companies.

Other brands listed are trademarks of their respective owners.

2013 Gilead Sciences, Inc.

GS9427-1318\2-27-000