Vitekta

Vitekta is a prescription medication is used to treat HIV infection in patients who have been tried on treatment for HIV before.

Vitekta belongs to a group of drugs called (HIV-1) integrase inhibitor. These work by decreasing the amount of HIV in the blood.

This medication comes in tablet form and is taken once daily, with food. Vitekta must be given with a protease inhibitor, ritonavir, and with another antiretroviral drug.

Common side effects of Vitekta include diarrhea and nausea.

Vitekta may cause serious side effects, including:

• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 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 right away if you start having new symptoms after starting your HIV-1 medicine.

Vitekta must be taken with an HIV protease inhibitor medicine along with ritonavir (Norvir). You must also take other antiretroviral medicines prescribed by your healthcare provider. 

It is not known if Vitekta is safe and effective in children.

When used with other HIV-1 medicines to treat HIV-1 infection, Vitekta may:

• Reduce the amount of HIV-1 in your blood. This is called "viral load".
• Increase the count of CD4+ (T) cells in your blood that help fight off other infections. 

Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve the immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).

Vitekta does not cure HIV-1 infections or AIDS. You must stay on continuous HIV-1 therapy to control HIV-1 infection and decrease HIV-related illnesses.

Avoid doing things that can spread HIV-1 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 safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. 

Ask your healthcare provider if you have any questions about how to prevent passing HIV-1 to other people.

Before you take Vitekta, tell your healthcare provider if you:

• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of elvitegravir in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of elvitegravir in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution for patients receiving elvitegravir.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Carbamazepine
• Fosphenytoin
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• St John's Wort

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Bosentan
• Calcium Carbonate
• Ceritinib
• Darunavir
• Dexamethasone
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Idelalisib
• Itraconazole
• Ketoconazole
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Orlistat
• Oxcarbazepine
• Prednisone
• Rifabutin
• Rifapentine
• Sodium Bicarbonate
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease, severe—Use is not recommended in patients with these conditions.

• It is used to treat HIV infection.

• If your child has an allergy to Vitekta (elvitegravir) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have liver disease.
• If you are taking cobicistat and you are also taking certain other drugs to treat HIV. There are many drugs that are not to be taken if you are taking Vitekta along with cobicistat. Ask your doctor or pharmacist if you are not sure.
• If you are taking any of these drugs: Boceprevir, carbamazepine, efavirenz, nevirapine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, or St. John's wort.
• If you are taking another drug that has the same drug in it.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Vitekta with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions

The concomitant use of Vitekta and other drugs may result in known or potentially significant drug interactions, some of which may lead to [see Drug Interactions (7)]:

• Loss of therapeutic effect of Vitekta and possible development of resistance
• Possible clinically significant adverse reactions from greater exposures of concomitant drugs or elvitegravir.

See Table 4 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations [see Drug Interactions (7)]. Consider the potential for drug interactions prior to and during Vitekta therapy; review concomitant medications during Vitekta therapy; and monitor for the adverse reactions associated with the concomitant drugs.

Use with Other Antiretroviral Agents

Use of Vitekta in combination with the fixed dose combination STRIBILD is not recommended, because elvitegravir is a component of STRIBILD.

Vitekta is indicated for use in combination with a protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s). Vitekta in combination with a protease inhibitor and cobicistat is not recommended because dosing recommendations for such combinations have not been established and may result in suboptimal plasma concentrations of Vitekta and/or the protease inhibitor, leading to loss of therapeutic effect and development of resistance.

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

NDC 61958-1301-1
30 tablets

Vitekta®
(elvitegravir) Tablets

85 mg

Note to pharmacist:
Do not cover ALERT box with pharmacy label.

ALERT: Find out about medicines that
should NOT be taken with Vitekta®

You should not use Vitekta if you are also taking dofetilide (Tikosyn).

You should not use Vitekta if you are allergic to elvitegravir or if you are also taking cobicistat (Stribild, Tybost) or any other medicines that contain elvitegravir.

To make sure Vitekta is safe for you, tell your doctor if you have:

• liver disease, especially hepatitis B or C.

Vitekta is not expected to harm an unborn baby. However, HIV can be passed to your baby if you are not properly treated during pregnancy. Tell your doctor if you are pregnant and take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Vitekta on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Avoid taking an antacid within 2 hours before or 2 hours after you take Vitekta. Some antacids can make it harder for your body to absorb elvitegravir.

Taking HIV medication will not prevent you from passing HIV to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Vitekta, especially:

• bosentan;

• buprenorphine, naloxone;

• dexamethasone;

• ketoconazole;

• methadone;

• St. John's wort;

• hepatitis C medications - boceprevir or telaprevir;

• hormonal birth control - ills, injections, implants, skin patches, vaginal rings;

• other HIV or AIDS medicines - didanosine, efavirenz, nevirapine;

• seizure medication - carbamazepine, oxcarbazepine, phenobarbital, phenytoin; or

• tuberculosis medicine - rifabutin, rifampin, rifapentine.

This list is not complete. Other drugs may interact with elvitegravir, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.