Elvitegravir (Oral)

Elvitegravir is used together with ritonavir and another HIV medicine (for example, atazanavir, darunavir, fosamprenavir, lopinavir, tipranavir) to treat infections caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is for patients who are already taking or have taken HIV medicines in the past.

Elvitegravir will not cure or prevent HIV infection or AIDS, but it helps stop HIV from reproducing and may slow down the damage to the immune system. This can help delay the problems that usually come with AIDS or HIV disease. Elvitegravir will not stop you from spreading HIV to others. People taking this medicine may still experience some of the issues typically related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine with cobicistat (Tybost®) or any other medicines that contain cobicistat (for example, Stribild®).

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (for example, St. John's wort) or vitamin supplements.

Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you or your child notice any changes in your health. Sometimes the immune system will begin to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (for example, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

This medicine does not lower the risk of passing the HIV infection to others through sexual contact or by contaminated blood. Make sure you understand and practice safe sex, even if your partner also has HIV. Avoid sharing needles with anyone.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

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

Pediatric

Appropriate studies have not been done to understand how elvitegravir affects children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any geriatric-specific issues that would limit the usefulness of elvitegravir in older adults. However, older patients are more likely to have kidney, liver, or heart problems related to age, which may require caution when taking elvitegravir.

Breast Feeding

There are no enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. It is very important that your healthcare professional knows if you are taking any of the medicines listed below while taking this medicine. The following interactions are significant and are not necessarily a complete list.

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
• Levoketoconazole
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• St John's Wort

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

• Aluminum
• Atazanavir
• Bosentan
• Cabotegravir
• Calcium
• Ceritinib
• Cobicistat
• Dabrafenib
• Desogestrel
• Dexamethasone
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Fedratinib
• Fluconazole
• Gestodene
• Iron
• Itraconazole
• Ketoconazole
• Levonorgestrel
• Magaldrate
• Magnesium
• Mavacamten
• Medroxyprogesterone
• Mestranol
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Orlistat
• Oxcarbazepine
• Prednisone
• Rifabutin
• Rifapentine
• Ritlecitinib
• Segesterone
• Sucralfate
• Tocilizumab
• Ulipristal
• Voriconazole
• Warfarin
• Zinc

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Diarrhea

Less common

• Headache
• Nausea

Less common or rare

• Discouragement
• Feeling sad or empty
• Heartburn
• Indigestion
• Irritability
• Lack of appetite
• Loss of interest or pleasure
• Rash
• Stomach discomfort, upset, or pain
• Thoughts or attempts at killing oneself
• Trouble concentrating
• Trouble sleeping
• Unusual tiredness or weakness
• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Vitekta

Pharmacologic Class: Integrase Inhibitor

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change the dose or stop taking this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Keep taking elvitegravir for the full time of treatment, even if you begin to feel better. It is also important that you continue taking all other medicines for HIV infection your doctor has instructed you to take. Elvitegravir will not work if it is taken alone. It must be taken with other HIV medicines.

This medicine works best when there is a constant amount in the blood. To help keep blood levels constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times during the day. For example, if you are taking one dose per day, try to take it at the same time each day. If you need help planning the best times to take your medicine, check with your doctor.

Take this medicine with food.

If you are also using didanosine, take it at least 1 hour before or 2 hours after taking elvitegravir. If you are also using an antacid, take it at least 2 hours before or after elvitegravir.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For treatment of HIV infection: Adults— 85 milligrams (mg) once a day together with any of the following: Ritonavir 100 mg once a day with atazanavir 300 mg once a day. Ritonavir 100 mg two times a day with lopinavir 400 mg two times a day. 150 mg once a day together with any of the following: Ritonavir 100 mg two times a day with darunavir 600 mg two times a day. Ritonavir 100 mg two times a day with fosamprenavir 700 mg two times a day. Ritonavir 200 mg two times a day with tipranavir 500 mg two times a day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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