Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide, (Oral route)
el-vi-TEG-ra-vir, koe-BIK-i-stat, em-trye-SYE-ta-been, ten-OF-oh-vir al-a-FEN-a-mide
Life-threatening and fatal cases of lactic acidosis and severe hepatomegaly with steatosis have occurred with concurrent use of antiretrovirals with nucleoside analogs. Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe, acute exacerbations of hepatitis B have occurred in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir disoproxil fumarate. If patients are coinfected with HBV and HIV-1, monitor hepatic function closely for several months or more following the discontinuation of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, and consider starting anti-hepatitis B therapy if appropriate .
Uses of This Medicine:
Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide combination is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have yet not received any medicine for HIV infection.
Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide combination will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. This medicine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide combination in children younger than 12 years of age. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide combination in the elderly.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
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.
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.
- Doxorubicin Hydrochloride Liposome
- Isavuconazonium Sulfate
- 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.
- Ado-Trastuzumab Emtansine
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Calcium Carbonate
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Irinotecan Liposome
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Trisilicate
- Morphine Sulfate Liposome
- Sodium Bicarbonate
- St John's Wort
- Vincristine Sulfate Liposome
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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:
- Bone problems (eg, fracture, osteomalacia), history of or
- Fanconi syndrome (kidney disease), history of or
- Hepatitis B infection, history of or
- Kidney failure, history of Use with caution. May make these conditions worse.
- Kidney disease, severe or
- Liver disease, severe Use is not recommended in patients with these conditions.
Proper Use of This Medicine:
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. You should talk to your doctor if you have any questions.
This medicine should be taken with food.
Do not change the dose or stop using 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.
If you are taking aluminum or magnesium-containing antacids (such as Maalox®, Mylanta®, Tums®), do not take them at the same time that you take this medicine. It is best to take these medicines at least 2 hours before or after taking Genvoya®. These medicines may keep Genvoya® from working properly.
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 and children 12 years of age and older One tablet once a day.
- Children younger than 12 years of age Use and dose must be determined by your doctor.
- For treatment of HIV infection:
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.
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Do not use this medicine if the seal on the bottle is broken or missing. Keep the bottle tightly closed. Keep the medicine in the original bottle that you were given at the pharmacy.
Precautions While Using This Medicine:
Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for any unwanted effects.
The medicines in this combination tablet are also available as Atripla®, Complera®, Emtriva®, Truvada®, Tybost®, Viread®, or Vitekta®. Do not take the elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide combination with any of these medicines.
This medicine should not be used together with adefovir (Hepsera®), alfuzosin (Uroxatral®), carbamazepine (Tegretol®), cisapride (Propulsid®), lamivudine (Combivir®, Epivir®, Epivir-HBV®, Epzicom®, Triumeq®, Trizivir®), lovastatin (Mevacor®), midazolam (Versed®), phenobarbital (Luminal®), phenytoin (Dilantin®), pimozide (Orap®), rifampin (Rifadin®, Rimactane®), ritonavir (Kaletra®, Norvir®), sildenafil (Revatio®), simvastatin (Zocor®), triazolam (Halcion®), St John's wort, ergotamine medicines (such as dihydroergotamine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®), certain other antiviral medications (acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir), aminoglycoside antibiotics, or high-dose or multiple NSAID pain medicines.
Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity. These reactions are more common if you are female, obese, or have been taking anti-HIV medicines for a long time. Call your doctor right away if you have abdominal or stomach pain, nausea, vomiting, decreased appetite, muscle cramping or pain, unusual tiredness or weakness, trouble breathing, or yellow skin or eyes.
This medicine may cause you to have excess body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.
Your immune system may get stronger when you start taking HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.
This medicine may also increase your risk of developing fractures (broken bones). Ask your doctor about this if you have any concerns.
This medicine does not decrease the risk of transmitting 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.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- Incidence not known
- Abdominal or stomach discomfort
- bloody urine
- bone pain
- dark urine
- decreased appetite
- decreased frequency or amount of urine
- fast, shallow breathing
- general feeling of discomfort
- increased thirst
- light-colored stools
- loss of appetite
- lower back or side pain
- muscle pain or cramping
- nausea and vomiting
- pain in the arms or legs
- right upper abdominal or stomach pain and fullness
- swelling of the face, fingers, or lower legs
- troubled breathing
- unusual tiredness or weakness
- weight gain
- yellow eyes and skin
- More common
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
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 or are bothersome or if you have any questions about them:
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.
Last Updated: 9/15/2016