Elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (Oral)

Overview

Elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide helps to treat an HIV (human immunodeficiency virus) infection. It's one product combining four medicines:

Elvitegravir - an HIV medication known as integrase inhibitor.

Cobicistat - a medication known as a pharmacokinetic enhancer, which helps make elvitegravir more effective. It has no effect on HIV but enhances the levels of blood and efficacy of other drugs.

Emtricitabine - an HIV medication known as nucleoside reverse-transcriptase inhibitor.

Tenofovir alafenamide - another HIV medication (a nucleoside reverse-transcriptase inhibitor).

These drugs work together to reduce the level of HIV in one's blood.

Elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide was approved by the FDA in November 2015 for people who are at least 12 years old and who are either beginning their first HIV treatment or those who want to change their current treatment routines (as long as they've been in a strong routine for at least six months, have no resistance to any of Genvoya's drugs, have no history of failure of HIV treatment, and have an unnoticeable viral load).

Genvoya comes in the form of a tablet and is usually taken once daily with food. Common Genvoya side effects include increases in cholesterol and nausea.

Conditions Treated

  • HIV

Type Of Medicine

  • Anti-infective agent

Side Effects

Trouble sleeping, back pain, unusual dreams, diarrhea, dizziness, headache or change in color of soles of feet or skin on palms may occur. If you suffer any of these effects and they worsen or continue, report it to your physician and pharmacist promptly.

Remember that your physician has prescribed elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide because they have concluded that its benefits outweigh the risk of side effects. The majority of people using this drug don't develop serious side effects.

As the immune system becomes stronger, it may start to drive away infections you had already, possibly making disease symptoms come back. You may also develop symptoms if your immunity gets overactive. This reaction may occur at any time (many months later or soon after beginning HIV treatment).

Get medical assistance promptly if you develop any of these very serious symptoms:

  • Unexplained weight loss
  • Joint pain
  • Severe or persistent headaches
  • Severe tiredness
  • Muscle aches or weakness that persists
  • Tingling or numbness of hands, arms, legs, or feet
  • Signs of infection (e.g. chills, fever, troubled breathing, swollen lymph nodes, non-healing skin sores, cough)
  • Vision changes
  • Signs of overactive thyroid (e.g. nervousness, irritability, heat intolerance, irregular or fast or pounding heartbeat)
  • Bulging eyes
  • Goiter (abnormal growth in the thyroid or neck)
  • Signs of a nerve condition called Guillan-Barre Syndrome (e.g. difficulty in swallowing, breathing, or moving your eyes, trouble speaking, paralysis, drooping face).

Tell your healthcare specialist promptly if you develop any serious effects, such as:

Signs of kidney issues (e.g. bloody or pink urine, change in urine amount)

Mood or mental changes (e.g. anxiety, depression)

Elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide rarely causes severe (sometimes deadly) blood and liver problems (lactic acidosis). Be sure to let your healthcare specialist if you suffer symptoms of liver issues, including:

  • Nausea or vomiting that persists
  • Abdominal or stomach pain
  • Loss of appetite
  • Lactic acidosis (e.g. deep or rapid breathing, nausea or vomiting, drowsiness, unusual weakness)
  • Jaundice (yellowing skin or eyes, dark urine)

These serious elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide side effects are more likely to occur if you're a woman or you're obese (extremely overweight).

Body fat changes can occur while you use Genvoya (such as having more fat in the stomach and upper back areas, reduced fat in the legs and arms). These changes have no known origin and long-term effects. Talk about the benefits and risks of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide treatment with your physician, in addition to the potential role of exercise in reducing this side effect

Tenofovir can increase the possibility of bone loss. Please discuss the benefits and risks of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide treatment with your physician, along with the potential role of vitamin D and calcium to ease this side effect. Your doctor may assess the density of your bone mineral if you're vulnerable to bone loss. Tell your doctor promptly if you develop any of these serious effects: easily broken bones, bone pain.

Elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide rarely causes a severe allergic reaction. However, seek medical assistance promptly if you develop any of these symptoms of a severe allergic reaction:

  • Rash
  • Swelling or itching (especially of the tongue, face or throat)
  • Troubled breathing
  • Severe dizziness

This isn't a comprehensive list of potential elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide side effects. If you develop other, different side effects, please contact your physician and pharmacist.

Dosage

Take Genvoya exactly as instructed by your healthcare provider. Don't take less or more of it, don't take it for longer than directed, and don't take it more times than instructed.

The recommended elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide dose is a single tablet taken once a day with food.

This drug comes with a leaflet containing patient information. Please read and follow all instructions carefully and be sure to re-read them every time you get a new prescription, in case they contain new information. If you've got any questions, speak to your doctor.

Don't adjust the dose or discontinue using Genvoya without first checking with your healthcare provider. When your Genvoya supply is running low, get in touch with your pharmacist or doctor ahead of time. Don't let yourself run out of Genvoya. This is vitally important, as the level of virus in the blood may go up if you stop taking elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide even for a brief period. The virus may become resistant to the drug and become more difficult to treat.

Interactions

Using Genvoya with any of the medicines below isn't recommended. Your healthcare specialist may opt to not treat you with Genvoya or adjust some of the alternative medicines you use:

  • Carbamazepine
  • Cisapride
  • Colchicine
  • Dihydroergotamine
  • Conivaptan
  • Doxorubicin Hydrochloride Liposome
  • Crizotinib
  • Doxorubicin
  • Eletriptan
  • Dronedarone
  • Eplerenone
  • Eliglustat
  • Ergotamine
  • Ergonovine
  • Isavuconazonium Sulfate
  • Fosphenytoin
  • Ivabradine
  • Lovastatin
  • Lomitapide
  • Alfuzosin
  • Maraviroc
  • Lurasidone
  • Pazopanib
  • Naloxegol
  • Midazolam
  • Pimozide
  • Methylergonovine
  • Ranolazine
  • Phenobarbital
  • Primidone
  • Rifampin
  • Riociguat
  • Romidepsin
  • Phenytoin
  • Silodosin
  • Sildenafil
  • Venetoclax
  • Simvastatin
  • Triazolam
  • Tolvaptan
  • St John's Wort

Using Genvoya with any of the medications below is normally not advised, but may be necessary in certain situations. If your healthcare specialist has prescribed both medicines together, they may adjust the frequency or dose with which you take one or both of the medications.

  • Ado-Trastuzumab Emtansine
  • Aluminum Carbonate, Basic
  • Alprazolam
  • Aluminum Hydroxide
  • Afatinib
  • Amiodarone
  • Amprenavir
  • Apixaban
  • Aluminum Phosphate
  • Aripiprazole
  • Aprepitant
  • Bedaquiline
  • Avanafil
  • Cabozantinib
  • Boceprevir
  • Bosentan
  • Bromocriptine
  • Bosutinib
  • Calcium Carbonate
  • Budesonide
  • Calcifediol
  • Carbamazepine
  • Cilostazol
  • Cabazitaxel
  • Cariprazine
  • Clarithromycin
  • Cyclophosphamide
  • Darunavir
  • Cobimetinib
  • Ceritinib
  • Cyclosporine
  • Dabrafenib
  • Dasatinib
  • Deflazacort
  • Daclatasvir
  • Delavirdine
  • Delamanid
  • Diazepam
  • Dihydroxyaluminum Aminoacetate
  • Dexamethasone
  • Digoxin
  • Docetaxel
  • Dihydroxyaluminum Sodium Carbonate
  • Donepezil
  • Domperidone
  • Erlotinib
  • Erythromycin
  • Disopyramide
  • Flecainide
  • Betrixaban
  • Everolimus
  • Fluoxetine
  • Eslicarbazepine Acetate
  • Etravirine
  • Fentanyl
  • Eszopiclone
  • Fosamprenavir
  • Fluticasone
  • Haloperidol
  • Hydrocortisone
  • Fosaprepitant
  • Ifosfamide
  • Ibrutinib
  • Iloperidone
  • Irinotecan Liposome
  • Itraconazole
  • Ketoconazole
  • Idelalisib
  • Ivacaftor
  • Levomilnacipran
  • Irinotecan
  • Magnesium Hydroxide
  • Magnesium Trisilicate
  • Magnesium Oxide
  • Macitentan
  • Lidocaine
  • Lopinavir
  • Lapatinib
  • Methadone
  • Magnesium Carbonate
  • Manidipine
  • Mexiletine
  • Midostaurin
  • Morphine Sulfate Liposome
  • Morphine
  • Mifepristone
  • Magaldrate
  • Netupitant
  • Nilotinib
  • Nifedipine
  • Nimodipine
  • Olaparib
  • Oxcarbazepine
  • Orlistat
  • Nevirapine
  • Oxycodone
  • Palbociclib
  • Panobinostat
  • Phenobarbital
  • Nisoldipine
  • Piperaquine
  • Phenytoin
  • Prednisone
  • Pimavanserin
  • Propafenone
  • Ponatinib
  • Quinidine
  • Quetiapine
  • Reboxetine
  • Rifabutin
  • Ritonavir
  • Regorafenib
  • Ribociclib
  • Retapamulin
  • Rifapentine
  • Rosuvastatin
  • Pixantrone
  • Rivaroxaban
  • Ruxolitinib
  • Rifampin
  • Salmeterol
  • Sirolimus
  • Saquinavir
  • Sodium Bicarbonate
  • Simeprevir
  • Sunitinib
  • Suvorexant
  • Tadalafil
  • Tamoxifen
  • Tacrolimus
  • St John's Wort
  • Telithromycin
  • Temsirolimus
  • Thiotepa
  • Tamsulosin
  • Trabectedin
  • Ticagrelor
  • Trazodone
  • Tramadol
  • Topotecan
  • Vilanterol
  • Tipranavir
  • Toremifene
  • Vemurafenib
  • Vilazodone
  • Vinblastine
  • Vincristine Sulfate Liposome
  • Vincristine
  • Vinflunine
  • Voriconazole
  • Vorapaxar
  • Warfarin
  • Vardenafil
  • Zolpidem
  • Valbenazine

Using elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide with any of the medicines below can increase the risk for some side effects, but taking both medicines could be the best option for you. If your doctor has prescribed both medicines, they may adjust your dose or how frequently you take one or both medicines.

  • Atazanavir
  • Aripiprazole Lauroxil
  • Indinavir
  • Darunavir
  • Nelfinavir

If you're taking calcium carbonate or antacids that contain aluminum or magnesium (such as Tums Mylanta, Maalox), don't take them together with elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. It's best to use these medications at least two hours after or before taking elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. These medications may stop elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide from working properly.

Warnings

Before you start using any medicine, make sure to let your doctor know of any medicines you are using, any allergies or medical conditions you may have and any other crucial details about your health. Especially let your physician know if you:

  • Have kidney problems
  • Have liver problems
  • Have bone problems
  • Are allergic to elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide or its ingredients
  • Have Hepatitis B infection
  • Are nursing (breastfeeding) an infant or planning to nurse one
  • Are pregnant/want to get pregnant

The following factors can affect how you take elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

Bone effects

Tenofovir alafenamide can decrease both growth and bone strength in teenagers. The effect of this medicine on risk of fractures and bone density is unclear, but other varieties of tenofovir alafenamide appear to be linked to reduced bone density. Contact your doctor if you suffer a bone fracture or bone pain while taking elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. Your doctor may carry out tests to assess the effect of the medication on your bones. Please discuss any concerns you have about bone health with your doctor.

Fat redistribution

Over time, elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide may alter how fat is spread in your body, potentially changing the shape of your body. You may notice more fat in the neck and upper back, breasts, chest and around the back and stomach areas, or you may notice fat loss in the face, legs and arms. The lasting effects of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide are not known.

Hepatitis B

If you have hepatitis B, your physician will discuss HIV treatment with you before you start taking elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. The safety and efficacy of using this medicine haven't been determined if you suffer from both hepatitis B and HIV. People who have taken tenofovir or emtricitabine (two of the medicines in this product) and have hepatitis B have experienced very serious recurrences of their condition when the tenofovir or emtricitabine has been stopped.

Kidney function

This medicine has been shown to change the function of kidneys. If you have kidney disease or reduced kidney function, talk to your physician about how elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide can affect your medical problem, how your medical issue may affect the dosage and efficacy of this medication, and whether you need any special monitoring.

Liver function

The liver gets rid of cobicistat and elvitegravir from the body and this may lead to liver issues. If you have reduced liver function or liver disease, talk to your healthcare provider about how elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide may affect your condition, how your condition can affect the dosage and efficacy of the medication, and whether you require any special monitoring.

If you have symptoms of liver issues (such as persistent vomiting, abdominal pain, fever, itching, feeling unwell, yellowing of eyes and skin, dark urine), get in touch with your doctor promptly.

Immune reconstitution syndrome

Elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide may lead to immune reconstitution syndrome, in which symptoms and signs of inflammation from earlier infections occur. These symptoms happen soon after beginning anti-HIV medicine and may vary. They're thought to happen due to the immune system getting better and being able to battle illnesses that have existed without symptoms (for example tuberculosis, pneumonia, or herpes). Let your doctor know about any new symptoms as soon as possible.

Enlarged liver and lactic acidosis

Elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide can lead to a serious but rare condition known as lactic acidosis (lactic acid buildup), along with a fatty enlarged liver. Your doctor will check on you periodically and do lab tests to assess your liver function. Please seek immediate medical care if you have any signs or symptoms of enlarged liver and lactic acidosis, such as vomiting, nausea, weakness, stomach pain, tiredness, dizziness, feeling cold, irregular heartbeat, or lightheadedness.

Pregnancy

Elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide should only be taken during pregnancy if the benefits are greater than the risks. Contact your doctor straight away if you get pregnant while using this medication.

Breastfeeding

It's unclear whether tenofovir alafenamide, elvitegravir, or cobicistat gets into human milk. Emtricitabine gets into human milk and can harm your baby. You should not breastfeed if you have HIV infection because this increases the chances of passing your HIV infection to a child who doesn't have the condition.

Children

The efficacy and safety of using elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide haven't been determined for kids who are younger than 12 or weigh under 35 kg.

Pancreatitis (inflammation of pancreas)

Pancreatitis may be caused or worsened by tenofovir. If you're susceptible to having pancreatitis or have had the condition in the past, you should be carefully monitored by your physician while taking elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. If you have signs of pancreatitis (such as back pain, pain in the left upper abdomen, fever, chills, nausea, swollen abdomen, rabid heartbeat), contact your doctor.

Stopping elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide

If you stop using this medicine, your HIV infection could worsen. Some people who have hepatitis B infection too experience a worsening of the condition when emtricitabine or tenofovir are discontinued. Please take elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide exactly as instructed by your physician, and don't stop using the medicine without first consulting your doctor.

Avoid activities that may spread the HIV to other people:

  • Don't re-use or share needles/other injection equipment.
  • Don't engage in any type of sex without condoms. Always protect yourself by using a polyurethane or latex condom to reduce the risk of coming into contact with blood, semen or vaginal secretions.

Storage

  • Keep elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide at room temperature.
  • Keep elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide away from moisture and light.
  • Don't keep elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide in the bathroom.
  • Store all medicines away from your pets and kids.

Summary

Taking elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide (Genvoya) may cause deadly damage to your liver and a possibly fatal condition known as lactic acidosis (lactic acid buildup in blood). Let your physician know if you've ever developed liver disease or have it now. You could also be at a higher risk of suffering lactic acidosis if you're very overweight, if you're female, or if you have been taking Genvoya for a long period of time.

If you suffer any of these symptoms, contact your doctor straight away or seek emergency medical care: vomiting, nausea, loss of appetite, pain in the right upper part of the stomach, flu-like symptoms, unusual bleeding/bruising, extreme tiredness, lightheadedness, dizziness, troubled breathing, brown or dark yellow urine, irregular or fast heartbeat, yellowing of eyes or skin, light-colored bowel movements, feeling cold (particularly in the legs or arms), or unusual muscle pain.

You shouldn't use elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide to treat hepatitis B virus (HBV), an ongoing infection of the liver. Tell your physician if you have HBV or think you have it. Your physician may examine you to find out if you have the infection before you start treatment with elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide. Your condition may worsen suddenly when you stop taking the medication. Your physician will assess you and order regular lab tests for a number of months after you've stopped taking elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide to find out if your HBV infection has become worse.

This medication is not recommended for use by kids younger than 12 or kids weighing less than 35 kg.

Honor all of your lab and doctor appointments. Your healthcare provider will order some tests prior to and during treatment to assess your response to elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide.

Discuss with your healthcare provider the risks of using elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide and don't stop using it without first consulting your doctor.

For more information about elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide, ask all your healthcare providers.