Cobicistat, elvitegravir, emtricitabine, and tenofovir

Cobicistat, elvitegravir, emtricitabine, and tenofovir are a combination of prescription medications used for the treatment of HIV infection. 

• Cobicistat, elvitegravir, emtricitabine, and tenofovir are available under the following different brand names: Genvoya, Stribild

Common side effects of Cobicistat, elvitegravir, emtricitabine, and tenofovir include:

• nausea
• occasional dizziness

Serious side effects of Cobicistat, elvitegravir, emtricitabine, and tenofovir include:

• headache
• difficulty falling asleep or staying asleep
• unusual dreams
• diarrhea
• gas
• rash
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty swallowing or breathing
• decreased urination
• pain in the arms, hands, feet, or legs
• pain in the upper right part of your stomach
• loss of appetite
• flu-like symptoms
• nausea
• vomiting
• extreme tiredness
• unusual bleeding or bruising
• weakness
• dizziness
• lightheadedness
• fast or irregular heartbeat
• trouble breathing
• dark yellow or brown urine
• light-colored bowel movements
• yellowing of the skin or eyes
• feeling cold, especially in the arms or legs
• muscle pain

 Rare side effects of Cobicistat, elvitegravir, emtricitabine, and tenofovir include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088

Adult dosage

Oral tablet

• 150 mg-150 mg-200 mg-10 mg;
• 150 mg-150 mg-200 mg-300 mg

HIV infection

Adult dosage

• 1 tablet orally once a day with food

Pediatric dosage

• Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide:
  • Below 25 kg: Safety and efficacy are not established
• Cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil fumarate (DF):
  • 12 years or older and at least 35 kg:
    • 1 tablet orally once a day with food

Dosage Considerations – Should be Given as Follows: 

• See “Dosages.”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Cobicistat, elvitegravir, emtricitabine, and tenofovir may have severe interactions with at least 35 other drugs.
• Cobicistat, elvitegravir, emtricitabine, and tenofovir may have serious interactions with at least 151 other drugs.
• Cobicistat, elvitegravir, emtricitabine, and tenofovir may have moderate interactions with at least 273 other drugs.
• Cobicistat, elvitegravir, emtricitabine, and tenofovir may have minor interactions with the following drugs:
  • buprenorphine
  • buprenorphine buccal
  • ganaxolone
  • ixazomib
  • naloxone

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

Coadministration with the following drugs:

• Alfuzosin
• Carbamazepine, phenobarbital, phenytoin
• Rifampin
• Lurasidone, pimozide
• Dihydroergotamine, ergotamine, methylergonovine
• Cisapride
• St. John’s wort (Hypericum perforatum)
• Lomitapide, lovastatin, simvastatin
• Phosphodiesterase-5 (PDE-5) inhibitor: Sildenafil when administered for treatment of pulmonary arterial hypertension
• Midazolam, triazolam

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Cobicistat, elvitegravir, emtricitabine, and tenofovir?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Cobicistat, elvitegravir, emtricitabine, and tenofovir?”

Cautions

• Tell your doctor about all your other medicines. Some drugs should not be used together.
• This medicine can harm your liver. Call your doctor at once if you have: upper stomach pain, loss of appetite, dark urine, clay-colored stools, or yellowing of your skin or eyes.
• Do not stop using this medicine without your doctor's advice. Get your prescription refilled before you run out of medicine completely.
• If you've had hepatitis B, it may come back or get worse after you stop using this medicine. You may need liver function tests for several months.

Pregnancy and Lactation

• This medicine may not work as well if you take it during pregnancy. Do not start taking the medicine if you are pregnant. Tell your doctor right away if you become pregnant.

Lactation

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