Darunavir and Cobicistat

Darunavir/cobicistat is a prescription medication used to treat human immunodeficiency virus (HIV) infection in adults.

It is a single product containing 2 medications: darunavir and cobicistat. Darunavir belongs to a group of drugs called protease inhibitors. It works by decreasing the amount of HIV in the blood. Cobicistat belongs to a group of drugs called pharmacokinetic enhancers. Cobicistat helps to keep darunavir in the body longer so that the medication will have a greater effect.

This medication comes in tablet form and is taken typically once a day, with food. Common side effects of darunavir/cobicistat include diarrhea, nausea, headache, abdominal pain and vomiting.

Darunavir/cobicistat is a prescription medication used to treat human immunodeficiency virus (HIV) infection in adults.

Darunavir and Cobicistat may be found in some form under the following brand names:

• Prezcobix

Serious side effects have been reported with darunavir/cobicistat. See the “Drug Precautions” section.

Common side effects of darunavir/cobicistat include the following:

• Diarrhea
• Nausea
• Rash
• Headache
• Abdominal Pain
• Vomiting

This is not a complete list of side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block activity of the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone
• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), St John's wort, and nimodipine (Nimotop)
• Ergot derivatives such as dihydroergotamine, ergotamine, methylergonovine
• Statins such as atorvastatin and rosuvastatin
• Hormonal contraceptives containing drospirenone and ethinyl estradiol (Gianvi, Loryna, Nikki, Ocella, Syeda, Vestura, Yasmin, Yaz, Zarah)
• St. Johns Wort
• Alfuzosin (Uroxatrol)
• Ranolazine (Ranexa)
• Dronedarone (Multaq)
• Colchicine (Colcrys)
• Rifampin
• Lurasidone (Latuda) or Pimozide (Orap)
• Ticagrelor (Brilinta)

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with darunavir/cobicistat including the following:

• Liver damage. Some people taking darunavir/cobicistat may develop liver problems which may be life-threatening. Your healthcare provider should do blood tests before and during your treatment. If you have chronic hepatitis B or C infection, your healthcare provider should check your blood tests more often because you have an increased chance of developing liver problems. Tell your doctor immediately if you notice signs and symptoms of liver problems such as:
  • Jaundice of the skin or eyes
  • Dark (tea colored) urine
  • Pale colored stools
  • Nausea
  • Vomiting
  • Loss of appetite
  • Pain
  • Aching
  • Sensitivity in the right upper quadrant of the stomach
• Severe skin reactions/rashes. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. Call your doctor right away if you develop a rash. Stop taking darunavir/cobicistat and call your doctor right away if you develop any skin changes with symptoms below:
  • Fever
  • Tiredness
  • Muscle or joint pain
  • Blisters or skin lesions
  • Mouth sores or ulcers
  • Red or inflamed eye, like "pink eye"
• Kidney damage. Tell your healthcare provider right away if you have some or all of the following symptoms of kidney damage:
  • Black or bloody stools (feces)
  • Feeling confused or changes in mood
  • Changes in appetite
  • Pain in the lower back
  • Bruising easily or bleeding that has trouble stopping
  • Having seizures
  • Feeling extremely tired or fatigued
  • Irregular urination including little to no urination
  • Nausea
  • Vomiting
  • Swelling of the feet
• Increases in blood sugars (hyperglycemia). Some people who take protease inhibitors including darunavir/cobicistat can get high blood sugar, develop diabetes, or your diabetes can get worse Tell your healthcare provider right away if you have some or all of the following symptoms of hyperglycemia:
  • Feeling hungry soon after eating
  • Urinating (peeing) very often
  • Feeling thirsty often
  • Having frequent headaches
  • Feeling tired or fatigued
• Changes in the way the body stores fat. The changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these conditions are not known. Tell your healthcare provider right away if you have some or all of the following symptoms of changes in fat storage:
  • Having more abdominal obesity,
  • Noticing a arms and legs getting thinner
  • Accumulation of fat around the face (moon face)
  • Accumulation of fat at the bottom of the neck and the top of the back (buffalo hump)
• 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.
• Damage and inflammation of the pancreas (pancreatitis). Tell your healthcare provider right away if you have some or all of the following symptoms of inflammation of the pancreas:
  • Pain in your stomach or abdomen
  • Swelling in the stomach or abdominal area
  • Nausea
  • Vomiting
  • Fever
  • Fast heart rate
  • Unexpected weight loss
• Bleeding disorders. Some people with hemophilia have increased bleeding with protease inhibitors including darunavir/cobicistat. Tell your healthcare provider right away if you have some or all of the following symptoms of a bleeding disorder:
  • Bleeding that does not stop easily or takes a long time to stop
  • Black or bloody stools (feces)
  • Reddish urine or blood in urine
  • Bruising easily
  • Bruises that get bigger or bruises that do not go away

Do not take darunavir/cobicistat if you:

• Are allergic to darunavir, cobicistat, or to any of its ingredients 
• Are taking other medications that are known to interact with darunavir/cobicistat

Grapefruit and grapefruit juice may interact with darunavir/cobicistat and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking darunavir/cobicistat, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to darunavir, cobicistat or to any of its ingredients
• have liver problems
• have kidney problems
• have high cholesterol
• have autoimmune conditions
• have or have had problems with your pancreas
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Darunavir/cobicistat falls into category C. There are no well-controlled studies that have been done in pregnant women. Darunavir/cobicistat should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if darunavir/cobicistat crosses into human milk. However, it is not recommended for HIV infected mothers to breastfeed their infants because breastfeeding increases the chance of passing the HIV virus to the infant through the breast milk. 

Take darunavir/cobicistat exactly as prescribed.

Do not change your dose or stop taking darunavir/cobicistat without talking to your doctor.

Darunavir/cobicistat comes in a tablet form and is taken once a day, with food. Darunavir/cobicistat should be taken with food.

Do not chew, divide, or break darunavir/cobicistat tablets. Swallow tablets whole.

If you miss a dose of darunavir/cobicistat, follow the instructions your health care provide has given you. 

Do not take more or less than your prescribed dose of darunavir/cobicistat at any one time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose for darunavir/cobicistat is 1 tablet (combination of 800 mg of darunavir and 150 mg of cobicistat) every day.

If you take too much darunavir/cobicistat, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If darunavir/cobicistat is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store darunavir/cobicistat at room temperature.
• Keep this and all medicines out of the reach of children