Description
Darunavir and cobicistat combination is used together with other medicines to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
Darunavir and cobicistat combination will not cure or prevent HIV infection or AIDS. It works by lowering the amount of HIV in the blood and it will also help your immune system. This may help delay some of the medical conditions that are usually result from AIDS or HIV disease. This medicine will not keep you from spreading HIV to other people.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of darunavir and cobicistat combination in children weighing 25 kilograms (kg) or more. However, safety and efficacy have not been established in children weighing less than 25 kg. Use is not recommended in children younger than 3 years of age because of darunavir's toxicity.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of atazanavir and cobicistat combination in the elderly. However, elderly patients are more likely to have age-related liver problems, which may require caution for patients receiving this medicine.
Breastfeeding
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.
Drug Interactions
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.
- Alfuzosin
- Alprazolam
- Astemizole
- Bromocriptine
- Carbamazepine
- Cisapride
- Colchicine
- Conivaptan
- Crizotinib
- Dihydroergotamine
- Domperidone
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Dronedarone
- Drospirenone
- Elbasvir
- Eletriptan
- Eplerenone
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Finerenone
- Flibanserin
- Fosphenytoin
- Gepirone
- Grazoprevir
- Isavuconazonium Sulfate
- Ivabradine
- Levoketoconazole
- Lisuride
- Lomitapide
- Lonafarnib
- Lovastatin
- Lurasidone
- Maraviroc
- Mavacamten
- Metergoline
- Methylergonovine
- Methysergide
- Midazolam
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.
- Abametapir
- Acalabrutinib
- Acebutolol
- Acecainide
- Adagrasib
- Adenosine
- Ado-Trastuzumab Emtansine
- Afatinib
- Ajmaline
- Alfentanil
- Alpelisib
- Alprazolam
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amlodipine
- Amobarbital
- Amoxapine
- Amprenavir
- Apalutamide
- Apixaban
- Aprepitant
- Aprindine
- Aprobarbital
- Aranidipine
- Aripiprazole
- Aripiprazole Lauroxil
- Artemether
- Asciminib
- Atazanavir
- Atenolol
- Atidarsagene Autotemcel
- Atogepant
- Atorvastatin
- Atrasentan
- Avacopan
- Avanafil
- Avapritinib
- Azathioprine
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.
- Amlodipine
- Apalutamide
- Atazanavir
- Cobicistat
- Darunavir
- Indinavir
- Nelfinavir
- Tenofovir Disoproxil Fumarate
Other Interactions
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:
- Diabetes or
- Fanconi syndrome (kidney disease), history of or
- Hemophilia (a bleeding problem) or
- Hyperglycemia (high blood sugar) or
- Kidney failure, history of or
- Liver disease (including hepatitis B or C) or
- Sulfa allergy—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
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. Ask your doctor if you have any questions.
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 also using didanosine (Videx®), take it 1 hour before or 2 hours after taking Prezcobix®.
Darunavir and cobicistat contains a fixed amount of medicine in each tablet.
Take this medicine with food.
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 and children weighing 40 kilograms (kg) or more—One tablet once a day. Each tablet contains 800 milligrams (mg) of darunavir and 150 mg of cobicistat.
- Children weighing 25 kg to less than 40 kg—One tablet once a day. Each tablet contains 675 mg of darunavir and 150 mg of cobicistat.
- Children weighing less than 25 kg—Use and dose must be determined by your doctor.
- Children younger than 3 years of age—Use is not recommended.
- For treatment of HIV infection:
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.
Precautions
It is very important that your doctor check your progress at regular visits, especially during the first few weeks that you take this medicine, to make sure it is working properly. Blood and urine tests may be needed to check for any unwanted effects.
This medicine should not be used together with alfuzosin (Uroxatral®), carbamazepine (Tegretol®), cisapride (Propulsid®), dronedarone (Multaq®), elbasvir/grazoprevir (Zepatier®), ivabradine (Corlaonor®), lomitapide (Juxtapid®, Lojuxta®), lovastatin (Mevacor®), lurasidone (Latuda®), naloxegol (Movantik®, Moventig®), oral midazolam (Versed®), phenobarbital (Luminal®), phenytoin (Dilantin®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®, Rimactane®), sildenafil (Revatio®), simvastatin (Zocor®), St. John's wort, triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, Ergomar®, Wigraine®). Do not use this medicine together with colchicine (Colcrys®) if you have kidney or liver disease.
Using this medicine while you are pregnant can harm your unborn baby. Birth control pills may not work as well to prevent pregnancy when used with this medicine. Use another form of birth control (eg, condoms, spermicide) along with your pills to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis) can occur with this medicine. Check with your doctor right away if you have any of the following symptoms: severe rash, blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red skin lesions, often with a purple center, skin rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.
This medicine may increase your risk for kidney problems, including acute kidney failure or Fanconi syndrome (when used together with tenofovir DF). Check with your doctor right away if you have changes in how much you urinate, decreased mental sharpness, nausea, vomiting, loss of appetite, or muscle twitches or cramps.
This medicine may increase blood sugar levels. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.
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 (eg, Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis) may also occur.
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 non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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:
Incidence not known
- Agitation
- blistering, peeling, or loosening of the skin
- chills
- clay-colored stools
- confusion
- cough
- dark urine
- decreased appetite
- decreased awareness or responsiveness
- decreased urine output
- depression
- diarrhea
- dizziness
- fever
- headache
- irritability
- itching, skin rash
- joint or muscle pain
- loss of appetite
- loss of consciousness
- lower back pain
- muscle cramps, spasms, stiffness, or twitching
- nausea
- pain or burning while urinating
- rapid weight gain
- red skin lesions, often with a purple center
- red, irritated eyes
- seizures
- severe sleepiness
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain or tenderness
- swelling of the face, hands, feet, lower legs, or ankles
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- vomiting
- yellow eyes or skin
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:
Incidence not known
- Increased amount of fat in the upper back and neck, or around the chest and stomach area
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.
DRG-20137722
