Description
Cobicistat is used to increase the effects of atazanavir or darunavir for the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).
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 cobicistat in combination with atazanavir to treat HIV infection in children weighing at least 35 kilograms (kg), or in combination with darunavir to treat HIV infection in children weighing at least 40 kg. However, safety and efficacy of cobicistat in combination with darunavir in children weighing less than 40 kg, or in combination with atazanavir in children weighing less than 35 kg have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cobicistat in the elderly.
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
- Bromocriptine
- Carbamazepine
- Cisapride
- Colchicine
- Conivaptan
- Crizotinib
- Dihydroergotamine
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Dronedarone
- Drospirenone
- Eletriptan
- Eplerenone
- Ergoloid Mesylates
- Ergonovine
- Ergotamine
- Finerenone
- Flibanserin
- Fosphenytoin
- Gepirone
- Isavuconazonium Sulfate
- Ivabradine
- Lisuride
- Lomitapide
- Lonafarnib
- Lovastatin
- Lurasidone
- Mavacamten
- Metergoline
- Methylergonovine
- Methysergide
- Midazolam
- Naloxegol
- Nicergoline
- Pacritinib
- Pazopanib
- Phenobarbital
- Phenytoin
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
- Acecainide
- Adagrasib
- Adenosine
- Ado-Trastuzumab Emtansine
- Afatinib
- Ajmaline
- Alfentanil
- Alpelisib
- Amineptine
- Amiodarone
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Amprenavir
- Apalutamide
- Apixaban
- Aprepitant
- Aprindine
- Aripiprazole
- Asciminib
- Atidarsagene Autotemcel
- Atogepant
- Atorvastatin
- Avacopan
- Avanafil
- Avapritinib
- Bedaquiline
- Benzhydrocodone
- Benzphetamine
- Betamethasone
- Betrixaban
- Bictegravir
- Boceprevir
- Bosentan
- Bosutinib
- Bretylium
- Brigatinib
- Budesonide
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
- Aripiprazole Lauroxil
- Atazanavir
- Darunavir
- Indinavir
- Nelfinavir
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:
- Kidney disease—Use with caution. May make this condition worse.
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. Talk to your doctor if you have any questions.
Take this medicine 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 also taking an antacid containing aluminum or magnesium, take it at least 2 hours before or after cobicistat with atazanavir. Ask your doctor or pharmacist before taking any other medicines for your stomach or heartburn.
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 enhancement of atazanavir:
- Adults and children weighing 35 kilograms (kg) or more—150 milligrams (mg) once a day, taken with atazanavir 300 mg once a day.
- Children weighing less than 35 kg—Use and dose must be determined by your doctor.
- For enhancement of darunavir:
- Adults and children weighing 40 kilograms (kg) or more—150 milligrams (mg) once a day, taken with darunavir 800 mg once a day.
- Children weighing less than 40 kg—Use and dose must be determined by your doctor.
- For enhancement of atazanavir:
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.
Store the medicine in its original bottle. Keep it tightly closed. Do not use this medicine if the seal on the bottle is broken or missing.
Precautions
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.
This medicine should not be used together with atazanavir or darunavir if you are also using any of the following: alfuzosin (Uroxatral®), carbamazepine (Tegretol®), colchicine (Colcrys®), dronedarone (Multaq®), drospirenone/ethinyl estradiol (Yasmin®, Yaz®), indinavir (Crixivan®), irinotecan (Camptosar®), lomitapide (Juxtapid®), lovastatin (Altoprev®, Mevacor®), lurasidone (Latuda®), midazolam (Versed®), nevirapine (Viramune®), phenobarbital (Luminal®), phenytoin (Dilantin®), pimozide (Orap®), ranolazine (Ranexa®), rifampin (Rifadin®), sildenafil (Revatio®), simvastatin (Simcor®, Zocor®), St John's wort, triazolam (Halcion®), or ergot medicines (eg, dihydroergotamine, ergotamine, methylergonovine, Cafergot®, Migranal®). Doing so may cause serious unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. Certain 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. If you think you have become pregnant while using this medicine, tell your doctor right away.
Using this medicine together with tenofovir DF may cause kidney problems (including Fanconi syndrome). Tell your doctor right away if you have bloody urine, decreased frequency or amount of urine, increased thirst, loss of appetite, lower back or side pain, nausea, vomiting, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, or weight gain.
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
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:
Less common
- Bloody urine
- chills
- clay-colored stools
- dark urine
- decreased frequency or amount of urine
- dizziness
- fast heartbeat
- fever
- headache
- hives or welts, itching, rash
- hoarseness
- increased thirst
- irritation
- joint pain, stiffness, or swelling
- loss of appetite
- lower back or side pain
- nausea
- pain in the groin or genitals
- redness of the skin
- sharp back pain just below the ribs
- stomach pain
- swelling of the eyelids, face, lips, hands, lower legs, or feet
- tightness in the chest
- trouble breathing or swallowing
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting
- vomiting of blood
- weight gain
- yellow eyes or skin
Less common
- Muscle pain, stiffness, cramps, or spasms
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:
Less common
- Diarrhea
- discouragement
- feeling sad or empty
- irritable
- loss of interest or pleasure
- trouble concentrating
- trouble sleeping
- upper abdominal or stomach pain
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.
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