This product is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. This product is a combination of two different drugs: darunavir and cobicistat. Darunavir belongs to a class of drugs known as protease inhibitors. Cobicistat is used to increase ("boost") the levels of darunavir.
Darunavir/cobicistat is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
How to use Darunavir-Cobicistat Tablet
Read the Patient Information Leaflet if available from your pharmacist before you start taking darunavir/cobicistat and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
The manufacturer directs not to crush or break the tablet before taking it. However, many similar drugs (immediate-release tablets) can be crushed or broken. Follow your doctor's directions on how to take this medication.
For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.
Do not take more or less of this drug than prescribed or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn't go away, headaches that are severe or don't go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).
This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
Darunavir/cobicistat may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.
Get medical help right away if you have any very serious side effects, including: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding.
Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.
This medication can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash, especially with symptoms such as fever, tiredness, muscle/joint pain, blisters, mouth sores, or red/swollen eyes.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking darunavir/cobicistat, tell your doctor or pharmacist if you are allergic to either of the medications; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (including hepatitis B, C), kidney disease, a certain bleeding problem (hemophilia), diabetes, heart problems (coronary artery disease, heart attack), lipid problems (high cholesterol or triglycerides/fats).
This medication is not recommended for use during pregnancy. It may not work well in a pregnant woman. If you become pregnant or think you may be pregnant, tell your doctor right away. Your doctor may change your HIV medications.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (such as liver/kidney function tests, viral load, T-cell counts, triglycerides/cholesterol, blood sugar) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.
Keep all regular medical and laboratory appointments.
If you miss a dose, take it as soon as you remember, unless it is less than 12 hours until the next dose. In that case, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised April 2019. Copyright(c) 2019 First Databank, Inc.
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