This drug 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.
Darunavir belongs to a class of drugs known as protease inhibitors. Darunavir must be given with certain other medications (such as cobicistat, ritonavir) to increase ("boost") the levels of darunavir. This helps darunavir work better.
Darunavir 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.
This medication is not recommended for use in children younger than 3 years due to the increased risk of serious side effects.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This product may also be used to lessen the risk of HIV infection after contact with the virus (for example, due to a needle stick). Ask your doctor for more details.
Read the Patient Information Leaflet if available from your pharmacist before you start taking darunavir and each time you get a refill. If you are using the liquid form of this medication, carefully read the Instructions for Use provided with the medication. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with food as directed by your doctor. Darunavir must be taken at the same time as certain other medications, usually once or twice a day. (See also Uses section.) The manufacturer recommends to swallow the tablets whole with a drink such as water or milk. If you cannot swallow whole tablets, ask your doctor if you can still use the tablets or if you should use the liquid form.
If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
The dosage is based on your age, laboratory tests, medical condition, and response to treatment. In children, the dosage is also based on body weight.
It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor.
This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time(s) each 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. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.
Since darunavir is always taken with other HIV medications, it may be difficult to tell whether darunavir is causing certain side effects. However, darunavir is known to cause diarrhea, nausea, vomiting, stomach pain, and headache. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
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.
Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, 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 difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).
This medication may rarely make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor right away if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.
Get medical help right away if any of these rare but serious side effects occur: symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), easy bruising/bleeding.
This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but very serious side effects: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin.
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.
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.
Darunavir 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.
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, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Since darunavir must be taken with ritonavir, tell your doctor if you are allergic to ritonavir. 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 problems (such as hepatitis B or C), diabetes, a certain bleeding problem (hemophilia), lipid problems (high cholesterol or triglycerides/fats), heart problems (coronary artery disease, heart attack).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. However, HIV medicines are now usually given to pregnant women with HIV. Treatment can decrease the risk of passing the HIV infection to your baby. Darunavir may be part of that treatment. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some of the products that may interact with this drug include: certain hepatitis C virus protease inhibitors (boceprevir, simeprevir, telaprevir), certain drugs used to treat seizures (such as phenytoin, primidone), barbiturates (such as phenobarbital, secobarbital), a certain combination HIV medication (elvitegravir/cobicistat/emtricitabine/tenofovir).
Darunavir can slow down the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include certain alpha blockers (such as alfuzosin, tamsulosin), certain benzodiazepines (midazolam, triazolam), "blood thinners" (such as apixaban, rivaroxaban), bosutinib, dronedarone, ergot alkaloids (such as dihydroergotamine, ergotamine), certain drugs to treat erectile dysfunction-ED or pulmonary hypertension (such as avanafil, sildenafil), lomitapide, pimozide, ranolazine, salmeterol, certain "statin" cholesterol drugs (such as lovastatin, simvastatin), tolvaptan, among others.
Other medications can affect the removal of darunavir from your body, which may affect how darunavir works. Examples include garlic supplements, certain rifamycins (rifampin, rifapentine), St. John's Wort, among others.
This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Talk to your doctor about additional or alternative reliable forms of birth control, and always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity to decrease the risk of spreading HIV to others. Tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your hormonal birth control is not working well.
Do not take this medication with other products that contain darunavir.
If overdose is suspected, contact a poison control center or emergency room 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 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 medical and laboratory appointments.
If you are taking this medication 2 times daily and you miss a dose, take it as soon as you remember unless it is less than 6 hours before the time for your next dose. If you are taking this medication once daily and you miss a dose, take it as soon as you remember unless it is less than 12 hours before the time for your next dose. In either case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Do not refrigerate or freeze the liquid form of this medication. 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 May 2016. Copyright(c) 2016 First Databank, Inc.
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