How does this medication work? What will it do for me?

Darunavir belongs to a class of medications called antiretrovirals, or more specifically, protease inhibitors (PIs). Darunavir is used in combination with ritonavir and other antiretroviral medications to treat infections caused by the human immunodeficiency virus (HIV). HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). It destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infections.

Darunavir works by blocking an enzyme called protease, which the virus needs to multiply. When used with ritonavir (another protease inhibitor) and other antiretroviral medications, darunavir reduces the amount of HIV in the blood and increases CD4 (T) cell counts.

This medication does not cure HIV infection or AIDS, but may improve your immune system and decrease the risk of infection. Darunavir does not reduce the risk of passing HIV to others through sexual contact, sharing needles, or being exposed to infected blood.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

75 mg
Each white, caplet-shaped, film-coated tablet, debossed with "75" on one side and "TMC" on the other side, contains darunavir 75 mg (corresponding to darunavir ethanolate 81.31). Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose; film coating: polyethylene glycol, polyvinyl alcohol - partially hydrolyzed, talc, and titanium dioxide.

150 mg
Each white, oval-shaped, film-coated tablet, debossed with "150" on one side and "TMC" on the other side, contains darunavir 150 mg (corresponding to darunavir ethanolate 162.62 mg). Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose; film coating: polyethylene glycol, polyvinyl alcohol - partially hydrolyzed, talc, and titanium dioxide.

400 mg
Each light orange, oval-shaped, film-coated tablet, debossed with "400MG" on one side and "TMC" on the other side, contains darunavir ethanolate equivalent to darunavir 400 mg. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose; film coating: polyethylene glycol, polyvinyl alcohol - partially hydrolyzed, sunset yellow FCF aluminum lake, talc, and titanium dioxide.

600 mg
Each orange, oval-shaped, film-coated tablet, debossed with "600MG" on one side and "TMC" on the other side, contains darunavir ethanolate equivalent to darunavir 600 mg. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose; film coating: polyethylene glycol, polyvinyl alcohol - partially hydrolyzed, sunset yellow FCF aluminum lake, talc, and titanium dioxide.

800 mg
Each dark red, oval-shaped, film-coated tablet debossed with "800" on one side and "T" on the other side contains darunavir ethanolate equivalent to 800 mg of darunavir. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, and microcrystalline cellulose; Film coating: Opadry II Dark Red (polyethylene glycol, polyvinyl alcohol - partially hydrolyzed, titanium dioxide, talc, iron oxide red).

100 mg/ml Oral Suspension
Each mL of white to off-white suspension contains 108.4 mg darunavir ethanolate equivalent to 100 mg darunavir. Nonmedicinal ingredients: hydroxypropyl cellulose, microcrystalline cellulose and carmellose sodium, sucralose, sodium methyl parahydroxybenzoate, masking flavor, citric acid monohydrate, and strawberry cream flavor.

How should I use this medication?

For people who have not taken other antiretroviral medications before, the recommended adult dose of darunavir is 800 mg taken once daily at the same time as 100 mg of ritonavir. For people who have taken other antiretroviral medications in the past, the recommended adult dose is either 800 mg taken once daily along with 100 mg ritonavir OR 600 mg twice daily along with 100 mg ritonavir with each dose.

The safety and effectiveness of darunavir for children and adolescents who have not taken other antiretroviral medications before has not been determined.

Darunavir may be used by children weighing at least 10 kg and   between 3 and 18 years of age, who have taken other antiretroviral medications in the past. The dose of darunavir is based on the child's body weight and should not be more than 600 mg taken twice a day, along with 100 mg ritonavir with each dose. (The recommended adult dose.)

Darunavir must be taken at the same time as ritonavir to maximize the benefit of controlling the HIV virus in your body. If you are also prescribed a medication called didanosine, take didanosine 2 hours before or after darunavir and ritonavir.

Darunavir should be taken with food. Try to take the doses of darunavir at the same time each day.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you are taking darunavir twice daily and you miss a dose by less than 6 hours, take the missed dose immediately. If you miss a dose by more than 6 hours, skip the missed dose and continue with your regular dosing schedule. If you are taking darunavir once daily and you miss a dose by less than 12 hours, take the missed dose immediately. If you miss a dose by more than 12 hours, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, avoid exposure to excessive heat and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take darunavir if you:

  • are allergic to darunavir or any ingredients of the medication
  • are allergic to ritonavir
  • have severe liver disease
  • are taking any of the following medications:
    • alfuzosin
    • amiodarone
    • ergot derivatives (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine)
    • lidocaine
    • lovastatin
    • midazolam
    • pimozide
    • quinidine
    • rifampin
    • sildenafil
    • simvastatin
    • St. John's wort
    • triazolam

What side effects are possible with this medication?

Many medications can cause side-effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal pain
  • changes in cholesterol levels
  • diarrhea
  • headache
  • increased fat in the upper back and around the back, neck, breast, chest, and stomach area (or loss of fat from the legs, arms, and face)
  • nausea
  • trouble sleeping
  • vomiting
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • increased bleeding for people who have hemophilia
  • signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • skin rash
  • symptoms of diabetes (e.g., excessive thirst, urination, or eating; unexplained weight loss; poor wound healing; or infections)
  • symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine)
  • symptoms of pancreatitis (e.g., abdominal pain, nausea, vomiting)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., swelling of face, throat, or tongue; hives; or difficulty breathing)
  • signs of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medication conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergies: People who are allergic to sulfonamide medications may experience an allergic reaction to darunavir. Advise your doctor of any allergies to any medications before taking darunavir.

Bleeding: Darunavir may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early. The risk of bleeding may be increased in people who have hemophilia. Discuss any concerns you may have with your doctor.

Blood tests: Darunavir can cause changes in your blood test results, such as red blood cell count, platelet count, cholesterol level, and sugar level. Your doctor will explain these to you and monitor your blood levels.

Diabetes: Antiretroviral medications such as darunavir may increase blood sugar levels. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is required.

Fat redistribution: Over time, this medication may change how fat is distributed in your body and may change your body shape. You may notice increased fat in the upper back and neck, breast, around the back, chest, and stomach area. Or you may notice loss of fat from the legs, arms, and face. The long-term effects of this are not known.

Immune reconstitution syndrome: This medication may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medications and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms, such as pneumonia, herpes, or tuberculosis. Report any new symptoms to your doctor immediately.

Liver problems: People with severe liver disease should not take darunavir. If you have mild to moderate liver disease, you can take this medication and should discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is required.

There have been reports of serious liver problems while taking darunavir. People with liver problems (including hepatitis B or hepatitis C infection) are at a greater risk of experiencing serious liver problems while taking this medication. Your doctor will monitor you and perform liver function tests regularly while you are taking this medication. If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Pancreatitis: This medication may cause inflammation of the pancreas (pancreatitis). If you have a history of or are at risk for developing pancreatitis, you should be closely monitored by your doctor while taking this medication. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is required.

If you develop signs of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), contact your doctor.

Skin rashes: This medication can cause skin rash, which is usually mild and moderate. However, darunavir can cause severe skin reactions. If you develop a skin rash with fever, fatigue, blisters, muscle aches, or sores in and around the mouth, stop taking this medication and contact your doctor immediately

Stopping the medication: If you stop taking this medication, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: The medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if darunavir passes into breast milk. However, since HIV can be transmitted by breast milk, women who have HIV are advised not to breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children under 3 years of age or for children who have not taken any antiretroviral medication in the past. This medication should not be given to children less than 3 years old due to the increased risk of severe side effects.

What other drugs could interact with this medication?

There may be an interaction between darunavir and any of the following:

  • alfuzosin
  • aliskiren
  • alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • amiodarone
  • aprepitant
  • anti-emetic medications (serotonin antagonists; e.g., granisetron, ondansetron)
  • anti-psychotics (e.g., chlorpromazine, haloperidol, olanzepine, quetiapine, risperidone)
  • apixaban
  • atomoxetine
  • "azole" antifungal agents (e.g., itraconazole, ketoconazole, voriconazole)
  • axitinib
  • barbiturates (e.g., butalbital, phenobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, triazolam)
  • birth control pills
  • bortezomib
  • bosentan
  • bosutinib
  • brinzolamide
  • bromocriptine
  • buspirone
  • busulfan
  • calcitriol
  • calcium channel blockers (e.g., amlodipine, diltiazem, felodipine, nifedipine, nisoldipine)
  • captopril
  • carbamazepine
  • carvedilol
  • certain benzodiazepines (e.g., alprazolam, midazolam, triazolam)
  • cetirizine
  • chloroquine
  • ciprofloxacin
  • colchicine
  • conivaptan
  • corticosteroids (e.g., budesonide, dexamethasone, fluticasone)
  • crizotinib
  • cyclosporine
  • dabigatran
  • dapsone
  • dasatinib
  • deferasirox
  • dextromethorphan
  • didanosine
  • digoxin
  • disopyramide
  • domperidone
  • doxorubicin
  • dutasteride
  • enzalutamide
  • ergot alkaloids (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine)
  • estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
  • etoposide
  • everolimus
  • fexofenadine
  • flecainide
  • flutamide
  • fusidic acid
  • garlic
  • grapefruit juice
  • guanfacine
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • ifosfamide
  • imatinib
  • irinotecan
  • isosorbide dinitrate, isosorbide mononitrate
  • ivermectin
  • lansoprazole
  • lapatinib
  • lidocaine
  • loperamide
  • loratadine
  • losartan
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • maraviroc
  • mefloquine
  • meperidine
  • methotrexate
  • metronidazole
  • mirtazapine
  • modafinil
  • montelukast
  • nadolol
  • nateglinide
  • nefazodone
  • nilotinib
  • norfloxacin
  • certain opioid narcotics (e.g., fentanyl, methadone, oxycodone, sufentanil)
  • oxcarbazepine
  • paclitaxel
  • pazopanib
  • phenytoin
  • phosphodiesterase-5 inhibitors (e.g., sildenafil, taladafil, vardenafil)
  • pimozide
  • prasugrel
  • praziquantel
  • primidone
  • procainamide
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogeterone, norethindrone)
  • propafenone
  • propranolol
  • other HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • quinidine
  • quinine
  • ranitidine
  • regorafenib
  • repaglinide
  • rifabutin
  • rifampin
  • riociguat
  • ritonavir
  • rivaroxaban
  • romidepsin
  • salmeterol
  • saxagliptin
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, paroxetine, sertraline)
  • silodosin
  • simeprevir
  • sirolimus
  • St. John's wort
  • "statin" cholesterol-reducing medications (e.g., atorvastatin, lovastatin, simvastatin)
  • tacrolimus
  • temsirolimus
  • teniposide
  • tetrabenazine
  • tetracycline
  • theophylline
  • ticagrelor
  • timolol
  • tolterodine
  • tolvaptan
  • tolterodine
  • tolvaptan
  • topotecan
  • tramadol
  • trazodone
  • tricyclic antidepressasnts (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • "triptan" migraine medications (e.g., eletriptan, sumatriptan)
  • ulipristal
  • valproic acid
  • vemurafenib
  • venlafaxine
  • vinblastine
  • vincristine
  • warfarin
  • zidovudine
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.