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

This combination medication contains four medications in one tablet: cobicistat, darunavir, emtricitabine and tenofovir alafenamideThese medications are antiretroviral medications. This medication is used to treat human immunodeficiency virus (HIV) infection in adults and adolescents between 12 and 18 years of age, who weigh at least 40 kg. This product should not be used in combination with any other product to treat HIV infection.

Darunavir is a protease inhibitor and works by blocking an enzyme called protease, which the virus needs to multiply. Cobicistat slows down the speed at which the body gets rid of darunavir. It is included in this medication to increase the amount of darunavir in your blood. Emtricitabine and tenofovir both belong to the class of antiretrovirals called nucleoside reverse transcriptase inhibitors (NRTIs). Reverse transcriptase is an enzyme that needed by HIV to multiply and infect other cells. These two medications prevent reverse transcriptase from working properly.

Antiretroviral medications work by interfering with enzymes that are needed for HIV to multiply, thus lowering the amount of HIV in the blood. They may also help the immune system by increasing the number of CD4 (T) cells in the body. This medication does not cure AIDS and does not reduce the risk of passing HIV to others through sexual contact or blood contamination. It may slow down the destruction of the immune system and help to delay the development of problems such as infections related to AIDS or HIV disease.

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?

Each yellow-to-yellowish-brown, capsule-shaped tablet of 22 mm × 10 mm, debossed with "8121" on one side and "JG" on the opposite side, contains 800 mg of darunavir (as 867 mg of darunavir ethanolate), 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamide (as 11.2 mg of tenofovir alafenamide hemifumarate). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose; film coating: polyethylene glycol (macrogol), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, and yellow ferric oxide.

How should I use this medication?

The usual dose is 1 tablet taken by mouth once daily with food. The tablet should be swallowed whole. Do not break, crush or chew the tablet.

It is important to use this medication exactly as prescribed by your doctor. If you do not, the amount of HIV virus in your blood may increase and the virus may develop resistance to this medication. Do not stop taking this medication without telling your doctor. Your HIV infection may get worse if you stop this medication.

Many things can affect the dose of a 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.

If you miss a dose, take it with food as soon as possible, and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take more than 1 dose of cobicistat - darunavir - emtricitabine - tenofovir alafenamide in 1 day. 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 in its original container at room temperature, protect it from moisture, 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 use this medication if you:

  • are allergic to cobicistat, darunavir, emtricitabine, tenofovir, or any ingredients of the medication
  • have severely reduced liver function
  • are taking certain other medications, including but not limited to:
    • alfuzosin
    • amiodarone
    • apixaban
    • carbamazepine
    • colchicine (in people with decreased kidney or liver function)
    • dronedarone
    • elbasvir/grazoprevir
    • ergot derivatives (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine)
    • lidocaine
    • lovastatin
    • lurasidone
    • midazolam
    • phenobarbital
    • phenytoin
    • pimozide
    • quinidine
    • rifampin
    • rivaroxaban
    • salmeterol
    • sildenafil (for treatment of pulmonary arterial hypertension)
    • simvastatin
    • St. John's wort
    • ticagrelor
    • triazolam

Do not give this medication to children younger than 3 years of age.

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.

  • diarrhea
  • muscle aches
  • nausea
  • rash
  • swollen belly
  • tiredness
  • weakness

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

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

  • bone pain or fractures
  • increased blood cholesterol, triglycerides
  • signs of kidney problems (e.g., increased thirst, changes in urination patterns, swelling of the legs and feet, feeling listless and tired)
  • signs of liver toxicity (e.g., yellowing of skin and eyes, dark urine, light-coloured bowel movements)
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

Seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (i.e., swelling of face or throat, hives, or difficulty breathing)
  • signs of lactic acidosis (e.g., dizziness, fatigue, unusual muscle pain, nausea, vomiting, stomach pain, feeling cold in legs and arms, fast heartbeat)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
  • symptoms of pancreatitis (upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

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 medical 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.

Allergy: Some people who are allergic to sulfonamide antibiotics also experience allergic reactions to the darunavir component of this medication. Before you take this medication, inform your doctor about any previous adverse reactions you have had to medications, especially sulfonamide antibiotics such as sulfamethoxazole-trimethoprim. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

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: This medication 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.

Bones: Tenofovir may weaken bones. Your doctor may monitor your bone mass while you are taking this medication, especially if you are at risk for bone fracture or for disease of the bone. If you experience unexplained bone pain or break a bone, contact your doctor. Your doctor may want you to start taking vitamin D and calcium supplements. If you have osteoporosis, 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 needed.

Diabetes: This medication may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

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 needed.

Hemophilia: Protease inhibitors like darunavir have been associated with increased bleeding when taken by people with hemophilia. If you have a bleeding disorder, 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 needed.

Hepatitis B and C: The safe use of this medication has not been established for people who are also infected with hepatitis B or hepatitis C. Your doctor may test you for hepatitis B infection before you start taking this medication. If this medication is used to treat HIV by people who have hepatitis B, worsening of hepatitis B may occur when the medication is stopped. If you also have hepatitis B and stop using this medication, your doctor will monitor your liver function closely for several months.

Immune reconstitution inflammatory 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 medication 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, hepatitis, or tuberculosis). Report any new symptoms to your doctor immediately.

Kidney function: Tenofovir can cause kidney problems, including severe kidney damage and kidney failure. Your doctor may monitor your kidney function with blood tests while you are taking this medication. Additional tests may be needed if you have a history of kidney problems or if you need to take another medication that can cause kidney problems.

If you experience signs of reduced kidney function, such as decreased urination, nausea, vomiting, or swelling of the feet and ankles, contact your doctor as soon as possible.

Lactic acidosis and enlarged liver: This medication can cause a rare but serious condition called lactic acidosis (buildup of lactic acid), together with an enlarged fatty liver. Your doctor will periodically monitor you and perform laboratory tests to check your liver function. Seek immediate medical attention if you notice any symptoms of this condition, such as:

  • dizziness
  • feeling cold
  • irregular heartbeat
  • lightheadedness
  • nausea
  • stomach pain
  • tiredness
  • vomiting
  • weakness

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, 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 needed.

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 risk of experiencing worsening of these problems while 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.

Other Medications for HIV: There are several combination medications available to treat HIV infection, and many of these have combinations that include one or more of the ingredients in this medication. They may also include ingredients that work the same way as the ingredients in this medication. Taking two combination medications is dangerous and can cause fatal drug interactions. With your doctor or pharmacist, review the ingredients of any medication that may be prescribed and compare it to the medications you are currently taking.

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. Contact your doctor if you develop signs of pancreatitis, such as:

  • back pain
  • chills
  • fever
  • nausea
  • rapid heartbeat
  • swollen abdomen
  • upper left abdominal pain

Skin rashes: This medication can cause skin rash, which is usually mild or 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.

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: Emtricitabine passes into breast milk. It is not known if cobicistat, darunavir, or tenofovir alafenamide pass into breast milk. Because HIV can be transmitted by breast milk, women who have HIV should not breast-feed.

Children: The safety and effectiveness of using this medication have not been established for children younger than 12 years of age or weighing less than 40 kg.

What other drugs could interact with this medication?

There may be an interaction between cobicistat – darunavir - emtricitabine - tenofovir alafenamide and any of the following:

  • acyclovir
  • alfuzosin
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • apixaban
  • aprepitant
  • antiarrythmics (e.g., amiodarone, digoxin, disopyramide, dronedarone, flecainide, mexiletine, propafenone, quinidine)
  • anti-cancer medications (e.g., cabazitaxel, docetaxel, doxorubicin, irinotecan, paclitaxel, vinblastine, vincristine)
  • antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine, rupatadine)
  • anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • atomoxetine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • benzodiazepines (e.g., alprazolam, diazepam, midazolam, triazolam)
  • beta-blockers (e.g., carvedilol, metoprolol, propranolol)
  • birth control pills
  • bosentan
  • brinzolamide
  • bromocriptine
  • buspirone
  • calcitriol
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • cannabis
  • captopril
  • celecoxib
  • chloroquine
  • cobicistat
  • colchicine
  • conivaptan
  • corticosteroids (e.g., budesonide, dexamethasone, fluticasone, hydrocortisone, prednisone)
  • cyclosporine
  • dabigatran
  • darifeancin
  • diabetes medications (e.g., chlorpropamide, gliclazide, glyburide, insulin, metformin, rosiglitazone)
  • digoxin
  • domperidone
  • edoxaban
  • enzalutamide
  • ergot derivatives (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine)
  • estrogens (e.g., conjugated estrogens, ethinyl estradiol)
  • grapefruit juice
  • guanfacine
  • hepatitis C antivirals (e.g., daclatasvir, dasabuvir, elbasvir, grazopravir, ledipasvir, paritaprevir, ombitasvir, sofosbuvir)
  • irinotecan
  • lomitapide
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • mefloquine
  • metoprolol
  • mifepristone
  • mirtazapine
  • modafinil
  • narcotic pain relievers (e.g., codeoine, fentanyl, methadone, oxycodone)
  • naloxegol
  • nefazodone
  • nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, ketorolac, naproxen)
  • omeprazole
  • oxybutynin
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • prasugrel
  • primaquine
  • progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone, norgestimate)
  • protein kinase inhibitors (e.g., bosutinib, dasatinib, erlotinib, imatinib, nilotinib)
  • quinine
  • rifabutin
  • rifampin
  • rilpivirine
  • rivaroxaban
  • romidepsin
  • St. John's wort
  • salmeterol
  • seizure medications (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, , fluoxetine, paroxetine, sertraline)
  • silodosin
  • sirolimus
  • solifenacin
  • "statin" cholesterol medications (e.g., atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin)
  • tacrolimus
  • tamoxifen
  • tamsulosin
  • theophylline
  • ticagrelor
  • tocilizumab
  • tolterodine
  • tolvaptan
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • ulipristal
  • venlafaxine
  • vilanterol
  • warfarin
  • zolpidem
  • 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.

All material copyright MediResource Inc. 1996 – 2019. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Symtuza