Symtuza

Symtuza is a prescription medication used to treat HIV-1 infection in adults who meet certain requirements.

It is a single product containing 4 medications: darunavir, cobicistat, emtricitabine, and tenofovir.

Darunavir, a protease inhibitor, along with emtricitabine and tenofovir, both nucleoside reverse transcriptase inhibitors (NRTIs), all work by decreasing the amount of HIV in the blood. Cobicistat is an inhibitor of an enzyme called CYP3A and works by increasing the amount of darunavir in the body and allowing it to have a greater effect.

This medication comes in tablet form and is taken once daily at the same time everyday, with food.

Common side effects include diarrhea, rash, and nausea.

Symtuza is a prescription medication used to treat HIV-1 infection in adults who have never used antiretroviral treatment or have been on stable antiretroviral treatment for 6 months or more with very low blood virus levels.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Symtuza. See the “Symtuza Precautions” section.

Common side effects of Symtuza include the following:

• diarrhea
• rash
• nausea
• feeling tired
• headache
• stomach problems
• gas

This is not a complete list of Symtuza side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other antiretroviral medications such as
  • efavirenz/emtricitabine/tenofovir (Atripla)
  • rilpivirine (Edurant)
  • emtricitabine (Emtriva)
  • elvitegravir, cobicistat, emtricitabine, and tenofovir (Stribild)
  • tenofovir and emtricitabine (Truvada)
  • tenofovir (Viread)
  • adefovir (Hepsera)
• drugs that are processed through the kidneys such as
  • antivirals such as acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir
  • aminoglycoside antibiotics such as gentamicin
  • high doses or combinations of nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen
• alfuzosin
• ranolazine
• antiarrhythmics such as dronedarone, amiodarone, and digoxin
• antibacterials such as clarithromycin, erythromycin, and telithromycin
• anticancer drugs such as dasatinib, nilotinib, vinblastine, and vincristine
• blood thinners such as apixaban, rivaroxaban, and warfarin
• seizure medications such as carbamazepine, phenobarbital, phenytoin, oxcarbazepine, and clonazepam
• antidepressants such as sertraline, paroxetine, amitriptyline, desipramine, imipramine, nortriptyline, and trazodone
• antifungals such as itraconazole, ketoconazole, posaconazole, and voriconazole
• colchicine
• antimalarial drugs such as artemether/lumefantrine
• antimycobacterials such as rifampin, rifabutin, and rifapentine
• antipsychotics such as lurasidone, pimozide, risperidone, and quetiapine
• certain blood pressure medications such as carvedilol, metoprolol, amlodipine, diltiazem, nifedipine, and verapamil
• steroids such as betamethasone, budesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, and triamcinolone
• bosentan
• ergot derivatives such as dihydroergotamine, ergotamine, and methylergonovine
• cisapride
• hepatitis C drugs such as elbasvir/grazoprevir and simeprevir
• St. John’s wort
• cholesterol medications such as lovastatin, simvastatin, atorvastatin, fluvastatin, pravastatin, and rosuvastatin
• oral birth control such as drospirenone/ethinyl estradiol (Yasmin, Gianvi, Loryna)
• immunosuppressants such as cyclosporine, sirolimus, and tacrolimus
• salmeterol
• pain medications such as fentanyl, oxycodone, and tramadol
• medications which treat addiction such as buprenorphine, buprenorphine/naloxone, and methadone
• erectile dysfunction medications such as sildenafil and tadalafil
• ticagrelor
• sedatives such as midazolam, triazolam, diazepam, and zolpidem

This is not a complete list of Symtuza drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Symtuza including the following:

• Liver problems, especially in people who are also infected with hepatitis B. Tell your healthcare provider right away if you have some or all of the following symptoms of liver problems.
  • loss of appetite or weight loss (anorexia)
  • nausea or vomiting
  • feeling tired
  • stomach pain or tenderness
  • dark urine or light colored stools
  • yellowing of your skin or the whites of your eyes
  • fever or rash
• Severe skin problems. Tell your healthcare provider right away if you have some or all of the following symptoms of severe skin problems.
  • painful sores or ulcers on your skin, lips or in your mouth
  • blisters
  • peeling skin
  • rash
  • pustules
• Drug interactions causing serious adverse reactions or decreases in effectiveness of HIV treatment. Tell your healthcare provider about all of the medications you are taking and check with your doctor before starting a new medication.
• Changes in your immune system (immune reconstitution syndrome) after starting HIV medications. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV medicine.
• A decline in kidney function. Toxicity from Symtuza may occur with kidney dysfunction. Your doctor may want to monitor your kidney functions with certain blood tests as well. Tell your healthcare provider right away if you have any of the following symptoms of kidney dysfunction:
  • swelling of face, ankles, hands, or feet
  • fatigue
  • paleness of skin
  • decreased urination
  • shortness of breath
  • changes in blood pressure
• Allergic reaction to sulfa.  Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction.
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing or swallowing
  • rash or hives
• Build-up of lactic acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take Symtuza or similar (nucleoside analogs) medicines. Lactic acidosis is a serious medical emergency that can lead to death. Lactic acidosis can be hard to identify early, because the symptoms could seem like symptoms of other health problems. Call your healthcare provider right away if you get any of the following symptoms which could be signs of lactic acidosis:
  • feeling very weak or tired
  • unusual (not normal) muscle pain
  • trouble breathing
  • stomach pain with nausea or vomiting
  • feeling cold, especially in your arms and legs
  • feeling dizzy or lightheaded
  • fast or irregular heartbeat
• High blood sugar or new diabetes. Tell your healthcare provider right away if you have some or all of the following symptoms of high blood sugar or diabetes.
  • coma
  • convulsions
  • confusion
  • increased thirst
  • fever
  • frequent urination
  • nausea
  • lethargy
  • weight loss
  • weakness
• Changes in body fat. Changes in body fat can happen in people who take HIV medicine. These changes may include increased amount of fat in the upper back and neck ("buffalo hump"), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms and face may also happen. The exact cause and long-term health effects of these conditions are not known.
• Increased bleeding in patients with hemophilia type A and B. Tell your healthcare provider right away if you experience an increase in bleeding or bruising while taking Symtuza.

Do not take Symtuza if you:

• are allergic to Symtuza or to any of its ingredients
• are on any of the following medications:
  • alfuzosin
  • carbamazepine
  • cisapride
  • colchicine, if you have liver or kidney problems
  • dronedarone
  • elbasvir and grazoprevir
  • ergot-containing medicines, such as:
    • dihydroergotamine
    • ergotamine tartrate
    • methylergonovine
  • lovastatin or a product that contains lovastatin
  • lurasidone
  • midazolam, when taken by mouth
  • phenobarbital
  • phenytoin
  • pimozide
  • ranolazine
  • rifampin
  • sildenafil, when used for the treatment of pulmonary arterial hypertension (PAH)
  • simvastatin or a product that contains simvastatin
  • St. John’s wort (Hypericum perforatum), or a product that contains St. John’s Wort
  • triazolam

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Symtuza there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Symtuza, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Symtuza or to any of its ingredients
• have liver problems, including hepatitis B or hepatitis C
• have kidney problems
• are allergic to sulfa (sulfonamide)
• have diabetes
• have hemophilia
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Symtuza is not recommended for use in pregnant women because two of the components, darunavir and cobicistat, are not as effective in pregnant women. Tell your doctor if you become pregnant while taking Symtuza and your doctor will prescribe you a different medication.

Do not breastfeed if you are taking Symtuza. The Centers for Disease Control and Prevention recommend that mothers with HIV not breastfeed because they can pass the HIV through their milk to the baby. Symtuza itself may also pass through breast milk and cause serious harm to the baby.

Take Symtuza exactly as prescribed.

This medication comes in tablet form and is taken once a day.

Take Symtuza with food.

If the tablet is difficult for you to swallow, it can be cut in half with a pill cutter. Take both halves right away after splitting.

Dot not miss a dose of Symtuza. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to Symtuza and become harder to treat.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Symtuza is one tablet daily. Each tablet contains 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine, and 10 mg tenofovir.

If you take too much Symtuza, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Symtuza at room temperature.
• Store Symtuza with the lid tightly closed and the desiccant inside to protect Symtuza from moisture.
• Keep this and all medicines out of the reach of children.

WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Symtuza. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Symtuza. If appropriate, anti-hepatitis B therapy may be warranted.