Generic Name: darunavir, cobicistat, emtricitabine, and tenofovir alafenamide
Dosage Form: Tablets
Date of Approval: July 17, 2018
Company: Janssen Pharmaceuticals, Inc.
Treatment for: HIV Infection
Medically reviewed on July 18, 2018
FDA Approves Symtuza
The U.S. Food and Drug Administration (FDA) has approved Symtuza (darunavir, cobicistat, emtricitabine and tenofovir alafenamide - D/C/F/TAF), the first and only complete, darunavir-based single-tablet regimen (STR) for the treatment of human immunodeficiency virus type 1 (HIV-1) in treatment-naïve and certain virologically suppressed adults.
Read this Patient Information before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Symtuza can cause serious side effects, including:
- Worsening of Hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV before starting treatment. If you have HBV infection and take Symtuza, your HBV may get worse (flare-up) if you stop taking Symtuza.
A “flare-up” is when your HBV infection suddenly returns in a worse way than before.
- Do not stop taking Symtuza without first talking to your healthcare provider.
- Do not run out of this medicine. Refill your prescription or talk to your healthcare provider before your prescription is all gone.
- If you stop taking Symtuza, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medicine to treat your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop treamtment.
- Change in liver enzymes. People with a history of hepatitis B or C virus infection or who have certain liver enzyme changes may have an increased risk of developing new or worsening liver problems during treatment with Symtuza. Liver problems can also happen during treatment in people without a history of liver disease. Your healthcare provider may need to do tests to check your liver enzymes before and during treatment.
- Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, vomiting, or stomach-area pain.
Symtuza may cause severe or life-threatening skin reactions or rash. Sometimes these skin reactions and skin rashes can become severe and require treatment in a hospital. Call your healthcare provider right away if you develop a rash. Stop taking Symtuza and call your healthcare provider right away if you develop any skin changes with symptoms below:
- muscle or joint pain
- blisters or skin lesions
- mouth sores or ulcers
- red or inflamed eyes, like “pink eye” (conjunctivitis)
See Symtuza side effects for more information about side effects.
What is Symtuza?
Symtuza is a prescription medicine that is used without other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults who:
- have not received anti-HIV-1 medicines in the past, or
- when their healthcare provider determines that they meet certain requirements.
HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
It is not known if this medicine is safe and effective in children under 18 years of age.
Who should not take Symtuza?
Do not take Symtuza with any of the following medicines:
- colchicine, if you have liver or kidney problems
- elbasvir and grazoprevir
- ergot-containing medicines, such as:
- ergotamine tartrate
- lovastatin or a product that contains lovastatin
- midazolam, when taken by mouth
- 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
Serious problems can happen if you take any of these medicines with Symtuza.
Before taking Symtuza
Before taking Symtuza, tell your healthcare provider about all of your medical conditions, including if you:
- 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.
- It is not known if this medicine will harm your unborn baby.
- Symtuza should not be used during pregnancy.
- Tell your healthcare provider if you become pregnant during treatment. Your healthcare provider will prescribe different medicines if you become pregnant.
Pregnancy Registry: There is a pregnancy registry for those who take antiretroviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry.
- are breastfeeding or plan to breastfeed. Do not breastfeed if you take Symtuza.
- You should not breastfeed if you have HIV-1 because of the risk of passing HIV to your baby.
- One of the medicines in Symtuza called emtricitabine can pass into your breast milk. It is not known if the other medicines can pass into your breast milk.
- Talk to your healthcare provider about the best way to feed your baby.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with Symtuza. Keep a list of your medicines to show your healthcare provider and pharmacist.
- You can ask your healthcare provider or pharmacist for a list of medicines that interact with Symtuza.
- Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Symtuza with other medicines.
How should I take Symtuza?
- Take this medicine exactly as your healthcare provider tells you.
- Do not change your dose or stop treatment without talking to your healthcare provider.
- Take Symtuza one time a day with food.
- If you have difficulty swallowing, the tablet may be split using a tablet-cutter. After splitting the tablet, the entire dose (both halves) should then be taken right away.
- Do not miss a dose.
- When your supply starts to run low, get more from your healthcare provider or pharmacy. 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 the medicine and it may become harder to treat.
- If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.
Symtuza side effects
Symtuza may cause serious side effects, including:
- See Important information.
- Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. 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 new symptoms after starting your HIV-1 medicine.
- New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and during treatment. Your healthcare provider may tell you to stop treatment if you develop new or worse kidney problems.
- Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
- Diabetes and high blood sugar (hyperglycemia). Some people who take protease inhibitors including Symtuza can get high blood sugar, develop diabetes, or your diabetes can get worse. Tell your healthcare provider if you notice an increase in thirst or if you start urinating more often during treatment.
- Changes in body fat can happen in people who take HIV-1 medicines. The changes may include an 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 for hemophiliacs. Some people with hemophilia have increased bleeding with protease inhibitors.
The most common side effects of Symtuza, include:
- stomach problems
These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Symtuza?
- Store the tablets at room temperature between 68°F to 77°F (20°C to 25°C).
- The pill bottle contains a desiccant and has a child-resistant cap.
- Keep the pill bottle tightly closed with the desiccant inside of it to protect the tablets from moisture.
General information about the safe and effective use of Symtuza.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information that is written for health professionals.
What are the ingredients in Symtuza?
Active ingredient: darunavir, cobicistat, emtricitabine, and tenofovir alafenamide
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing polyethylene glycol (macrogol), polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, and yellow ferric oxide.