Starting SYMTUZA®

Here’s who can take SYMTUZA®

HIV-positive adults who have never received HIV medicines in the past, or whose healthcare providers have determined that they meet certain requirements can take SYMTUZA®.

Just diagnosed? Getting on treatment as soon as possible is very important for your health and may reduce the risk of passing HIV to others. After you and your healthcare provider decide to start treatment, they may recommend SYMTUZA® because it contains an ingredient called darunavir. Darunavir is recommended by the Department of Health and Human Services in cases where treatment is to be initiated before resistance testing results are available.1

 

1. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents Living with HIV. Department of Health and Human Services. http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed December 18, 2019.

Certain people shouldn't take SYMTUZA®

Certain people shouldn’t take SYMTUZA®, which is why it’s important to talk to 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
  • Are breastfeeding or plan to breastfeed

Some medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements interact with SYMTUZA®, and can cause serious problems. Please see Important Safety Information for a list of medications that should not be taken with SYMTUZA®. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not start taking a new medicine without first telling your healthcare provider. Your healthcare provider can tell you if it is safe to take SYMTUZA® with other medicines.

 
 

How to take SYMTUZA®

Here are some tips to help you when you first start on SYMTUZA®.

You should take SYMTUZA® once a day with food at the same time every day. Make SYMTUZA® part of your daily routine. This might mean taking SYMTUZA® with breakfast or dinner.

Do not change your dose or stop taking SYMTUZA® without talking to your healthcare provider. If you take too much SYMTUZA®, call your healthcare provider or go to the nearest hospital emergency room right away.

Getting started with SYMTUZA®

Starting a new treatment takes support. If you have any questions, be sure to talk to your healthcare provider.

What to do if you miss a dose

When your SYMTUZA® supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of HIV in your blood may increase if the medicine is stopped for even a short time. The virus may develop drug resistance to SYMTUZA® and become harder to treat. Do not miss a dose of SYMTUZA® and take it exactly as your healthcare provider prescribes.

Side effects of SYMTUZA®

In clinical trials where patients received SYMTUZA®, 2% or fewer stopped taking it because of negative side effects. Most side effects were mild or moderate.

What are the possible side effects of SYMTUZA®?

The most common side effects of SYMTUZA® are:
diarrhea, rash, nausea, fatigue, headache, stomach problems, and gas.

SYMTUZA® can cause serious side effects including:

  • Worsening of hepatitis B virus infection. Your healthcare provider will test you for hepatitis B virus (HBV) before starting treatment with SYMTUZA®. If you have HBV infection and take SYMTUZA®, your HBV may get worse (flare-up) if you stop taking SYMTUZA®.
    • Do not stop taking SYMTUZA® without first talking to your healthcare provider.
    • Do not run out of SYMTUZA®. Refill your prescription or talk to your healthcare provider before your SYMTUZA® 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 taking SYMTUZA®.
  • 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 with SYMTUZA® 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 with SYMTUZA®
  • 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 turn yellow
    • Dark “tea-colored” urine
    • Light-colored stools
    • Loss of appetite for several days or longer
    • Nausea
    • Vomiting
    • Stomach area pain

SYMTUZA® may cause severe or life-threatening skin reactions or rashes which may sometime 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:

  • Fever
  • Tiredness
  • Muscle or joint pain
  • Blisters or skin lesions
  • Mouth sores or ulcers
  • Red or inflamed eyes, like "pink eye" (conjunctivitis)

SYMTUZA® may cause serious side effects including:

  • Immune system changes can happen in people who start HIV medications.
  • 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 while you are taking SYMTUZA®.
  • 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 while taking SYMTUZA®.
  • Changes in body fat can happen in people taking HIV-1 medications.
  • Increased bleeding can occur in people with hemophilia who are taking SYMTUZA®.

 

These are not all of the possible side effects of SYMTUZA®.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Product Information for more details.

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