Risks and Side Effects

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What is RUKOBIA?
RUKOBIA is a prescription medicine used with other antiretroviral (ARV) medicines to treat HIV-1 in adults who have received several anti-HIV-1 regimens in the past, and have HIV-1 virus that is resistant to many ARV medicines, and are failing their current ARV therapy because it is not working, are not able to tolerate the side effects, or have other safety concerns.

These are not all the risks and side effects of RUKOBIA, and this information does not replace talking with your healthcare provider about your medical conditions or treatment. For more information, talk to your doctor and refer to the Patient Information for RUKOBIA. 

Who Should Not Take RUKOBIA?

Do not take RUKOBIA if you:

  • are allergic to fostemsavir or any of the ingredients in RUKOBIA.
  • take certain medicines, including: enzalutamide, carbamazepine, phenytoin, rifampin, mitotane, St. John’s wort (Hypericum perforatum).

What are the possible side effects of RUKOBIA?

RUKOBIA can cause serious side effects including:

  • 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 you start taking RUKOBIA.
  • Heart rhythm problems (QTc prolongation). RUKOBIA may cause a heart rhythm problem called QTc prolongation. QTc prolongation causes an irregular heartbeat. If you are elderly, you may be at a greater risk for developing this heart problem with RUKOBIA. 
  • Tell your healthcare provider right away if you feel dizzy, lightheaded, feel changes in your heartbeat, or you faint (lose consciousness).
  • Changes in liver function blood tests results. People with HIV-1 who take RUKOBIA and who also have hepatitis B or C virus infections, may be more likely to develop new or worsening changes in certain liver function blood tests during treatment with RUKOBIA.
    • If you stop your anti-hepatitis B treatment, this could mean that your hepatitis B may become active again (reactivated). Your healthcare provider may do blood tests to check your liver during treatment with RUKOBIA especially if you have hepatitis B virus infection.
    • Take any anti-hepatitis B or anti-hepatitis C medicines as prescribed by your healthcare provider during treatment with RUKOBIA.

The most common side effect of RUKOBIA is nausea.

These are not all of the possible side effects of RUKOBIA.

Call your doctor for medical advice about side effects. 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.

You should always talk with your doctor about any side effect.

What should I tell my doctor before taking RUKOBIA?

Tell your healthcare provider about all of your medical conditions, including if you: 

  • have or have had a heart problem, including a heart rhythm problem called QTc prolongation (irregular heartbeat).
  • have or have had liver problems, including hepatitis B or C virus infection.
  • are pregnant or plan to become pregnant. It is not known if RUKOBIA will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with RUKOBIA.
  • are breastfeeding or plan to breastfeed. Do not breastfeed if you take RUKOBIA.
    • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
    • It is not known if RUKOBIA can pass to your baby in your breast milk.
      Talk with your healthcare provider about the best way to feed your baby during your treatment with RUKOBIA.

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 RUKOBIA.

Especially tell your healthcare provider if you take birth control pills (oral contraceptives) that contain ethinyl estradiol. The amount of ethinyl estradiol can become increased in your blood during treatment with RUKOBIA. Talk to your healthcare provider about which oral contraceptives may be right for you during treatment with RUKOBIA.

Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. 

  • You can ask your healthcare provider or pharmacist for a list of medicines that interact with RUKOBIA. 
  • Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take RUKOBIA with other medicines. 

TALK TO YOUR DOCTOR

Here are some questions about RUKOBIA you can ask at your next appointment.

Doctor Discussion Guide

LEARN MORE ABOUT
RUKOBIA

See how RUKOBIA may help you meet your treatment goals.

About RUKOBIA

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