Side effects of DELSTRIGO

You make your own path, so stay aware of side effects along the way.

A low rate of side effects

DELSTRIGO has a low rate of side effects. In a study of adults who were new to treatment, the most common side effects over 96 weeks were the following:

  • 7% of participants had dizziness
  • 5% of participants had nausea
  • 5% of participants had abnormal dreams

These are not all the possible side effects of DELSTRIGO.

In this study, fewer patients stopped taking DELSTRIGO than Atripla because of side effects:

Some side effects can be serious

DELSTRIGO can cause serious side effects, including: worsening of hepatitis B virus (HBV). If you have both HIV-1 and HBV and stop taking DELSTRIGO, your HBV may suddenly get worse. Do not stop taking DELSTRIGO without first talking to your health care provider, as they will need to monitor your health. Your health care provider should test you for HBV infection before you start treatment with DELSTRIGO.

Serious side effects can also include:

  • New or worse kidney problems, including kidney failure. Your health care provider should do blood and urine tests to check your kidneys before you start and during treatment. They may tell you to stop taking DELSTRIGO if you develop new or worsening kidney problems.
  • Bone problems, such as bone pain and softening or thinning (which may lead to fractures), in some people who take DELSTRIGO. Your health care provider may need to do tests to check your bones.
  • Tell your health care provider if you have any of the following symptoms during treatment with DELSTRIGO: bone pain that does not go away or worsening bone pain; pain in your arms, legs, hands or feet; broken (fractured) bones; or muscle pain or weakness. These may be symptoms of a bone or kidney problem.
  • Changes in your immune system (Immune Reconstitution Syndrome) 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 health care provider right away if you start having any new symptoms after starting your HIV-1 medicine.

For those concerned about cholesterol

HIV-1 may have a negative impact on your bad cholesterol (LDL-C). In a study of adults who were new to treatment, DELSTRIGO did not raise bad cholesterol, while Atripla did.

At week 48, the effects on bad cholesterol (LDL-C) were:

The effects on bad cholesterol at week 96 were similar to those seen at week 48.

The benefit of these changes has not been demonstrated.

What is DELSTRIGO?

DELSTRIGO is a complete, one-pill prescription HIV medicine used to treat HIV-1 infection in adults who have not received HIV-1 medicines in the past, or to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Important Safety Information

Worsening of hepatitis B virus infection (HBV). If you have both Human Immunodeficiency Virus-1 (HIV-1) and HBV and stop taking DELSTRIGO, your HBV may suddenly get worse. Do not stop taking DELSTRIGO without first talking to your healthcare provider, as they will need to monitor your health. Your healthcare provider should test you for HBV infection before you start treatment with DELSTRIGO.

 

Do not take DELSTRIGO if you are currently taking any of the following medicines:

  • carbamazepine
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • enzalutamide
  • rifampin
  • rifapentine
  • mitotane
  • St. John’s wort

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. If you have taken any of the medicines in the past 4 weeks, talk to your healthcare provider or pharmacist before starting DELSTRIGO.

 

Do not take DELSTRIGO if you have ever had an allergic reaction to lamivudine.

 

New or worse kidney problems, including kidney failure, can happen while you are taking DELSTRIGO. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, your healthcare provider may tell you to stop taking DELSTRIGO.

 

Some people who take DELSTRIGO experience bone problems such as pain, softening, or thinning of the bone. Tell your healthcare provider if you have any of the following symptoms during treatment with DELSTRIGO: bone pain that does not go away or worsening bone pain; pain in your arms, legs, hands or feet; broken bones; or muscle pain or weakness.

 

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.

 

The most common side effects of DELSTRIGO include: dizziness, nausea, and abnormal dreams.

 

These are not all the possible side effects of DELSTRIGO. For more information, ask your healthcare provider or pharmacist.

 

Before starting DELSTRIGO, tell your healthcare provider about all your medical conditions, including if you have hepatitis B virus infection; kidney problems; bone problems, including a history of bone fractures; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. It is not known if DELSTRIGO can harm your unborn baby. Do not breastfeed if you take DELSTRIGO. Women with HIV should not breastfeed because their babies could be infected with HIV through their breast milk.

 

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 DELSTRIGO. Keep a list of your medicines to show your healthcare provider and pharmacist. Tell your healthcare provider if you have taken rifabutin in the past 4 weeks. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take DELSTRIGO with those other medicines.

 

Take DELSTRIGO every day exactly as your healthcare provider tells you to take it. Take DELSTRIGO 1 time each day, at about the same time every day.

 

DELSTRIGO is usually taken by itself (without other HIV medicines).

 

If you take the medicine rifabutin during treatment with DELSTRIGO, your healthcare provider will also prescribe an additional dose of doravirine for you. Carefully follow your healthcare provider’s instruction about when to take doravirine and how much to take. This is usually 1 tablet of doravirine about 12 hours after your last dose of DELSTRIGO. Do not change your dose or stop taking DELSTRIGO without talking to your healthcare provider first.

 

Take DELSTRIGO on a regular dosing schedule as instructed by your healthcare provider. Do not miss doses.

 

Get your DELSTRIGO refilled from your healthcare provider or pharmacy before you run out.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call the FDA at 1-800-FDA-1088.

 

Please read the accompanying Patient Information for DELSTRIGO, including an important warning about the potential worsening of hepatitis B after stopping DELSTRIGO, and discuss it with your doctor. The physician Prescribing Information also is available.

 

Products mentioned are trademarks of their respective owners.

What is DELSTRIGO (doravirine, lamivudine, and tenofovir disoproxil fumarate)?

DELSTRIGO is a complete, one-pill prescription HIV medicine used to treat HIV-1 infection in adults who have not received HIV-1 medicines in the past, or to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

DELSTRIGO is a complete, one-pill prescription HIV medicine used to treat HIV-1

DELSTRIGO is a complete, one-pill prescription HIV medicine used to treat HIV-1 infection in adults who have not received HIV-1 medicines in the past, or to replace their current HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Important Safety Information for DELSTRIGO (doravirine, lamivudine, and tenofovir disoproxil fumarate)

Worsening of hepatitis B virus infection (HBV). If you have both Human Immunodeficiency Virus-1 (HIV-1) and HBV and stop taking DELSTRIGO, your HBV may suddenly get worse. Do not stop taking DELSTRIGO without first talking to your healthcare provider, as they will need to monitor your health. Your healthcare provider should test you for HBV infection before you start treatment with DELSTRIGO.

 

Do not take DELSTRIGO if you are currently taking any of the following medicines:

  • carbamazepine
  • oxcarbazepine
  • phenobarbital
  • phenytoin
  • enzalutamide
  • rifampin
  • rifapentine
  • mitotane
  • St. John’s wort

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one that is listed above. If you have taken any of the medicines in the past 4 weeks, talk to your healthcare provider or pharmacist before starting DELSTRIGO.

 

Do not take DELSTRIGO if you have ever had an allergic reaction to lamivudine.

 

New or worse kidney problems, including kidney failure, can happen while you are taking DELSTRIGO. Your healthcare provider should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, your healthcare provider may tell you to stop taking DELSTRIGO.

 

Some people who take DELSTRIGO experience bone problems such as pain, softening, or thinning of the bone. Tell your healthcare provider if you have any of the following symptoms during treatment with DELSTRIGO: bone pain that does not go away or worsening bone pain; pain in your arms, legs, hands or feet; broken bones; or muscle pain or weakness.

 

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.

 

The most common side effects of DELSTRIGO include: dizziness, nausea, and abnormal dreams.

 

These are not all the possible side effects of DELSTRIGO. For more information, ask your healthcare provider or pharmacist.

 

Before starting DELSTRIGO, tell your healthcare provider about all your medical conditions, including if you have hepatitis B virus infection; kidney problems; bone problems, including a history of bone fractures; are pregnant or plan to become pregnant; or are breastfeeding or plan to breastfeed. It is not known if DELSTRIGO can harm your unborn baby. Do not breastfeed if you take DELSTRIGO. Women with HIV should not breastfeed because their babies could be infected with HIV through their breast milk.

 

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 DELSTRIGO. Keep a list of your medicines to show your healthcare provider and pharmacist. Tell your healthcare provider if you have taken rifabutin in the past 4 weeks. Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take DELSTRIGO with those other medicines.

 

Take DELSTRIGO every day exactly as your healthcare provider tells you to take it. Take DELSTRIGO 1 time each day, at about the same time every day.

 

DELSTRIGO is usually taken by itself (without other HIV medicines).

 

If you take the medicine rifabutin during treatment with DELSTRIGO, your healthcare provider will also prescribe an additional dose of doravirine for you. Carefully follow your healthcare provider’s instruction about when to take doravirine and how much to take. This is usually 1 tablet of doravirine about 12 hours after your last dose of DELSTRIGO. Do not change your dose or stop taking DELSTRIGO without talking to your healthcare provider first.

 

Take DELSTRIGO on a regular dosing schedule as instructed by your healthcare provider. Do not miss doses.

 

Get your DELSTRIGO refilled from your healthcare provider or pharmacy before you run out.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call the FDA at 1-800-FDA-1088.

 

Please read the accompanying Patient Information for DELSTRIGO, including an important warning about the potential worsening of hepatitis B after stopping DELSTRIGO, and discuss it with your doctor. The physician Prescribing Information also is available.

 

Products mentioned are trademarks of their respective owners.

Worsening of hepatitis B virus infection (HBV). If you have both Human Immunodeficiency Virus-1 (HIV-1) and HBV and stop

Worsening of hepatitis B virus infection (HBV). If you have both Human Immunodeficiency Virus-1 (HIV-1) and HBV and stop taking DELSTRIGO, your HBV may suddenly get worse. Do not stop taking DELSTRIGO without first talking to your doctor, as they will need to monitor your health. Your healthcare provider should test you for HBV infection before you start treatment with