SIDE EFFECTS OF DELSTRIGO
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: dizziness 7%, nausea 5%, and abnormal dreams 5%. These are not all the possible side effects of DELSTRIGO.
In this study, fewer patients stopped taking DELSTRIGO than Atripla because of side effects.
when taking DELSTRIGO
VS
when taking Atripla (another HIV-1 medicine)
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 healthcare provider, as they will need to monitor your health. Your doctor should test you for HBV infection before you start treatment with DELSTRIGO.
New or worse kidney problems, including kidney failure. Your doctor 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 doctor may need to do tests to check your bones.
Tell your doctor 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 doctor right away if you start having any new symptoms after starting your HIV-1 medicine.
HIV may have a negative effect on your cholesterol.
In a study of adults who were new to treatment, DELSTRIGO did not increase bad cholesterol, while Atripla did.
At week 48, the effects on bad cholesterol (LDL-C) were:
EFFECTS ON BAD CHOLESTEROL (LDL-C)
-2.1 mg/dL
VS
8.3 mg/dL
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.
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 doctor 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 doctor 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 doctor 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 doctor should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, your doctor 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 doctor 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 doctor 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 doctor or pharmacist.
Before starting DELSTRIGO, tell your doctor 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.
including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your doctor and pharmacist. Tell your doctor if you have taken rifabutin in the past 4 weeks. . Your doctor can tell you if it is safe to take DELSTRIGO with those other medicines.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call FDA at 1-800-FDA-1088.
Products mentioned are trademarks of their respective owners.
US-DOR-00485 03/20
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).
. 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 doctor 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 doctor 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 doctor 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 doctor should do blood and urine tests to check your kidneys. If you develop new or worse kidney problems, your doctor 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 doctor 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 doctor 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 doctor or pharmacist.
Before starting DELSTRIGO, tell your doctor 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.
including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your doctor and pharmacist. Tell your doctor if you have taken rifabutin in the past 4 weeks. . Your doctor can tell you if it is safe to take DELSTRIGO with those other medicines.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call FDA at 1-800-FDA-1088.
