Apretude (cabotegravir) is a brand-name injection that’s prescribed to prevent HIV in certain adults and adolescents. As with other drugs, Apretude can cause side effects, such as diarrhea, headache, and fever.
Apretude belongs to a drug class called HIV integrase inhibitors. The drug is not available in a generic version.
Read on to learn about potential common, mild, and serious side effects of Apretude. For a general overview of the drug, including details about its uses, see this article.
Apretude can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Apretude in clinical trials:
- fever
- nausea, vomiting, or diarrhea
- sleepiness or sleep disorders, such as insomnia
- injection site reactions*
- headache*
* For more information about this side effect, see “Side effect specifics” below.
Mild side effects can occur with Apretude use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Apretude’s prescribing information.
Mild side effects that have been reported with Apretude include:
- fever
- nausea, vomiting, or diarrhea
- sleepiness or sleep disorders, such as insomnia
- dizziness
- abdominal pain
- gas
- fatigue
- muscle pain
- rash
- decreased appetite
- weight gain
- back pain
- respiratory infections, such as the common cold
- injection site reactions*
- headache*
- mild allergic reaction†
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Apretude and want to tell the FDA about it, visit MedWatch.
* For more information about this side effect, see “Side effect specifics” below.
† An allergic reaction is possible after using Apretude. However, it’s not clear whether this side effect occurred in clinical trials. To learn more, see the “Side effect specifics” section below.
Apretude may cause serious side effects. Though serious side effects from Apretude aren’t common, they can occur. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Apretude’s prescribing information.
If you develop serious side effects while taking Apretude, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported and their symptoms include:
- Liver problems. Symptoms can include:
- yellowing of the eyes or skin
- nausea or vomiting
- abdominal pain
- fatigue
- Depression or other mood changes.*
- Risk of drug resistance when used for PrEP in certain people.†
- Severe allergic reaction.‡
* For more information about this side effect, see “Side effect specifics” below.
† Apretude has a
‡ An allergic reaction is possible after using Apretude. However, it’s not clear whether this side effect occurred in clinical trials. To learn more, see the “Side effect specifics” section below.
Learn more about some of the side effects that Apretude may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Apretude.
Risk of drug resistance when used for PrEP in certain people
Apretude has a
Apretude is approved by the FDA to prevent HIV in people at high risk of infection. However, this medication should only be used in people who are HIV-negative. This is because taking Apretude if you have HIV may cause you to develop resistance to Apretude. Resistance can occur when a virus, such as HIV, no longer responds to medication. This could mean that your HIV is more difficult to treat.
It’s possible that HIV may not cause symptoms. However, in some cases, you may experience symptoms, which can include:
- fever
- headache
- night sweats
- mouth sores
- swollen lymph nodes
What you can do
Before you start treatment with Apretude, your doctor will test you for HIV. In addition, they will recommend an HIV test before you receive each injection of Apretude. As long as you do not have HIV, you can continue receiving Apretude for PrEP.
However, if you test positive for HIV, your doctor will recommend stopping treatment with Apretude and starting an HIV treatment plan instead. If you develop symptoms of HIV while receiving Apretude, be sure to tell your doctor right away.
Injection site reactions
It’s possible to develop an injection site reaction from receiving Apretude. An injection site reaction can occur after you receive your dose of Apretude. It can happen in the area where you were given your Apretude injection, in your buttock muscle.
Injection site reactions were among the most common side effects reported in Apretude’s clinical trials. Examples of injection site reactions include:
- pain
- swelling or warmth
- bruising
- discoloration of the skin
- itchiness
- a lump under the skin
- loss of feeling at the injection site
What you can do
If you develop an injection site reaction after receiving your dose of Apretude, talk with your doctor. They may recommend a warm compress to help with muscle pain. Or your doctor may recommend ice if you have swelling, warmth, or skin discoloration at the injection site. In other cases, they may recommend an over-the-counter medication such as Benadryl (diphenhydramine) or Tylenol (acetaminophen).
Talk with your doctor about the best ways to manage your injection site reaction.
Depression or other mood changes
It’s possible to develop depression or other mood changes during treatment with Apretude. However, these were not common side effects reported in clinical trials. It’s possible for depression or other mood changes to be serious or even life threatening. In some cases, depression can even increase your risk of suicidal thoughts or behaviors.
Symptoms of depression or mood changes may include:
- feeling sad
- hopelessness
- anxiety
- having thoughts of hurting yourself
- losing interest in activities that you used to enjoy
What you can do
If you develop symptoms of depression or changes in your mood, be sure to talk with your doctor right away. They can recommend the best ways to manage your symptoms. In addition, your doctor can help determine whether you should stop treatment with Apretude and switch to another medication for PrEP.
Headache
Headaches were one of the most common side effects reported in Apretude’s clinical trials.
What you can do
If you develop headaches that are severe or bothersome while you’re receiving Apretude, talk with your doctor. They can recommend ways to help manage this side effect. For example, your doctor may recommend taking an over-the-counter pain medication, such as Tylenol (acetaminophen) or Advil (ibuprofen).
Allergic reaction
As with most drugs, Apretude can cause an allergic reaction in some people. However, it’s not clear whether this side effect occurred in clinical trials. However, other integrase inhibitors, such as Apretude, may cause an allergic reaction. So it’s possible that Apretude can as well.
Symptoms can be mild or serious and can include:
- skin rash
- itching
- flushing
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Apretude. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Suicide prevention
If you know someone at immediate risk of self-harm, suicide, or hurting another person:
- Ask the tough question: “Are you considering suicide?”
- Listen to the person without judgment.
- Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
- Stay with the person until professional help arrives.
- Try to remove any weapons, medications, or other potentially harmful objects.
If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.
Tell your doctor about any medical conditions that you have. They can help determine whether Apretude may be a safe treatment option for you.
Boxed warning: Risk of drug resistance when used for PrEP in certain people
This drug has a
Other precautions
Be sure to talk with your doctor about your health history before you take Apretude. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. These are considered drug-condition or drug-factor interactions. The conditions and factors to consider include:
Liver problems. Tell your doctor if you have any liver problems, such as cirrhosis, before starting Apretude. This medication may cause liver problems to occur. If you already have a condition affecting your liver, Apretude may make your condition worse. In some cases, your doctor may recommend more frequent monitoring of your liver while you’re taking Apretude. Or your doctor may recommend a different treatment option for you.
Allergic reaction. If you’ve had an allergic reaction to Apretude or any of its ingredients, your doctor will likely not prescribe Apretude. Ask your doctor whether other medications may be better options for you.
Mental health conditions. If you have mental health conditions, such as depression or bipolar disorder, tell your doctor before starting Apretude. In rare cases, Apretude may increase your risk of depression. If you have an existing mental health condition, Apretude may make your condition worse. If you experience new or worsening changes in mood, talk with your doctor right away. They may recommend a different treatment option for you.
Alcohol with Apretude
There are no known interactions between Apretude and alcohol. However, it’s possible for alcohol to increase your risk for certain side effects. Some examples include:
- nausea or vomiting
- dizziness
- headache
- liver problems, such as cirrhosis
If you drink alcohol and have questions about how much, if any, is safe to consume during treatment with Apretude, talk with your doctor.
Pregnancy and breastfeeding while taking Apretude
It’s not known if Apretude may be safe to take during pregnancy. At this time, there isn’t enough information to determine whether Apretude may be safe to take during pregnancy. Animal studies show that the drug may cause congenital anomalies (commonly known as birth defects) or pregnancy loss. However, animal studies don’t always indicate what may happen in humans.
If you and your doctor decide you will receive Apretude during pregnancy, a pregnancy registry is available. A pregnancy registry collects information from people who receive Apretude during pregnancy. The registry aims to determine what effects a drug may have on a developing fetus. For more information, visit the Antiretroviral Pregnancy Registry (APR) website or call 800-258-4263.
It’s also not known if it may be safe to receive Apretude while breastfeeding. At this time, it’s not known if the drug may be present in breast milk or what effects it may have on a child who is breastfed. Animal studies show that the drug is present in milk. However, animal studies don’t always indicate what may happen in humans.
It’s also important to note that Apretude may be present in your body for up to 12 months after your dose. If you’re pregnant or can become pregnant, or you’re breastfeeding, talk with your doctor before starting Apretude.
In most cases, side effects of Apretude are mild. However, serious side effects can also occur from treatment with Apretude.
If you’d like to learn more about Apretude, talk with your doctor or pharmacist. They can help answer any questions you have about side effects of taking the drug.
Besides talking with your doctor, you can do some research on your own. These articles might help:
- More information about Apretude. For details about other aspects of Apretude, refer to this article.
- Cost. If you’d like to learn about Apretude and cost, see this article.
- A look at HIV. For details about HIV, see our HIV and AIDS hub.
Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.