Key takeaways

  • Apretude (cabotegravir extended-release injectable suspension) is a prescription drug used to help prevent HIV.
  • Apretude can cause side effects that range from mild to serious.
  • Examples include injection site pain and liver damage.

Specifically, Apretude is approved to help prevent HIV in at-risk adults and adolescents weighing at least 35 kilograms (kg). (For reference, 1 kg is about 2.2 pounds [lb]. This means individuals must weigh at least 77 lb.) They also must meet certain other criteria.

Keep reading to learn about the common, mild, and serious side effects that Apretude can cause. For a general overview of the drug, including details about its uses, see this article.

Apretude has a boxed warning. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Boxed warnings” section.

Some people may experience mild to serious side effects during their Apretude therapy. Examples of the drug’s commonly reported side effects include:

  • diarrhea
  • fatigue
  • fever
  • headache
  • injection site reaction

Mild side effects have been reported with Apretude. These include:

  • abdominal pain
  • diarrhea
  • dizziness
  • fatigue
  • fever
  • gas
  • headache
  • injection site reaction
  • nausea
  • sleep problems, such as trouble sleeping or unusual dreams

In most cases, these side effects should be temporary. And some may be managed easily. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop using Apretude unless your doctor recommends it.

Apretude may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

Apretude may cause serious side effects. The following list 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 include:

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medication safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while taking Apretude and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

Help is out there

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

  • Call or text the 988 Suicide and Crisis Lifeline at 988 or chat at 988lifeline.org. Caring counselors are available to listen and provide free and confidential support 24/7.
  • Text HOME to the Crisis Text Line at 741741 to connect with a volunteer crisis counselor for free and confidential support 24/7.
  • Not in the United States? Find a helpline in your country with Befrienders Worldwide.
  • Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you’re not in the same household, stay on the phone with them until help arrives.

Allergic reaction

For some people, Apretude can cause an allergic reaction.

Allergic reaction has been reported by people using Apretude as part of a treatment plan with other medications. But it’s not known whether the allergic reaction was caused by Apretude or a different medication.

In general, symptoms of allergic reaction can be mild or serious.

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should keep using Apretude.

If you have symptoms of a severe allergic reaction, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

Your doctor can confirm whether you’ve had a serious allergic reaction to Apretude. If they do, they may have you switch to a different therapy.

Here are answers to some commonly asked questions about Apretudes side effects.

Is weight gain or weight loss a side effect of Apretude?

Weight loss was not a side effect reported in Apretude’s clinical trials. The drug isn’t known to cause weight loss.

However, weight gain is a possible side effect of Apretude. In studies, weight gain was a rare side effect reported in people using Apretude. Weight gain reported with Apretude ranged from about 2.5 lb to about 9 lb.

If you experience weight gain while using Apretude and have concerns about it, tell your doctor. They can determine the most likely cause and suggest ways to manage it, if needed.

Can Apretude cause long-term side effects?

Possibly. Long-term side effects include those that may start at any time you’re using a drug. These can occur even if you’ve used it for a long time. It also includes side effects that may not go away, even after you stop using the drug.

Apretude is a long-acting injection, so the drug can stay in your body for long periods of time. After your last injection, small amounts can be present in your body for a year or longer. This means side effects may take a long time to go away, even if they become serious or bothersome.

Talk with your doctor to learn more about possible side effects of Apretude and how long they may last.

Apretude has a boxed warning for the risk of drug resistance in people with undiagnosed HIV. A boxed warning is the most serious warning from the FDA.

Risk of drug resistance in people with undiagnosed HIV

Preexposure prophylaxis (PrEP) helps prevent HIV. Apretude is a PrEP therapy. In people with undiagnosed HIV who use Apretude, drug resistance can develop. Due to this risk, your doctor must test you for HIV before starting Apretude and before each injection. You’ll be able to receive an injection only if your test for HIV is negative.

If you develop symptoms of HIV while using Apretude, tell your doctor right away. Symptoms may include:

What might help

Due to the risk of drug resistance, you should use Apretude only if you have a negative HIV test.

If you have a positive HIV test before starting Apretude, your doctor may recommend HIV treatment instead of Apretude for PrEP. If you have a positive HIV test or develop symptoms of HIV during Apretude therapy, your doctor will likely stop giving you Apretude. And they’ll likely recommend HIV treatment instead.

Learn more about some of the side effects Apretude may cause.

Injection site reaction

Injection site reaction was the most common side effect reported in studies of Apretude. Injection site reaction includes the following symptoms where Apretude is injected:

  • bruising, redness, or discoloration of the skin
  • hardness of the skin
  • lump under the skin
  • pain
  • swelling
  • warmth

Most often, injection site reaction lasts only a few days. It also tends to become less common and less severe with each injection.

Some factors can increase the risk of injection site reaction when using this drug. These include the following:

  • You’ve had a reaction to another drug in the same class of drugs as Apretude: Because of this, you may have a higher chance of injection site reaction with Apretude.
  • The medication is too cold: Receiving an injection of Apretude that hasn’t reached room temperature can increase your chance of injection site reaction.
  • Injection sites are not rotated: Apretude injections are given only in the buttock muscle. Over time, this may cause irritation at the injection site.

What might help

If you have an injection site reaction after an Apretude injection, tell your doctor. They’ll be able to recommend ways to help ease your symptoms. They may suggest applying a warm or cold compress to the area or taking over-the-counter medications.

Liver damage

Liver damage was a rare side effect reported in studies of Apretude. Liver damage may cause symptoms such as:

Liver damage has occurred in people who have had liver problems in the past and those who have not.

What might help

Due to this risk, your doctor may check your liver function with lab tests from time to time.

If you have symptoms of liver damage during Apretude therapy, tell your doctor right away. They’ll likely recommend stopping Apretude.

Below is important information you should consider before starting Apretude.

Boxed warning: Risk of drug resistance in people with undiagnosed HIV

Apretude has a boxed warning. A boxed warning is the most serious warning from the FDA. For details, see the “Boxed warnings” section.

Other precautions

Before taking Apretude, discuss your health history with your doctor. Apretude may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

Disclaimer: Healthline 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.