Apretude (cabotegravir)

Apretude generic

Apretude is available only as a brand-name medication. It’s not currently available in a generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Apretude for PrEP

The FDA approves prescription drugs such as Apretude to treat certain conditions.

Apretude for HIV PrEP

Apretude is FDA-approved for HIV PrEP in people at risk of contracting HIV through sexual activity. Apretude is approved for this use in adults and adolescents ages 12 years and older who weigh at least 35 kg, which is about 77 lb.

HIV PrEP explained

A doctor may prescribe HIV PrEP as a treatment to help prevent HIV. They may recommend it for someone at risk of contracting HIV-1 (the most common form of HIV). This may be because of:

• having a sexual partner who’s HIV-positive
• having sexual partner(s) who don’t know their HIV status
• not always using condoms
• having other sexually transmitted infections (STIs) or having had STIs in the past 6 months

Apretude is a long-acting antiretroviral that stops HIV from multiplying. (Antiretrovirals are drugs used to treat or prevent HIV.) If you’re exposed to HIV while you have Apretude in your body, the medication can stop the virus from increasing in numbers. This can prevent it from causing HIV. However, note that Apretude isn’t always effective at preventing HIV. It’s still possible to contract HIV even if you’re receiving Apretude.

Your doctor will only prescribe Apretude if you test negative for HIV. They will test you before you start Apretude and before you receive each injection of the drug. (If people with undiagnosed HIV use Apretude, the virus could develop resistance to the drug. This could make HIV harder to treat.)

To help lower your risk of contracting HIV while receiving Apretude for PrEP, it’s important to keep all your appointments. You should also use condoms to help prevent HIV and other STIs.

During Apretude treatment, it’s important to see a doctor right away to get tested for HIV if you:

• have sex without a condom or a condom breaks during sex
• have symptoms of STIs such as chlamydia or gonorrhea (having an STI can make it easier to contract HIV)
• develop any early symptoms of HIV, which may include:
  • fever
  • fatigue
  • muscle aches
  • skin rash
  • vomiting
  • diarrhea
  • night sweats
  • headache
  • swollen lymph nodes in your neck or groin
  • sore throat

If you test positive for HIV while receiving Apretude for PrEP, you’ll need to stop Apretude. Your doctor will switch you to an HIV treatment regimen.

To learn more about HIV, you can visit our hub for HIV and AIDS.

Note: Apretude has a boxed warning about the risk of drug resistance. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients to side effects that could be dangerous. See “Apretude precautions” below for details.

Effectiveness for HIV PrEP

Clinical trials have confirmed the efficacy of Apretude for HIV PrEP. To find out how the drug performed in these trials, see Apretude’s prescribing information.

Apretude is recommended as a treatment option for HIV PrEP in guidelines from the Centers for Disease Control and Prevention (CDC).

Apretude and children

Apretude is FDA-approved for HIV PrEP in adolescents who weigh at least 35 kg, which is about 77 lb.

Apretude injection dosage

Apretude is used for HIV PrEP. The following information describes dosages that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Apretude comes as a long-acting liquid suspension in a single-dose vial. Each vial contains 600 milligrams (mg) of the drug in 3 milliliters (mL) of suspension. This may also be written as 200 mg/mL.

Apretude is given as an intramuscular injection. Your doctor or healthcare professional will inject the dose of Apretude into the muscle of your buttock. You will receive your injections in your doctor’s office or clinic.

Dosing for HIV PrEP

The recommended dosage of Apretude for PrEP is one injection of 600 mg, followed by a second injection of 600 mg 1 month later. After this, the recommended dosage is one injection of 600 mg every 2 months.

Your doctor may recommend taking cabotegravir tablets (Vocabria) for about 1 month before you start Apretude for PrEP. (Cabotegravir is the active ingredient in Apretude.) If this applies to you, you should receive your first Apretude injection on the last day of taking Vocabria or within 3 days after stopping Vocabria.

If you don’t take Vocabria before starting Apretude, you can receive your first Apretude injection at any time.

Your doctor will test you for HIV before you have your first injection of Apretude for PrEP. They’ll also test you before each following injection. If you test positive for HIV, your doctor won’t administer Apretude. Instead, they’ll prescribe different medications to treat HIV.

Children’s dosage

Apretude is FDA-approved for HIV PrEP in adolescents ages 12 years and older who weigh at least 35 kg, which is about 77 lb. The recommended dosing for adolescent children is the same as for adults. This dosage is described above.

What if I miss a dose?

If you miss an appointment to receive your dose of Apretude, call your doctor’s office right away to reschedule. The date of your next injection and whether your treatment schedule changes will depend on when you had your last injection. In some cases, your doctor may recommend taking cabotegravir tablets (Vocabria) for up to 2 months to replace a missed injection. Your doctor will recommend the best course of action for your situation.

To help make sure that you don’t miss a dose, be sure to put all your appointments on a calendar. You could also try using a medication reminder. This can include setting an alarm. You could also download a reminder app on your phone.

Will I need to use this drug long term?

Apretude is meant to be a long-term treatment. If you and your doctor determine that Apretude is safe and effective for you, you’ll likely take it long term.

To learn more, you can refer to this in-depth Apretude dosage article.

Apretude cost

As with all medications, the price of Apretude can vary. The actual price you’ll pay depends on your insurance plan if you have one, your location, and the pharmacy you use.

Before approving coverage for Apretude, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure whether you’ll need prior authorization for Apretude, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Apretude, or if you need help understanding your insurance coverage, help is available.

The Apretude Savings Program may help you save on the cost of Apretude. For more information and to find out if you’re eligible for support, call 844-588-3288 or visit the program website.

To learn more, you can refer to this in-depth Apretude cost article. And to learn more about saving money on prescriptions, check out this article.

Generic version

Apretude is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Drug coupons

You can visit Optum Perks for price estimates of Apretude (see below). These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with any insurance copays or benefits.

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Retail price refers to the manufacturer’s published list price and is up to date as of 3/2023. Retail and discounted prices are U.S.-only and can vary based on region and pharmacy. We cannot guarantee that the discounted price listed here will exactly match the price at your pharmacy. Please contact your pharmacy for the exact price.

Optum Perks and Healthline are subsidiaries of RVO Health.

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Apretude side effects

Apretude can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Apretude. These lists do not include all possible side effects.

Note that Apretude is a long-acting injection. The drug may stay in your body for 12 months or longer after stopping treatment. If you have side effects with Apretude, they may last for a long time.

For more information about the possible side effects of Apretude, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may concern or bother you.

Note: The FDA tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Apretude, you can do so through MedWatch.

Mild side effects

Mild side effects of Apretude can include:

• injection site reactions, such as pain, swelling, warmth, redness, discoloration, bruising, hardness, itching, or numbness
• diarrhea
• nausea and vomiting
• abdominal pain
• flatulence (gas)
• fatigue
• headache
• dizziness
• sleep problems, such as sleepiness, insomnia, or unusual dreams
• muscle or back pain
• reduced appetite
• rash
• fever
• upper respiratory infection, such as the common cold
• weight gain

Most of these side effects may go away within a few days to a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

Note: This is a partial list of mild side effects from Apretude. To learn about other mild side effects, talk with your doctor or pharmacist, or view Apretude’s prescribing information.

Serious side effects

Serious side effects from Apretude aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Liver damage. Symptoms can include:
  • pain on the right side of your abdomen
  • nausea and vomiting
  • pale stools
  • dark urine
  • itching
  • jaundice
• Depression. Symptoms can include:
  • feeling sad or hopeless
  • anxiety or irritability
  • eating more or less than usual
  • changes in sleep, such as trouble getting to sleep or waking early
  • fatigue
  • losing interest in activities you used to enjoy
  • suicidal thoughts and behaviors
• Risk of drug resistance when used for PrEP in people who have HIV.*
• Allergic reaction.

To learn more, you can refer to this in-depth Apretude side effects article.

* Apretude has a boxed warning for this side effect. This is a serious warning from the FDA. To learn more, see the “Apretude precautions” section below.

Side effects in children

Apretude is approved for use in adolescents ages 12 years and older who weigh at least 35 kg, which is about 77 lb. In clinical trials, side effects reported in adolescent children were similar to side effects reported in adults receiving Apretude. Examples of these side effects are listed in the section above.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Apretude. This side effect wasn’t reported in clinical trials of this drug, but can still occur.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

Call your doctor right away if you have an allergic reaction to Apretude, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Alternatives to Apretude

Other drugs are available for HIV PrEP. Some may be a better fit for you than others. If you’re interested in finding an alternative to Apretude, talk with your doctor. They can tell you about other medications that may work well for you.

Alternatives for HIV PrEP

Examples of other drugs that may be used for HIV PrEP include:

• cabotegravir sodium (Vocabria)
• emtricitabine and tenofovir alafenamide (Descovy)
• emtricitabine and tenofovir disoproxil fumarate (Truvada)

Apretude vs. Truvada

Apretude and Truvada are different HIV PrEP medications. Apretude is a long-acting injection that you typically take every 2 months. It contains one active drug, cabotegravir.

Truvada is an oral tablet that you take once per day. It contains two active drugs, emtricitabine and tenofovir disoproxil fumarate.

Two clinical trials compared Apretude with Truvada. Both trials found Apretude to be more effective than Truvada at preventing HIV. To find out how the drugs performed in these trials, see Apretude’s prescribing information.

Apretude and Truvada can cause different side effects. Apretude can remain in your body for 12 months or longer after stopping treatment. So, side effects with Apretude could last much longer than side effects with Truvada.

If you’re interested in taking HIV PrEP, talk with your doctor about which medication may be most suitable for you.

Common questions about Apretude

Here are answers to some frequently asked questions about Apretude.

Can Apretude be used to treat HIV?

No, Apretude can’t be used to treat HIV. The drug is only approved for HIV pre-exposure prophylaxis (PrEP). This means Apretude is only prescribed to help prevent HIV in people who are at risk of contracting HIV through sexual activity. If you test positive for HIV while receiving Apretude, your doctor will switch you to an HIV treatment regimen.

To treat HIV, you must use at least two antiretroviral drugs from different classes. (Antiretrovirals are drugs used to prevent and treat HIV.) Apretude only contains one antiretroviral drug, called cabotegravir. To treat HIV, your doctor will prescribe cabotegravir in combination with a different antiretroviral called rilpivirine.

A medication called Cabenuva contains a long-acting cabotegravir injection and a long-acting rilpivirine injection. Cabenuva is approved to treat HIV.

Can Cabenuva be prescribed as an alternative to Apretude?

No, Cabenuva can’t be prescribed as an alternative to Apretude.

Cabenuva is used to treat HIV, whereas Apretude is used for HIV PrEP. Cabenuva contains two active drugs, a long-acting cabotegravir injection and a long-acting rilpivirine injection. Apretude only contains cabotegravir.

If you have questions about alternatives to Apretude, talk with your doctor. You can also see “Alternatives to Apretude” above.

How Apretude is given

Apretude is given by intramuscular injection. A healthcare professional will inject Apretude in your buttock. This will take place in your doctor’s office or clinic.

When it’s given

Your doctor may recommend taking cabotegravir tablets (Vocabria) for about 1 month before you start Apretude for HIV PrEP. In this case, you should receive your first Apretude injection on the last day of taking Vocabria, or within 3 days after stopping Vocabria.

If you don’t take Vocabria before starting Apretude, you can receive your first Apretude injection at any time.

In both cases, your first two injections of Apretude will be given 1 month apart. After this, you’ll have one injection every 2 months.

If you miss an appointment to have a dose of Apretude, call your doctor’s office right away to reschedule. Your doctor will recommend the best course of action for your situation.

To help make sure that you don’t miss an appointment to have your dose of Apretude, be sure to put all your appointments on a calendar. You could also try using a medication reminder. This can include setting an alarm. You could also download a reminder app on your phone.

Apretude and alcohol

Alcohol doesn’t affect the way Apretude works. However, drinking alcohol while you’re receiving Apretude may raise your risk for certain side effects. These include nausea, vomiting, headache, and dizziness.

Drinking heavily with Apretude could also raise your risk for liver damage. Both Apretude and drinking large amounts of alcohol can cause liver damage.

If you drink alcohol, talk with your doctor about how much (if any) is safe to drink while you’re receiving Apretude.

Apretude interactions

Apretude can interact with several other medications. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Apretude and other medications

Below is a list of medications that can interact with Apretude. This list does not contain all drugs that may interact with Apretude.

Before taking Apretude, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Types of drugs that can interact with Apretude include:

• Certain seizure medications. Certain seizure medications can make Apretude less effective at preventing HIV. For this reason, your doctor will likely not prescribe Apretude if you’re taking any of the following:
  • carbamazepine (Carbatrol, Equetro, Tegretol, others)
  • oxcarbazepine (Trileptal, Oxtellar XR)
  • phenobarbital
  • phenytoin (Dilantin)
• Certain antibacterials. Certain antibacterials can make Apretude less effective at preventing HIV. For this reason, your doctor will likely not prescribe Apretude if you’re taking any of the following:
  • rifampin (Rifadin, Rimactane)
  • rifapentine (Priftin)
• UGT1A1 or UGT1A9 inducers. UGT1A1 and UGT1A9 are enzymes that help break down certain drugs in your body, including Apretude. Drugs that are UGT1A1 or UGT1A9 inducers can speed up the breakdown of Apretude, which can make it less effective at preventing HIV. The drugs listed above are examples of strong UGT1A1 or UGT1A9 inducers. Other examples are listed below. Your doctor may adjust your dosing schedule of Apretude if you take it with one of these drugs:
  • rifabutin (Mycobutin)
  • rifabutin, amoxicillin, and omeprazole (Talicia)
• Methadone (Methadose). Taking Apretude with methadone could reduce the effect of methadone. Your doctor may adjust your dosage of methadone if you take it with Apretude.

Apretude and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Apretude. However, you should still check with your doctor or pharmacist before using any of these products while taking Apretude.

Apretude and foods

There aren’t any foods that have been specifically reported to interact with Apretude. If you have any questions about eating certain foods with Apretude, talk with your doctor.

How Apretude works

HIV is a type of virus called a retrovirus. Apretude is a type of drug called an antiretroviral. Antiretrovirals are drugs used to treat or prevent HIV.

Apretude is a type of antiretroviral called an integrase strand inhibitor. It works by blocking the action of integrase, which is one of the enzymes (type of protein) that HIV uses to make new copies of itself. Blocking this enzyme stops HIV from increasing in numbers.

If you’re exposed to HIV while you have Apretude in your body, the medication can stop the virus from increasing in numbers. This can prevent it from causing HIV.

Apretude is a long-acting drug that’s slowly absorbed from the injection site into your bloodstream over a 2-month period. This produces a steady level of the drug in your bloodstream.

Note that Apretude isn’t always effective at preventing HIV. It’s still possible to contract HIV even if you’re receiving Apretude. It’s important to use condoms to help protect you from HIV and other sexually transmitted infections.

How long does it take to work?

Apretude starts working to prevent HIV soon after you receive your first injection. However, it takes about 7 days for the drug to reach its maximum level in your bloodstream.

Apretude and pregnancy

It’s not known if Apretude is safe to take during pregnancy. The drug hasn’t been studied in people who are pregnant.

One clinical study found that a drug from the same class as Apretude, called dolutegravir (Tivicay), may raise the risk of congenital anomalies (commonly known as birth defects) when used during pregnancy. But this doesn’t mean that Apretude may also have this effect.

In animal studies, researchers looked at the effect of giving oral cabotegravir (the active drug in Apretude) to pregnant female animals. In some studies, doses of cabotegravir higher than those used in humans had harmful effects on fetuses. But in other studies, no harmful effects were seen. Note that animal studies don’t always predict what may happen in humans.

If you’re pregnant or plan to become pregnant, talk with your doctor about the pros and cons of receiving Apretude. Note that Apretude is a long-acting injection, and the drug can remain in your body for 12 months or longer after stopping treatment.

If you take Apretude during pregnancy, you’re encouraged to sign up for the Antiretroviral Pregnancy Registry. This registry monitors the health of pregnant people who take antiretrovirals (drugs to treat or prevent HIV) and their babies. It aims to help healthcare professionals find out how safe antiretroviral drugs are for use during pregnancy. To find out more, talk with your doctor, call 800-258-4263, or refer to the pregnancy registry website.

Apretude and birth control

It’s not known if Apretude is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Apretude.

For more information about taking Apretude during pregnancy, see the “Apretude and pregnancy” section above.

Apretude and breastfeeding

It’s not known if Apretude is safe to take while breastfeeding. It’s unknown if the drug can pass into breast milk.

If you’re breastfeeding or plan to breastfeed, talk with your doctor about the risks and benefits of receiving Apretude. Note that Apretude is a long-acting injection, and the drug can remain in your body for 12 months or longer after stopping treatment.