Isentress
Isentress (raltegravir) is used for treating people of all ages with human immunodeficiency virus (HIV). It belongs to the integrase inhibitor drug class. It works to stop the virus from spreading. This medication comes as brand-name tablets that are swallowed whole, chewable tablets, and granules for oral suspension. It's taken by mouth either once or twice daily (depending on the dosage). Side effects include headache, trouble sleeping, and nausea. Isentress (raltegravir) is taken with other types of HIV medications for a complete antiretroviral (ARV) treatment regimen.
What is Isentress (raltegravir)?
What is Isentress (raltegravir) used for?
- Treatment of HIV
How Isentress (raltegravir) works
Isentress (raltegravir) is an integrase inhibitor. It working by blocking integrase, an enzyme that HIV uses to make more copies of itself. When integrase gets blocked, the virus can't grow and spread.
Drug facts
Side effects of Isentress (raltegravir)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (4%)
- Trouble sleeping (4%)
- Nausea (3%)
Less Common Side Effects
- Dizziness
- Fatigue
- Elevated liver enzymes
Note: Side effects were reported by adults new to HIV treatment who were taking Isentress (raltegravir) film-coated tablets.
Isentress (raltegravir) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe muscle damage: severe muscle pain, weakness, brownish-red urine
- Severe skin reaction or severe allergic reaction: rash, hives, peeling skin, blisters, mouth sores, feeling unwell, muscle or joint aches, swelling of the face or lips, swelling around the eyes, difficulty breathing
The following Isentress (raltegravir) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common or rare
Blood in the urine
burning or stinging of the skin
dark urine
decreased frequency or amount of urine
fast heartbeat
hoarseness
increased thirst
irritation
joint pain, stiffness, or swelling
light-colored stools
loss of appetite
lower back or side pain
pain in the groin or genitals
painful blisters on the trunk of the body
painful cold sores or blisters on the lips, nose, eyes, or genitals
redness of the skin
sharp back pain just below the ribs
swelling of the eyelids, face, lips, hands, lower legs, or feet
tightness in the chest
trouble breathing or swallowing
unusual tiredness or weakness
upper right stomach pain
vomiting
yellow eyes and skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
Dizziness
trouble sleeping
Less common or rare
Belching
indigestion
lack or loss of strength
stomach discomfort, upset, or tenderness
thoughts of killing oneself or changes in behavior
Incidence not known
Delusions of persecution, mistrust, suspiciousness, or combativeness
fear or nervousness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Pros and cons of Isentress (raltegravir)
Pros
- Can take with or without food
- Available as chewable tablets and an oral suspension for young children
- Approved for people of all ages (including full-term newborns who weigh at least 4.5 lbs)
Cons
- Must take with other HIV medications
- Not a first-choice HIV treatment option for most people according to clinical guidelines
- Might not a good option for people at risk for muscle damage or rhabdomyolysis (severe muscle breakdown)
Pharmacist tips for Isentress (raltegravir)
- You can take Isentress (raltegravir) with or without food.
- Depending on your dosage and the formulation of Isentress (raltegravir) you have, the medication is either taken once or twice a day. Make sure to take it as instructed by your prescriber or as written on your prescription bottle. Ask your prescriber or pharmacist if you have any questions about how to take Isentress (raltegravir).
- Choose a convenient time for you to take Isentress (raltegravir). Make it a part of your daily routine to take the medication at the same time(s) every day. This is helpful for remembering to take Isentress (raltegravir) and for keeping the amount of medication in your body consistent. Forgetting to take your HIV medications can make the virus become resistant and make the infection harder to treat.
- Speak with your prescriber if you want to switch between the different formulations of Isentress (raltegravir). The film-coated tablets, chewable tablets, and granules for oral suspension have different dosages and can't be easily switched with one another.
- For Isentress (raltegravir) or Isentress HD (raltegravir) film-coated tablets: Swallow the film-coated tablets whole with a glass of water.
- For Isentress (raltegravir) chewable tablets: You can either chew the chewable tablets or you can swallow them whole with a glass of water. You can crush the 25 mg chewable tablet; follow the instructions to crush, mix with liquid, and take the mixture right after preparing if needed.
- For Isentress (raltegravir) granules for oral suspension: Follow the instructions to mix the granules with water to make the oral suspension. Swirl the mixture in the cup; don't shake it. Once everything is mixed, draw up the dose into an oral syringe and take the medication within 30 minutes.
- Avoid aluminum or magnesium-containing antacids, like Mylanta. These types of antacids can lessen the amount of Isentress (raltegravir) that gets absorbed into your body, which might make the HIV medication work less well.
Common questions about Isentress (raltegravir)
Isentress (raltegravir) and Isentress HD (raltegravir) film-coated tablets shouldn't be crushed. Damaging the coating on the tablet can affect how the medication gets released into the body. There are other formulations of Isentress (raltegravir) available for children if they're having trouble swallowing pills whole: chewable tablets and packets of granules for oral suspension. The 25 mg chewable tablet can be crushed and mixed with liquid for children. And the granules get mixed with water to make a suspension. Ask your prescriber about other options if you or your child has trouble swallowing.
No, Isentress (raltegravir) isn't approved for use as pre-exposure prophylaxis (PrEP). In other words, the medication can't be used to help prevent you from getting an HIV infection before you're potentially exposed to the virus. There are three FDA-approved PrEP treatments. These medications are Truvada (emtricitabine / tenofovir disoproxil fumarate), Descovy (emtricitabine / tenofovir alafenamide), and Apretude (cabotegravir). Discuss with a healthcare professional or HIV specialist if you're interested in starting an antiretroviral medication to prevent HIV.
Yes, the CDC recommends taking Isentress (raltegravir) 400 mg twice daily together with once-daily Truvada (emtricitabine / tenofovir disoproxil fumarate) for post-exposure prophylaxis (PEP). PEP is used to prevent HIV infection in people who don't have HIV and think they've been exposed to the virus. You must start this PEP regimen within 72 hours of getting exposed to the virus, and it's typically taken for 28 days. Talk to a healthcare professional right away if you think you've been exposed to HIV and you'd like to start PEP.
Speak with your prescriber about whether it's okay for you to drink any amount of alcohol while you're taking Isentress (raltegravir). Alcohol doesn't appear to change how the medication works in your body. But drinking alcohol can sometimes lead to forgetfulness, especially if you drink a large amount at one time. This forgetfulness can potentially cause you to miss doses of your HIV medication, which raises the risk for the virus to become harder to treat. Drinking too much alcohol can also put you at greater risk for liver damage, a side effect that Isentress (raltegravir) can already cause.
Isentress (raltegravir) might stay in your system for about 2 days after a single dose. This estimation is based on the medication's half-life, which is a measure of how long it takes for half the amount of medication to clear from your system after a single dose.
Yes. It's possible that your HIV specialist might prescribe both Isentress (raltegravir) and Truvada (emtricitabine / tenofovir disoproxil fumarate) for you to make up a complete HIV treatment regimen. Isentress (raltegravir) and Truvada belong to different subclasses of HIV medications and they work differently to help treat HIV. Keep in mind that this combination typically isn't recommended for most people with HIV.
To treat HIV, you should take Isentress (raltegravir) and your other HIV medications until your prescriber tells you to stop. Stopping your HIV medications earlier than prescribed can raise the risk that the virus can become resistant to treatment and be harder to fight off. But some reasons why your prescriber might stop treatment early include that you're having severe side effects (like a severe allergic reaction) and that you're switching to a different HIV medication. For post-exposure prophylaxis (PEP), you'll take Isentress (raltegravir) with Truvada (emtricitabine / tenofovir disoproxil fumarate) for 28 days.
In general, people tend to gain weight after they start taking HIV medications. Some studies suggest that people might gain more weight with a subclass of HIV medications called integrase inhibitors, which includes Isentress (raltegravir), than with other subclasses of HIV medications. It's not clear why this happens so more research is needed to see whether the medication directly causes weight gain. Talk to your prescriber if you notice concerning weight gain while you're taking Isentress (raltegravir). They can recommend ways to manage weight, like planning nutritious meals.
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Risks and warnings for Isentress (raltegravir)
Isentress (raltegravir) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Severe skin reaction and allergic reaction
Some people taking Isentress (raltegravir) have had severe and potentially life-threatening skin reactions, such as Stevens-Johnson syndrome. It's also possible to have a serious allergic reaction to the medication. Stop taking Isentress (raltegravir) and go to the emergency room right away if you have a severe rash or a rash with fever, blisters, peeling skin, or mouth sores. Also stop taking the medication and call 911 as soon as possible if you have swelling in the face or difficulty breathing.
Overactive immune system
- Risk factors: Current untreated infection
Taking HIV medications, such as Isentress (raltegravir), can cause an intense immune response called immune reconstitution syndrome. Your immune system becomes stronger and more active once you start taking Isentress (raltegravir) to treat HIV. Your immune system then begins to fight off any infections in the body that it was too weak to defend against before. This intense immune response can lead to a lot of inflammation.
In rare situations, your immune system can become so strong that it starts to attack healthy cells in your body, which can lead to certain autoimmune conditions. These autoimmune problems can develop after many months of taking Isentress (raltegravir).
Call your prescriber if you have a fever, difficulty breathing, cough, or any unusual, sudden changes to your health after you start Isentress (raltegravir). These might be signs and symptoms of immune reconstitution syndrome and its complications.
Risk for muscle damage
- Risk factors: Taking other medications that can cause muscle pain or muscle damage, like statins | History of rhabdomyolysis
Some adults who took Isentress or Isentress HD film-coated tablets had abnormal creatine kinase levels in their blood, which can be a sign of muscle damage. In fact, some people had muscle pain or even developed rhabdomyolysis (or "rhabdo"), severe muscle breakdown that can be serious and can lead to kidney damage. Get medical help right away if you start having symptoms of rhabdomyolysis, such as severe muscle pain, weakness all over your body, or brownish-red urine.
Chewable tablets not recommended for people with phenylketonuria (PKU)
The chewable tablet formulation of Isentress (raltegravir) contains phenylalanine, a component of the artificial sweetener aspartame. This ingredient is harmful to people with a genetic condition called phenylketonuria (PKU). Ask your prescriber for other formulations of Isentress (raltegravir) that's safer for you if you have PKU.
Isentress (raltegravir) dosage
Typical dosage for Isentress (raltegravir)
The dose depends on whether you've already started HIV treatment and what HIV medications you've taken before. Dosing for Isentress HD film-coated tablets and Isentress film-coated tablets, chewable tablets, and granules for oral suspension is slightly different.
Adults
- New to HIV treatment or are already taking Isentress (raltegravir)
- Once-daily dosing: The typical dose is two Isentress HD 600 mg tablets by mouth once daily.
- Twice-daily dosing: The typical dose is one 400 mg Isentress tablet by mouth twice daily.
- Have taken other HIV medications before: The typical dose is one Isentress 400 mg tablet by mouth twice daily.
- The dose is different if you're taking Isentress (raltegravir) with rifampin.
Children
- Children can take the film-coated tablets, chewable tablets, or granules for oral suspension. The formulation will depend on their age, weight, and ability to swallow.
- The prescriber will determine the dose based on your child's weight. In general, Isentress (raltegravir) is commonly taken by mouth twice daily. There are some situations where the medication is taken just once daily, such as for newborns or for children who are taking the Isentress HD 600 mg tablets.
Interactions between Isentress (raltegravir) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aluminum
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Amprenavir
- Cabotegravir
- Calcium
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Fosamprenavir
- Iron
- Magaldrate
- Magnesium
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Trisilicate
- Orlistat
- Sucralfate
- Zinc
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
How much does Isentress (raltegravir) cost?
$70.19
What are alternatives to Isentress (raltegravir)?
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