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
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What are the side effects of Isentress (raltegravir)?
Common Side Effects
- Headache (4%)
- Trouble sleeping (4%)
- Nausea (3%)
Other Side Effects
- Dizziness
- Fatigue
- Elevated liver enzymes
Serious Side Effects
- 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
Source: DailyMed
The following 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.
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.
Frequently asked questions about Isentress (raltegravir)
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What are the 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 forms
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 100mg | 6 packets | $62.00 | $10.33 |
Typical dosing 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
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?
What are alternatives to Isentress (raltegravir)?
Treatment of HIV infection in people aged 4 weeks and older
Treatment of HIV infection in adults
What is the latest news about Isentress (raltegravir)?
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References
Best studies we foundCenters for Disease Control and Prevention. (2024). Clinical guidance for PEP.
Centers for Disease Control and Prevention. (2024). Clinical guidance for PrEP.
ClinicalInfoHIV.gov. (n.d.). Immune reconstitution inflammatory syndrome (IRIS).
ClinicalInfoHIV.gov. (n.d.). Integrase strand transfer inhibitor (INSTI).
ClinicalInfoHIV.gov. (2024). What to start: Initial combination antiretroviral regimens for people with HIV.
Eckard, A. R., et al. (2020). Weight gain and integrase inhibitors. Current Opinion in Infectious Diseases.
HIVinfo.NIH.gov. (2021). Drug resistance.
HIVinfo.NIH.gov. (2021). What to start: Choosing an HIV treatment regimen.
HIVinfo.NIH.gov. (2024). HIV and nutrition and food safety.
HIVinfo.NIH.gov. (2024). Post-exposure prophylaxis (PEP).
MedlinePlus. (2023). Creatine kinase.
Merck Sharp & Dohme LLC. (2022). Isentress (raltegravir) for oral suspension: Instructions for use for babies and toddlers.
Merck Sharp & Dohme LLC. (2024). Isentress- raltegravir tablet, film coated; Isentress- raltegravir tablet, chewable; Isentress- raltegravir granule, for suspension [package insert]. DailyMed.
National Human Genome Research Institute. (2014). About phenylketonuria.
Sax, P. E., et al. (2020). Weight gain following initiation of antiretroviral therapy: Risk factors in randomized comparative clinical trials. Clinical Infectious Diseases.
Thapa, S., et al. (2023). Immune reconstitution inflammatory syndrome. StatPearls.
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