
What are the side effects of Isentress or Isentress HD?
The most common side effects of ISENTRESS or ISENTRESS HD include: trouble sleeping, headache, dizziness, nausea, and tiredness.
What are the side effects of Isentress (raltegravir)?
What are the important side effects of Isentress (raltegravir)? Some patients taking raltegravir experience serious skin and allergic reactions. These reactions can be severe or life-threatening if not treated promptly. Patients who develop any type of skin rash with other symptoms should call their doctor right away.
What happens if you drink alcohol while taking Isentress?
Alcohol doesn’t affect how Isentress works, and there aren’t any warnings about avoiding alcohol while you’re taking the drug. However, if you find that Isentress makes you feel tired or dizzy, drinking alcohol could worsen these side effects. If you drink alcohol, talk with your doctor about whether Isentress is right for you.
Can Isentress cause kidney failure?
In rare cases, Isentress can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark-colored urine.
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What does Isentress do to your body?
It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Raltegravir is known as an integrase inhibitor. It blocks the virus from growing and infecting more cells.
Does Isentress cause weight gain?
Weight gain may occur when taking Isentress. In clinical trials, Isentress wasn't found to be a direct cause of weight changes. However, recent studies show that HIV medications such as Isentress may increase body mass index (BMI) in people with HIV.
How long do you take Isentress for?
How long do you take Isentress (raltegravir)? If you are taking Isentress (raltegravir) for PEP, it should be taken for 28 days. If you are taking it as part of your HIV regimen, you should continue to take it until your healthcare provider tells you to stop.
Who should not take Isentress?
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Isentress HD® film-coated tablets in children weighing 40 kilograms (kg) or more. Safety and efficacy have not been established in children weighing less than 40 kg.
Does Isentress make you feel sick?
The most common side effects of ISENTRESS or ISENTRESS HD include: trouble sleeping, headache, dizziness, nausea, and tiredness.
Can Isentress cause kidney failure?
In rare cases, raltegravir can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.
Is Isentress safe?
Important Safety Information Some people who take ISENTRESS or ISENTRESS HD develop severe skin reactions and allergic reactions that can be serious, and may be life-threatening or lead to death. If you develop a rash, call your doctor right away.
What is Isentress 400 mg tablet used for?
Isentress is an antiviral medicine that works against the Human Immunodeficiency Virus (HIV). This is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). The virus produces an enzyme called HIV integrase. This helps the virus to multiply in the cells in your body.
Can you take Isentress alone?
Raltegravir is a medication to treat human immunodeficiency virus (HIV) or to reduce the risk of getting HIV. You should only take this medication with other medications. You should never take raltegravir alone.
What does Truvada and Isentress do?
Truvada and Isentress Isentress (raltegravir) is a type of drug called an HIV integrase inhibitor. Isentress is often used in combination with Truvada for treating HIV. According to HIV treatment guidelines, taking Truvada with Isentress is a first-choice option for people who are starting HIV treatment.
How often do you take Isentress?
For oral dosage form (Isentress® film-coated tablets): Adults—400 milligrams (mg) two times a day. For patients who are also taking rifampin, the dose is usually 800 mg (two 400 mg tablets) two times a day. Children—Use and dose must be determined by your doctor.
How do you take Isentress?
Raltegravir (Isentress®) tablets, chewable tablets, and oral suspension are usually taken with or without food twice a day. Raltegravir (Isentress® HD) tablets are usually taken with or without food once a day. Take raltegravir at the same time(s) every day.
Can Isentress cause depression?
Raltegravir (Isentress) may lead to a temporary worsening of pre-existing depression, according to a number of case reports published in the September 12th edition of AIDS.
Does Isentress cause anxiety?
Anxiety, suicidal ideation, and suicidal behavior (particularly in patients with history of psychiatric illness) have also been reported during postmarketing experience.
What does Truvada and Isentress do?
Truvada and Isentress Isentress (raltegravir) is a type of drug called an HIV integrase inhibitor. Isentress is often used in combination with Truvada for treating HIV. According to HIV treatment guidelines, taking Truvada with Isentress is a first-choice option for people who are starting HIV treatment.
Can you take Isentress alone?
Raltegravir is a medication to treat human immunodeficiency virus (HIV) or to reduce the risk of getting HIV. You should only take this medication with other medications. You should never take raltegravir alone.
What are the side effects of isentress HD?
They can make it hard for you to do your daily activities. . The most common side effects of ISENTRESS HD include: trouble sleeping, headache, dizziness, nausea, and tiredness. These are not all possible side effects. Some side effects can be serious.
Does isentres have side effects?
ISENTRESS has a low rate of side effects. When a medicine has a different effect on you than it was meant to have. Side effects can be unpleasant. They can make it hard for you to do your daily activities. . The most common side effects of ISENTRESS include: trouble sleeping, headache, dizziness, nausea, and tiredness.
Does isentres HD cause nausea?
People taking ISENTRESS or ISENTRESS HD may still develop infections or other conditions associated with HIV-1 infections. The most common side effects of ISENTRESS or ISENTRESS HD include: trouble sleeping, headache, dizziness, nausea, and tiredness.
Can you breastfeed if you take isentres?
Do not breastfeed if you take ISENTRESS or ISENTRESS HD. Women with HIV should not breastfeed because their babies could be infected with HIV through their breast milk.
What are the effects of isentress on the liver?
increased levels of liver enzymes, increased blood glucose, vomiting, suicidal thoughts or actions, weakness, and. serious skin and allergic reactions. Drug interactions of Isentress include medicines which alter the activity of UGT1A1 enzymes, such as rifampin, which may affect blood levels of Isentress.
What is the phase III of Isentress?
In Phase III studies of Isentress, patients with chronic (but not acute) active hepatitis B and/or hepatitis C virus co-infection were permitted to enroll provided that baseline liver function tests did not exceed 5 times the upper limit of normal (ULN).
What Are the Side Effects of HIV Medications?
It’s important to know the potential side effects of all the drugs you take to control your HIV infection, as well as potential drug interactions. All of the NNRTIs (nonnucleoside analogue reverse transcriptase inhibitors), for example, are associated with important drug-drug interactions so they must be used with caution in patients on other medications. Learn more about the side effects of the drugs in standard treatment regimens.
How long does it take to get Isentress?
The median duration of therapy in these trials was 96 weeks for subjects receiving Isentress and 38 weeks for subjects receiving placebo. The total exposure to Isentress was 708 patient-years versus 244 patient-years on placebo.
Can Isentress be used in pregnancy?
Use of Isentress in pregnant women has not been adequately evaluated. Due to the lack of conclusive safety data, Isentress should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Isentress is excreted into human milk.
How many adverse reactions were there to zidovudine?
There were no drug related clinical adverse reactions and three drug-related laboratory adverse reactions (one case of transient Grade 4 neutropenia in a subject receiving zidovudine -containing regimen for prevention of mother to child transmission (PMTCT), and two bilirubin elevations (one each, Grade 1 and Grade 2) considered non-serious and not requiring specific therapy).
Does Isentress cure HIV?
Although Isentress does not cure HIV or AIDS, continuous HIV treatment with Isentress can help patients control the infection and decrease their risk of acquiring HIV-related illnesses.
What are the side effects of isentress?
Common side effects of Isentress include: changes in the shape or location of body fat (especially in arms, legs, face, neck, breasts, and trunk). Tell your doctor if you have serious side effects of Isentress including: signs of a new infection (such as fever or chills, cough, or flu symptoms), a severe skin reaction.
What is an isentress?
What Is Isentress? Isentress (raltegravir) is an antiviral medication used to treat HIV, which causes acquired immunodeficiency syndrome ( AIDS ). Isentress is not a cure for HIV or AIDS.
How much is isentress?
For the treatment of adult patients with HIV-1 infection, the dosage of Isentress is one 400 mg film-coated tablet administered orally, twice daily. Consult your doctor for pediatric dosing.
Is isentress a phase 3 study?
In Phase III studies of ISENTRESS, patients with chronic (but not acute) active hepatitis B and/or hepatitis C virus co-infection were permitted to enroll provided that baseline liver function tests did not exceed 5 times the upper limit of normal (ULN). In the treatment-experienced studies, BENCHMRK 1 and BENCHMRK 2, 16% of all patients (114/699) were co-infected; in the treatment-naive studies, STARTMRK and ONCEMRK, 6% (34/563) and 3% (23/797), respectively, were co-infected. In general the safety profile of ISENTRESS in subjects with hepatitis B and/or hepatitis C virus co-infection was similar to that in subjects without hepatitis B and/or hepatitis C virus co-infection, although the rates of AST and ALT abnormalities were higher in the subgroup with hepatitis B and/or hepatitis C virus co-infection for all treatment groups.
Does isentres 400 mg cause cancer?
In studies of ISENTRESS 400 mg twice daily, cancers were reported in treatment-experienced subjects who initiated ISENTRESS or placebo, both with OBT, and in treatment-naive subjects who initiated ISENTRESS or efavirenz, both with emtricitabine (+) tenofovir disoproxil fumarate; several were recurrent. The types and rates of specific cancers were those expected in a highly immunodeficient population (many had CD4+ counts below 50 cells/mm 3 and most had prior AIDS diagnoses). The risk of developing cancer in these studies was similar in the group receiving ISENTRESS and the group receiving the comparator.
Does isentress cause bruising?
Tell your doctor if you have serious side effects of Isentress including: pale skin, easy bruising or bleeding, signs of a new infection (such as fever or chills, cough, or flu symptoms), drowsiness, confusion, increased thirst, lower back pain, urinating less than usual or not at all,
Does isentress interact with rifampin?
Isentress may interact with rifampin, phenobarbital, or cholesterol medications. Tell your doctor all medications and supplements you use.
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Are you currently using Isentress?
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What to know before taking isentress?
Before using Isentress, tell your doctor if you are allergic to any drugs, or if you have a muscle disorder, kidney disease, or liver disease.
How to take isentress?
Take Isentress exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What other drugs will affect Isentress?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
How much does Isentress weigh?
Isentress is for use in adults and children who weigh at least 4.4 pounds (2 kilograms). Isentress HD 600mg tablets are for use in adults, and in children weighing at least 88 pounds (40 kg).
What is isentress powder?
Isentress oral suspension is a powder that must be mixed with water before you take it.
Can isentress cause skin rash?
Isentress may cause a severe skin reaction that can be fatal. Stop taking this medicine and get emergency medical help if you have skin redness or a rash that spreads and causes blistering and peeling.
What are the side effects of isentress?
And as with adults, the most common side effects in children were headache, trouble sleeping, and nausea.
What is the drug used for isentress?
Isentress is a type of drug called an antiretroviral, and it’s meant to be used with other antiretrovirals. Isentress contains the drug raltegravir.
Does the active drug in Isentress come in a combination tablet?
No. Isentress contains the drug raltegravir, which doesn’t currently come in a combination tablet form to treat HIV. Isentress is meant to be taken with other HIV drugs. So if you use Isentress, you’ll need more than one pill to treat HIV.
How much does Isentress HD weigh?
Isentress can be given to children who weigh at least 4.4 pounds (2 kg). Isentress HD can be given only to children who weigh at least 88 pounds (40 kg). The specific dosage will be based on the form of Isentress your child takes and their weight.
What is isentress used for?
Isentress uses. The Food and Drug Administration (FDA) approves prescription drugs such as Isentress to treat certain conditions. Isentress may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.
How many forms does an isentress have?
Isentress comes in three forms, and each contains different strengths:
Why is it important to dispose of isentress?
If you no longer need to take Isentress and have leftover medication , it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.
How many mg of RAL isentress?
To meet this need, a once-daily formulation of RAL, Isentress HD (two 600-mg tablets), was created and found to be equally efficacious at maintaining viral suppression and raising CD4 counts compared with the 400 mg twice-a-day version. Isentress HD was approved by the FDA in 2017, a full decade after the original was put on the market.
How Much Does Isentress Cost in the U.S.?
Isentress dosed at 400 mg has a cost of $1,735 for a month’s supply; Isentress HD dosed at 600 mg has the same cost ( $1,735/month ).
What happens if you don't have insurance for raltegravir?
If you don’t have insurance or your insurance won’t cover the majority of raltegravir’s cost (you are “underinsured”), there is a patient assistance program that can help reduce or eliminate the cost, depending on your financial situation.
Is Isentress a drug?
Isentress (also known by its generic name, raltegravir, or RAL) was the first medication in the integrase inhibitor class to be FDA-approved as part of a comprehensive HIV treatment regimen. Isentress is currently listed as part of a recommended initial combination antiretroviral (ARV) treatment regimen for people who have never taken HIV medications before, according to official U.S. health department guidelines. It is recommended to be part of a three-drug regimen, along with:

Treatment-Naive Adults
Treatment-Experienced Adults
Common side effects
- Dizziness
- Fatigue
- Headache disorder
- Nausea
- Insomnia
Common side effects
- Dizziness
- Fatigue
- Headache disorder
- Nausea
- Insomnia
- Dyspepsia
- Herpes zoster
- Herpes simplex infection
- Fever
- General weakness
- Vomiting
- Acute abdominal pain
If any of these effects persist or worsen, tell your doctor or pharmacist promptly
- Headache
- Nausea
- Trouble sleeping
As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time . Get medical help right away if you have any serious symptoms, including
- Unexplained weight loss
If any of these effects persist or worsen, tell your doctor or pharmacist promptly
- Headache
- Nausea
- Trouble sleeping
As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time . Get medical help right away if you have any serious symptoms, including
- Unexplained weight loss
- Severe tiredness
- Muscle aches/weakness that doesn't go away
- Headaches that are severe or don't go away
- Joint pain
- Numbness/tingling of the hands/feet/arms/legs
- Vision changes
- Signs of infection
- Signs of an overactive thyroid
- Signs of a certain nerve problem known as Guillain-Barre syndrome
Tell your doctor right away if you have any serious side effects, including
- Signs of kidney problems
- Persistent nausea/vomiting
- Loss of appetite
- Severe stomach/abdominal pain
- Dark urine
- Yellowing eyes/skin
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including
- Rash
- Itching/swelling
- Severe dizziness
- Trouble breathing
Other things to note
- Changes in body fat may occur while you are taking this medication . The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.
Selected Adverse Events -Adults
Patients with Co-Existing Conditions -Adults
Pediatrics
Postmarketing Experience