Brand Name
Isentress
Generic Name
Raltegravir
View Brand Information FDA approval date: October 12, 2007
Classification: Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Form: Tablet, Granule
What is Isentress (Raltegravir)?
ISENTRESS® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus infection in patients 4 weeks of age and older. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.
Approved To Treat
Save this treatment for later
Not sure about your diagnosis?
Related Clinical Trials
Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I/II Proof of Concept Study
Summary: The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.
An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments
Summary: The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events. The primary objectives of this study are as follows: * To provide continued access to the study drug received in the parent protocol or swit...
Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives
Summary: The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral therapy (ART) and virally suppressed, leading up to a hybrid type I effectiveness-implementation trial randomizing individual AGYWLHIV to receive long-acting (LA) injectable cab...
Related Latest Advances
Brand Information
ISENTRESS (RALTEGRAVIR)
1INDICATIONS AND USAGE
ISENTRESS® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in patients 4 weeks of age and older.
- The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response
2DOSAGE FORMS AND STRENGTHS
- Film-coated Tablets
- Chewable Tablets
- For Oral Suspension
3CONTRAINDICATIONS
None
4ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4.1Postmarketing Experience
The following adverse reactions have been identified during postapproval use of ISENTRESS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: thrombocytopenia
Gastrointestinal Disorders: diarrhea
Hepatobiliary Disorders: hepatic failure (with and without associated hypersensitivity) in patients with underlying liver disease and/or concomitant medications
Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis
Nervous System Disorders: cerebellar ataxia
Psychiatric Disorders: anxiety, paranoia
5OVERDOSAGE
No specific information is available on the treatment of overdosage with ISENTRESS. Doses as high as 1600-mg single dose and 800-mg twice-daily multiple doses were studied in healthy volunteers without evidence of toxicity. Occasional doses of up to 1800 mg per day were taken in the clinical studies of HIV-1 infected subjects without evidence of toxicity.
In the event of an overdose, it is reasonable to employ the standard supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required. The extent to which ISENTRESS may be dialyzable is unknown.
6DESCRIPTION
ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is
The empirical formula is C
Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol.
Each 400 mg film-coated tablet of ISENTRESS for oral administration contains 434.4 mg of raltegravir (as potassium salt), equivalent to 400 mg of raltegravir free phenol and the following inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc and titanium dioxide.
Each 100 mg chewable tablet of ISENTRESS for oral administration contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, red iron oxide, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide.
Each 25 mg chewable tablet of ISENTRESS for oral administration contains 27.16 mg of raltegravir (as potassium salt), equivalent to 25 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide.
Each packet of ISENTRESS for oral suspension 100 mg, contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, banana with other natural flavors, carboxymethylcellulose sodium, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, macrogol/PEG 400, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, microcrystalline cellulose, monoammonium glycyrrhizinate, oleic acid, sorbitol, sucralose and sucrose.
7HOW SUPPLIED/STORAGE AND HANDLING
ISENTRESS tablets 400 mg are pink, oval-shaped, film-coated tablets with "227" on one side. They are supplied as follows:
- NDC 68071-2113-6 bottles of 6
8PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
9Patient Information
ISENTRESS® (eye sen tris )
film-coated tablets
ISENTRESS® (eye sen tris ) chewable tablets
ISENTRESS® (eye sen tris )
for oral suspension
film-coated tablets
ISENTRESS® (eye sen tris ) chewable tablets
ISENTRESS® (eye sen tris )
for oral suspension
Read this Patient Information before you start taking ISENTRESS and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is ISENTRESS?
ISENTRESS is a prescription HIV medicine used with other antiretroviral medicines to treat Human Immunodeficiency Virus-1 (HIV-1) infection in people 4 weeks of age and older. HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).
It is not known if ISENTRESS is safe and effective in babies under 4 weeks of age.
When used with other HIV medicines to treat HIV-1 infection, ISENTRESS may help:
- reduce the amount of HIV in your blood. This is called "viral load".
- increase the number of white blood cells called CD4+ (T) cells in your blood, which help fight off other infections.
- reduce the amount of HIV-1 and increase the CD4+ (T) cells in your blood, which may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
ISENTRESS does not cure HIV-1 infection or AIDS.
You must stay on continuous HIV therapy to control HIV-1 infection and decrease HIV-related illnesses.
Avoid doing things that can spread HIV-1 infection to others.
- Do not share or re-use needles or other injection equipment.
- Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
- Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.
Ask your doctor if you have any questions on how to prevent passing HIV to other people.
What should I tell my doctor before taking ISENTRESS?
Before you take ISENTRESS, tell your doctor if you:
- have liver problems
- have a history of a muscle disorder called rhabdomyolysis or myopathy
- have increased levels of creatine kinase in your blood
- have phenylketonuria (PKU). ISENTRESS chewable tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU.
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if ISENTRESS can harm your unborn baby.
- are breastfeeding or plan to breastfeed.
Tell your doctor about all the medicines you take, including, prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with ISENTRESS. Keep a list of your medicines to show your doctor and pharmacist.
- You can ask your doctor or pharmacist for a list of medicines that interact with ISENTRESS.
- Do not start taking a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take ISENTRESS with other medicines.
How should I take ISENTRESS?
- Take ISENTRESS exactly as prescribed by your doctor.
- Do not change your dose of ISENTRESS or stop your treatment without talking with your doctor first.
- Stay under the care of your doctor while taking ISENTRESS.
- ISENTRESS film-coated tablets must be swallowed whole.
- ISENTRESS chewable tablets may be chewed or swallowed whole.
- ISENTRESS for oral suspension should be given to your child within 30 minutes of mixing.
- Do not switch between the film-coated tablet, the chewable tablet, or the oral suspension without talking with your doctor first.
- Do not run out of ISENTRESS. Get a refill of your ISENTRESS from your doctor or pharmacy before you run out.
- If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not double your next dose or take more ISENTRESS than prescribed.
- If you take too much ISENTRESS, call your doctor or go to the nearest hospital emergency room right away.
What are the possible side effects of ISENTRESS?
ISENTRESS can cause serious side effects including:
- Serious skin reactions and allergic reactions. Some people who take ISENTRESS develop serious skin reactions and allergic reactions that can be severe, and may be life-threatening or lead to death. If you develop a rash with any of the following symptoms, stop using ISENTRESS and call your doctor right away:
- fever
- generally ill feeling
- extreme tiredness
- muscle or joint aches
- blisters or sores in mouth
- blisters or peeling of the skin
- redness or swelling of the eyes
- swelling of the mouth or face
- problems breathing
Sometimes allergic reactions can affect body organs, such as your liver. Call your doctor right away if you have any of the following signs or symptoms of liver problems:
- yellowing of your skin or whites of your eyes
- dark or tea colored urine
- pale colored stools (bowel movements)
- nausea or vomiting
- loss of appetite
- pain, aching, or tenderness on the right side of your stomach area
- Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your doctor right away if you start having new symptoms after starting your HIV-1 medicine.
The most common side effects of ISENTRESS include:
- trouble sleeping
- headache
- dizziness
- nausea
- tiredness
Less common side effects of ISENTRESS include:
- depression
- hepatitis
- genital herpes
- herpes zoster including shingles
- kidney failure
- kidney stones
- indigestion or stomach area pain
- vomiting
- suicidal thoughts and actions
- weakness
Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. These may be signs of a rare serious muscle problem that can lead to kidney problems.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ISENTRESS. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ISENTRESS?
Film-Coated Tablets:
- Store ISENTRESS film-coated tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Chewable Tablets:
- Store ISENTRESS chewable tablets at room temperature between 68°F to 77°F (20°C to 25°C).
- Store ISENTRESS chewable tablets in the original package with the bottle tightly closed.
- Keep the drying agent (desiccant) in the bottle to protect from moisture.
For Oral Suspension:
- Store ISENTRESS for oral suspension at room temperature between 68°F to 77°F (20°C to 25°C).
- Store in the original container. Do not open the foil packet until ready for use.
Keep ISENTRESS and all medicines out of the reach of children.
General information about ISENTRESS
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use ISENTRESS for a condition for which it was not prescribed. Do not give ISENTRESS to other people, even if they have the same symptoms you have. It may harm them.
You can ask your doctor or pharmacist for information about ISENTRESS that is written for health professionals.
For more information go to www.ISENTRESS.com or call 1-800-622-4477.
What are the ingredients in ISENTRESS?
ISENTRESS film-coated tablets:
Active ingredient: raltegravir
Inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate.
The film coating contains: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc and titanium dioxide.
ISENTRESS chewable tablets:
Active ingredient: raltegravir
Inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. The 100 mg chewable tablet also contains red iron oxide.
ISENTRESS for oral suspension:
Active ingredient: raltegravir
Inactive ingredients: ammonium hydroxide, banana with other natural flavors, carboxymethylcellulose sodium, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, macrogol/PEG 400, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, microcrystalline cellulose, monoammonium glycyrrhizinate, oleic acid, sorbitol, sucralose and sucrose.
This Patient Information has been approved by the U.S. Food and Drug Administration.
10Instructions for Use
ISENTRESS (eye sen tris)
(raltegravir)
(raltegravir)
Read this Instructions for Use before you mix and give a dose of ISENTRESS for oral suspension to your child for the first time, and each time you get a refill. There may be new information. These instructions will help you to correctly mix and give a dose of ISENTRESS for oral suspension to your child.
See the
Your doctor will decide the right dose based on your child's weight.
Ask your doctor or pharmacist if you have any questions about how to mix or give ISENTRESS for oral suspension to your child.
How should I store ISENTRESS for oral suspension?
- Store ISENTRESS for oral suspension at room temperature between 68°F to 77°F (20°C to 25°C).
- Store in the original container. Do not open the foil packets until ready for use.
Keep ISENTRESS for oral suspension and all medicines out of the reach of children.
For more information go to www.ISENTRESS.com or call 1-800-622-4477.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.