Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking Isentress?
ISENTRESS contains the active ingredient raltegravir. ISENTRESS is used in combination
with other anti-HIV medicines to treat adults, adolescents, and children 2 years of
age and older who are infected with HIV.
For more information, see Section
1. Why am I taking ISENTRESS? in the full CMI.
2. What should I know before I take Isentress?
Do not use if you have ever had an allergic reaction to ISENTRESS or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
4. How do I take ISENTRESS?
Adults: Take one ISENTRESS 400mg tablet twice daily or two ISENTRESS HD 600mg once daily as
directed by your doctor or pharmacist. Swallow whole.
Children and Adolescents: Your child's doctor will tell you how many tablets your child should take and the
type of ISENTRESS (ISENTRESS or ISENTRESS HD tablet or ISENTRESS chewable table) based
on your child's age and weight.
5. What should I know while taking ISENTRESS?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using ISENTRESS.
Do not change your dose or stop taking ISENTRESS or your other HIV medicines without
first talking with your doctor
|
|
Things you should not do
|
Do not stop taking your medicine or lower the dosage without checking with your doctor.
The amount of virus in your blood may increase if the medicine is stopped for even
a short period of time. HIV may develop resistance to ISENTRESS and become harder
to treat
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how ISENTRESS
affects you.
There have been side effects reported with ISENTRESS that may affect your ability
to drive or operate machinery.
|
|
Looking after your medicine
|
Keep your tablets in a cool dry place where the temperature stays below 30°C and where
children cannot reach them
Keep your tablets in the bottle until it is time to take them, if you take the tablets
out of the bottle they may not keep well
|
6. Are there any side effects?
The most common side effects are nausea, headache, diarrhoea, tiredness, inflammation
of the nasal passages and throat, trouble sleeping, upper respiratory tract infection,
cough, fever, bronchitis, back pain and depression.
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects: any severe skin reaction, hives or nettlerash, fainting, fast or irregular heart beat
or tightness in the chest.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
raltegravir
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ISENTRESS. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ISENTRESS
Where to find information in this leaflet:
1. Why am I taking ISENTRESS?
ISENTRESS contains the active ingredient raltegravir.
ISENTRESS is used in combination with other anti-HIV medicines to treat adults, adolescents,
and children 2 years of age and older who are infected with HIV. The children and
adolescents (2 - 18 years of age) who participated in the ISENTRESS studies had previously
taken HIV medicines.
ISENTRESS belongs to a group of medicines called integrase inhibitors. It works by
blocking HIV integrase, one of the enzymes that is needed during the replication process
for HIV to make more virus. When integrase is blocked by ISENTRESS, the virus is not
able to reproduce normally. This helps reduce the amount of virus in the blood.
When used with other anti-HIV medicines, ISENTRESS helps reduce the amount of HIV
virus in your blood (called "viral load") and increase the number of CD4 (T) cells
(Immune Cells that help fight infection). Reducing the amount of HIV in the blood
may keep your immune system healthy, so it can help fight infection.
ISENTRESS may not have these effects in all patients.
ISENTRESS does not cure HIV infection or AIDS.
It is very important that you stay under the care of your doctor during treatment
with ISENTRESS.
2. What should I know before I take ISENTRESS?
Warnings
Do not use ISENTRESS if:
you are allergic to raltegravir, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
have or have had any allergies to any other medicines, foods, preservatives or dyes
are not sure whether you should start taking this medicine.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Phenylketonuria
Tell your doctor if you have phenylketonuria.
ISENTRESS chewable tablets contain aspartame, a source of phenylalanine, which may
be harmful to people with phenylketonuria.
Pregnancy
Check with your doctor if you are pregnant or intend to become pregnant.
You should not take ISENTRESS when you are pregnant unless your doctor says you should.
Your doctor will discuss the risks and benefits of using ISENTRESS 400 mg twice daily
if you are pregnant.
There are limited data on the use of ISENTRESS HD 1200 mg (2 x 600 mg) once daily
in pregnant women
Breastfeeding
Do not breast-feed if you are taking this medicine.
It is recommended that HIV-infected women should not breast-feed their infants because
of the possibility that your baby can be infected with HIV through your breast milk.
Talk with your doctor about the best way to feed your baby.
Child under the age of 2 years
Do not give this medicine to a child under the age of 2 years. ISENTRESS has not been
studied in children under the age of 2.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins, or supplements that you buy without a prescription from your
pharmacy, supermarket or health food shop.
ISENTRESS can be taken with most medicines, however some medicines are not recommended
with ISENTRESS. Some medicines may interfere with ISENTRESS and affect how it works.
Medicines that may
increase
the effect of ISENTRESS include:
Atazanavir, for treatment of HIV
Medicines that may
reduce
the effect of ISENTRESS include:
Antacids
Rifampin, a medicine used to treat tuberculosis
Tipranavir/Ritonavir, for treatment of HIV
Phenytoin and Phenobarbitone, medicines used to treat seizures
These medicines may affect how well ISENTRESS works. You may need different amounts
of your medicines, or you may need to take different medicines.
Keep a list of all your medicines and to show your doctor or pharmacist.
Do not start taking a new medicine without telling your doctor or pharmacist. They
can tell you if it is safe to take ISENTRESS with other medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ISENTRESS.
4. How do I take ISENTRESS?
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist
for help.
How much to take
Adults
Take one ISENTRESS 400mg tablet twice daily or two ISENTRESS HD 600mg once daily as
directed by your doctor or pharmacist. Swallow whole
Children and Adolescents
Your child's doctor will tell you how many tablets your child should take and the
type of ISENTRESS (ISENTRESS or ISENTRESS HD tablet or ISENTRESS chewable table) based
on your child's age and weight
The 100mg chewable tablet is scored and can be split into equal halves.
Do not take more than 300mg of the chewable tablet twice a day.
Chewable tablets are to be chewed, not swallowed whole.
Do not switch between the 400mg or 600mg tablet and the chewable tablet.
When to take ISENTRESS
ISENTRESS should be used at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It is very important to take each of your anti-HIV medicines as prescribed and at
the right times of day. This can help your medicines work better. It also lowers the
chance that your medicines will stop working to fight HIV (drug resistance).
How to take ISENTRESS
Take ISENTRESS as directed by mouth, with or without food.
ISENTRESS must be used with other anti-HIV medicines
If taking iron salts (to treat and prevent iron deficiency or anaemia): You should
wait at least two hours between taking iron salts and taking ISENTRESS, as these medicines
may reduce ISENTRESS efficacy.
How long to take ISENTRESS
Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important
to keep taking your medicine even if you feel well.
Do not change your dose or stop taking ISENTRESS or your other HIV medicines without
first talking with your doctor.
When your supply of ISENTRESS starts to run low, get more from your doctor or pharmacy.
This is very important because the amount of virus in your blood may increase if the
medicine is stopped for even a short period of time. HIV may develop resistance to
ISENTRESS and become harder to treat.
If you forget to take ISENTRESS
If you miss your dose at the usual time, take it as soon as you remember.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much ISENTRESS
If you think that you have used too much ISENTRESS, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking ISENTRESS?
Things you should do
Do not give your medicine to anyone else, even if they have the same condition as
you.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking ISENTRESS.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.
If you become pregnant while taking this medicine, tell your doctor immediately.
Starting antiretroviral treatment
In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation
from opportunistic infections (eg: pneumonia, tuberculosis or a painful blistering
rash known as shingles) may occur when combination antiretroviral treatment is started.
Call your doctor straight away if you:
notice any symptoms of infection
Tell and remind any doctor, dentist, pharmacist or other health professional you visit
that you are using ISENTRESS.
Things you should not do
Do not stop taking your medicine or lower the dosage without checking with your doctor.
The amount of virus in your blood may increase if the medicine is stopped for even
a short period of time. HIV may develop resistance to ISENTRESS and become harder
to treat.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ISENTRESS
affects you.
There have been side effects reported with ISENTRESS that may affect your ability
to drive or operate machinery. Individual responses to ISENTRESS may vary.
Looking after your medicine
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
Keep this leaflet with the medicine, you may need to read it again.
Keep your tablets in the bottle until it is time to take them.
If you take the tablets out of the pack/bottle they may not keep well.
Follow the instructions on the bottle on how to take care of your medicine properly.
Keep your tablets in a cool dry place away from moisture, heat or sunlight where the
temperature stays below 30°C; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines
Getting rid of any unwanted medicine
If your doctor tells you to stop taking this medicine or it is out of date, take it
to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Your doctor will discuss these with you and will explain the risks and benefits of
your treatment. Less serious side effects
|
Less serious side effects
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What to do
|
|
The most common side effects are:
Nausea
Headache
Diarrhoea
Tiredness
Inflammation of the nasal passages and throat
Trouble sleeping
Upper respiratory tract infection
Cough
Fever
Bronchitis
Back pain
Depression
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Hypersensitivity reaction
Severe skin reactions
Pinkish, itchy swellings on the skin, also called hives or nettlerash
Tiredness, headaches, being short of breath when exercising, dizziness and looking
pale.
Frequent infections such as fever, severe chills, sore throat or mouth ulcers
Abdominal pain, nausea, vomiting, vomiting blood and blood in the bowel motions
Loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin
and eyes, and dark coloured urine
That you are bleeding or bruising more easily than normal
Aching muscles, muscle tenderness or weakness, not caused by exercise. (On rare occasions,
muscle problems can be serious, including muscle breakdown resulting in kidney damage.)
Fainting
Fast or irregular heartbeat
Wheeziness due to tightness in the chest
Since the medicine has been on the market the following side effects have been reported:
Depression
Suicidal thoughts and actions
Low Blood platelet count
Muscle tenderness or weakness
Clumsiness and lack of coordination
Rash with or without increase in some white blood cells
Liver Failure
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Serious side effects are rare.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell, or if any known side effect does not go away or gets worse.
Other side effects not listed here may occur in some people.
The long-term effects of ISENTRESS are unknown at this time. Tell your doctor if you
notice any other effects.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ISENTRESS 400 mg Tablet contains
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Active ingredient
(main ingredient)
|
Raltegravir 400 mg
|
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Other ingredients
(inactive ingredients)
|
Microcrystalline cellulose
Lactose monohydrate
Calcium phosphate dibasic anhydrous
Hypromellose 2208
Poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant)
Sodium stearyl fumarate
Magnesium stearate.
The pink film coating contains the following inactive ingredients:
Polyvinyl alcohol
Titanium dioxide
Polyethylene glycol 3350
Talc
Iron oxide red
Iron oxide black
|
What ISENTRESS HD 600 mg Tablet contains
|
Active ingredient
(main ingredient)
|
Raltegravir 600 mg
|
|
Other ingredients
(inactive ingredients)
|
Hypromellose 2910
Croscarmellose sodium
Microcrystalline cellulose
Magnesium stearate
Carnauba wax
The yellow film coating contains the following inactive ingredients:
Lactose monohydrate
Hypromellose 2910
Titanium dioxide
Glycerol triacetate
Iron oxide yellow
Iron oxide black
|
What ISENTRESS 25 mg and 100 mg Chewable Tablets contains
|
Active ingredient
(main ingredient)
|
Raltegravir 25 mg and 100 mg
|
|
Other ingredients
(inactive ingredients)
|
Hydroxypropylcellulose
Sucralose
Saccharin sodium
Sodium citrate
Mannitol
Iron oxide red CI77411 (100 mg tablet only)
Iron oxide yellow CI77492
Ammonium glycyrrhizinate
Sorbitol
Fructose
Natural and artificial flavours (orange, banana and masking that contains aspartame)
Crospovidone
Magnesium stearate
Sodium stearyl fumarate
Ethylcellulose 20cP
Ammonium hydroxide
Medium chain triglycerides
Oleic acid
Hypromellose 2910/6cp
Macrogol 400
|
Do not take this medicine if you are allergic to any of these ingredients.
ISENTRESS tablets do not contain sucrose, gluten, tartrazine or any other azo dyes.
ISENTRESS 25 mg and 100 mg chewable tablets are banana-orange flavoured.
ISENTRESS chewable tablets contain phenylalanine as part of the artificial sweetener,
aspartame. The artificial sweetener may be harmful to people with phenylketonuria.
The chewable tablets do not contain sucrose, gluten, tartrazine or any other azo dyes.
What ISENTRESS looks like
ISENTRESS is available as a 400mg tablet and as a chewable tablet formulation in 100
mg (scored) and 25mg strengths. ISENTRESS HD is available as a 600 mg tablet.
ISENTRESS HD 600 mg (AUST R 280294) is yellow, oval shaped tablet with the corporate logo and "242" on
one side and plain on the other. Available in bottles containing 60 tablets
ISENTRESS 400 mg (AUST R 140238) is pink, oval shaped tablet with "227" on one side and plain on the
other. Available in bottles containing 60 tablets
ISENTRESS Chewable tablet 25 mg (AUST R 193383) is pale yellow round tablet with the corporate logo on one side and
"473" on the other side. Available in bottles containing 60 chewable tablets
ISENTRESS Chewable tablet 100 mg (AUST R 193388) is pale orange oval tablet scored on both sides; one side is plain,
and the other side is imprinted with the corporate logo and "477" on either side of
the score. Available in bottles containing 60 chewable tablets.
Who distributes ISENTRESS
ISENTRESS is supplied in Australia by:
Merck Sharp & Dohme (Australia) Pty Limited
Level 1, Building A, 26 Talavera Road, Macquarie Park
NSW 2113, Australia
This leaflet was prepared in November 2023.
WRM-WPPI-MK0518-MF-042023WPPI-MK0518-MF-032023
RCN000025612, 000025862
Copyright © 2023 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.