ISENTRESS raltegravir 100 mg chewable tablet bottle

Main information

  • Trade name:
  • ISENTRESS raltegravir 100 mg chewable tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ISENTRESS raltegravir 100 mg chewable tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 193388
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

193388

ISENTRESS raltegravir 100 mg chewable tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Merck Sharp & Dohme (Australia) Pty Ltd

Postal Address

North Ryde Post Business Centre,Locked Bag 2234,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

6/02/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ISENTRESS raltegravir 100 mg chewable tablet bottle

Product Type

Single Medicine Product

Effective date

27/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ISENTRESS, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adults,

adolescents and children from the age of 2 years. This indication is based on analyses of plasma HIV-1 RNA levels in controlled studies of ISENTRESS

(see CLINICAL TRIALS). The indication in paediatric patients is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy

of ISENTRESS through at least 24 weeks in a multicentre, open label, non-comparative study in HIV-1 infected, treatment-experienced children and

adolescents 2 to 18 years of age. The use of other active antiretroviral agents in combination with ISENTRESS is associated with a greater likelihood of

treatment response (see CLINICAL TRIALS). There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1

infection.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

2 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

60 chewable tablets

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Tablet, chewable

Route of Administration

Oral

Visual Identification

Pale orange, oval shaped tablet scored on both sides: one side is imprinted

with the Merck logo and '477' on either side of the score.

Active Ingredients

Raltegravir potassium

108.6 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 28.11.2017 at 06:47:14 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ISENTRESS

®

and

ISENTRESS HD

®

raltegravir

Consumer Medicine Information

The following information is applicable to ISENTRESS (400 mg tablet, 25 mg and 100 mg chewable tablet) and

ISENTRESS HD (600 mg tablet)

What is in this leaflet

This leaflet answers some common

questions about the ISENTRESS

product range.

It does not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking ISENTRESS

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor, pharmacist or treatments

officer at your local AIDS Council.

Keep this leaflet with the medicine.

You may need to read it again.

What ISENTRESS is

used for

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.

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.

Before you take

ISENTRESS

When you must not take it

Do not take ISENTRESS if you

have an allergy to:

any medicine containing

raltegravir

any of the ingredients listed at the

end of this leaflet.

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

Be sure to tell your doctor

immediately if you are pregnant or

if you are breast-feeding.

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 no data on the use of

ISENTRESS HD 1200 mg (2 x 600

mg) once daily in pregnant women.

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.

Do not give this medicine to a child

under the age of 2 years.

ISENTRESS has not been studied in

children under 2 years.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged, return

it to your pharmacist for disposal.

ISENTRESS

AND ISENTRESS HD

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor about all the

medicines you take, including

prescription medicines, vitamins,

and herbal supplements. Some

medicines are not recommended

with ISENTRESS.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

ISENTRESS is not recommended for

use during breast-feeding.

Tell your doctor if you have

phenylketonuria.

ISENTRESS chewable tablets

contain aspartame, a source of

phenylalanine, which may be

harmful to people with

phenylketonuria.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

ISENTRESS.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

get without a prescription from

your pharmacy, supermarket or

health food shop, including

antacids.

ISENTRESS can be taken with most

medicines, however some medicines

are not recommended with

ISENTRESS. Tell your doctor if you

take:

antacids

atazanavir, for treatment of HIV

tipranavir/ritonavir, for treatment

of HIV

rifampin, a medicine used to treat

tuberculosis

medicines used to treat seizures

known as phenytoin and

phenobarbitone

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 to

show your doctor or pharmacist.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

Do not start taking a new medicine

without telling your doctor or

pharmacist. Your doctor or

pharmacist can tell you if it is safe to

take ISENTRESS with other

medicines.

How to 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

Take ISENTRESS exactly as your

doctor has prescribed, by mouth,

with or without food.

Adults: Take one ISENTRESS 400

mg tablet twice daily or two

ISENTRESS HD 600mg tablets 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 tablet),

based on your child's age and

weight.

The 100 mg chewable tablet is

scored and can be split into equal

halves.

Do not take more than 300 mg of

the chewable tablet twice a day.

Chewable tablets are to be chewed,

not swallowed whole.

Do not switch between the 400 mg

or 600 mg tablet and the chewable

tablet.

How to take it

Take ISENTRESS as directed by

mouth, with or without food.

ISENTRESS must be used with

other anti-HIV medicines.

When to take it

Take your medicine 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).

It does not matter if you take this

medicine before or after food.

How long to take it

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

ISENTRESS

AND ISENTRESS HD

develop resistance to ISENTRESS

and become harder to treat.

If you forget to take it

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 take a double dose of

ISENTRESS to make up for the

dose that 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

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone 13 11 26) for advice.

You may need urgent medical

attention.

While you are using

ISENTRESS

Things you must do

ISENTRESS does not reduce the

chance of passing HIV to others

through sexual contact, sharing

needles, or being exposed to your

blood.

Continue to practice safer sex. Never

re-use or share needles.

Ask your doctor if you have any

questions about safer sex or how to

prevent passing HIV to other people.

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.

Things you must 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.

Things to be careful of

Be careful driving or operating

machinery 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.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

ISENTRESS.

Like all medicines, ISENTRESS can

cause side effects, although not

everybody gets them.

In studies, side effects usually were

mild and did not cause patients to

stop taking ISENTRESS. The side

effects reported in patients were

similar to side effects in patients

treated with a tablet containing no

medication (a placebo). The most

common side effects are nausea,

headache, diarrhoea, tiredness

inflammation of the nasal passages

and throat, trouble sleeping and

upper respiratory tract infection,

cough, fever, bronchitis, back pain

and depression.

Additionally, 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, severe skin

reactions, liver failure.

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.

Tell your doctor immediately if you

notice any symptoms of infection.

Tell your doctor or pharmacist if

you develop any unusual side effect

or if any known side effect does not

go away or gets worse.

ISENTRESS helps most people with

HIV infection, but it may have

unwanted side effects. All medicines

can have side effects. Sometimes

they are serious, most of the time

they are not. You may need medical

treatment if you get some of the side

effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

headache

nausea

diarrhoea

tiredness

upper respiratory tract infection

(inflammation of the nasal

passages and throat)

trouble sleeping

cough

fever

The above list includes the more

common side effects of your

medicine. They are usually mild and

short-lived.

Tell your doctor as soon as possible

if you notice any of the following:

ISENTRESS

AND ISENTRESS HD

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.

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency at your

nearest hospital:

any severe skin reaction

pinkish, itchy swellings on the

skin, also called hives or

nettlerash

fainting

fast or irregular heart beat

wheeziness due to tightness in the

chest

Because these side effects are

serious, you may need urgent

medical attention or hospitalisation.

Other side effects not listed above

may also occur in some patients.

The long-term effects of

ISENTRESS are unknown at this

time. Tell your doctor if you notice

any other effects.

Storage

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.

Keep your tablets in a cool dry

place where the temperature stays

below 30°C.

Do not store ISENTRESS or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

What it 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.

600 mg tablet - yellow, oval

shaped tablet with MSD logo and

"242" on one side and plain on

the other. Available in bottles

containing 60 tablets.

400mg tablet - pink, oval shaped

tablet with "227" on one side and

plain on the other. Available in

bottles containing 60 tablets.

100 mg chewable tablet - pale

orange oval tablet scored on both

sides; one side is plain, and the

other side is imprinted with the

Merck logo and "477" on either

side of the score. Available in

bottles containing 60 chewable

tablets.

25 mg chewable tablet - pale

yellow round tablet with Merck

logo on one side and "473" on the

other side. Available in bottles

containing 60 chewable tablets.

ISENTRESS 25 mg and 100mg

chewable tablets are banana-orange

flavoured.

Ingredients

Active ingredient:

ISENTRESS HD 600mg contains

600mg of raltegravir

ISENTRESS 400 mg contains

400 mg of raltegravir

ISENTRESS 100 mg contains

100 mg raltegravir

ISENTRESS 25 mg contains 25

mg raltegravir.

Inactive ingredients:

ISENTRESS HD 600mg Tablets

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

The tablets do not contain sucrose,

gluten, tartrazine or any other azo

dyes.

ISENTRESS 400mg Tablets

microcrystalline cellulose

lactose monohydrate

calcium phosphate dibasic

anhydrous

hypromellose 2208

poloxamer 407 (contains 0.01%

butylated hydroxytoluene as

antioxidant)

sodium stearyl fumarate

magnesium stearate.

ISENTRESS

AND ISENTRESS HD

The pink film coating contains the

following inactive ingredients:

polyvinyl alcohol

titanium dioxide

polyethylene glycol 3350

talc

iron oxide red

iron oxide black

The tablets do not contain sucrose,

gluten, tartrazine or any other azo

dyes.

ISENTRESS Chewable Tablets

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

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.

Manufacturer

ISENTRESS is supplied in Australia

Merck Sharp & Dohme (Australia)

Pty Limited

Level 1, Building A, 26 Talavera

Road, Macquarie Park, NSW 2113

Australian Register Numbers:

Tablet

600 mg bottle - AUST R 280294

400 mg bottle - AUST R 140238

Chewable Tablet

100 mg bottle - AUST R 193388

25 mg bottle - AUST R 193383

This leaflet was prepared in

December 2018.

Copyright © 2016 Merck Sharp &

Dohme Corp., a subsidiary of Merck

& Co., Inc., Whitehouse Station,

N.J., U.S.A.

WPPI-MK0518-MF-012018

ISENTRESS

AND ISENTRESS HD