TRIUMEQ

Main information

  • Trade name:
  • TRIUMEQ dolutegravir (as sodium) 50 mg/abacavir (as sulfate) 600 mg/lamivudine 300mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRIUMEQ dolutegravir (as sodium) 50 mg/abacavir (as sulfate) 600 mg/lamivudine 300mg tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218644
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218644

TRIUMEQ dolutegravir (as sodium) 50 mg/abacavir (as sulfate) 600 mg/lamivudine 300mg tablet bottles

ARTG entry for

Medicine Registered

Sponsor

ViiV Healthcare Pty Ltd

Postal Address

PO Box 18095,MELBOURNE CITY MC, VIC, 8001

Australia

ARTG Start Date

14/01/2015

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. TRIUMEQ dolutegravir (as sodium) 50 mg/abacavir (as sulfate) 600 mg/lamivudine 300mg tablet bottle

Product Type

Single Medicine Product

Effective date

9/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

TRIUMEQ is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age who are

antiretroviral treatment-naïve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents

(dolutegravir, abacavir or lamivudine) in TRIUMEQ.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

36 Months

Store below 30

degrees Celsius

Child resistant closure

Protect from Moisture

Keep Container

Tightly Closed/Airtight

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

30 tablets

(S4) Prescription Only Medicine

Components

1. TRIUMEQ dolutegravir (as sodium) 50 mg/abacavir (as sulfate) 600 mg/lamivudine 300mg tablet bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Purple, biconvex, film coated oval tablets (approximately 22 x 11 mm),

debossed with "572 Tri" on one face.

Active Ingredients

Abacavir sulfate

702 mg

Dolutegravir

50 mg

Lamivudine

300 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 19.10.2017 at 05:31:46 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

TRIUMEQ

Film-coated tablets

50 mg dolutegravir (as dolutegravir sodium) / 600 mg abacavir (as abacavir sulfate) / 300mg lamivudine

Consumer Medicine Information

PATIENTS TAKING TRIUMEQ, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY

REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT

WITH TRIUMEQ IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER

YOU SHOULD STOP TAKING TRIUMEQ IF:

1)

YOU GET A SKIN RASH OR

2)

YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING GROUPS:

-

FEVER

-

SHORTNESS OF BREATH, SORE THROAT OR COUGH

-

NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN

-

SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING

IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO TRIUMEQ TABLETS, NEVER TAKE

TRIUMEQ, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA, TRIZIVIR &

ZIAGEN) AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE FATAL.

THERE IS AN ALERT CARD INCLUDED IN THE TRIUMEQ PACK, TO REMIND YOU AND MEDICAL STAFF

ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED FROM THE PACK AND

KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER BEFORE YOU TAKE TRIUMEQ.

What is in this leaflet?

Please read this leaflet carefully

before you take TRIUMEQ. This

leaflet answers some common

questions about TRIUMEQ

(dolutegravir/abacavir/lamivudine). It

does not contain all of 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 expected benefits of you taking

TRIUMEQ against the risks this

medicine could have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What is TRIUMEQ

used for?

TRIUMEQ contains three active

ingredients that are used to treat HIV

infection in adults and children over

12 years old: dolutegravir, abacavir,

and lamivudine. Dolutegravir

belongs to a group of anti-retroviral

medicines called integrase inhibitors

(INIs). Abacavir and lamivudine

belong to a group of anti-retroviral

medicines called nucleoside analogue

reverse transcriptase inhibitors

(NRTIs).

TRIUMEQ does not cure HIV

infection; it reduces the amount of

virus in your body, and keeps it at a

low level. TRIUMEQ also increases

the CD4 cell count in your blood.

CD4 cells are a type of white blood

cells that are important in helping

your body to fight infection.

To control your HIV infection, and to

stop your illness from getting worse,

you must keep taking all your

medicines, unless your doctor tells

you to stop taking any.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

TRIUMEQ is not addictive.

TRIUMEQ is not recommended for

children under the age of 12 years as

the dosage cannot be modified.

This medicine is available only with

a doctor's prescription.

Before you take

TRIUMEQ

When you must not take it

You must not take TRIUMEQ if:

TRIUMEQ

you have ever had an allergic

reaction to abacavir, which is

also included in medicines

called KIVEXA, TRIZIVIR

and ZIAGEN

if you are allergic to the active

ingredients dolutegravir or

lamivudine, or any of the other

ingredients listed toward the

end of this leaflet.

if you're taking another

medicine called dofetilide or

pilsicanide (to treat heart

conditions)

if you have a serious liver

disease TRIUMEQ may not be

suitable for you.

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.

If you are not sure whether you

should start taking this medicine, talk

to your doctor.

Special Warning -

Hypersensitivity Reactions

TRIUMEQ contains abacavir and

dolutegravir. Both of these active

substances can cause a serious

allergic reaction known as a

hypersensitivity reaction.

Abacavir hypersensitivity reactions

can be life-threatening if treatment

with abacavir containing products is

not stopped.

Research has found that people

with a gene called HLA-B (type

5701) are more likely to have a

hypersensitivity reaction to

abacavir. However, even if you do

not have this gene type it is still

possible for you to get this

reaction. If you know you have this

gene type, be sure to tell your

doctor before you take abacavir.

The most common symptoms of

this reaction include high

temperature (fever) and a skin

rash. Other most frequently seen

symptoms include nausea,

vomiting, diarrhoea or abdominal

pain; severe tiredness or body

aches or generally feeling ill;

headache; shortness of breath, sore

throat or cough. If you develop any

of these symptoms call your doctor

IMMEDIATELY WHO WILL

ADVISE YOU WHETHER YOU

SHOULD STOP TAKING

TRIUMEQ TABLETS. If your

doctor is not available you must

urgently seek other medical advice

(eg. the Accident and Emergency

unit of the nearest hospital) before

taking the next dose.

Other symptoms may include joint

or muscle pain, swelling of the

neck or itchy skin. Occasionally

inflammation of the eye

(conjunctivitis), ulcers in the

mouth or low blood pressure may

occur. The symptoms of this

allergic reaction can occur at any

time during treatment with

TRIUMEQ tablets. However they

usually occur in the first six weeks

of treatment, and get worse with

continued treatment.

If you have had this serious

reaction to TRIUMEQ tablets,

NEVER take TRIUMEQ or any

other medicinal product containing

abacavir (ZIAGEN, KIVEXA,

TRIZIVIR) again as within hours

you may experience a life-

threatening lowering of your blood

pressure or death.

Occasionally life threatening

hypersensitivity reactions have

occurred when medicine

containing abacavir was restarted

in patients who reported only one

of the symptoms on the Alert Card

before stopping.

On very rare occasions,

hypersensitivity has been reported

when treatment containing

abacavir was re-started in patients

who had no symptoms of

hypersensitivity before stopping.

If you have stopped taking

TRIUMEQ tablets for any reason

it is important that you contact

your doctor before restarting. This

is especially so if you think you are

having side-effects from other

medicines or have another illness.

Your doctor will check whether

any symptoms you had before

stopping may be related to this

hypersensitivity reaction. If your

doctor thinks there is a possibility

that they were related, you may be

told never to take TRIUMEQ

tablets again. It is important that

you follow this advice.

If you are hypersensitive to

TRIUMEQ tablets you should

return all of your unused

TRIUMEQ tablets to your doctor

or pharmacist for proper disposal.

The TRIUMEQ pack includes an

Alert Card, to remind you and

medical staff about abacavir

hypersensitivity. Detach this card and

keep it with you at all times.

Before you start to take it

Some other conditions may develop

during HIV treatment.

Old infections may flare up

People with advanced HIV infection

(AIDS) have weak immune systems,

and are more likely to develop

serious infections (opportunistic

infections). When these people start

treatment, they may find that old,

hidden infections flare up, causing

signs and symptoms of inflammation.

These symptoms are probably caused

by the body's immune system

becoming stronger, so that the body

starts to fight these infections.

If you get any symptoms of

infection while you're taking

TRIUMEQ:

Tell your doctor immediately. Don't

take other medicines for the infection

without your doctor's advice.

Tell your doctor if you have

allergies to any other medicines,

foods, preservatives or dyes.

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Your doctor can discuss with you the

risks and benefits involved.

Abacavir and lamivudine belong to a

group of anti-retroviral medicines

TRIUMEQ

called nucleoside analogue reverse

transcriptase inhibitors (NRTIs). In

babies and infants exposed to NRTIs

during pregnancy or labour small

temporary increases in blood levels

of a substance called lactate have

been observed. Additionally there

have been very rare reports of

diseases that affect the nervous

system such as a delayed

development and seizures. Overall, in

children whose mothers took NRTIs

during pregnancy, the benefit from

the reduced chance of being infected

with HIV is likely to be greater than

the risk of suffering from side

effects.

Where possible, women who are

HIV-positive should not breast feed.

This is because HIV infection can be

passed on to the baby in breast milk.

If formula feeding is not possible,

you should get advice from your

doctor.

A small amount of the ingredients in

TRIUMEQ can also pass into your

breast-milk.

If you have not told your doctor

about any of the above, tell him/

her before you start taking

TRIUMEQ.

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.

Don't take TRIUMEQ with these

medicines:

dofetilide, to treat heart

conditions

These medicines should not be

used with TRIUMEQ:

zalcitabine or emtricitabine, to

treat HIV infection

sorbitol-containing medicines

(usually liquids) used regularly

Tell your doctor if you're being

treated with any of these.

Methadone and TRIUMEQ

If you are taking methadone, your

doctor may need to adjust your

methadone dose, as abacavir (one of

the active substances in TRIUMEQ)

increases the rate at which

methadone leaves your body. This is

unlikely to affect most methadone

users.

Tell your doctor if you are taking:

metformin, to treat diabetes

medicines called antacids, to treat

indigestion and heartburn. Do not

take an antacid that contains

aluminium, calcium or

magnesium during the 6 hours

before you take TRIUMEQ, or

for at least 2 hours after you take

it. These antacids, readily

available over the counter, will

decrease the effectiveness of

TRIUMEQ if taken at the same

time as TRIUMEQ.

calcium and iron supplements. Do

not take a calcium or iron

supplement during the 6 hours

before you take TRIUMEQ, or

for at least 2 hours after you take

it. If you take food with your

medicine you can take a calcium

or iron supplement at the same

time as TRIUMEQ.

etravirine, efavirenz,

fosamprenavir/ritonavir,

nevirapine or tipranavir/ritonavir,

to treat HIV infection

rifampicin, to treat tuberculosis

(TB) and other bacterial

infections

co-trimoxazole, an antibiotic used

to treat PCP - Pneumocystis

carinii pneumonia or

toxoplasmosis

phenytoin and phenobarbital, to

treat epilepsy

carbamazepine, to treat epilepsy

and bipolar disorder

St. John's wort, (Hypericum

perforatum), a herbal remedy to

treat depression

Tell your doctor or pharmacist if you

are taking any of these. Your doctor

may decide to adjust your dose or

that you need extra checkups.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

this medicine.

How do I take

TRIUMEQ?

Follow all directions given to you

by your doctor or pharmacist

carefully, and take great care not

to miss any doses if at all possible.

If you do not understand the

instructions on the box/bottle, ask

your doctor or pharmacist for

help.

How much to take

The usual dose of TRIUMEQ in

adults and in children over the age of

12 years weighing at least 40 kg is

one combined tablet (50 mg

dolutegravir, 600 mg abacavir, 300

mg lamivudine) taken once a day.

If you weigh less than 40kg, you

cannot take TRIUMEQ, because the

dose of each component of this

medicine cannot be adjusted to your

weight. Your doctor might prescribe

the components separately for you.

How to take it

Swallow the tablets whole with a

full glass of water.

Antacid medicines

Antacids which contain calcium,

aluminium or magnesium will

reduce the effectiveness of

TRIUMEQ during the 6 hours

before you take TRIUMEQ, or for

at least 2 hours after you take it.

Other acid-lowering medicines like

ranitidine and omeprazole can be

taken at the same time as

TRIUMEQ. TALK TO YOUR

DOCTOR FOR FURTHER

ADVICE BEFORE TAKING

ACID-LOWERING MEDICINES

WITH TRIUMEQ.

TRIUMEQ

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 does not matter if you take this

medicine before or after food.

How long to take it for

Continue taking your medicine for

as long as your doctor tells you.

If you forget to take it

If you miss a dose, take it as soon as

you remember. But if your next dose

is due within 4 hours, skip the dose

you missed and take the next one at

the usual time. Then continue your

treatment as before.

Don't take a double dose to make up

for a missed dose. Just take it as soon

as you remember.

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 Poisons Information Centre (In

Australia call 131126. In New

Zealand call 0800 POISON or 0800

764 766) for advice if you think you

or anyone else may have taken too

much TRIUMEQ, even if there are

no signs of discomfort or

poisoning. If you are not sure what

to do, contact your doctor or

pharmacist.

You may need urgent medical

attention.

Don't stop TRIUMEQ without

advice

Take TRIUMEQ for as long as your

doctor recommends. Don't stop

unless your doctor advises you to.

If you have stopped taking

TRIUMEQ for any reason,

particularly because you think you

are having side effects or for other

illness, it is important that you

contact your doctor before restarting.

In some cases your doctor will ask

you to restart TRIUMEQ in a place

where you will be able to get ready

access to medical care if needed.

If you have hepatitis B infection, you

should not stop TRIUMEQ tablets

without instructions from your

doctor, as you may have a recurrence

of your hepatitis. This may occur due

to you suddenly stopping lamivudine.

While you are using

TRIUMEQ

You will need regular blood tests

For as long as you're taking

TRIUMEQ, your doctor will arrange

regular blood tests to check for side

effects.

Stay in regular contact with your

doctor

TRIUMEQ helps to control your

condition, but it is not a cure for HIV

infection. You need to keep taking it

every day to stop your illness from

getting worse. Because TRIUMEQ

does not cure HIV infection, you

may still develop other infections and

illnesses linked to HIV infection.

Keep in touch with your doctor, and

don't stop taking TRIUMEQ without

your doctor's advice.

Protect other people

HIV infection is spread by sexual

contact with someone who has the

infection, or by transfer of infected

blood (for example, by sharing

injection needles). TRIUMEQ will

not stop you passing HIV infection

on to other people. To protect other

people from becoming infected with

HIV:

Use a condom when you have

oral or penetrative sex.

Don't risk blood transfer - for

example, don't share needles.

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking TRIUMEQ.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Keep all of your doctor's

appointments so that your progress

can be checked.

Things you must not do

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Do not stop taking your medicine

or lower the dosage without

checking with your doctor.

Things to be careful of

TRIUMEQ can make you dizzy

and have other side effects that

make you less alert.

Don't drive or use machines unless

you are sure you're not affected.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

TRIUMEQ.

This medicine helps most people

with HIV, but it may have unwanted

side effects in a few people. All

medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

When you're being treated for HIV, it

can be hard to tell whether a

symptom is a side effect of

TRIUMEQ or other medicines you

TRIUMEQ

are taking, or an effect of the HIV

disease itself. So it is very important

to talk to your doctor about any

changes in your health.

Some side effects may only be seen

in your blood tests, and may not

appear immediately after you start

taking TRIUMEQ. If you get any of

these effects, and if they are severe,

your doctor may advise you to stop

taking TRIUMEQ.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Hypersensitivity reactions

TRIUMEQ contains abacavir and

dolutegravir. Both of these active

substances can cause a serious

allergic reaction known as a

hypersensitivity reaction.

These hypersensitivity reactions have

been seen more frequently in people

taking medicines that contain

abacavir.

Who gets these reactions?

Anyone taking TRIUMEQ could

develop a hypersensitivity reaction,

which could be life threatening if

they continue to take TRIUMEQ.

You are more likely to develop such

a reaction if you have a gene called

HLA-B*5701 (but you can get a

reaction even if you don't have this

gene). If possible, you will have been

tested for this gene before

TRIUMEQ was prescribed for you. If

you know you have this gene, tell

your doctor before you take

TRIUMEQ.

What are the symptoms?

The most common symptoms are:

fever (high temperature) and

skin rash.

Other common symptoms are:

nausea (feeling sick), vomiting

(being sick), diarrhoea,

abdominal (stomach) pain, severe

tiredness, shortness of breath,

cough, headache, muscle pain and

discomfort.

Other less common symptoms can

include:

pains in the joints , swelling of

the neck, serious breathing

problems, sore throat

occasionally, inflammation of the

eye (conjunctivitis), mouth ulcers,

low blood pressure, tingling or

numbness of the hands or feet.

When do these reactions happen?

Hypersensitivity reactions can start at

any time during treatment with

TRIUMEQ, but are more likely

during the first 6 weeks of treatment.

Contact your doctor immediately:

1 if you get a skin rash, OR

2 if you get symptoms from at least

2 of the following groups:

fever

shortness of breath, sore throat or

cough

nausea or vomiting, diarrhoea or

stomach pain

severe tiredness or achiness, or

generally feeling ill.

Your doctor may advise you to stop

taking TRIUMEQ.

Always carry your Alert Card

while you are taking TRIUMEQ.

If you have stopped taking

TRIUMEQ:

If you have stopped taking

TRIUMEQ because of a

hypersensitivity reaction, you must

NEVER AGAIN take TRIUMEQ, or

any other medicine containing

abacavir (ZIAGEN, KIVEXA or

TRIZIVIR). If you do, within hours,

your blood pressure could fall

dangerously low, which could result

in death. You should also never again

take medicines containing

dolutegravir.

If you have stopped taking

TRIUMEQ for any reason, especially

because you think you are having

side effects, or because you have

another illness:

Talk to your doctor before you start

again. Your doctor will check

whether your symptoms were related

to a hypersensitivity reaction. If the

doctor thinks they may have been,

you will then be told never again to

take TRIUMEQ, or any other

medicine containing abacavir. You

may also be told never again to take

any other medicine containing

dolutegravir. It is important that you

follow this advice.

Occasionally, reactions have

developed in people who start taking

abacavir again, and had only one

symptom on the Alert Card before

they stopped taking it.

Very rarely, reactions have

developed in people who start taking

abacavir again, but who had no

symptoms before they stopped taking

If your doctor advises that you can

start taking TRIUMEQ again, you

may be asked to take your first doses

in a place where you will have ready

access to medical care if you need it.

If you are hypersensitive to

TRIUMEQ, return all your unused

TRIUMEQ tablets for safe disposal.

Ask your doctor or pharmacist for

advice.

The TRIUMEQ pack includes an

Alert Card, to remind you and

medical staff about hypersensitivity

reactions. Detach this card and keep

it with you at all times.

Symptoms of infection and

inflammation

People with advanced HIV infection

(AIDS) have weak immune systems,

and are more likely to develop

serious infections (opportunistic

infections). When they start

treatment, the immune system

becomes stronger, so the body starts

to fight infections.

Symptoms of infection and

inflammation may develop, caused

by either:

old, hidden infections flaring up

again as the body fights them

TRIUMEQ

the immune system attacking

healthy body tissue (autoimmune

disorders)

The symptoms of autoimmune

disorders may develop many months

after you start taking medicine to

treat your HIV infection.

Symptoms may include:

muscle weakness and/or muscle

pain

joint pain or swelling

weakness beginning in the hands

and feet and moving up towards

the trunk of the body

palpitations or tremor

hyperactivity (excessive

restlessness and movement).

If you get any symptoms of infection

while you're taking TRIUMEQ:

Tell your doctor immediately. Don't

take other medicines for the infection

without your doctor's advice.

Fat loss or fat gain

Fat loss or fat gain has been observed

with combined antiretroviral therapy.

A causal relationship for this has not

been established. Should any change

in body shape be noticed, seek

medical advice.

Lactic acidosis is a rare but

serious side effect

Some people taking TRIUMEQ, or

other medicines like it (NRTIs),

develop a condition called lactic

acidosis, together with an enlarged

liver.

Lactic acidosis is caused by a build-

up of lactic acid in the body. It is

rare; if it happens, it usually develops

after a few months of treatment. It

can be life-threatening, causing

failure of internal organs.

Lactic acidosis is more likely to

develop in people who have liver

disease, especially in women.

Signs of lactic acidosis include:

deep, rapid, difficult breathing

drowsiness

numbness or weakness in the

limbs

feeling sick (nausea), being sick

(vomiting)

stomach pain.

During your treatment, your doctor

will monitor you for signs of lactic

acidosis. If you have any of the

symptoms listed above or any other

symptoms that worry you see your

doctor as soon as possible.

As well as the conditions listed

above, other side effects can develop

during combination therapy for HIV.

Very common side effects

These may affect more than 1 in 10

people:

headache

diarrhoea

feeling sick (nausea)

Common side effects

These may affect up to 1 in 10

people:

being sick (vomiting)

stomach pains (abdominal pain)

and bloating (abdominal

distension)

stomach (abdominal) discomfort

wind (flatulence)

indigestion (dyspepsia)

gastro-oesophageal reflux disease

loss of appetite

feeling drowsy

tiredness, lack of energy

general feeling of being unwell

high temperature (fever)

dizziness

nightmares and abnormal dreams

sleep disorder

depression (feelings of deep

sadness and unworthiness)

anxiety

hair loss

abacavir hypersensitivity reaction

(See hypersensitivity reactions'

earlier in this section)

skin rash

itching (pruritis)

joint pain

muscle pain and discomfort

Common side effects that may show

up in blood tests are:

increase in triglycerides (type of

fat) in the blood

increase in glucose (sugar) in the

blood

Uncommon side effects

These may affect up to 1 in 100

people:

dolutegravir allergic reaction (See

'allergic reactions' earlier in this

section)

inflammation of the liver

(hepatitis)

suicidal thoughts and behaviours

(mainly in patients who have had

depression or mental health

problems before)

Uncommon side effects that may

show up in blood tests are:

a low red blood cell count

(anaemia) or low white blood cell

count (neutropenia)

a decrease in the number of cells

involved in blood clotting

(thrombocytopenia)

an increase in the level of liver

enzymes

Rare side effects

These may affect up to 1 in 1000

people:

lactic acidosis (see 'lactic acidosis

is a rare but serious side effect'

earlier in this section)

inflammation of the pancreas

(pancreatitis)

breakdown of muscle tissue

Rare side effects that may show up in

blood tests are:

increase in an enzyme called

amylase

Very rare side effects

These may affect up to 1 in 10,000

people:

TRIUMEQ

tingling or numbness of the hands

and feet (paraesthesiae)

numbness, tingling or weakness

of the arms and legs (peripheral

neuropathy)

skin rash, which may form

blisters and looks like small

targets (central dark spots

surrounded by a paler area, with a

dark ring around the edge)

(erythema multiforme)

widespread rash with blisters and

peeling skin, particularly around

the mouth, nose, eyes and genitals

(Stevens-Johnson syndrome), and

a more severe form causing skin

peeling in more than 30% of the

body surface (toxic epidermal

necrolysis).

Very rare side effects that may show

up in blood tests are:

failure of the bone marrow to

produce new red blood cells (pure

red cell aplasia)

Tell your doctor or pharmacist if

you notice anything that is making

you feel unwell.

Other side effects not listed above

may also occur in some people.

After using TRIUMEQ

Storage

Store in the original package in

order to protect from moisture.

Keep the bottle tightly closed. Do

not remove the desiccant.

Keep your tablets in a cool dry

place where the temperature stays

below 30°C.

Do not store TRIUMEQ or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

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

TRIUMEQ tablets are purple, oval,

biconvex film-coated tablets

debossed with '572 Trı' on one side

and are available in bottles of 30

tablets with child-resistant closure.

Ingredients

TRIUMEQ contains 50 mg of

dolutegravir (as dolutegravir

sodium), 600 mg of abacavir (as

abacavir sulfate) and 300 mg

lamivudine as the active ingredients.

TRIUMEQ tablets also contain the

following inactive ingredients:

mannitol

microcrystalline cellulose

povidone

sodium starch glycolate

magnesium stearate

polyvinyl alcohol

titanium dioxide

macrogol 3350

talc

iron oxide red

iron oxide black

Supplier

ViiV Healthcare Pty Ltd

Level 4, 436 Johnston St,

Abbotsford, Victoria, 3067

Australia.

Where to go for further

information:

Pharmaceutical companies are not in

a position to give people an

individual diagnosis or medical

advice. Your doctor or pharmacist is

the best person to give you advice on

the treatment of your condition. You

may also be able to find general

information about your disease and

its treatment from patient information

groups and product specific

organisations.

Trade marks are owned by or

licensed to the ViiV Healthcare

group of companies.

This leaflet was prepared on

15 September 2017

TRIUMEQ tablets: AUST R 218644

© 2017 ViiV Healthcare group of

companies or its licensor.

Version 7.0

TRIUMEQ

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

2-7-2018

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling

Fagron Sterile Services is voluntarily recalling two (2) lots of Neostigmine Methylsulfate 5mL syringes to the user/hospital/clinic level. The specified product lots are being recalled because of a confirmed customer complaint that some syringe units containing Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL are incorrectly labelled as Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL. Secondary packages are properly labelled as Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL.

FDA - U.S. Food and Drug Administration

31-5-2018

Dolutegravir

Dolutegravir

Safety advisory - new study suggests possible risk of birth defects

Therapeutic Goods Administration - Australia

23-5-2018

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)

The U.S. Food and Drug Administration (FDA) is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir (Juluca, Tivicay, Triumeq) used to treat human immunodeficiency virus (HIV).

FDA - U.S. Food and Drug Administration

18-5-2018

Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects

Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects

Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects. Neural tube defects are birth defects that can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly. To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir lat...

FDA - U.S. Food and Drug Administration

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

18-10-2018

Kivexa (ViiV Healthcare BV)

Kivexa (ViiV Healthcare BV)

Kivexa (Active substance: abacavir / Lamivudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6924 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000581/T/0076

Europe -DG Health and Food Safety

2-10-2018

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Teva B.V.)

Lamivudine Teva Pharma B.V. (Active substance: Lamivudine) - Centralised - Yearly update - Commission Decision (2018)6476 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Trizivir (ViiV Healthcare BV)

Trizivir (ViiV Healthcare BV)

Trizivir (Active substance: abacavir, lamivudine, zidovudine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6483 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/338/T/108

Europe -DG Health and Food Safety

27-6-2018

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Bayer AG)

EU/3/15/1606 (Active substance: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate) - Transfer of orphan designation - Commission Decision (2018)4094 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/184/15/T/02

Europe -DG Health and Food Safety

18-5-2018

Juluca (ViiV Healthcare UK Limited)

Juluca (ViiV Healthcare UK Limited)

Juluca (Active substance: dolutegravir / rilpivirine) - Centralised - Authorisation - Commission Decision (2018)3161 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4427

Europe -DG Health and Food Safety

16-5-2018

Tivicay (ViiV Healthcare BV)

Tivicay (ViiV Healthcare BV)

Tivicay (Active substance: dolutegravir) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3052 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2753/T/39

Europe -DG Health and Food Safety

14-5-2018

Girolan and its associated name Apralan

Girolan and its associated name Apralan

Girolan and its associated name Apralan (Active substance: Apramycin sulfate) - Community Referrals - Art 34 - Commission Decision (2018)2989 of Mon, 14 May 2018 European Medicines Agency (EMA) procedure number: EMEA/V/A/122

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (IQVIA RDS Ireland Limited)

EU/3/16/1714 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-a-L-talofuranosyl)-paromamine sulfate) - Transfer of orphan designation - Commission Decision (2018)1823 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/119/16/T/01

Europe -DG Health and Food Safety