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.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I given OPDUALAG?
OPDUALAG is a medicine that contains two active ingredients, nivolumab and relatlimab,
in a single vial. OPDUALAG is used to treat advanced melanoma (a type of skin cancer)
in adults and in adolescents (12 years of age and older weighing at least 40 kg)
For more information, see Section
1. Why am I using OPDUALAG? in the full CMI.
2. What should I know before I am given OPDUALAG?
Do not take this medicine if you are allergic to the active ingredient in OPDUALAG
(nivolumab and relatlimab) 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. For more information, see Section
2. What should I know before I use OPDUALAG? in the full CMI.
3. What if I am taking other medicines?
Tell your doctor if you are taking or have recently taken any other medicines. Do
not take any other medicines during your treatment without talking to your doctor
first. A list of these medicines is in Section
3. What if I am taking other medicines? in the full CMI.
4. How am I given OPDUALAG?
You will receive treatment with OPDUALAG in a hospital or clinic, under the supervision
of an experienced healthcare professional. OPDUALAG will be given to you as an infusion
(a drip) into a vein (intravenously). Your doctor will continue giving you OPDUALAG
for as long as you keep benefitting from it or until you no longer tolerate the treatment.
More information can be found in Section
4. How you will be given OPDUALAG? in the full CMI.
5. What should I know while using OPDUALAG?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using OPDUALAG.
Before you are given OPDUALAG, tell your doctor if you have autoimmune disease, melanoma
of the eye, if you have cancer that has spread to the brain, you have a history of
inflammation of the lungs or if you are taking any medicines that suppress your immune
system, such as corticosteroids.
Tell your doctor if you are pregnant, think you may be pregnant or are planning to
become pregnant.
Be aware of important symptoms of inflammation described in the CMI. Tell your doctor,
pharmacist or nurse straight away if you get any of these symptoms during treatment
with OPDUALAG. OPDUALAG acts on your immune system and may cause inflammation in parts
of your body which may be life threatening and need treatment or withdrawal of OPDUALAG.
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Things you should not do
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Do not use OPDUALAG if you are allergic to relatlimab, nivolumab or any of the other
ingredients of this medicine. Talk to your doctor if you are not sure. Do not use
this medicine during pregnancy as it may be harmful to your baby. Do not breast feed
whilst taking OPDUALAG.
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Driving or using machines
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OPDUALAG may have a minor influence on the ability to drive and use machines; however,
use caution when performing these activities until you are sure that OPDUALAG does
not adversely affect you.
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6. Are there any side effects?
Like all medicines, this medicine can cause side effects, although not everybody gets
them. Your doctor will discuss these with you and will explain the risks and benefits
of your treatment. Sometimes they are serious and you may require medical attention.
Contact your doctor immediately or go to the Emergency Department at your nearest
hospital if you have any signs or symptoms of inflammation or if they get worse. 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.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s): nivolumab and relatlimab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using OPDUALAG. 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 OPDUALAG.
Where to find information in this leaflet:
1. Why am I given OPDUALAG?
OPDUALAG is a medicine that contains two active substances: nivolumab and relatlimab,
which are monoclonal antibodies. They are designed to recognise and attach to a specific target substance in the body.
Nivolumab attaches to a target protein called programmed death 1 receptor (PD 1).
Relatlimab attaches to a target protein called lymphocyte activation gene 3 (LAG 3).
Those proteins can switch off the activity of T cells (a type of white blood cell
that forms part of the immune system, the body’s natural defence). By attaching to
LAG 3 and PD 1, nivolumab and relatlimab block their action and prevent them from
switching off your T cells. This helps increase their activity against the melanoma
cancer cells.
OPDUALAG is used to treat:
advanced (unresectable or metastatic melanoma) in adults and in adolescents (12 years
and older weighing at least 40 kg).
2. What should I know before I am given OPDUALAG?
Warnings
Do not use OPDUALAG if:
you are allergic to nivolumab and relatlimab or any of the other ingredients of this
medicine. Always check the ingredients and speak to your doctor to make sure you can
use this medicine.
Do not use OPDUALAG if you are pregnant unless your doctor specifically tells you
to.
Talk to your doctor before using OPDUALAG as it may cause:
Problems with your lungs such as breathing difficulties or cough. These may be signs of inflammation of the
lungs (pneumonitis or interstitial lung disease).
Diarrhoea (watery, loose or soft stools) or any symptoms of inflammation of the intestines (colitis), such as stomach pain and mucus or blood in stool.
Inflammation of the liver (hepatitis). Signs and symptoms of hepatitis may include abnormal liver function tests,
eye or skin yellowing (jaundice), pain on the right side of your stomach area, or
tiredness.
Inflammation or problems with your kidneys. Signs and symptoms may include abnormal kidney function tests, or decreased volume
of urine.
Problems with your hormone producing glands (including the pituitary, the thyroid, the parathyroid and adrenal glands) that may
affect how these glands work. Signs and symptoms that these glands are not working
properly may include fatigue (extreme tiredness), weight change or headache, decreased
blood levels of calcium and visual disturbances.
Diabetes (symptoms include excessive thirst, the passing of a greatly increased amount of
urine, increase in appetite with a loss of weight, feeling tired, drowsy, weak, depressed,
irritable and generally unwell) or diabetic ketoacidosis (acid in the blood produced from diabetes).
Inflammation of the skin that can lead to severe skin reaction (known as toxic epidermal necrolysis and Stevens
Johnson syndrome). Signs and symptoms of severe skin reaction may include rash, itching,
and peeling of the skin (possibly fatal).
Inflammation of the heart muscle (myocarditis). Signs and symptoms may include chest pain, irregular and/or rapid
heartbeat, fatigue, swelling in the ankles or shortness of breath.
Solid organ transplant rejection.
Haemophagocytic lymphohistiocytosis. A rare disease in which your immune system makes too many of otherwise normal infection
fighting cells called histiocytes and lymphocytes. Symptoms may include enlarged liver
and/or spleen, skin rash, lymph node enlargement, breathing problems, easy bruising,
kidney abnormalities, and heart problems.
Graft versus host disease. This may happen if you received a stem cell transplant that used donor stem cells
(allogeneic) before treatment with OPDUALAG.
Tell your doctor immediately if you have any of these signs or symptoms or if they get worse. These signs and
symptoms are sometimes delayed, and may develop weeks or months after your last dose.
Check with your doctor if you:
have any history of inflammation of the lungs
have been taken medicines to suppress your immune system
were previously given immunotherapy and experienced serious side effects because of
that medicine; have an autoimmune disease (a condition where the body attacks its own organs) like Crohn’s disease, ulcerative colitis, or lupus
have received an organ transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
have been told that your cancer has spread to your brain
have melanoma of the eye
are pregnant or think you might be or plan to become pregnant. OPDUALAG can harm your unborn baby. Your healthcare provider should do a pregnancy
test before you start receiving OPDUALAG.
are breastfeeding or intend to breastfeed
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?
Pregnancy and breastfeeding
Do not use OPDUALAG if you are pregnant unless your doctor specifically tells you
to. The effects of OPDUALAG in pregnant women are not known, but it is possible that
the active substances, relatlimab and nivolumab, could harm an unborn baby.
Ask your doctor if you can breast-feed during or after treatment with OPDUALAG. It is not known if this medicine passes into human milk. A risk to the breast-fed
infant cannot be excluded.
If you are pregnant, breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor for advice before taking this medicine.
You must use effective contraception while you are being treated with OPDUALAG and
for at least 5 months following the last dose of OPDUALAG, if you are a woman who
could become pregnant. Talk to your doctor about contraceptive methods that may be
right for you while you are taking OPDUALAG.
Tell your doctor straight away if you become pregnant during treatment.
Use in children or adolescents
This medicine is not recommended for use in children and adolescents under 12 years
of age.
OPDUALAG contains sugar (as sucrose)
OPDUALAG contains sugar. If you have been told by your doctor that you have intolerance
to some sugars, contact your doctor before taking this medicine.
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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect OPDUALAG.
Tell your doctor if you are taking any medicines that suppress your immune system,
such as corticosteroids, since these medicines may interfere with the effect of OPDUALAG.
However, once you are treated with OPDUALAG, your doctor may give you corticosteroids
to reduce any possible side effects that you may have during your treatment and this
will not impact the effect of the medicine.
Do not take any other medicines during your treatment without talking to your doctor
first.
4. How am I given OPDUALAG?
How is OPDUALAG given
You will receive treatment with OPDUALAG in a hospital or clinic, under the supervision
of an experienced healthcare professional.
OPDUALAG will be given to you as an infusion (a drip) into a vein (intravenously).
How much you will be given
The recommended dose in adult patients is:
OPDUALAG (480 mg nivolumab and 160 mg relatlimab) every 4 weeks administered as an
intravenous infusion over 30 minutes
The recommended dose in adolescent patients (12 years and older) weighing at least 40 kg is:
OPDUALAG (480 mg nivolumab and 160 mg relatlimab) every 4 weeks administered as an
intravenous infusion over 30 minutes
Depending on your dose, the appropriate amount of OPDUALAG will be diluted with sodium
chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for
injection before use. More than one vial of OPDUALAG may be necessary to obtain the
required dose.
How often will you receive OPDUALAG
OPDUALAG is given every 4 weeks.
Your doctor will continue giving you OPDUALAG for as long as you keep benefitting
from it or until you no longer tolerate the treatment.
Your healthcare provider will do blood tests regularly to check you for side effects.
If you miss any appointments, call your doctor as soon as possible to reschedule your
appointment
If you have any further questions on the use of this medicine, ask your doctor.
5. What should I know while receiving OPDUALAG?
Things you should do
Keep all of your doctor’s appointments so that your progress can be checked.
Tell any other doctors, dentists, and pharmacists who are treating you that you are
being treated with OPDUALAG.
Be aware of important symptoms of inflammation. OPDUALAG acts on your immune system
and may cause inflammation in any parts of your body. Inflammation may cause serious
damage to your body and some inflammatory conditions may be life threatening and need
treatment or withdrawal of OPDUALAG.
Tell your doctor immediately if you experience any signs or symptoms of inflammation.
Tell your doctor immediately if you become pregnant while being treated with OPDUALAG
Use an effective method of contraception during treatment and for 5 months after stopping
treatment.
Call your doctor straight away, or go to the Emergency Department at your nearest
hospital if you:
experience 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.
These could be symptoms of a serious allergic reaction.
Experience signs and symptoms of a serious immune related problem or side effect (see
Section 6, Are there any side effects in this CMI).
Things you should not do
Do not use this medicine during pregnancy without speaking to your doctor.
Do not breast feed if you are taking OPDUALAG without speaking to your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how OPDUALAG
affects you.
OPDUALAG may have a minor influence on the ability to drive and use machines; however,
use caution when performing these activities until you are sure that OPDUALAG does
not adversely affect you.
Looking after your medicine
It is unlikely that you will be asked to store OPDUALAG yourself. It will be stored
in the hospital or clinic where it is given to you.
6. Are there any side effects?
Like all medicines, this medicine can cause side effects, although not everybody gets
them. Your doctor will discuss these with you and will explain the risks and benefits
of your treatment.
OPDUALAG can cause your immune system to attack normal organs and tissues in any area
of your body and can affect the way they work. These problems can sometimes become
severe or can lead to death. These problems may happen anytime during treatment or
even after your treatment has ended. You may have more than one of these problems
at the same time.
Do not try to treat your symptoms with other medicines on your own. Your doctor may
give you other medicines in order to prevent complications and reduce your symptoms,
withhold the next dose of OPDUALAG,
or stop your treatment with OPDUALAG altogether.
Serious side effects
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Serious side effects
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What to do
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Lung problems:
inflammation of the lung (pneumonitis) characterised by new or worsening cough
shortness of breath
breathing difficulties or chest pain
Intestinal problems:
diarrhoea (watery, loose or soft stools) or more frequent bowel movements than usual
stool that are black, tarry, sticky, or have blood or mucus
severe stomach-area (abdominal) pain or tenderness
Inflammation of the intestines (colitis)
Liver problems:
inflammation of the liver (hepatitis) and Inflammation of the bile duct system (cholangitis).
yellowing of your skin or the whites of your eyes (jaundice)
severe nausea or vomiting
pain on the right side of your stomach area (abdomen)
dark urine (tea colored)
tiredness
bleeding or bruising more easily than normal, fever or chills
Hormone gland problems:
headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
your voice gets deeper
dizziness or fainting
drowsiness, weakness, feeling generally unwell
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems:
inflammation of the kidney
kidney failure; high levels of proteins in the urine
decrease in your amount of urine
blood in your urine
swelling in your ankles
loss of appetite
Skin problems:
rash
itching
skin blistering or peeling (pemphigoid)
painful sore or ulcers in mouth or nose, throat, or genital area
Heart problems:
chest pain
irregular and/or rapid heartbeat
swelling in your ankles
fatigue
shortness of breath
fluid around the heart
inflammation of the heart muscle
These are not all of the signs and symptoms of immune system problems that can happen
with OPDUALAG. Call or see your healthcare provider right away for any new or worsening
sign or symptoms, which may include:
inflammation of the brain (encephalitis),
confusion, sleepiness, memory problems, fever, changes in mood or behavior, stiff
neck, balance problems, seizures, tingling or numbness of the arms or legs
dizziness; inflammation of the nerves (causing numbness, weakness, tingling or burning
pain of the arms and legs); impairment of the sense of taste
double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
persistent or severe muscle pain or weakness, muscle cramps
low red blood cells, bruising
a temporary inflammation of the nerves that causes pain, weakness, and paralysis in
the extremities (Guillain- Barré syndrome); inflammation of the optic nerve that may
cause a complete or partial loss of vision
increased secretion of tears; increase blood congestion in the eye; an inflammatory
disorder, most likely of autoimmune origin, affecting the eyes, skin and the membranes
of the ears, brain and spinal cord (Vogt-Koyanagi-Harada syndrome)
condition in which the immune system attacks its own tissues, causing widespread inflammation
and tissue damage in the affected organs, such as joints, skin, brain, lungs, kidneys,
and blood vessels (systemic lupus erythematosus)
condition in which the immune system attacks the glands that make moisture for the
body, such as tears and saliva (Sjogren’s syndrome)
inflammation of the pancreas
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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 or they get worse.
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Other side effects
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Very Common side effects
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What to do
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decreased appetite
nausea; stomach pain; constipation
itching; skin colour change in patches (vitiligo)
pain in the muscles, bones and joints
feeling tired or weak, fever
Changes in the results of tests carried out by your doctor may show:
abnormal liver function (increased amounts of the liver enzymes alkaline phosphatase,
aspartate aminotransferase, alanine aminotransferase in your blood)
abnormal kidney function (increased amounts of creatinine in your blood), changes
in blood levels of different salts (sodium, potassium, magnesium, calcium)
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Speak to your doctor or seek medical attention if you have any of these side effects.
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Common side effects
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infections of the upper respiratory tract
decreased number of platelets (cells which help the blood to clot); increase in some
white blood cells
overactive thyroid gland; decreased secretion of hormones produced by adrenal glands
(glands situated above the kidneys); inflammation of the thyroid gland; inflammation
of the pituitary gland situated at the base of the brain
weight loss; low sugar levels in the blood; high uric acid levels in the blood; decreased
levels of albumin in the blood
dizziness; inflammation of the nerves (causing numbness, weakness, tingling or burning
pain of the arms and legs); impairment of the sense of taste
dry eyes, inflammation of the eye (which causes pain and redness, vision problems
or blurry vision)
inflammation of a vein, which can cause redness, tenderness and swelling
nasal congestion
vomiting; dry mouth; mouth ulcers and cold sores; difficulty in swallowing; inflammation
of the stomach (gastritis)
dry skin; unusual hair loss or thinning; thickened, sometimes scaly, skin growth;
sensitivity to light
painful joints; muscle spasms; muscle weakness
oedema (swelling); flu-like symptoms; chills
reactions related to the administration of the medicine
Changes in the results of tests carried out by your doctor may show:
abnormal liver function (higher blood levels of the waste product bilirubin)
increased levels of different enzymes in the blood
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Uncommon side effects
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inflammation and infection in the hair follicles
disorder in which red blood cells are destroyed faster than they can be made
underactive function of the pituitary gland situated at the base of the brain; underactive
function of the glands producing sex hormones
asthma
inflammation of the food pipe
inflammation of the bile duct
skin disease with thickened patches of red skin, often with silvery scales (psoriasis);
hives (itchy, bumpy rash); skin rashes; patches of white skin (vitiligo)
inflammation of the bursa, fluid-filled sacs that act as a cushion between bones,
tendons, joints, and muscles; inflammation of the muscles causing weakness, swelling,
and pain or stiffness
inflammation of muscles causing pain or stiffness; inflammation of the joints (painful
joint disease)
absence of sperm in the semen
Changes in the results of tests carried out by your doctor may show:
abnormal c-reactive protein increased
red blood cell sedimentation rate increased
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
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
OPDUALAG is only available with a doctor's prescription.
What OPDUALAG contains
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Active ingredients
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The active substances are nivolumab and relatlimab
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Other ingredients
(inactive ingredients)
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The other ingredients are:
histidine
histidine hydrochloride monohydrate
sucrose
pentetic acid
polysorbate 80 (E433)
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What OPDUALAG looks like
OPDUALAG concentrate for solution for infusion (sterile concentrate) is a clear to
opalescent, colourless to slightly yellow liquid that may contain few light particles.
It is available in cartons containing one glass vial (AUST R 372783).
Who distributes OPDUALAG in Australia
Bristol-Myers Squibb Australia Pty Ltd
4 Nexus Court, Mulgrave,
Victoria 3170, Australia.
Toll free number: 1800 067 567
OPDUALAG™ is a trademark of Bristol-Myers Squibb Company.
This leaflet was prepared in October 2023.