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.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I using POMALYST?
POMALYST contains the active ingredient pomalidomide. POMALYST is used in combination
with another medicine called 'dexamethasone' (steroid medicine) to treat adult patients
diagnosed with Multiple Myeloma (MM) (a cancer of the bone marrow). It is prescribed
for patients whose disease has progressed after two prior therapies.
POMALYST is also used in combination with dexamethasone and another medicine called
‘bortezomib’ to treat adult MM patients whose disease has progressed after one therapy.
For more information, see Section
1. Why am I using POMALYST? in the full CMI.
2. What should I know before I use POMALYST?
Do not use if you have ever had an allergic reaction to pomalidomide 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 POMALYST? in the full CMI.
3. What if I am taking other medicines?
4. How do I use POMALYST?
Your doctor will tell you how much POMALYST to take and for how long you will need
to take it, will monitor your progress and may adjust your dose or stop your treatment
based on the results of your blood tests and on your general condition.
Follow all directions given to you by your doctor carefully. They may differ from
the information contained in this leaflet.
5. What should I know while using POMALYST?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using POMALYST.
If you are a female patient, tell your doctor immediately if you suspect that you
may be pregnant. You should also immediately stop taking POMALYST in this case.
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Things you should not do
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Do not stop taking POMALYST (unless you suspect that you are pregnant) or change the
dose without first checking with your doctor.
Do not become pregnant or breastfeed whilst taking POMALYST.
Do not donate sperm during treatment or for 1 week after stopping treatment.
Do not have sexual intercourse without using effective means of contraception.
Do not donate blood during treatment or for 1 week after stopping treatment.
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Driving or using machines
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POMALYST may cause dizziness or confusion in some people. If you have any of these
symptoms, do not drive, operate machinery or do anything else that could be dangerous.
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Looking after your medicine
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Keep your capsules in a cool dry place where the temperature stays below 25°C.
Keep your capsules in the original pack until it is time to use them.
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6. Are there any side effects?
You may experience serious side effects when taking POMALYST.
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WARNING: POMALYST (pomalidomide) is structurally related to ‘thalidomide’, which
is known to cause severe life-threatening human birth defects (deformed babies) and
death to an unborn baby if taken during pregnancy. If POMALYST is taken during pregnancy,
it may cause birth defects or death to an unborn baby. Do not take POMALYST if you
are pregnant or think that you are pregnant.
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Active ingredient(s):
[pomalidomide] (poe" ma lid' oh mide)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking POMALYST. 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 POMALYST.
Where to find information in this leaflet:
1. Why am I using POMALYST?
POMALYST contains the active ingredient pomalidomide.
POMALYST belongs to a group of medicines called immunomodulating agents.
POMALYST is used in combination with another medicine called 'dexamethasone' (steroid
medicine) to treat adult patients diagnosed with Multiple Myeloma (MM) (a cancer of
the bone marrow). It is prescribed for patients whose disease has progressed after
two prior therapies.
POMALYST is also used in combination with dexamethasone and another medicine called
‘bortezomib’ to treat adult MM patients whose disease has progressed after one therapy.
Ask your doctor if you have any questions about how Pomalyst works or why this medicine
has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
Pomalyst will only be prescribed to you by a doctor who has experience in medicines
to treat cancers of the blood.
2. What should I know before I use POMALYST?
Warnings
Do not use POMALYST if:
You are allergic to pomalidomide, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
You are pregnant or think that you are pregnant.
POMALYST may cause birth defects (deformed babies) and may affect your developing
baby if you take it during pregnancy.
You are able to become pregnant, unless you are willing to follow the required pregnancy
prevention measures (outlined in Celgene's i- access® program - see section 'The i-access® program').
If you are not sure whether you should start taking this
medicine, talk to your doctor.
Follow your doctor's instructions carefully.
You will have been given specific instructions by your doctor particularly on the
potential effects of pomalidomide on unborn babies.
Check with your doctor if you:
If you have not fully understood these instructions, ask your doctor again before
taking POMALYST.
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
Check with your doctor if you are pregnant or intend to
become pregnant.
Talk to your doctor if you are breastfeeding or intend to
breastfeed.
The i-access® program
Your doctor will have enrolled you in the i-access program to ensure that pomalidomide
is used safely.
POMALYST (pomalidomide) is structurally related to 'thalidomide', which is known to
cause severe life-threatening human birth defects (deformed babies) and death to an
unborn baby if taken during pregnancy. If POMALYST is taken during pregnancy, it may
cause birth defects or death to an unborn baby.
To avoid exposure to unborn babies, POMALYST has restricted availability under a Pregnancy
Prevention Program (i-access). This program is designed to ensure that this medicine
is always prescribed and taken in the recommended way. Importantly, only patients
who are formally enrolled in this program and agree to fully comply with all the requirements
of this program can receive POMALYST.
Some of the requirements of the i-access® program are outlined in the following sections. Your doctor will discuss all the
details with you.
1. For women taking POMALYST
Before starting this treatment, your doctor will discuss your potential to become
pregnant, even if you think this is unlikely e.g., if your periods have stopped.
Follow instructions below if you are able to become pregnant:
Your doctor will discuss the potential risk to unborn babies if POMALYST is taken
during pregnancy.
You will be required to have pregnancy tests before treatment, every 4 weeks during
treatment, and 4 weeks after stopping treatment.
Take POMALYST medicine as soon as you get it from the pharmacy following a negative
pregnancy test.
Use reliable means of contraception for at least 4 weeks before starting POMALYST
treatment, during treatment and treatment interruption, and for at least 4 weeks after
POMALYST treatment has stopped.
Your doctor will tell you what method of contraception to use.
Effective methods of contraception include the following:
Implant
Levonorgestrel-releasing intrauterine system (IUS)
Medroxyprogesterone acetate depot
Tubal sterilisation
Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed
by two negative semen analyses
Ovulation inhibitory progesterone-only pills (i.e., desogestrel).
Combined oral contraceptive pills are not recommended
as they can increase the risk of blood clots blocking blood
vessels in patients with MM being treated with this
medicine.
You must stop taking POMALYST and inform your doctor straight away if:
You miss or think you have missed a period, or you have unusual menstrual bleeding,
or suspect you are pregnant.
You have heterosexual intercourse without using reliable means of contraception.
Discuss with your doctor if you should breast-feed whilst taking this medicine.
It is not known if POMALYST is excreted in human milk. Therefore, you should discuss
with your doctor whether to discontinue breast-feeding while you are receiving this
medicine.
2. For men taking POMALYST
Before starting this treatment, discuss with your doctor if your partner is able to
become pregnant.
If your partner is able to become pregnant, use barrier methods of contraception (e.g.,
condoms) even if you are vasectomised, during POMALYST treatment, during treatment
interruption, and for at least 1 week after treatment has stopped.
Tell your doctor immediately if your partner becomes pregnant whilst you are taking
this medicine.
Do not donate semen during treatment or during treatment interruption, or for 1 week
after stopping treatment.
3. For all patients taking POMALYST
Discuss with your doctor if you have or have had any of the following medical conditions:
Blood clots
Frequent bleeding or bruising
Frequent infections
Peripheral neuropathy (numbness, tingling, weakness, abnormal co-ordination or pain
in your hands and feet)
Abnormal kidney function
Allergic reactions to thalidomide or lenalidomide
Hepatitis B virus infection.
If you have not told your doctor about any of the above, tell him/her before you start
taking POMALYST.
Do not donate blood during POMALYST treatment or during treatment interruption, and
for at least 1 week after stopping treatment.
In Australia, patients with myeloma are permanently excluded from donating blood.
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
Tell your doctor if you smoke.
Smoking may affect POMALYST or may affect how it works.
Your doctor will ask you to have regular blood tests during treatment with POMALYST.
Your doctor may adjust your dose of POMALYST or stop your treatment based on the results
of your blood tests and on your general condition.
Do not give this medicine to a child or adolescent under the age of 18 years.
Safety and effectiveness in children younger than 18 years have not been established.
It is important to note that a small number of patients with multiple myeloma may
develop additional types of cancer (regardless of their type of therapy). At this
stage, it cannot be excluded that this risk may be slightly increased with POMALYST
treatment. Therefore, your doctor will carefully evaluate the benefit and risk when
you are prescribed this medicine. Superficial skin cancers have been observed in a
small number of multiple myeloma patients treated with POMALYST.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines or have recently
taken any other medicines, including any medicines that you buy without a prescription
from a pharmacy, supermarket, or health food shop.
Tell your doctor if you are taking medications used to treat depression or obsessive-compulsive
disorder (OCD).
Some of these medicines and POMALYST may interfere with each other.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect POMALYST.
4. How do I use POMALYST?
How much to take/use
Follow all directions given to you by your doctor carefully. They may differ from
the information contained in this leaflet.
Your doctor will tell you how much POMALYST to take and for how long you will need
to take it. Your doctor will monitor your progress and may adjust your dose.
Your doctor may adjust your dose of POMALYST or stop your treatment based on the results
of your blood tests and on your general condition.
When to take / use POMALYST
Take your medicine at about the same time each day. If you are on dialysis, on dialysis
days take your medicine after dialysis.
How to take POMALYST
Swallow the capsules whole with a full glass of water once a day as directed by your
doctor.
POMALYST can be taken with or without food.
Do not open, break, or chew the capsules.
If powder from the capsules contacts the skin, wash the skin immediately and thoroughly
with soap and water. If pomalidomide contacts the mucous membranes e.g., the eyes,
flush thoroughly with water.
If you forget to use POMALYST
If it is less than 12 hours before your next dose, skip the dose you missed and take
your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose 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 when to take your medicine, ask your pharmacist for
some hints.
If you use too much POMALYST
If you think that you have used too much POMALYST, you may need urgent medical attention.
You should immediately:
In Australia, phone the Poisons Information Centre
(by calling
13 11 26), or
In New Zealand, phone the National Poisons Centre (by calling 0800 POISON or 0800
764 766)
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 using POMALYST?
Things you should do
Female patients:
Tell your doctor immediately if you become pregnant or suspect that you may be pregnant.
You should also immediately stop taking POMALYST in this case.
All patients:
Tell any other doctors, dentists, and pharmacists who are treating you that you are
taking POMALYST.
If you are about to start any new medicine, remind your doctor, dentist, or pharmacist
that you are taking POMALYST.
Keep all your doctor's appointments so that your progress can be checked.
Your doctor will do some tests (blood tests) regularly to make sure the medicine is
working and to prevent unwanted side effects.
Things you should not do
Female patients:
Do not become pregnant whilst taking POMALYST.
Male patients:
Do not donate semen during treatment or treatment interruption, or for at least 1
week after stopping treatment.
All patients:
Do not have sexual intercourse without using effective means of contraception described
to you by your doctor.
Do not donate blood during treatment or treatment interruption, or for at least 1
week after stopping treatment.
In Australia, patients with myeloma are permanently excluded from donating blood.
Do not stop taking POMALYST (unless you suspect that you are pregnant) or change the
dose without first checking with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Do not take this medicine to treat any other complaints unless your doctor or pharmacist
tells you to.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering. In that case, return it to your pharmacist.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how POMALYST
affects you.
POMALYST may cause dizziness or confusion in some people. If you have any of these
symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may interfere with the way this medicine works
Looking after your medicine
Keep your capsules in a cool dry place where the
temperature stays below 25°C.
Keep your capsules in the original pack until it is time to use them
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 you no longer need to use 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.
Medicines should not be disposed of via wastewater or household waste. These measures
will help to protect the environment.
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.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects
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Serious side effects
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What to do
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Heart palpitations or fast heartbeat, chest pains, dizziness or fainting, shortness
of breath, weakness, or reduced ability to exercise.
These could be symptoms of atrial fibrillation (irregular heartbeat).
Bleeding or bruising more easily than normal
POMALYST can reduce the number of platelets, which are responsible for making the
blood clot properly. Your doctor will monitor your blood cell numbers during treatment
with POMALYST.
Tiredness, headaches, shortness of breath, dizziness and looking pale
POMALYST can reduce the number of red blood cells that carry oxygen around the body.
Chest pain and dry cough
This may be due to a chest infection e.g., pneumonia.
Wheezing, shortness of breath or a chronic cough
These may be symptoms caused by inflammation of the connective tissues in the lungs.
Numbness, tingling, abnormal co-ordination or pain in your hands and feet
This may be due to nerve damage.
Blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg,
a change in the way you walk or problems with your balance, persistent numbness, decreased
sensation or loss of sensation, memory loss or confusion.
These may be symptoms of a serious and potentially fatal brain condition known as
progressive multifocal leukoencephalopathy (PML).
Shortness of breath, wheezing or difficulty breathing; swelling of the face, lips,
mouth, tongue or throat which may cause difficulty in swallowing or breathing; swelling
of other parts of the body; rash, itching or hives on the skin; flaking or peeling
of the skin.
These could be symptoms of an allergic reaction.
Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals; painful
red area on the skin that spreads quickly; peeling of the skin. You may have a high
temperature, chills and muscle ache at the same time.
These could be due to rare but severe skin reactions such as Stevens-Johnson Syndrome,
Toxic Epidermal Necrolysis and Drug Reaction with Eosinophilia and Systemic Symptoms.
Sudden pain in your chest or difficulty in breathing
This may be due to blood clots in the artery leading to your lungs. These can happen
during treatment, or after treatment has stopped.
Chest pain, severe weakness, rapid or irregular heartbeat, and/or sudden, severe shortness
of breath.
This could be due to heart failure, a condition where the heart muscle cannot pump
blood strongly enough to supply blood throughout the body.
Pain or swelling in your legs, especially in your lower leg or calves
This may be due to blood clots in the veins of your leg. These can happen during treatment,
or after treatment has stopped.
Fever, severe chills, rapid breathing, shortness of breath, rapid pulse, confusion,
nausea,
vomiting, diarrhoea, pain or burning when you urinate, cough, phlegm, sore mouth or
throat, or mouth ulcers.
These could be symptoms of sepsis (blood infection) or other serious infections such
as pneumonia.
Passing little or no urine, drowsiness, nausea, vomiting or breathlessness.
These could be symptoms of kidney disease.
Yellowing of the skin and/or eyes.
These are symptoms of jaundice which can result from liver failure, or a liver disease
called hepatitis.
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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.
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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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Constipation, diarrhoea, feeling sick (nausea), vomiting, decrease in appetite, pain
in the lower abdomen or pelvic area, gastrointestinal bleeding.
Itchiness or rash.
Dizziness or spinning sensation, shaking or tremors, feeling faint or confused.
Bone pain or muscle spasms.
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Speak to your doctor if you have any of these side effects and they worry you.
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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
This medicine is only available with a doctor's prescription.
What POMALYST contains
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Active ingredient
(main ingredient)
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Pomalidomide
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Other ingredients
(inactive ingredients)
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mannitol
pregelatinised starch
sodium stearyl fumarate.
The capsule shells contain gelatin, titanium dioxide and the following colourants:
1 mg capsules: indigo carmine and yellow iron oxide.
2 mg capsules: indigo carmine, yellow iron oxide and erythrosine.
3 mg capsules: Indigo carmine and yellow iron Oxide.
4 mg capsules: Indigo carmine and brilliant blue FCF
The white ink contains Shellac, titanium dioxide, simethicone, propylene glycol and
ammonium hydroxide/ strong ammonia solution.
The black ink contains: Shellac, Iron oxide black, propylene glycol and strong ammonia
solution)
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Potential allergens
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Does not contain lactose.
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Do not take this medicine if you are allergic to any of these ingredients.
What POMALYST looks like
The capsules are provided in packs. There are two (2) pack sizes available. A pack
will contain either three blisters, each with seven capsules, giving a total of twenty-one
(21) capsules per pack or two blisters, each with seven capsules, giving a total of
fourteen (14) capsules per pack.
POMALYST 1 mg capsules are yellow opaque body/dark blue opaque cap capsules with "POML
1 mg" written on them. (AUST R 212657)
POMALYST 2 mg capsules are orange opaque body/dark blue opaque cap capsules with "POML
2 mg" written on them. (AUST R 212654)
POMALYST 3 mg capsules are green opaque body/dark blue opaque cap capsules with "POML
3 mg" written on them. (AUST R 212656)
POMALYST 4 mg capsules are blue opaque body/dark blue opaque cap capsules with "POML
4 mg" written on them. (AUST R 212655)
Who distributes POMALYST
Celgene Pty Limited
Level 2, 4 Nexus Court
Mulgrave, VIC 3170
Telephone: 1800 CELGENE
(1800 235 4363)
POMALYST® is registered trademark of Celgene Corporation, a Bristol-Myers Squibb Company.
This leaflet was prepared in August 2023.