Pomalyst

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Pomalidomide 2 mg;  
Available from:
Celgene Limited
INN (International Name):
Pomalidomide 2 mg
Dosage:
2 mg
Pharmaceutical form:
Capsule
Composition:
Active: Pomalidomide 2 mg   Excipient: Erythrosine Gelatin Indigo carmine Iron oxide yellow Mannitol Pregelatinised maize starch Sodium stearyl fumarate Titanium dioxide
Prescription type:
Prescription
Manufactured by:
Lonza AG
Therapeutic indications:
Pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/PCTFE (Aclar)/ Al in printed carton - 21 capsules - 48 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-9621a
Authorization date:
2014-09-08

Read the complete document

Pomalyst

(pomalidomide) capsules – NZ CMI

Celgene V1.7.0 – 29 October 2020

New Zealand Consumer Medicine Information

Pomalyst

®

(pomalidomide) capsules

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Pomalyst.

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 Pomalyst

against the benefits this medicine is expected to 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 POMALYST IS USED FOR

Pomalyst contains an active substance called 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.

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.

Pomalyst

(pomalidomide) capsules – NZ CMI

Celgene V1.7.0 – 29 October 2020

BEFORE YOU TAKE POMALYST

When you must not take it

Do not take Pomalyst if you have an allergy to pomalidomide or any of the other 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.

If you think you may be allergic to Pomalyst, ask your doctor for advice.

Do not take this medicine if 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.

Do not take this medicine if 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 ‘Before you start to take it’).

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

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.

If you have not fully understood these instructions, ask your doctor again before taking

Pomalyst.

Your doctor will have enrolled you in the

i-access

program to ensure that pomalidomide is used

safely.

The i-access

®

program

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 is available only under a special distribution program

called the

i-access

program. 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.

Pomalyst

(pomalidomide) capsules – NZ CMI

Celgene V1.7.0 – 29 October 2020

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 your 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.

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.

Pomalyst

(pomalidomide) capsules – NZ CMI

Celgene V1.7.0 – 29 October 2020

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 New Zealand, 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.

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.

HOW TO TAKE POMALYST

Follow all directions given to you by your doctor carefully

They may differ from the information contained in this leaflet.

How much to take

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.

How to take it

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.

Pomalyst

(pomalidomide) capsules – NZ CMI

Celgene V1.7.0 – 29 October 2020

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

When to take it

Take your medicine at about the same time each day. If you are on dialysis, on dialysis days

take your medicine after dialysis.

How long to take it

Your doctor will tell you how long to continue taking Pomalyst.

If you forget to take it

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 take too much (overdose)

In New Zealand, immediately telephone your doctor or the National Poisons Centre (telephone

0800 POISON or 0800 64 766) for advice, or go to Accident and Emergency at your nearest

hospital, if you think that you or anyone else may have taken too much Pomalyst.

In Australia, immediately telephone your doctor or Poisons Information Centre (telephone

13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that

you or anyone else may have taken too much Pomalyst.

Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for

these places handy

WHILE YOU ARE TAKING POMALYST

Things you must do

Female patients:

Tell your doctor immediately if you suspect that you may be pregnant. You should also

immediately stop taking Pomalyst in this case.

Pomalyst

(pomalidomide) capsules – NZ CMI

Celgene V1.7.0 – 29 October 2020

All patients:

Tell any other doctors, dentists, and pharmacists who are treating you that you are

taking Pomalyst

If you are about to be started on any new medicine, remind your doctor, dentist or

pharmacist that you are taking Pomalyst

Keep all of 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 must 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 New Zealand, 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.

Things to be careful of

Be careful driving or operating machinery until you know how Pomalyst affects you.

This medicine 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.

SIDE EFFECTS

Pomalyst

(pomalidomide) capsules – NZ CMI

Celgene V1.7.0 – 29 October 2020

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking

Pomalyst.

Like all medicines, Pomalyst can have side effects, although not everybody gets them and some are

uncommon. Sometimes they are serious, most of the time they are not. You may need medical

attention if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Tell your doctor if you notice any of the following and they worry you:

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.

The above list mainly includes the more common side effects of your medicine.

Tell your doctor immediately if you notice the following:

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).

The above list includes serious side effects that may require medical attention.

If any of the following happens, stop taking Pomalyst and see a doctor immediately or go to

Accident and Emergency at your nearest hospital

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.

Pomalyst

(pomalidomide) capsules – NZ CMI

Celgene V1.7.0 – 29 October 2020

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 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.

The above list includes very serious side effects. You may need urgent medical attention or

hospitalisation.

Tell your doctor or pharmacist immediately if any of the side effects gets worse, or if you notice

any other side effects not listed in this leaflet.

AFTER TAKING POMALYST

Storage

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 this medicine 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

Pomalyst

(pomalidomide) capsules – NZ CMI

Celgene V1.7.0 – 29 October 2020

If your doctor tells you to stop taking this medicine or the expiry date has passed, take any

unused Pomalyst capsules to your pharmacist.

Medicines should not be disposed of via wastewater or household waste. These measures will help to

protect the environment.

PRODUCT DESCRIPTION

What Pomalyst looks like

The capsules are provided in packs. Each pack contains three blisters, each with seven capsules,

giving a total of twenty-one (21) capsules per pack.

Pomalyst 1 mg capsules are yellow opaque body/dark blue opaque cap capsules with “POML 1 mg”

written on them.

Pomalyst 2 mg capsules are orange opaque body/dark blue opaque cap capsules with “POML 2 mg”

written on them.

Pomalyst 3 mg capsules are green opaque body/dark blue opaque cap capsules with “POML 3 mg”

written on them.

Pomalyst 4 mg capsules are blue opaque body/dark blue opaque cap capsules with “POML 4 mg”

written on them.

Ingredients

Pomalyst capsules contain an active ingredient called pomalidomide.

The other ingredients are:

mannitol,

pregelatinised starch, and

sodium stearyl fumarate.

The capsule shells contain:

1 mg capsules: gelatine, titanium dioxide, colourants (indigo carmine and yellow iron oxide),

white ink (Shellac, titanium dioxide, simethicone, propylene glycol and ammonium hydroxide)

and black ink (Shellac, iron oxide black, propylene glycol and ammonium hydroxide)

2 mg capsules: gelatine, titanium dioxide, colourants (indigo carmine, yellow iron oxide and

erythrosine) and white ink (Shellac, titanium dioxide, simethicone, propylene glycol and

ammonium hydroxide)

3 mg capsules: gelatine, titanium dioxide, colourants (Indigo carmine and yellow iron oxide)

and white ink (Shellac, titanium dioxide, simethicone, propylene glycol and ammonium

hydroxide)

4 mg capsules: gelatine, titanium dioxide, colourants (Indigo carmine and brilliant blue FCF)

and white ink (Shellac, titanium dioxide, simethicone, propylene glycol and ammonium

hydroxide)

This medicine does not contain lactose.

Pomalyst

(pomalidomide) capsules – NZ CMI

Celgene V1.7.0 – 29 October 2020

SPONSOR DETAILS

Supplier

The sponsor in New Zealand is:

Celgene Limited

PO Box 3035

Wellington.

Telephone: 0800 526 529.

® = Registered Trademark

DATE OF PREPARATION

This leaflet was updated on 29 October 2020.

Read the complete document

POMALYST

(pomalidomide) capsules – NZ Data Sheet

Page 1

Celgene V1.7 – 29 October 2020 (CCDS V12)

NEW ZEALAND DATA SHEET

Teratogenic effects:

Pomalyst (pomalidomide) is a thalidomide analogue. Thalidomide is a known human teratogen

that causes severe life-threatening human birth defects. If pomalidomide is taken during

pregnancy, it may cause birth defects or death to an unborn baby. Women should be advised to

avoid pregnancy whilst taking Pomalyst (pomalidomide), during dose interruptions, and for

4 weeks after stopping the medicine.

PRODUCT NAME

Pomalyst 1 mg capsules.

Pomalyst 2 mg capsules.

Pomalyst 3 mg capsules.

Pomalyst 4 mg capsules.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1 mg capsule contains 1 mg pomalidomide.

Each 2 mg capsule contains 2 mg pomalidomide.

Each 3 mg capsule contains 3 mg pomalidomide.

Each 4 mg capsule contains 4 mg pomalidomide.

For the full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

Presentation

Pomalyst 1 mg capsules: dark blue/yellow size 4 gelatin capsules marked “POML” in white ink and

“1 mg” in black ink.

Pomalyst 2 mg capsules: dark blue/orange size 2 gelatin capsules marked “POML 2 mg” in white ink.

Pomalyst 3 mg capsules: dark blue/green size 2 gelatin capsules marked “POML 3 mg” in white ink.

Pomalyst 4 mg capsules: dark blue/blue size 2 gelatin capsules marked “POML 4 mg” in white ink.

Description

Pomalidomide is a yellow solid powder. It is practically insoluble in water over the pH range 1.2-6.8

and is slightly soluble (eg. acetone, methylene chloride) to practically insoluble (eg. heptanes,

ethanol) in organic solvents. Pomalidomide has a chiral carbon atom and exists as a racemic mixture

of the R(+) and S(-) enantiomers.

CLINICAL PARTICULARS

Therapeutic Indications

Pomalidomide, in combination with dexamethasone, is indicated for the treatment of patients with

relapsed and refractory multiple myeloma who have received at least two prior treatment regimens,

including both lenalidomide and bortezomib, and have demonstrated disease progression on the last

therapy.

Dose and Method of Administration

POMALYST

(pomalidomide) capsules – NZ Data Sheet

Page 2

Celgene V1.7 – 29 October 2020 (CCDS V12)

Treatment must be initiated and monitored under the supervision of a registered Specialist Physician

experienced in the management of haematological and oncological malignancies.

4.2.1

Dose

The recommended starting dose of pomalidomide is 4 mg/day taken orally on Days 1-21 of repeated

28-day cycles (21/28 days) until disease progression. The recommended dose of dexamethasone is

40 mg/day on Days 1, 8, 15 and 22 of each 28-day treatment cycle.

To initiate a cycle of pomalidomide, the platelet count must be ≥ 50 x 10

/L and the neutrophil count

must be ≥ 1.0 x 10

Dosing is continued or modified based upon clinical and laboratory findings.

4.2.2

Dose Modification or Interruption

To initiate a new cycle of pomalidomide, the platelet count must be ≥ 50 x 10

/L and the neutrophil

count must be ≥ 1.0 x 10

Instructions for dose interruptions and reductions for pomalidomide related to haematologic adverse

reactions are outlined in

Table 1

below.

Table 1: Pomalyst Dose Modification Instructions for Haematological Toxicities

Thrombocytopenia (Platelet counts)

When platelets

Recommended action

First fall to < 25 x 10

Interrupt treatment, and conduct CBC weekly

Return to ≥ 50 x 10

Resume treatment at 3 mg daily

For each subsequent drop < 25 x 10

Interrupt treatment

Return to ≥ 50 x 10

Resume treatment at 1 mg less than previous dose.

Neutropenia [Absolute Neutrophil counts (ANC)]

When ANC:

Recommended action

First fall to < 0.5 x 10

Or febrile neutropenia is observed

(fever ≥ 38.5 °C and ANC <1 x 10

Interrupt treatment, and conduct CBC weekly.

Consider treatment with G-CSF

Return to ≥ 1 x 10

Resume treatment at 3 mg daily

For each subsequent drop < 0.5 x 10

Interrupt treatment

Return to ≥ 1 x 10

Resume treatment at 1 mg less than previous dose

ANC – Absolute Neutrophil Count; CBC – Complete Blood Count; G-CSF – Granulocyte- Colony Stimulating Factor

For other Grade 3/4 adverse reactions judged to be related to pomalidomide, stop treatment and restart

treatment at 1 mg less than the previous dose when an adverse reaction has resolved to ≤ Grade 2 at

the physician’s discretion.

If toxicities occur after dose reductions to 1 mg, then the medicine should be discontinued.

If strong inhibitors of CYP1A2 are co-administered with pomalidomide, reduce the dose of

pomalidomide by 50%.

Discontinuation

POMALYST

(pomalidomide) capsules – NZ Data Sheet

Page 3

Celgene V1.7 – 29 October 2020 (CCDS V12)

Pomalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash.

Pomalidomide must be discontinued for angioedema, anaphylaxis, Grade 4 rash, exfoliative or bullous

rash, or if Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or drug reaction with

eosinophilia and systemic symptoms (DRESS) is suspected, and should not be resumed following

discontinuation for these reactions.

4.2.3

Special Populations

Paediatric Population

There is no experience in treating children and adolescents with pomalidomide. Therefore,

pomalidomide should not be used in the paediatric age group (0-18 years).

Use in the Elderly

For patients > 75 years of age, the dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of

each 28-day treatment cycle. For these patients a dose adjustment in pomalidomide is not required.

Use in Patients with Impaired Renal Function

No dose adjustment of pomalidomide is required for patients with renal impairment. Patients on

dialysis: on haemodialysis days, patients should take pomalidomide following haemodialysis.

Use in Patients with Impaired Hepatic Function

Patients with serum total bilirubin > 34.2 µmol/L were excluded from clinical studies.

Patients with hepatic impairment should be carefully monitored for adverse reactions and a dose

reduction or interruption of pomalidomide should be considered as needed.

4.2.4

Method of Administration

Pomalidomide should be taken orally about the same time each day.

Pomalidomide capsules should be swallowed whole, preferably with water, either with or without

food.

In the event of a missed dose, if less than 12 hours has elapsed since missing a dose, the patient can

take the dose. If more than 12 hours has elapsed since missing a dose, the patient should not take the

dose, but take the next dose at the normal time on the following day.

Contraindications

Pregnancy.

Females of childbearing potential and male patients unless all of the conditions of the

i-access

Program have been met (see section 4.4 [Special Warnings and Precautions for

Use]).

Hypersensitivity to the active substance or to any of the excipients.

Special Warnings and Precautions for Use

4.4.1

Use in Pregnancy (Pregnancy Category X)

A teratogenic effect of pomalidomide in humans cannot be ruled out. Because pomalidomide is a

structural analogue of thalidomide, a known human teratogen, the conditions of the i-access®

Program for pregnancy prevention must be fulfilled for all patients.

4.4.1.1 The i-access

®

Program Conditions for Pregnancy Prevention

POMALYST

(pomalidomide) capsules – NZ Data Sheet

Page 4

Celgene V1.7 – 29 October 2020 (CCDS V12)

Pomalyst is available under a restricted distribution program (

i-access

). Only physicians and

pharmacists registered with this program can prescribe and dispense the product. In addition,

Pomalyst must only be dispensed to patients who are registered and meet all the conditions of the

program.

4.4.1.1.1 Females of Non-Child Bearing Potential

A female patient or a female partner of a male patient is considered to have childbearing potential

unless she meets at least one of the following criteria:

50 years and naturally amenorrhoeic for

1 year*

Premature ovarian failure confirmed by a specialist gynaecologist

Previous bilateral salpingo-oophorectomy, or hysterectomy

XY genotype, Turner syndrome, uterine agenesis.

*Amenorrhoea following cancer therapy does not rule out childbearing potential.

Female patients of non-child bearing potential are only required to comply with the General

Conditions listed within the pregnancy prevention programme.

4.4.1.1.2 Females of Child Bearing Potential

Female patients of child bearing potential must comply with the following requirements on

counselling, contraception and pregnancy testing.

If pregnancy occurs in a female treated with pomalidomide, treatment must be stopped and the patient

should be referred to a physician specialised or experienced in teratology for evaluation and advice.

Similarly, if pregnancy occurs in a partner of a male patient taking pomalidomide, the female partner

should be referred to a physician specialised or experienced in teratology for evaluation and advice.

Counselling

For female patients of childbearing potential, pomalidomide is contraindicated unless all of the

following are met:

She understands the potential teratogenic risk to the unborn child.

She understands and agrees to comply with the requirement for effective contraception,

without interruption, 4 weeks before starting treatment, throughout the entire duration of

treatment including during dose interruptions, and 4 weeks after the end of treatment.

Even if a female of childbearing potential has amenorrhea she must follow all the

requirements on effective contraception.

She should be capable of complying with effective contraceptive measures.

She is informed and understands the potential consequences of pregnancy and the need to

rapidly consult her physician there is a risk of pregnancy.

She understands the requirement to commence the treatment as soon as pomalidomide is

dispensed following a negative pregnancy test.

She understands the requirement and accepts to undergo medically supervised pregnancy

testing every 4 weeks

She acknowledges that she understands the hazards and necessary precautions associated with

the use of pomalidomide.

Contraception

Females of childbearing potential must use one effective method of contraception for 4 weeks before

therapy, during therapy, and until 4 weeks after pomalidomide therapy, even in case of dose

interruption. If not established on effective contraception, the patient must be referred to an

POMALYST

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appropriately trained health care professional for contraceptive advice in order that contraception can

be initiated.

Table 2

lists examples of suitable methods of contraception.

Table 2: Recommended Methods of Contraception

Contraceptive Method

Comments

Contraceptive implant

Contraceptive implants and levonorgestrel-releasing intrauterine

systems are associated with an increased risk of infection at the

time of insertion and irregular vaginal bleeding. Prophylactic

antibiotics should be considered particularly in patients with

neutropenia.

Copper-releasing intrauterine devices are generally not

recommended due to the potential risks of infection at the time of

insertion and menstrual blood loss which may compromise patients

with neutropenia or thrombocytopenia.

Levonorgestrel-releasing

intrauterine system (IUS)

Medroxyprogesterone

acetate depot

Tubal ligation

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).

Because of the increased risk of venous thromboembolism in

patients with multiple myeloma taking pomalidomide and

dexamethasone, combined oral contraceptive pills are not

recommended. If a patient is currently using combined oral

contraception the patient should switch to one of the effective

methods listed above. The risk of venous thromboembolism

continues for 4-6 weeks after discontinuing combined oral

contraception. The efficacy of contraceptive steroids may be

reduced during co-treatment with dexamethasone.

Pregnancy Testing

Medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be performed

for females of childbearing potential as outlined below.

Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day. For

women of childbearing potential, dispensing and commencement of pomalidomide should occur

within a maximum of 7 days of a negative pregnancy test.

Prior to Starting Treatment

A medically supervised pregnancy test should be performed when pomalidomide is prescribed. The

test should occur either at the time of consultation, or in the 3 days prior to the visit to the prescriber

and at a point where the patient has been using effective contraception for at least 4 weeks. The test

should ensure the patient is not pregnant when she starts treatment with pomalidomide.

Follow-Up and End of Treatment

A medically supervised pregnancy test should be repeated every 4 weeks, including 4 weeks after the

end of treatment. These pregnancy tests should be performed on the day of the prescribing visit or in

the 3 days prior to the visit to the prescriber.

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4.4.1.1.3 Male Patients

Male patients must comply with the following requirements on counselling and contraception as

clinical data has demonstrated the presence of pomalidomide in human semen.

Counselling and Contraception

He understands the potential teratogenic risk if engaged in sexual activity with a woman of

childbearing potential.

He understands and complies with the need for the use of a condom, even if he is vasectomised,

if engaged in sexual activity with a woman of childbearing potential throughout treatment

duration, during dose interruption and for 1 week after discontinuation of treatment.

He understands that if his partner becomes pregnant whilst he is taking pomalidomide or

during the 1

week after he discontinues taking pomalidomide, he should inform his treating

physician immediately.

He understands that he must not donate sperm during therapy (during dose interruption) or for

1 week following discontinuation of pomalidomide.

4.4.1.1.4 Prescribers

Ensure that females of child bearing potential comply with the conditions of the

i-access

Program, including confirmation that they have an adequate level of understanding of the

requirements.

Provide full patient information about the potential teratogenic risk and the strict pregnancy

prevention measures as specified in the

i-access

Program to female patients of childbearing

potential and, as appropriate, to male patients.

Ensure that all patients acknowledge and agree to comply with the conditions of the

i-access

program.

4.4.1.1.5 Sponsor

The sponsor will provide educational material to healthcare professionals to reinforce the warnings

about the potential teratogenicity of pomalidomide, to provide advice on contraception before therapy

is started, and to provide guidance on the need for pregnancy testing.

4.4.1.1.6 General Conditions

All patients should be instructed never to give this medicinal product to another person and to return

any unused capsules to the pharmacist at the end of treatment.

All patients should not donate blood during therapy including dose interruptions, or for 1 week

following discontinuation of pomalidomide. In New Zealand, patients with myeloma are permanently

excluded from donating blood.

4.4.2

Additional Precautions

4.4.2.1 Haematological Events

Neutropenia was the most frequently reported Grade 3/4 hematologic adverse reaction in subjects

with relapsed/refractory multiple myeloma, followed by anaemia and thrombocytopenia.

Grade 3 or 4 neutropenia occurred in 41.7% of patients who received Pom + LD-dex, compared with

14.8% who received HD-dex. In Pom + LD-dex treated patients, neutropenia did not lead to treatment

discontinuation, and was associated with treatment interruption in 21.0% of patients, and with dose

reduction in 7.7% of patients.

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Grade 3 or 4 febrile neutropenia (FN) was experienced in 6.7% of patients who received Pom + LD-

dex, and in no patients who received HD-dex. FN was associated with dose interruption in 3.7% of

patients, and with dose reduction in 1.3% of patients, and with no treatment discontinuations.

Grade 3 or 4 thrombocytopenia occurred in 20.7% of patients who received Pom + LD-dex and in

24.2% who received HD-dex. In Pom + LD-dex treated patients, thrombocytopenia led to dose

reduction in 6.3% of patients, to dose interruption in 8% of patients and to treatment discontinuation

in 0.7% of patients.

Monitor patients for haematologic toxicities, especially neutropenia. Monitor complete blood counts

weekly for the first 8 weeks and monthly thereafter. A dose modification may be required (see

section 4.2 [Dose and Method of Administration]). Patients may require use of blood product support

and/or growth factors.

4.4.2.2 Thromboembolic Events

Patients receiving pomalidomide have developed venous thromboembolic events (VTE) reported as

serious adverse events. Anti-coagulation therapy (unless contraindicated) is recommended (such as

aspirin, warfarin, heparin or clopidogrel). A decision to take prophylactic measures should be made

carefully after an assessment of an individual patient’s underlying risk factors.

4.4.2.3 Peripheral Neuropathy

Patients with ongoing ≥Grade 2 peripheral neuropathy were excluded from clinical studies with

pomalidomide. Appropriate caution should be exercised when considering the treatment of such

patients with pomalidomide.

4.4.2.4 Cardiac Dysfunction

Patients with significant cardiac dysfunction (congestive heart failure [NY Heart Association Class III

or IV]; myocardial infarction within 12 months of starting study; unstable or poorly controlled angina

pectoris) were excluded from clinical studies with pomalidomide. There is no experience of

pomalidomide in patients with pre-existing cardiac dysfunction due to exclusion from clinical trials.

4.4.2.5 Tumour Lysis Syndrome

Tumour lysis syndrome (TLS) may occur in patients treated with pomalidomide. Patients at risk for

TLS are those with high tumour burden and those with pre-existing renal impairment prior to

treatment. These patients should be monitored closely and appropriate precautions taken.

4.4.2.6 Second Primary Malignancies

Second primary malignancies have been reported in patients receiving pomalidomide. The clinical

significance of these observations is unclear. Physicians should carefully evaluate patients before and

during treatment using standard cancer screening for occurrence of SPM and institute treatment as

indicated.

4.4.2.7 Allergic Reactions and Serious Skin Reactions

Patients with a prior history of serious allergic reactions associated with thalidomide or lenalidomide

were excluded from clinical studies. Such patients may be prone to a higher risk of hypersensitivity

and should not receive pomalidomide (see section 4.3 [Contraindications]).

Angioedema, anaphylaxis and severe dermatologic reactions including Stevens-Johnson syndrome

(SJS,) and toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic

symptoms (DRESS) have been reported. DRESS may present with a cutaneous reaction (such as rash

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or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications

such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. These events can be fatal.

Pomalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash.

Pomalidomide must be discontinued for angioedema, anaphylaxis, Grade 4 rash, exfoliative or bullous

rash or if SJS, TEN or DRESS is suspected, and should not be resumed following discontinuation for

these reactions.

4.4.2.8 Dizziness and Confusion

Dizziness and confusion have been reported. Instruct patients to exercise caution in situations where

dizziness or confusion may be a problem.

4.4.2.9 Hepatic Disorders

Markedly elevated levels of alanine aminotransferase and bilirubin have been observed in patients

treated with pomalidomide (see section 4.8 [Undesirable Effects]). There have also been cases of

hepatitis that resulted in discontinuation of pomalidomide. Regular monitoring of liver function is

recommended.

4.4.2.10 Infection

Reactivation of hepatitis B has been reported rarely in patients receiving pomalidomide in

combination with dexamethasone who have previously been infected with the hepatitis B virus

(HBV). Some of these cases have progressed to acute hepatic failure, resulting in discontinuation of

pomalidomide. Caution should be exercised when pomalidomide in combination with dexamethasone

is used in patients previously infected with HBV. These patients should be closely monitored for signs

and symptoms of active HBV infection throughout therapy.

4.4.2.11 Progressive Multifocal Leukoencephalopathy

Cases of progressive multifocal leukoencephalopathy (PML), including fatal cases, have been

reported with pomalidomide in combination with immunosuppressive therapy including

dexamethasone. PML was reported several months to several years after starting the treatment with

pomalidomide. Physicians should consider PML in the differential diagnosis in patients with new or

worsening neurological, cognitive or behavioural signs or symptoms and appropriate diagnostic

measures for PML are recommended. If PML is suspected, further pomalidomide dosing must be

suspended until PML has been excluded. If PML is confirmed, pomalidomide must be permanently

discontinued.

4.4.2.12 Interstitial Lung Disease (ILD)

ILD and related events, including cases of pneumonitis, have been observed with pomalidomide.

Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms

should be performed to exclude ILD. Pomalidomide should be interrupted pending investigation of

these symptoms and if ILD is confirmed, appropriate treatment should be initiated. Pomalidomide

should only be resumed after a thorough evaluation of the benefits and the risks.

Interaction with Other Medicines and Other Forms of Interaction

4.5.1

Effect of Other Medicinal Products on Pomalidomide

Pomalidomide is partly metabolized by CYP1A2 and CYP3A4/5. It is also a substrate for P-

glycoprotein.

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Co-administration of pomalidomide with the strong CYP3A4/5 and P-gp inhibitor ketoconazole, or

the strong CYP3A4/5 inducer carbamazepine, had no clinically relevant effect on exposure to

pomalidomide.

Data from a study to evaluate the contribution of a CYP1A2 inhibitor to metabolism changes supports

dose adjustment of pomalidomide.

Cigarette smoking reduces pomalidomide AUC by 32% due to CYP1A2 induction (see section 5.2.3

[Metabolism]). Advise patients that smoking may reduce the efficacy of pomalidomide.

Pomalidomide is not a substrate of organic anion transporting polypeptides OATP1B1 or OATP1B3.

4.5.2

Effect of Pomalidomide on Other Medicinal Products

The potential for such drug-drug interactions has not been evaluated clinically.

In Vitro

Studies

Pomalidomide does not inhibit CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19,

CYP2D6, CYP2E1 or CYP3A4/5

in vitro

. In addition, pomalidomide does not induce CYP1A2,

CYP2B6, CYP2C9, CYP2C19 or CYP3A4/5

in vitro

Pomalidomide is not an inhibitor of P-glycoprotein (P-gp), and had little to no inhibitory effect on

breast cancer resistant protein (BCRP), Organic Anion Transporter Protein (OATP)1B1, OATP1B3,

Organic Anion Transporters OAT1 and OAT3 and Organic Cation Transporter OCT2 based on

in vitro

studies.

4.5.3

Dexamethasone

Co-administration of multiple doses of 4 mg pomalidomide with 20 mg to 40 mg dexamethasone (a

weak to moderate inducer of several CYP enzymes including CYP3A) to patients with multiple

myeloma had no effect on the pharmacokinetics of pomalidomide compared with pomalidomide

administered alone. Dexamethasone is a weak to moderate enzyme inducer and its effect on warfarin

is unknown. Close monitoring of warfarin concentration is advised during treatment.

4.5.4

Other Forms of Interaction

During the pivotal clinical study CC-4047-MM-003 pomalidomide was administered without regard

to food. In addition, PK data support that co-administration of pomalidomide with a high-fat and

high-calorie meal has a minimal effect on the overall extent of absorption (see section 5.2

[Pharmacokinetic Properties]).

Therefore, pomalidomide can be administered without regard to food intake (see section 4.2 [Dose

and Method of Administration]).

Fertility, Pregnancy and Lactation

4.6.1

Pregnancy (Pregnancy Category X)

A teratogenic effect of pomalidomide in humans cannot be ruled out. Because pomalidomide is a

structural analogue of thalidomide, a known human teratogen, the conditions of the

i-access

Program

for pregnancy prevention must be fulfilled for all patients. See section 4.3 [Contraindications] and

section 4.4 [Special Warnings and Precautions for Use].

4.6.2

Breast-Feeding

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It is not known if pomalidomide is excreted in human milk. Pomalidomide was detected in milk of

lactating rats following administration to the mother. Because of the potential for adverse reactions in

nursing infants from pomalidomide, a decision should be made whether to discontinue nursing or to

discontinue the medicine, taking into account the importance of the medicine to the mother.

4.6.3

Fertility

No fertility data is available in humans.

Effects on Ability to Drive and Use Machines

Patients should be warned that confusion, fatigue, dizziness and depressed level of consciousness

have been reported with pomalidomide usage and if affected, patients should be instructed not to drive

cars, use machines or perform hazardous tasks while being treated with pomalidomide.

Undesirable Effects

4.8.1

Tabulated Summary of Adverse Events

In the randomised study (CC-4047-MM-003), 302 patients with relapsed and refractory MM were

exposed to 4 mg pomalidomide administered once daily for 21 days of each 28-day cycle in

combination with a weekly low dose of dexamethasone. The most commonly reported adverse events

were blood and lymphatic system disorders including anaemia (45.7%), neutropenia (45.3%) and

thrombocytopenia (27%); general disorders and administration site conditions including fatigue

(28.3%), pyrexia (21%) and oedema peripheral (13%); and infections and infestations including

pneumonia (10.7%).

Adverse events tended to occur more frequently within the first 2 cycles of treatment with

pomalidomide.

Table 3

shows the adverse events that occurred at a frequency of greater than or equal

to 10% in either of the arms in study CC-4047-MM-003.

Table 3: Most Frequently Reported Treatment-Emergent Adverse Events in CC-4047-MM-003

(≥ 10.0%)

Adverse Events

% occurrence in

Pom + LD-dex

(N=300)

% occurrence in

HD-dex

(N=149)

Infections and infestations

Pneumonia

10.7

Blood and lymphatic system disorders

Anaemia

Neutropenia

Thrombocytopenia

Leukopenia

45.7

45.3

27.0

12.3

42.3

19.5

26.8

Metabolism and nutrition disorders

Decreased appetite

Hypercalcaemia

10.0

10.7

Psychiatric disorders

Insomnia

20.8

Respiratory, thoracic and mediastinal disorders

Dyspnoea

Cough

16.7

15.0

11.4

Gastrointestinal disorders

Constipation

Diarrhoea

19.3

18.3

12.1

16.1

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