POMAGEN CAPSULES 3MG [SIN16985P]

Product Info

POMAGEN CAPSULES 3MG

[SIN16985P]

Indication

1. What Pomagen is and what it is used for

What Pomagen is
Pomagen contains the active substance ‘pomalidomide’. This medicine is related to thalidomide and belongs to a group of medicines which affect the immune system (the body’s natural defences).

What Pomagen is used for
Pomagen is used to treat adults with a type of cancer called ‘multiple myeloma’.

Pomagen is either used with:
• two other medicines - called ‘bortezomib’ (a type of chemotherapy medicine) and ‘dexamethasone’ (an anti-inflammatory medicine) in people who have had at least one other treatment - including lenalidomide.

Or

• one other medicine - called ‘dexamethasone’ in people whose myeloma has become worse, despite having at least two other treatments - including lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a type of cancer which affects a certain type of white blood cell (called the ‘plasma cell’). These cells grow out of control and accumulate in the bone marrow. This results in damage to the bones and kidneys.

Multiple myeloma generally cannot be cured. However, treatment can reduce the signs and symptoms of the disease, or make them disappear for a period of time. When this happens, it is called ‘response’.

How Pomagen works
Pomagen works in a number of different ways:

• by stopping the myeloma cells developing

• by stimulating the immune system to attack the cancer cells

• by stopping the formation of blood vessels supplying the cancer cells.

The benefit of using Pomagen with bortezomib and dexamethasone
When Pomagen is used with bortezomib and dexamethasone, in people who have had at least one other treatment, it can stop multiple myeloma getting worse:

• On average, Pomagen when used with bortezomib and dexamethasone stopped multiple myeloma from coming back for up to 11 months - compared with 7 months for those patients who only used bortezomib and dexamethasone.

The benefit of using Pomagen with dexamethasone
When Pomagen is used with dexamethasone, in people who have had at least two other treatments, it can stop multiple myeloma getting worse:

• On average, Pomagen when used with dexamethasone stopped multiple myeloma from coming back for up to 4 months - compared with 2 months for those patients who used only dexamethasone.

Dosing

3. How to take Pomagen

Pomagen must be given to you by a doctor with experience in treating multiple myeloma.

Always take your medicines exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

When to take Pomagen with other medicines

Pomagen with bortezomib and dexamethasone

• See the leaflets that come with bortezomib and dexamethasone for further information on their use and effects.

• Pomagen, bortezomib and dexamethasone are taken in ‘treatment cycles’. Each cycle lasts 21 days (3 weeks).

• Look at the chart below to see what to take on each day of the 3-week cycle:

  • Each day, look down the chart and find the correct day to see which medicines to take.

  • Some days, you take all 3 medicines, some days just 2 or 1 medicines, and some days none at all.

• After completing each 3-week cycle, start a new one.

Pomagen with dexamethasone only

• See the leaflet that comes with dexamethasone for further information on its use and effects.

• Pomagen and dexamethasone are taken in ‘treatment cycles’. Each cycle lasts 28 days (4 weeks).

• Look at the chart below to see what to take on each day of the 4-week cycle:

  • Each day, look down the chart and find the correct day to see which medicines to take.

  • Some days, you take both medicines, some days just 1 medicine, and some days none at all.

• After completing each 4-week cycle, start a new one.

How much Pomagen to take with other medicines

Pomagen with bortezomib and dexamethasone

• The recommended starting dose of Pomagen is 4 mg per day.

• The recommended starting dose of bortezomib will be worked out by your doctor and based on your height and weight (1.3 mg/m² body surface area).

• The recommended starting dose of dexamethasone is 20 mg per day. However, if you are over 75, the recommended starting dose is 10 mg per day.

Pomagen with dexamethasone only

• The recommended dose of Pomagen is 4 mg per day.

• The recommended starting dose of dexamethasone is 40 mg per day. However, if you are over 75, the recommended starting dose is 20 mg per day.

Your doctor may need to reduce the dose of Pomagen, bortezomib or dexamethasone or stop one or more of these medicines based on the results of your blood tests, your general condition, other medicines you may be taking (e.g. ciprofloxacin, enoxacin and fluvoxamine) and if you experience side effects (especially rash or swelling) from treatment.
If you suffer from liver or kidney problems your doctor will check your condition very carefully whilst you are receiving this medicine.

How to take Pomagen

• Do not break, open or chew the capsules. If powder from a broken Pomagen capsule makes contact with the skin, wash the skin immediately and thoroughly with soap and water.

• Healthcare professionals, caregivers and family members should wear disposable gloves when handling the blister or capsule. Gloves should then be removed carefully to prevent skin exposure, placed in a sealable plastic polyethylene bag and disposed of in accordance with local requirements. Hands should then be washed thoroughly with soap and water. Women who are pregnant or suspect they may be pregnant should not handle the blister or capsule.

• Swallow the capsules whole, preferably with water.

• You can take the capsules either with or without food.

• Take Pomagen at about the same time each day.

To remove the capsule from the blister, press only one end of the capsule out to push it through the foil. Do not apply pressure on the center of the capsule as this can cause it to break.

Your doctor will advise you of how and when to take Pomagen if you have kidney problems and are receiving dialysis treatment.

Duration of the treatment with Pomagen
You should continue the cycles of treatment until your doctor tells you to stop.

If you take more Pomagen than you should
If you take more Pomagen than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Pomagen
If you forget to take Pomagen on a day when you should, take your next capsule as normal the next day. Do not increase the number of capsules you take to make up for not taking Pomagen the previous day.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Contraindications

2. What you need to know before you take Pomagen

Do not take Pomagen:

• if you are pregnant or think you may be pregnant or are planning to become pregnant – this is because Pomagen is expected to be harmful to an unborn child. (Men and women taking this medicine must read the section “Pregnancy, contraception and breast-feeding – information for women and men” below – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see “Pregnancy, contraception and breast-feeding – information for women and men” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and will provide you with this confirmation.

• if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If you think you may be allergic, ask your doctor for advice.

If you are uncertain whether any of the conditions above apply to you, talk to your doctor, pharmacist or nurse before taking Pomagen.