Pomalidomide 1 mg/2 mg/3 mg/4 mg Capsules

POMALIDOMIDE FORRESTER belongs to a group of medicines called immunomodulatory medicines, a group of medicines which affect the immune system (the body's natural defences). POMALIDOMIDE FORRESTER is used with another medicine called 'dexamethasone' (an anti-inflammatory medicine) to treat adults with a type of cancer called 'multiple myeloma’. It is used in people whose myeloma has become worse, despite having received at least two other kinds of treatment.

Your doctor will have enrolled you in the ACTIVE RISK MANAGEMENT PROGRAM to ensure that POMALIDOMIDE FORRESTER is used safely.

Do not take POMALIDOMIDE FORRESTER:

• If you are allergic (hypersensitive) to pomalidomide or any of the other ingredients of POMALIDOMIDE FORRESTER (see section 6). If you think you may be allergic, ask your doctor for advice.
• If you are pregnant or think you may be pregnant or planning to become pregnant, as POMALIDOMIDE FORRESTER is harmful to an unborn child (see sections: Take special care with POMALIDOMIDE FORRESTER and Pregnancy and breastfeeding).
• If you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see sections: Take special care with POMALIDOMIDE FORRESTER and Pregnancy and breastfeeding). 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 a male patient and you are not able to follow or comply with the required contraceptive measures (see sections: Take special care with POMALIDOMIDE FORRESTER and Pregnancy and breastfeeding)

If any of these apply to you, tell your doctor before you take POMALIDOMIDE FORRESTER.

Warnings and precautions

Tell your doctor or healthcare provider before taking POMALIDOMIDE FORRESTER:

• If you had blood clots in the past. During treatment with POMALIDOMIDE FORRESTER you have an increased risk of developing blood clots in the veins and arteries.
• If you have had a heart attack, other heart problems, have ever had a blood clot, or if you smoke, have high blood pressure or high cholesterol levels. Your doctor will regularly monitor your symptoms.
• Before treatment with POMALIDOMIDE FORRESTER, your doctor may test your thyroid function because POMALIDOMIDE FORRESTER could cause your thyroid to be underactive.
• If you have weakness, numbness and pain from nerve damage, usually in the hands and feet (peripheral neuropathy).
• If you have previously experienced a combination of any of the following symptoms: widespread rash, red skin, high body temperature, flu-like symptoms, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes – these are signs of a severe skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome (see Possible side effects).
• If you have had an allergic reaction whilst taking thalidomide or pomalidomide (other medicine used to treat Multiple Myeloma) such as rash, itching, swelling, dizziness or trouble breathing.
• If you have kidney problems. Your doctor may adjust your dose of POMALIDOMIDE FORRESTER based on this information.
• If you have any signs of an infection, such as a cough or fever.
• If you have or have ever had previous viral infection, particularly: hepatitis B infection, varicella zoster, HBV. If you are unsure, talk to your doctor. Treatment with POMALIDOMIDE FORRESTER may cause the virus to become active again, in patients who carry the virus. This results in a recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection.

If any of the above apply to you, tell your doctor or healthcare provider before starting treatment.

Take special care with POMALIDOMIDE FORRESTER:

For women taking POMALIDOMIDE FORRESTER: Before starting the treatment, you should ask your doctor if you are able to become pregnant, even if you think this is unlikely. If you are able to become pregnant:

• You will have pregnancy tests under the supervision of your doctor (before treatment, every 4 weeks during treatment, and 4 weeks after the treatment has finished) except in the case of confirmed tubal sterilisation.
• You must use two effective methods of contraception for 4 weeks before starting the treatment, during treatment including dose interruptions and until 4 weeks after stopping treatment. Your doctor will advise you on appropriate methods of contraception.

For men taking POMALIDOMIDE FORRESTER: POMALIDOMIDE FORRESTER passes into human semen, if your female partner is pregnant or able to become pregnant, and she doesn’t use effective methods of contraception, you must use condoms during treatment including dose interruptions and for at least 4 weeks after the end of treatment (even if you have undergone a vasectomy). Male patients taking POMALIDOMIDE FORRESTER should not donate sperm or semen during treatment including dose interruptions and for 4 weeks following the end of treatment.

All patients: Before and during treatment with POMALIDOMIDE FORRESTER you will have regular blood tests as POMALIDOMIDE FORRESTER may cause a fall in the blood cells that help fight infection (white blood cells) and help the blood to clot (platelets).

Do not share medicines prescribed for you with any other person. POMALIDOMIDE FORRESTER must be given to you by a doctor with experience in treating multiple myeloma. POMALIDOMIDE FORRESTER is taken in combination with another medicine called dexamethasone. Always take POMALIDOMIDE FORRESTER exactly as your doctor has told you. Check with your doctor if you are unsure. Your doctor will prescribe the correct dose for your condition. Your doctor may adjust your dose of POMALIDOMIDE FORRESTER or stop your treatment based on the results of your blood tests and on your general condition (see Section: ‘Take special care with POMALIDOMIDE FORRESTER’).

You should swallow the POMALIDOMIDE FORRESTER capsule whole, preferably with water, once a day. Do not break, open or chew the capsules. The POMALIDOMIDE FORRESTER capsules can be taken either with or without food. You should take POMALIDOMIDE FORRESTER at about the same time each day. POMALIDOMIDE FORRESTER and dexamethasone are taken in treatment cycles.

• Each cycle lasts 28 days (4 weeks).

How much to take: The usual starting dose is 4 mg POMALIDOMIDE FORRESTER taken once a day. In every 4-week cycle, POMALIDOMIDE FORRESTER should be taken once a day for 3 weeks, followed by a week off. This means:

• Days 1 to 21: take POMALIDOMIDE FORRESTER once a day.
• Days 22 to 28: do not take POMALIDOMIDE FORRESTER.

Dexamethasone: The usual starting dose of dexamethasone is 40 mg per day. In every 4-week cycle a dose of dexamethasone should be taken on the first day of each week only. This means:

• Days 1, 8, 15 and 22 of each cycle: take a dose of dexamethasone.
• Days 2 to 7, 9 to 14, 16 to.21 and·23 to 28: do not take dexamethasone.

Older patients: For patients above the age of 75 years the usual starting dose of dexamethasone is reduced to 20 mg per day. After completing each cycle, start a new one. Your doctor may need to reduce the dose of POMALIDOMIDE FORRESTER or dexamethasone or stop the treatment based on the results of your blood tests, your general condition and if you experience side effects from treatment. If you suffer from liver or kidney problems your doctor will check your condition very carefully whilst you are receiving POMALIDOMIDE FORRESTER.

If you have the impression that the effect of POMALIDOMIDE FORRESTER is too strong or too weak, talk to your doctor or pharmacist.

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

If you take more POMALIDOMIDE FORRESTER than you should: In the event of over dosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take a dose of POMALIDOMIDE FORRESTER: If you forget to take POMALIDOMIDE FORRESTER 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 POMALIDOMIDE FORRESTER the previous day.

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

POMALIDOMIDE FORRESTER can cause side effects. Not all side effects reported for POMALIDOMIDE FORRESTER are included in this information leaflet. Should your general health worsen, or if you experience any untoward effects while taking POMALIDOMIDE FORRESTER, please consult your healthcare provider for advice.

If any of the following happens, stop taking POMALIDOMIDE FORRESTER and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to POMALIDOMIDE FORRESTER. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Fever, sore throat, cough, or any other signs of infection (due to reduced number of white blood cells, which fight infection), dangerously low blood pressure due to severe infection (septic shock).
• Recurrence of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown-coloured urine, right-sided abdominal pain, fever and feeling nauseous or being sick. Tell your doctor straightaway if you notice any of these symptoms.
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance of your skin or growths on your skin. If you notice any changes to your skin whilst taking POMALIDOMIDE FORRESTER, tell your doctor as soon as possible.
• Treatment with POMALIDOMIDE FORRESTER can cause a decrease in the numbers of red and white blood cells and platelets in your blood. You may experience a reduction in the number of:

• Platelets, which may make you more prone to bruising, or to bleeding without obvious injury (e.g. bleeding from your bowels, stomach, mouth and gums or bleeding in the brain or bleeding in the liver)
• Red blood cells, which can cause anaemia, with symptoms such as tiredness, weakness and paleness
• White blood cells, which may make you more prone to getting flu-like symptoms and infections or severe infection (sepsis). Symptoms may include fever, chills, sore throat, cough, mouth ulcers, shortness of breath.

The breakdown of cancer cells resulting in the release of toxic compounds into the bloodstream (tumour lysis syndrome). This can result in kidney problems.

• Bleeding within the skull (intracranial haemorrhage), stroke (damage to the brain from interruption of its blood supply)
• Chest pain spreading to the arms, neck, jaw, back or stomach, feeling sweaty, and breathless, feeling sick or vomiting (which may be symptoms of a heart attack / myocardial infarction), heart disorders (e.g. changes in the way your heart beats, chest pain or discomfort, fast or slow irregular heartbeat, obstruction in blood flow to your heart), shortness of breath especially when lying down (which may be a symptom of heart failure)
• Chest pain, or leg pain and swelling, especially in your lower leg or calves caused by blood clots
• Shortness of breath (from serious chest infection, inflammation of the lung or blood clot)
• Bleeding in the intestines
• Inflammation of the liver (hepatitis) which may cause yellow skin or eyes (jaundice), nausea, abdominal pain, fatigue and fever
• An allergic reaction which may begin as a rash in one area but spread with extensive loss of skin over the whole body, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and leukocytoclastic vasculitis
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a severe allergic reaction (symptoms include skin rash, fever, and inflammation of the liver, lung, and heart)
• Reduced amount of urine, swelling of your legs, ankles, and feet from retention of fluids caused by the failure of the kidneys to eliminate water waste, condition where your kidneys suddenly stop working properly.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Infections, including bacterial, viral or fungal, sinus infection (pressure behind the eyes and the cheeks, runny, stuffy nose), sore throat, sneezing, coughing, tiredness, body aches, inflammation of the colon caused by the bacteria Clostridium difficile, flu, urinary tract infection.
• Wheezing, shortness of breath or a dry cough, which may be symptoms caused by inflammation of the tissue in the lungs, may occur.
• Infection of the lungs, upper and lower respiratory tract.
• Fever and flu-like symptoms including fever, muscle ache, headache, and chills.
• Decreased appetite, high or low levels of potassium and low levels of urea in your blood, low levels of sodium in your blood which can cause tiredness and confusion, muscle twitching, fits (epileptic seizures), high blood sugar, low levels of magnesium or phosphate in your blood, high or low levels of calcium in your blood.
• Feeling confused, inability to sleep (insomnia), depression
• Loss of consciousness, weakness, numbness and pain from nerve damage, usually in the hands and feet (peripheral neuropathy), dizziness, tremor, burning or prickling sensation that is usually felt in the hands, arms, legs, or feet, altered taste, fainting
• Spinning sensation (vertigo)
• Clouding of the eye (cataract)
• High or low blood pressure
• Shortness of breath (dyspnoea), nosebleeds
• Diarrhoea, nausea (feeling sick), constipation, vomiting (being sick), abdominal pain, painful swelling and sores inside the mouth, dry mouth, bloating and swelling in the belly area
• Rash, itching, dry skin
• Bone pain, muscle spasms, muscle weakness, back pain
• Urinary retention
• Pelvic pain
• Tiredness, fever, swelling of your lower legs or hands, chest pain
• Decrease neutrophil, white blood cell and platelet count, increased liver enzymes.
• Fall.

Less frequent side effects:

• Increase in blood pressure within blood vessels that supply the lungs (pulmonary hypertension)
• Abnormal increase of bilirubin in your blood which may indicate liver damage and may result in jaundice.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of POMALIDOMIDE FORRESTER.

Store at or below 30 °C. Do not remove capsule from blister until required for use. Store all medicines out of reach of children. Do not use after the expiry date printed on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).