Pomaxel 1 mg/2 mg/3 mg/4 mg Capsules

POMAXEL contains the active substance ‘pomalidomide’. This medicine is related to thalidomide and belongs to a group of medicines which affect how your immune system works (your body’s natural defences). POMAXEL is used to treat adults with a type of cancer called ‘multiple myeloma’. POMAXEL is taken with:

• one other medicine, called ‘dexamethasone’ (a type of medicine to treat inflammatory and autoimmune disorders), in people whose myeloma has become worse, despite having at least two other treatments, including both lenalidomide and a proteasome inhibitor, e.g. bortezomib.

What is multiple myeloma

Multiple myeloma is a type of cancer, which affects a certain kind of white blood cell, called the plasma cell. These cells collect in the bone marrow and divide, becoming out of control. This can damage the bones and kidneys. POMAXEL can stop the signs and symptoms of multiple myeloma getting worse. It has also been shown to delay multiple myeloma from coming back following treatment.

Do not take POMAXEL

• if you are allergic to pomalidomide or any of the other ingredients of POMAXEL (listed in section 6).
• if you are pregnant, think you may be pregnant or are planning to become pregnant, as POMAXEL is expected to be harmful to an unborn child (men and women to read section 2, ‘ Pregnancy, breastfeeding and fertility ’, below).
• if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see section 2, ‘ Pregnancy, breastfeeding and fertility ’). If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and provide you with this confirmation.

Warnings and Precautions

Special care should be taken with POMAXEL:

• if you are pregnant, think you may be pregnant or are planning to become pregnant, as POMAXEL is expected to be harmful to an unborn child (see section 2, ‘ Pregnancy, breastfeeding and fertility ’).
• if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see section 2, ‘Pregnancy, breastfeeding and fertility’). If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and provide you with this confirmation.
• even if you suffer from amenorrhoea (absence of menstruation), resulting from cancer therapy or during breast-feeding, as it doesn’t rule out becoming pregnant.
• if you are a male patient, you should be aware of the risk engaging in sexual activity with a woman of childbearing potential.
• if a women becomes pregnant while the male patient is taking or 4 weeks after he has stopped taking POMAXEL, he must inform his treating doctor immediately.
• if the women is not using effective contraception, use of condoms is necessary (even if you had a vasectomy) with a pregnant woman or woman of childbearing potential, during the course of the treatment, during dose interruption and for 4 weeks after treatment.
• if you are able to become pregnant, at least two reliable contraception methods should be used for at least 4 weeks before starting therapy, during and until at least 4 weeks after therapy.
• if you have had blood clots in the past or using oral contraceptives - you have an increased risk of developing blood clots in the veins and arteries during treatment.
• if you obtained additional contraceptive therapy (implants or devices), you have an increased risk of infection and irregular bleeding. Antibiotics should be considered, especially if you suffer from neutropenia (abnormally low count of white blood cells).
• Inserting of a copper-releasing intrauterine device is not recommended, as you have an increased risk of infection, at the time of insertion and menstrual blood loss, especially if you suffer from severe neutropenia (abnormally low count of white blood cells) or thrombocytopenia (low blood platelet count).
• you should not donate blood, semen or sperm during therapy or for at least 4 weeks after stopping the treatment.
• if you suffer from abnormally low count of a type of white blood cells (neutropenia). Common symptoms include fever, mouth ulcers and sore throat.
• if you experience bleeding, including a nosebleed or are taking other medicine that increases the risk of bleeding.
• if you have ever had blood clots in the past. Treatment with POMAXEL may increase the risk of getting blood clots in your veins and arteries. Your doctor may recommend you take additional treatments (e.g. warfarin) or lower the dose of POMAXEL to reduce the chances of getting blood clots.
• if you experience tiredness, cold sensitivity, constipation, dry skin and unexplained weight gain, it can be symptoms of hypothyroidism.
• if you experience pain, pins-and-needles sensation, numbness and weakness, it can be signs of peripheral neuropathy.
• if you have had a heart attack, have heart failure, have difficulty breathing or if you smoke, have high blood pressure or high cholesterol levels.
• if you experience nausea, vomiting, diarrhoea, muscle cramps, weakness, numbness or tingling, tiredness, irritability, decreased urination, irregular heart rate, confusion, restlessness, delirium, hallucinations or seizures, it can be signs of Tumour Lysis Syndrome (TLS).
• It is important to note that patients you may develop additional types of cancer, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed this medicine.
• if you experience a combination of any of the following symptoms: widespread rash, blisters, peeling, red skin, high body temperature, tiredness, flu-like symptoms, sore throat, coughing, itching, mouth-ulcers, it may be signs of Steven Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosiniphilia and Systemic Symptoms (DRESS) (see also section 4 ‘ Possible side effects ’).
• if you ever had an allergic reaction such as rash, itching, swelling, feeling dizzy or trouble breathing while taking related medicines called ‘thalidomide’ or ‘lenalidomide’.
• if you experience dizziness and confusion.
• if you experience a persistent dry cough, shortness of breath either at rest or after exertion. These symptoms can be due to inflammation of the lungs (pneumonitis) or Interstitial lung disease (ILD), that leads to irreversible damage to your lungs.
• if you suffer from liver failure or any other liver function abnormalities.
• if you have or have ever had previous viral infection, particularly hepatitis B infection. Treatment with POMAXEL may cause the hepatitis B virus to become active again in patients who carry the virus, resulting in a recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection.
• at any time during or after treatment, tell your doctor or nurse immediately if you experience general weakness, clumsiness and balance issues, sensory loss, difficulty using arms and legs, changes in vision, loss of language skills, facial drooping, personality changes or memory loss or confusion. These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms prior to treatment with pomalidomide, tell your doctor immediately about any change in these symptoms.
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Tests, checks and donations

You should not donate blood during treatment and for 4 weeks after the end of treatment. Before and during the treatment with POMAXEL you will have regular blood tests. This is because POMAXEL may cause a fall in the blood cells that help fight infection (white blood cells) and help the blood to clot (platelets). Your doctor will ask you to have a blood test:

• before treatment
• every week for the first 8 weeks of treatment
• then at least every month after that

As a result of these tests, your doctor may change your dose of POMAXEL or stop your treatment. The doctor may also change the dose or stop POMAXEL because of your general health concerns. Due to POMAXEL that can harm an unborn child, a medically supervised pregnancy test will need to be performed during your consultation, when POMAXEL is prescribed, or at least 7 days prior to your visit to your prescribing doctor once you have been using effective contraception for at least 4 weeks.

Follow-up pregnancy tests should be repeated at least every 4 weeks, including at least 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation.

Children and adolescents

POMAXEL is not recommended for use in children and adolescents under 18 years.

Other medicines and POMAXEL

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines). In particular, tell your doctor or nurse if you are taking any of the following medicines:

• some antifungal medicines, such as ketoconazole
• certain antibiotics (for example ciprofloxacin, enoxacin)
• certain anti-depressants, such as fluvoxamine
• medicine used as a blood-thinner, such as warfarin

Do not share medicines prescribed for you with any other person. Always take POMAXEL exactly as your doctor has told you. Check with your doctor if you are unsure. POMAXEL should be taken by mouth at about the same time each day. The capsules should not be opened, broken, or chewed. POMAXEL capsules should be swallowed whole, preferably with water, either with or without food.

Recommended dose:

The recommended starting dose of POMAXEL is 4 mg once daily, on days 1-21 of a 28-day repeatable treatment cycle. The recommended dose of dexamethasone is 40 mg once daily, on days 1, 8, 15 and 22 of a 28-day repeatable treatment cycle. Your doctor will tell you how long your treatment with POMAXEL will last. Do not stop treatment early. If you have the impression that the effect of POMAXEL is too strong or too weak, tell your doctor or pharmacist.

If you take more POMAXEL than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take POMAXEL

Do not take / receive a double dose to make up for forgotten individual doses.

POMAXEL can have side effects. Not all side effects reported for POMAXEL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking POMAXEL, please consult your health care provider for advice. If any of the following happens, stop taking POMAXEL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting

These are all very serious side effects listed above. If you have them, you may have had a serious reaction to POMAXEL. 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:

• Flu-like symptoms, fever, shivering, change in behaviour or skin rash, that can be all signs of life-threatening Neutropenic sepsis (low white blood cells in the blood).
• Abnormal bleeding due to low blood platelet count (thrombocytopenia or pancytopenia).
• Low blood levels of sodium, which may cause tiredness and confusion, muscle twitching, fits (epileptic seizures) or coma.
• Brain bleed – symptoms include headache, nausea and vomiting, sudden tingling, weakness, numbness or paralysis of face, arm or leg.
• Heart failure – symptoms include shortness of breath, tiredness, swollen legs and rapid heartbeat.
• Heart attack – symptoms include tightness or pain in the chest, neck, back or arms as well as tiredness, light-headedness, abnormal heartbeat and anxiety.
• Shortness of breath, chest pain and cough, that can be signs of a blood clot in the lung.
• Gastrointestinal bleeding (severe, persistent or bloody diarrhoea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile).
• Decreased urination, swelling, nausea, tiredness and shortness of breath (due to infection of blood called sepsis or septic shock).
• Tumour Lysis Syndrome (TLS) – symptoms include nausea, vomiting, diarrhoea, muscle cramps, weakness, numbness or tingling, tiredness, irritability, decreased urination, irregular heart rate, confusion, restlessness, delirium, hallucinations or seizures.
• Trouble walking, speaking and understanding, as well as paralysis or numbness of the face, arm or leg (stroke).
• Widespread rash, blisters, peeling, red skin, high body temperature, tiredness, flu-like symptoms, sore throat, coughing, itching, mouth-ulcers, it may be signs of Steven Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosiniphilia and Systemic Symptoms (DRESS).
• Neutropenia, febrile neutropenia, pancytopenia or leukopenia (fever, mouth ulcer, sore throat, or susceptibility to infection due to low white blood cell count).
• Depressed level of consciousness.
• Yellowing of the skin and whites of the eyes, darkening of urine, sometimes to a brownish tone or/and abdominal pain, nausea, tiredness.
• Hepatitis B reactivation (yellowing of the eyes or skin (jaundice), loss of appetite, nausea or vomiting, lighter coloured stools, pain in the liver).

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:

• Pneumonia, Bronchopneumonia, Bronchitis, Respiratory tract infection or Upper respiratory tract infection (infection that inflames the air sacs in one or both lungs, that can be due to bacterial, viral or fungal infections, including opportunistic infections).
• Cold symptoms due to Nasopharyngitis (common viral infection of the nose and throat).
• Herpes zoster (painful rash that may appear as a stripe of blisters on the torso).
• Tiredness, skin paleness, shortness of breath, light-headedness, dizziness or a fast heartbeat, due to low red blood cell count (anaemia pr pancytopenia).
• Angioedema (swelling of the deeper layers of the skin, caused by a build-up of fluid).
• Hives (itchy, raised, red or skin-coloured welts on the skin's surface).
• Decreased appetite.
• High blood levels of potassium, which may cause abnormal heart rhythm.
• High blood levels of uric acid, which may cause severe pain in joints, joint stiffness, redness and swelling.
• Confusional state.
• Weakness, numbness and pain from nerve damage, usually in the hands and feet (peripheral sensory neuropathy).
• Dizziness.
• Involuntary shaking or movement.
• Dizziness/ vertigo.
• Irregular, rapid heart rate.
• Leg pain or swelling, that can be signs of a blood clot.
• Shortness of breath.
• Cough.
• Nosebleed.
• Diarrhoea, nausea, constipation or vomiting.
• Rash.
• Itchy skin.
• Bone pain.
• Muscle spasms.
• Difficulty urinating.
• Pain or discomfort, ranging from a sharp jab to a dull ache, in the lowest part of the abdomen and pelvis.
• Tiredness.
• Fever.
• Swelling of the lower legs or hands.
• Increased Alanine aminotransferase (ALT). An ALT test measures the amount of this enzyme in the blood. Higher-than-normal levels of ALT can indicate liver damage.

Less frequent side effects:

• Interstitial lung disease (scarring of the lungs). Symptoms include a dry cough and shortness of breath.
• Basal cell carcinoma or squamous cell carcinoma (types of skin cancer).
• Underactive thyroid, that include symptoms such as fatigue, cold sensitivity, constipation, dry skin and unexplained weight gain.

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

Reporting of side effect

If you get side effects, talk to your doctor. 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 POMAXEL.

• Store all medicines out of reach of children.
• Store at or below 30 °C. Keep in the original packaging until required for use.
• Do not use after the expiry date stated on the label / carton.
• Do not use POMAXEL if you notice any visible signs of deterioration.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

Shelf-life

24 months