Phenasen ® 10 mg/10 ml Solution

PHENASEN is used to treat acute promyelocytic leukemia or ‘APL’. This is a type of myeloid leukaemia – a disease with abnormal white blood cells and abnormal bleeding and bruising.

PHENASEN is used in adult patients with:

• newly diagnosed low-to-intermediate risk APL
• those whose leukaemia has not responded to other therapies.

Do not receive PHENASEN:

• If you have an allergy or are hypersensitive to any medicine containing arsenic or arsenic trioxide or to any of the ingredients of PHENASEN.
• If you have heart conditions, such as heart block, congestive heart failure (a chronic progressive condition that affects the pumping power of your heart muscles) or prolonged QT intervals (the heart muscle takes longer than normal to recharge between beats).
• If you take medicines that may affect your heart.
• Impaired kidney function
• Life-threatening liver problems
• If you are pregnant or breastfeeding.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection if:

• you have allergies to any other medicines, foods, preservatives or dyes.
• If you are pregnant. It may affect your developing baby if you are given it during pregnancy.
• If you are breastfeeding as the active ingredient in PHENASEN passes into breast milk and there is a possibility that your baby may be affected.
• you have or have had any of the following medical conditions:
• low levels of potassium, magnesium, calcium and creatinine in the body (electrolyte imbalance);
• congestive heart failure;
• rapid or irregular heart beat;
• liver problems;
• a history of kidney problems.

If any of the above apply to you, or you are not sure, talk to your doctor, pharmacist or nurse before using PHENASEN.

Tests and checks

Your doctor will do the following tests and checks:

• Blood tests to check the amount of potassium, magnesium, calcium and creatinine in your blood before your first dose of PHENASEN.
• Blood tests on your potassium, calcium and liver function should be repeated during your treatment with this medicine.
• An ECG (an electrical recording of the heart) before your first dose – and then twice a week when you are using the medicine.
• If you are at risk for a certain type of abnormal heartbeat (such as ‘torsade de pointes’ or ‘QTc prolongation’), your heart will be monitored throughout your treatment.
• Your doctor may monitor your health during and after treatment since arsenic trioxide, the active substance in this medicine, may cause other cancers. Report any new and unusual side effects whenever you see your doctor.
• Follow-up of your cognitive and mobility functions if you are at risk for vitamin B1 deficiency.

Children/ and adolescents

Do not give PHENASEN to children under 18 years of age as it is unlikely to be safe.

Other medicines and PHENASEN:

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Please consult your doctor, pharmacist or other healthcare professional, for advice.

Tell your doctor if you are taking any of the following medicines:

• fluid or water tablets (diuretics);
• some medicines used to treat fungal infections such as amphotericin B;
• medicines which affect heart rhythm (prolong the Q-T interval) for example:
• some antibiotics e.g. erythromycin
• antipsychotics e.g. thioridazine
• some types of anti- dysrhythmic medicines e.g.quinidine;
• antidepressants e.g.amitriptyline;
• some antihistamines e.g. terfenadine.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself PHENASEN. It will be given to you by a person who is qualified to do so.

PHENASEN must only be given by a doctor or nurse under the supervision of a medical practitioner experienced in cancer treatment. PHENASEN is given as a drip (infusion) into a vein over 1-2 hours. The infusion may last longer if you get side effects such as flushing and feeling dizzy.

Your doctor will decide what dose of PHENASEN you will receive and how long you will receive it. This depends on your medical condition and other factors, such as your weight. Your doctor will decide exactly how long you must continue using PHENASEN.

If you receive more PHENASEN than you should:

Since a healthcare professional will administer PHENASEN, he/she will control the dosage. However, in the event of an overdosage your doctor will manage the overdosage. You may have fits, muscle weakness and confusion. If you notice these signs, tell your doctor straight away who will stop treatment with PHENASEN.

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

If you missed a dose of PHENASEN:

Since a healthcare professional will administer PHENASEN, it is unlikely that the dose will be missed.

PHENASEN can cause side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while receiving this medicine, please consult your doctor, pharmacist or other health care professional for advice.

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

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• hives;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to PHENASEN. 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:

• chest pain;
• irregular heart beat;
• difficulty or pain when breathing;
• stroke;
• passing little or no urine;
• signs of APL differentiation syndrome as listed below:
• unexplained fever;
• shortness of breath, difficulty breathing;
• and/or weight gain.

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

Tell your doctor if you notice any of the following:

The following side effects have been reported frequently:

• Tiredness;
• Fever;
• Nausea, vomiting, diarrhoea, stomach pain, sore mouth;
• Bleeding or bruising more easily than usual;
• Sore throat,cough, difficulty breathing, chest pain;
• Headache,difficulty sleeping;
• Fast and abnormal heart beat;
• Skin rash, itching;
• Bone or joint pain;
• Numbness, aching or weakness of the arms and legs or other muscles;
• Altered moods;
• Infections;
• Tingling in the hands and feet;
• Fits or convulsions;
• Abnormal blood results – shown in tests: reduced potassium or magnesium, abnormal liver function tests including excess bilirubin or ‘gamma-glutamyltransferase’;
• Signs of hyperglycaemia (high blood sugar):
• large amounts of urine;
• excessive thirst;
• dry mouth and skin.

The above list includes serious side effects, if you have them, you may have had a serious allergic reaction to PHENASEN. You may need urgent medical attention or hospitalisation.

The following side effects have been reported less frequently:

• Disturbances in the electrolytes in the body, e.g. low or high levels of magnesium, high levels of sodium and high levels of potassium;
• Disturbances in the metabolic systems in the body, e.g. high concentrations of ketone bodies, formed by the breakdown of fatty acids (ketoacidosis) and too much bilirubin in the blood (when red blood cells break down, a substance called bilirubin is formed) (hyperbilirubinaemia) and abnormal liver function;
• Pain;
• Bleeding in the lungs, excess fluid builds around the lung (pleural effusion), a deficiency in the amount of oxygen reaching the tissues (hypoxia);
• Fluid around the heart;
• A reduction of the number of white cells in the blood (leucopenia) and inflammation of a blood vessel or blood vessels (vasculitis);
• General inflammation of the skin (dermatitis) and redness of the skin (erythema);
• Bleeding;
• Blood clots;
• Suppression of the immune system, which may lead to shingles (herpes zoster).

Contact your doctor, pharmacist or other health care professional for advice as soon as possible if you suffer from any of the above side effects.

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 or nurse. This includes any possible side effects not listed in this leaflet. 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 PHENASEN.

• Store at or below 30 ºC.

• Store all medicines out of reach of children.

• Store in the original package / container.

• Do not store in a bathroom.

• Do not use after the expiry date stated on the label / carton / vial.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

• Do not use PHENASEN if you notice if the solution is cloudy, discoloured, turbid, or a precipitate or particles are present. The solution is normally clear and colourless.