Spalcarb

SPALCARB belongs to a group of medicines known as alkylating agents. It has anti-tumour properties and it is used to treat patients with advanced or recurrent ovarian cancer. There is limited evidence to support the use of SPALCARB in small lung cancer and cancer of the head and neck.

Do not use SPALCARB Intravenous Infusion

• if you are allergic to carboplatin or to any of the ingredients of this medicine (listed in section 6)
• if you have had hypersensitivity to similar platinum containing medicines in the past
• if you have severe kidney disease
• if you have fewer blood cells than normal (your doctor will check this with a blood test)
• if you have a tumour that bleeds
• if you are pregnant and breast feeding

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using SPALCARB

• if you have mild renal disease. Your doctor will want to monitor you more regularly.
• if you are elderly (over 65 years old).
• if you have been treated with cisplatin or similar anti-cancer medicines in the past, carboplatin may cause abnormalities in your nervous system, such as pins and needles or hearing and vision problems. Your doctor may regularly assess you.
• if you have headache, altered mental functioning, seizures and abnormal vision (from blurriness to vision loss).
• if you develop extreme tiredness and shortness of breath with decreased number of red blood cells, (haemolytic anaemia), alone or combined with low platelet count, abnormal bruising (thrombocytopenia) and kidney disease where you pass little or no urine (symptoms of Haemolytic-uraemic syndrome).
• if you have fever (temperature greater than or equal to 38 o C), or chills, which could be signs of infection. You may be at risk of getting an infection of the blood.

SPALCARB is given by intravenous injection. The infusion bags must be covered with aluminium foil to protect the solution from light. SPALCARB should be administered under the supervision of a qualified doctor experienced in the use of antineoplastic therapy.

Dosing

The exact amount of medicine has been carefully worked out by your doctor. SPALCARB is often given together with certain other medicines, in which case your doctor may adjust the dosage. Your doctor may also adjust the dosage if you are an older patient.

SPALCARB commonly causes nausea and vomiting. However, it is important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor, nurse or pharmacist for ways to lessen these effects, especially if they are severe.

If you use more SPALCARB than you should

Since a health care provider will administer SPALCARB, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use SPALCARB

Since a health care provider will administer SPALCARB, it is unlikely that the dose will be missed.

SPALCARB can have side effects. Not all side effects reported for SPALCARB are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SPALCARB, please consult your health care provider for advice.

If any of the following happens, stop using SPALCARB and tell your doctor immediately:

• abnormal bruising, bleeding, or signs of infection such as a sore throat and high temperature
• severe allergic reaction (anaphylaxis/anaphylactic reactions) - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
• haemolytic-uraemic syndrome (a disease characterised by acute kidney failure), decreased urination or blood in the urine

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

Tell your doctor immediately if you notice any of the following:

• A side effect called tumour lysis syndrome, which can be caused by the rapid breakdown of tumour cells and may cause irregular heartbeat, kidney failure or abnormal blood test results. This is a serious side effect. You may need urgent medical attention.

Tell your doctor if you notice any of the following side effects:

• Frequent:
• tiredness, shortness of breath and paleness caused by anaemia (a condition in which there is a decreased number of red blood cells)
• feeling sick (nausea) or being sick (vomiting)
• stomach pain and cramp
• signs of infection such as fever or sore throat
• flu-like symptoms
• symptoms of severe allergic reaction include sudden wheeziness or tightness of chest, swelling of the eyelids, face or lips, facial flushing, low blood pressure, rapid heart beat, hives, shortness of breath, dizziness and anaphylactic shock
• tingling or numbness in your hands, feet, arms or legs
• burning or prickling sensation
• decreased tendon reflex
• taste disturbance or loss of taste
• temporary worsening of eyesight or changes to your vision
• ringing in the ears or changes in your hearing
• heart disorders
• tightness of the chest or wheezing
• interstitial lung disease (a group of lung disorders in which the deep lung tissues become inflamed)
• diarrhoea or constipation
• sore lips or mouth ulcers (mucous membrane disorders)
• hair loss
• rash and/or itchy skin
• pain or discomfort in your bones, joints, muscles, or surrounding structures (musculoskeletal disorder)
• problems with your kidneys or urine
• extreme tiredness/weakness (asthenia)

Frequency unknown:

• temporary sight loss
• scarring of the lungs which causes shortness of breath and/or cough (pulmonary fibrosis)
• cancers caused by treatment with SPALCARB (secondary malignancies)
• feeling unwell with high temperature due to low levels of white blood cells (febrile neutropenia)
• a group of symptoms such as headache, altered mental functioning, seizures and abnormal vision (from blurriness to vision loss). These are symptoms of reversible posterior leukoencephalopathy syndrome, a rare neurological disorder
• dry mouth, tiredness, and headache due to excessive loss of body water (dehydration)
• loss of appetite, anorexia
• pancreatitis
• stroke (sudden numbness or weakness in the face, arm, or leg, especially on one side of the body)
• severely impaired liver function, damage or death of liver cells
• heart failure
• obstruction in a blood vessel (embolism and veno-occlusive disease), swelling or tenderness of leg/arm
• changes in blood pressure (hypertension or hypotension)
• skin disorders such as hives, rash, skin redness (erythema), and itching
• swelling or soreness where the injection was given
• fewer red blood cells due to their excessive breakdown (haemolytic anaemia)
• mental changes (encephalopathy)
• lung infection
• muscle cramping, muscle weakness, confusion, visual loss or disturbances, irregular heartbeat, kidney failure or abnormal blood test results (symptoms of tumour lysis syndrome which can be caused by the rapid breakdown of tumour cells)

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 SPALCARB.

Store all medicines out of reach of children.

Store at or below 25 °C

Store in the original package to protect from light.