Paclitaxel 30 mg/5 ml Solution

Paclitaxel is an anti-cancer medicine, that inhibits the growth of cancer cells.

Paclitaxel Fresenius is used in the treatment of a number of different types of cancer:

Ovarian cancer:

• as palliative therapy (after initial surgery in combination with the platinum-containing medicine cisplatin).
• as palliative therapy after failure of other anti-cancer medicines.

Breast cancer:

• as treatment for advanced disease or disease which has spread to other parts of the body (metastatic disease). Prior treatment should have included an anthracycline (e.g. doxorubicin) (unless contraindicated).

Advanced non-small-cell lung cancer:

• as palliative treatment in patients where surgery and/or radiation therapy are not suitable.

PACLITAXEL FRESENIUS should not be administered to you:

• if you are allergic (hypersensitive) to paclitaxel, any of the ingredients in Paclitaxel Fresenius or other medicines formulated with poly-oxy-ethylated castor oil (see What Paclitaxel Fresenius contains);
• if you have a low white blood cell count (this is checked by blood tests);
• if you are pregnant or breastfeeding your baby;
• if you are less than 18 years of age.

Warnings and precautions

Tell your doctor or health care professional before being given Paclitaxel Fresenius infusion if you have:

• a heart disorder, as Paclitaxel Fresenius may affect your heart;
• liver problems;
• abnormal white blood cell counts;
• irregular heart beats, dizziness or faintness during treatment;
• tingling, burning or numbness in your fingers and/or toes (peripheral neuropathy).

Other medicines and PACLITAXEL FRESENIUS

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.) Tell your doctor if you are receiving, or have received:

• any other cancer medicines, such as cisplatin, doxorubicin;
• ketoconazole and other similar types of antifungal medicines;
• erythromycin (an antibiotic);
• fluoxetine (an antidepressant);
• gemfibrozil (a medicine used in the treatment of high cholesterol);
• clopidogrel (a medicine used to prevent blood clots);
• cimetidine (a stomach acid reducer);
• ritonavir, saquinavir, indinavir and nelfinavir (antiviral medicines used to treat HIV);
• rifampicin (an antibiotic used for several infections, including tuberculosis (TB));
• carbamazepine, phenytoin, phenobarbital (medicines used to prevent and control seizures);
• efavirenz, nevirapine (antiviral medicines used to treat HIV).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before receiving Paclitaxel Fresenius.

Pregnancy

You should not receive Paclitaxel Fresenius if you are pregnant, planning to become pregnant or think you may be pregnant. Paclitaxel Fresenius may cause birth defects in your baby, therefore you should prevent pregnancy during treatment with Paclitaxel Fresenius. You and/or your partner must use an effective method of contraception during your treatment with Paclitaxel Fresenius and for six months after treatment has finished. If you become pregnant during treatment, or within the six months after treatment has finished, inform your doctor immediately.

Breastfeeding

It is not known if Paclitaxel Fresenius is excreted in breastmilk. Because of the possibility of harm to the baby. You should stop breastfeeding your baby if you receive Paclitaxel Fresenius. Tell your doctor if you are breastfeeding your baby. You should not receive Paclitaxel Fresenius if you are breastfeeding your baby.

Fertility

Paclitaxel Fresenius may affect fertility, which may be permanent. If you are a male you should seek advice on conservation of sperm before treatment with Paclitaxel Fresenius.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself Paclitaxel Fresenius. It will be given to you by a person who is qualified to do so. Since serious allergic reactions may occur, you will be treated with certain medicines (such as corticosteroids, antihistamines and antacids) before receiving Paclitaxel Fresenius. Your doctor will decide on the correct dose and duration of the treatment based on your condition. Tell your doctor or healthcare professional if you have pain at the injection site during treatment. He/she will check if the needle has been properly inserted into the vein.

If you have the impression that Paclitaxel Fresenius is too strong or too weak, tell your doctor or healthcare professional.

If you receive more Paclitaxel Fresenius than you should

Since a healthcare provider will administer Paclitaxel Fresenius, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage symptomatically.

If you forget to use Paclitaxel Fresenius

It is important that you keep to the schedule as determined by your doctor. Talk to your doctor if you have missed a dose of Paclitaxel Fresenius. You will not receive a double dose to make up for the forgotten dose.

Paclitaxel Fresenius can have side effects. Not all side effects reported for Paclitaxel Fresenius are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving Paclitaxel Fresenius, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens, tell your doctor immediately if you notice any of the following:

• Swelling of the hands, feet, ankles, face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing.
• Flushing, skin reactions, rash, hives, itching, red skin, severe skin peeling.
• Rapid breathing and a change in mental status, such as reduced alertness or confusion, fever, chills, or a low body temperature may be the first signs that a serious condition (shock due to blood poisoning) is developing.
• Severe chest pains, possibly radiating to the jaw or arm, sweating, breathlessness and nausea (heart attack).
• Pain and/or swelling of the arms or legs. This may be due to blood clots in the veins (thrombosis) and inflammation in the veins associated with blood clots (thrombophlebitis).
• Shortness of breath, cough, coughing up blood or pain in the chest or shoulder (e.g. pulmonary embolism). Some of these effects may not occur immediately (lung fibrosis).
• Persistent watery diarrhoea, which may be bloodstained (pseudomembranous colitis).
• Yellow skin and eyes, nausea (inflammation of the pancreas or liver).
• Inability to pass stools (bowel obstruction), blood in stools, pain.

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

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

• Various types of infections. This may be due to a too low white cell count; tell your doctor if you have fever, a sore throat, headaches and feel unwell.
• Low red blood cell count, low platelet count, low white blood cell count, usually only noticed with blood tests. Tell your doctor if you are tired and pale and bruise more easily than usual.
• Tingling feeling (pins and needles) in parts of the body and numbness.
• Slow heartbeat (bradycardia).
• Low blood pressure (you may feel dizzy when upright).
• Diarrhoea, nausea, vomiting.
• Stomach pain, a red and sore mouth, open sores and bleeding (inflammation of the mucous membranes).
• Hair loss.
• Muscle pain, pain in the joints of the arms and legs.
• Laboratory tests may show that liver function is affected.

Less frequent side effects:

• Pain, redness, swelling at site of injection.
• Acute leukaemia (blood cancer) or related condition (myelodysplastic syndrome) which your doctor will check for.
• Shortness of breath, weakness or feeling tired, with paler than usual skin and easy bruising or bleeding (acute myeloid leukaemia, myelodysplastic syndrome).
• Lack of appetite.
• Feeling confused.
• Seizures.
• Vision problems, seeing “floaters” or flashes of light (photopsia).
• Hearing loss, ringing in the ears, vertigo (a spinning sensation, balance problems).
• Palpitations, rapid beating of the heart, feeling faint.
• High blood pressure (usually only detected by measuring the blood pressure).
• Coughing, difficulty breathing, wheezing.
• Constipation.
• Accumulation of fluid in the bowel (ascites).
• Effect on the brain (encephalopathy).
• Pruritus, rash, skin redness (erythema).
• Nail and skin problems (including skin discolouration), loosening of finger or toenails (you should wear protection on your hands and feet when exposed to the sun).
• Laboratory tests may show that your kidney function has been affected.

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, pharmacist or nurse. 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 PACLITAXEL FRESENIUS.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Store in the original package in order to protect from light.
• Do not use this medicine after the expiry date stated on the container.
• Discard any unused portion according to the hospital’s safety rules for chemotherapeutic substances.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets or drains).