• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Abraxane is and what it is used for
2. What you need to know before you are given Abraxane
3. How to use Abraxane
4. Possible side effects
5. How to store Abraxane
6. Contents of the pack and other information

Abraxane contains, as its active substance, paclitaxel attached to the human protein albumin, in the form of tiny particles known as nanoparticles. Paclitaxel belongs to a group of medicines called “taxanes” used in cancer.

• Paclitaxel is the part of the medicine that affects the cancer, it works by stopping cancer cells from dividing – this means that they die.
• Albumin is the part of the medicine that helps paclitaxel dissolve in the blood and get across the walls of the blood vessels into the tumour. This means that other chemicals that can cause side effects that can be life threatening are not needed. Such side effects occur far less with Abraxane.

Abraxane is used to treat the following types of cancer:

Breast Cancer

• Breast cancer which has spread to other parts of the body (this is called “metastatic” breast cancer).
• Abraxane is used in metastatic breast cancer when at least one other therapy has been tried but has not worked and you are unsuitable for treatments containing a group of medicines called “anthracyclines”.
• People with metastatic breast cancer who received Abraxane where another therapy had failed, were more likely to experience a reduction in tumour size, and lived longer than people who took an alternative therapy.

Pancreatic cancer

• Abraxane is used together with a medicine called gemcitabine if you have metastatic cancer of the pancreas. People with metastatic pancreatic cancer (pancreatic cancer that has spread to other parts of the body) who received Abraxane with gemcitabine in a clinical trial lived longer than people who had only received gemcitabine.

Lung Cancer

• Abraxane is also used together with a medicine called carboplatin if you have the most common type of lung cancer, called “non-small cell lung cancer”.
• Abraxane is used in non-small cell lung cancer where surgery or radiotherapy would not be suitable to treat the disease.

• if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Abraxane (listed in section 6);
• if you are breast-feeding;
• if you have a low white blood cell count (baseline neutrophil counts <1500 cells/mm³ - your doctor will advise you on this).

Talk to your doctor or nurse before using Abraxane

• if you have poor kidney function;
• if you have severe liver problems;
• if you have heart problems.

Talk to your doctor or nurse if you experience any of these conditions whilst being treated with Abraxane, your doctor may wish to stop treatment or reduce the dose:

• if you experience any abnormal bruising, bleeding, or signs of infections such as a sore throat or a fever;
• if you experience numbness, tingling, pricking sensations, sensitivity to touch, or muscle weakness;
• if you experience breathing problems, like shortness of breath or dry cough.

Abraxane is only for adults and should not be taken by children and adolescents aged below 18 years.

Tell your doctor if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Abraxane can affect the way some other medicines work. Also, some other medicines can affect the way Abraxane works.

Take care and speak to your doctor when taking Abraxane at the same time as any of the following:

• medicines for treating infections (i.e. antibiotics such erythromycin, rifampicin, etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine you are taking is an antibiotic), and including medicines for treating fungal infections (e.g. ketoconazole)
• medicines used to help you stabilize your mood also sometimes referred to as anti-depressants (e.g. fluoxetine)
• medicines used to treat seizures (epilepsy) (e.g. carbamazepine, phenytoin)
• medicines used to help you lower blood lipid levels (e.g. gemfibrozil)
• medicine used for heartburn or stomach ulcers (e.g. cimetidine)
• medicines used to treat HIV and AIDS (e.g. ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, nevirapine)
• a medicine called clopidogrel used to prevent blood clots.

Paclitaxel may cause serious birth defects and should therefore not be used if you are pregnant. Your doctor will arrange a pregnancy test before starting treatment with Abraxane.

Women of childbearing age should use effective contraception during and up to 1 month after receiving treatment with Abraxane.

Do not breast feed when taking Abraxane as it is not known if the active ingredient paclitaxel passes into the mother’s milk.

Male patients are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment and should seek advice on conservation of sperm prior to treatment because of the possibility of irreversible infertility due to therapy with Abraxane.

Ask your doctor for advice before taking this medicine.

Some people may feel tired or dizzy after being given Abraxane. If this happens to you, do not drive or use any tools or machines.

If you are given other medicines as part of your treatment, you should ask your doctor for advice on driving and using machines.

This medicine contains less than 1 mmol sodium (23 mg) per 100 mg, that is to say essentially ‘sodium free’.

For treatment of metastatic breast cancer, Abraxane is usually given once every three weeks (on day 1 of a 21-day cycle).

For treatment of advanced pancreatic cancer, Abraxane is given on days 1, 8 and 15 of each 28-day treatment cycle with gemcitabine being given immediately after the Abraxane.

For treatment of non-small cell lung cancer Abraxane is given once every week (i.e. on days 1, 8 and 15 of a 21-day cycle), with carboplatin being given once every three weeks (i.e. only on day 1 of each 21-day cycle), immediately after the Abraxane dose has been given.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is paclitaxel.

Each vial contains 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles.

After reconstitution, each ml of dispersion contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.

The other ingredient is human albumin solution (containing sodium caprylate and N-acetyl-L-tryptophan), see section 2 “Abraxane contains sodium”.

Abraxane is a white to yellow powder for dispersion for infusion. Abraxane is available in glass vials containing 100 mg or 250 mg of paclitaxel formulated as albumin bound nanoparticles.

Each pack contains 1 vial.

For any information about this medicine, please contact the Marketing Authorisation Holder.