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Abraxane (paclitaxel) – Package leaflet - L01CD01

Updated on site: 05-Oct-2017

Package leaflet: Information for the user

Abraxane 5 mg/ml powder for suspension for infusion

paclitaxel

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-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.

What is in this leaflet:

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

1.What Abraxane is and what it is used for

What Abraxane is

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.

What Abraxane is used for

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.

2. What you need to know before you are given Abraxane

Do not use Abraxane

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).

Warnings and precautions

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.

Children and adolescents

This medicine has not been studied in children and adolescents, as breast cancer, pancreatic cancer and lung cancer do not occur in these age groups.

Other medicines and Abraxane

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.

Pregnancy breast-feeding and fertility

Paclitaxel may cause serious birth defects and should therefore not be used if you are pregnant.

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 not father 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.

Driving and using machines

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.

Abraxane contains sodium

Each ml of Abraxane contains approximately 4.2 mg of sodium. This should be taken into consideration if you are on a controlled sodium diet.

3.How to use Abraxane

Abraxane will be given to you by a doctor or nurse into a vein from an intravenous drip. The dose you receive is based on your body surface area and blood test results. The usual dose is for breast cancer is 260 mg/m2 of body surface area given over a 30 minute period. The usual dose for advanced pancreatic cancer is 125 mg/m2 of body surface area given over a 30 minute period. The usual dose for non-small cell lung cancer is 100 mg/m2 of body surface area given over a 30 minute period.

How often will you receive Abraxane?

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

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The very common side effects may affect more than 1 in 10 people:

Loss of hair (the majority of cases of hair loss happened less than one month after starting Abraxane. When it happens, hair loss is pronounced (over 50%) in the majority of patients)

Rash

Abnormal decrease in the number of types of white blood cells (neutrophils, lymphocytes or leukocytes) in the blood

Deficiency of red blood cells

Reduction in the number of platelets in the blood

Effect on peripheral nerves (pain, numbness, tingling or loss of feeling)

Pain in a joint or joints

Pain in the muscles

Nausea, diarrhoea, constipation, sore mouth, loss of appetite

Vomiting

Weakness and tiredness, fever

Dehydration, taste disturbance, weight loss

Low levels of potassium in the blood

Depression, sleep problems

Headache

Chills

Difficulty in breathing

Dizziness

Swelling of mucosal and soft tissues

Increased liver function tests

Pain in extremities

Cough

Abdominal pain

Nose bleeds

The common side effects may affect up to 1 in 10 people:

Itching, dry skin, nail disorder

Infection, fever with decrease in the number of a type of white blood cell (neutrophils) in the blood, flushing, thrush, severe infection in your blood which may be caused by reduced white blood cells

Reduction in all blood cell counts

Chest or throat pain

Indigestion, abdominal discomfort

Stuffy nose

Pain in back, bone pain

Diminished muscular coordination or difficulty in reading, increased or decreased tears, loss of eyelashes

Changes in heart rate or rhythm, heart failure

Decreased or increased blood pressure

Redness or swelling at the site where the needle entered the body

Anxiety

Infection in the lungs

Infection in the urinary tract

Obstruction in the gut, inflammation of the large bowel, inflammation of the bile duct

Acute kidney failure

Increased bilirubin in the blood

Coughing up blood

Dry mouth, difficulty in swallowing

Muscle weakness

Blurred vision

The uncommon side effects may affect up to 1 in 100 people:

Increased weight, increased lactate dehydrogenase in the blood, decreased kidney function, increased blood sugar, increased phosphorus in the blood

Decreased or lack of reflexes, involuntary movements, pain along a nerve, fainting, dizziness when standing up, shaking, facial nerve paralysis

Irritated eyes, painful eyes, red eyes, itchy eyes, double vision, reduced vision, or seeing flashing lights, blurred vision due to swelling of the retina (cystoid macular oedema)

Ear pain, ringing in your ears

Coughing with phlegm, shortness of breath when walking or climbing stairs, runny nose, or dry nose, decreased breath sounds, water on the lung, loss of voice, blood clot in the lung, dry throat

Gas, stomach cramps, painful or sore gums, rectal bleeding

Painful urination, frequent urination, blood in the urine, inability to hold your urine

Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin from sunlight, skin discolouration, increased sweating, night sweats, white areas on the skin, sores, swollen face

Decreased phosphorus in the blood, fluid retention, low albumin in the blood, increased thirst, decreased calcium in the blood, decreased sugar in the blood, decreased sodium in the blood

Pain and swelling in the nose, skin infections, infection due to catheter line

Bruising

Pain at site of tumour, death of the tumour

Decreased blood pressure when standing up, coldness in your hands and feet

Difficulty walking, swelling

Allergic reaction

Decreased liver function, increased size of liver

Pain in the breast

Restlessness

Small bleedings in your skin due to blood clots

A condition involving destruction of red blood cells and acute kidney failure

The rare side effects may affect up to 1 in 1,000 people:

Skin reaction to another agent or lung inflammation following radiation

Blood clot

Very slow pulse, heart attack

Leaking of drug outside the vein

A disorder of the electrical conduction system of the heart (atrioventricular block)

The very rare side effects may affect up to 1 in 10,000 people:

Severe inflammation/eruption of the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Reporting of side effects

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Abraxane

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP. The expiry date refers to the last day of that month.

Unopened vials: Keep the vial in the outer carton in order to protect from light.

After first reconstitution the suspension should be used immediately. If not used immediately, the suspension may be stored in a refrigerator (2°C-8°C) for up to 8 hours in the vial when kept in the outer carton in order to protect it from light.

The reconstituted suspension in the intravenous drip may be stored for up to 8 hours at a temperature not above 25ºC.

Your doctor or pharmacist is responsible for disposing of any unused Abraxane correctly.

6.Contents of the pack and further information

What Abraxane contains

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 suspension contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.

The other ingredient is human albumin (containing sodium, sodium caprylate and N-acetyl DL tryptophanate).

What Abraxane looks like and contents of the pack

Abraxane is a white to yellow powder for suspension 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.

Marketing Authorisation Holder and Manufacturer

Celgene Europe Limited

1 Longwalk Road

Stockley Park

Uxbridge

UB11 1DB

United Kingdom

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

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

-------------------------------------------------------------------------------------------------------------------------

Medical or healthcare professionals

The following information is intended for medical or healthcare professionals only:

Instructions for use, handling and disposal

Preparation and administration precautions

Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Abraxane. Gloves, goggles and protective clothing should be used. If Abraxane suspension contacts the skin, the skin should be washed immediately and thoroughly with soap and water. If Abraxane contacts mucous membranes, the membranes should be flushed thoroughly with water. Abraxane should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents. Pregnant staff should not handle Abraxane.

Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during administration of the medicinal product. Limiting the infusion of Abraxane to 30 minutes, as directed, reduces the likelihood of infusion-related reactions.

Reconstitution of the product and administration

Abraxane should be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents.

Abraxane is supplied as a sterile lyophilised powder for reconstitution before use. After reconstitution, each ml of suspension contains 5 mg of paclitaxel formulated as albumin bound nanoparticles. Reconstituted Abraxane suspension is administered intravenously using an infusion set incorporating a 15 µm filter.

Reconstitution of 100 mg:

Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 100 mg vial of Abraxane over a minimum of 1 minute.

Reconstitution of 250 mg:

Using a sterile syringe, 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into the 250 mg vial of Abraxane over a minimum of 1 minute.

The solution should be directed onto the inside wall of the vial. The solution should not be injected directly onto the powder as this will result in foaming.

Once the addition is complete, the vial should be allowed to stand for a minimum of 5 minutes to ensure proper wetting of the solid. Then, the vial should gently and slowly be swirled and/or inverted for at least 2 minutes until complete resuspension of any powder occurs. The generation of foam should be avoided. If foaming or clumping occurs, the suspension should stand for at least 15 minutes until foam subsides.

The reconstituted suspension should be milky and homogenous without visible precipitates. Some settling of the reconstituted suspension may occur. If precipitates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use.

Inspect the suspension in the vial for particulate matter. Do not administer the reconstituted suspension if particulate matter is observed in the vial.

The exact total dosing volume of 5 mg/ml suspension required for the patient should be calculated and the appropriate amount of reconstituted Abraxane should be injected into an empty, sterile, PVC or non-PVC type intravenous bag

The use of medical devices containing silicone oil as a lubricant (i.e. syringes and IV bags) to reconstitute and administer Abraxane may result in the formation of proteinaceous strands. Administer Abraxane using an infusion set incorporating a 15 µm filter to avoid administration of these strands. Use of a 15 µm filter removes strands and does not change the physical or chemical properties of the reconstituted product.

Use of filters with a pore size less than 15 µm may result in blockage of the filter.

The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.

Following administration, it is recommended that the intravenous line be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection to ensure administration of the complete dose.

Any unused product or waste material should be disposed of in accordance with local requirements.

Stability

Unopened vials of Abraxane are stable until the date indicated on the package when the vial is kept in the outer carton in order to protect from light. Neither freezing nor refrigeration adversely affects the stability of the product. This medicinal product does not require any special temperature storage conditions.

Stability of the reconstituted suspension in the vial

After first reconstitution, the suspension should be filled into an infusion bag immediately. However, chemical and physical in use stability has been demonstrated for 8 hours at 2°C-8°C in the original carton, and protected from bright light.

Stability of the reconstituted suspension in the infusion bag

After reconstitution, the reconstituted suspension in the infusion bag should be used immediately. However chemical and physical in use stability has been demonstrated for 8 hours not above 25°C.

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF

THE MARKETING AUTHORISATION(S)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for paclitaxel albumin, the scientific conclusions of CHMP are as follows:

Drug interaction regarding CYP2C8:

Paclitaxel is metabolised by CYP2C8 and CYP3A4. Inhibition of these enzymes may lead to increased exposure of paclitaxel and hence increased toxicity of paclitaxel. It was only recently that the strong, time-dependent CYP2C8-inhibiting effects of clopidogrel’s metabolite clopidogrel acyl-β-D- glucuronide, in humans were found. During the current PSUR review period. The first description of the clinical relevance of the interaction between paclitaxel and clopidogrel has been published by Bergmann et al. (Br J Clin Pharmacol. 2016), and in addition, this interaction has also been described in an article by Shinoda et al., Biomed Tep 2016.

Therefore, in view of the data presented in the reviewed PSUR(s), the PRAC considered that changes to the product information of medicinal products containing paclitaxel albumin were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for paclitaxel albumin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing paclitaxel albumin is unchanged subject to the proposed changes to the product information.

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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