Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - abraxane

Document Subject

Generated Narrative: MedicinalProductDefinition mp6a4f56969477d35dda930b9433ba77df

identifier: http://ema.europa.eu/identifier/EU/1/07/428/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Abraxane 5 mg/ml powder for dispersion for infusion.

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-6a4f56969477d35dda930b9433ba77df

identifier: http://ema.europa.eu/identifier/EU/1/07/428/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - abraxane

Attesters

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

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.

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

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. 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.

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

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.

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)

Not known side effects (frequency cannot be estimated from the available data):

• Hardening/thickening of the skin (scleroderma).

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.

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 dispersion should be used immediately. If not used immediately, the dispersion may be stored in a refrigerator (2 C-8 C) for up to 24 hours in the vial when kept in the outer carton in order to protect it from light.

The reconstituted dispersion in the intravenous drip may be stored in a refrigerator (2 C-8 C) for up to hours protected from light.

The total combined storage time of reconstituted medicinal product in the vial and in the infusion bag when refrigerated and protected from light is 24 hours. This may be followed by storage in the infusion bag for 4 hours below 25 C.

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

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 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 .

What Abraxane looks like and contents of the pack 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.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG Plaza Blanchardstown Corporate Park 2 Dublin 15, D15 TIreland

Manufacturer

Celgene Distribution B.V.
Orteliuslaan 13528 BD Utrecht
Netherlands

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: