Powder for solution for infusion 5 mg / ml 
(White-yellow powder.)

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Abraxane is and what it is used for 
2. What you need to know before you take Abraxane 
3. How to use Abraxane 
4. Possible side effects 
5. How to store Abraxane 
6. Contents of the packaging and other information 

1. What Abraxane is and what it is used for

What Abraxane is

The active substance in Abraxane is paclitaxel. Paclitaxel is bound to the human protein et alalbumin in the form of very small particles called nanoparticles. Paclitaxel belongs to a group of medicines called “taxanes” and is used to treat cancer.

  • Paclitaxel is part of the medicine that affects cancer. It works by preventing cancer cells from dividing, which means they die.
  • Albumin is the part of the drug that helps paclitaxel to dissolve in the blood, pass through the walls of blood vessels, and penetrate into the tumor. This means that other chemical substances that can cause side effects that can be life-threatening are not needed. Such side effects occur to a much lesser extent with Abraxane.

What Abraxane is used for

Abraxane is used to treat the following types of cancer:

Breast cancer

  • Breast cancer that has spread to other parts of the body (this is called “metastatic” breast cancer).
  • Abraxane is used for metastatic breast cancer when at least one other treatment has been tried but has not worked, and when treatments with a group of medicines called ‘anthracyclines’ are not appropriate.
  • People with metastatic breast cancer who received Abraxane when another treatment did not work had a greater reduction in tumor size and lived longer than people who received another treatment.

Pancreatic cancer

  • Abraxane is used in combination with a medicine called gemcitabine if you have metastatic pancreatic cancer (pancreatic cancer has spread to other parts of the body). People with metastatic pancreatic cancer who received Abraxane with gemcitabine in a clinical trial lived longer than those who received gemcitabine alone.

Lung cancer

  • Abraxane is also used 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 when surgery or radiation therapy is not appropriate to treat the disease.

2. What you need to know before you receive 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 low white blood cell count (neutrophil count <1.5 x 10 9 / L before treatment – your doctor will tell you).

Warnings and cautions

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 symptoms during treatment with Abraxane, as treatment may need to be stopped or the dose reduced:

  • if you get abnormal bruising, bleeding, or signs of infection such as sore throat or fever
  • if you experience numbness, tingling or tingling, are sensitive to touch or muscle weakness
  • if you experience breathing problems, e.g. shortness of breath or dry cough.

Children and young people

Abraxane is for adults only and should not be taken by children and adolescents under 18 years of age.

Other medicines and Abraxane

Tell your doctor if you are taking or have recently taken any other medicines. This also applies to over-the-counter ones, including herbal preparations. This is because Abraxane may affect the effectiveness of other medicines. In addition, other medicines may affect the way Abraxane works.

Be careful and talk to your doctor while taking Abraxane while taking any of the following:

  • medicines to treat your infections (ie antibiotics such as erythromycin and rifampicin; ask your doctor, nurse, or pharmacist if you are not sure if the medicine you are taking is an antibiotic ) and medicines to treat fungal infections (eg ketoconazole )
  • drugs used to help stabilize your mood also called antidepressants (eg fluoxetine)
  • medicines used to treat seizures ( epilepsy ) (eg carbamazepine and phenytoin )
  • medicines used to lower blood lipid levels (eg gemfibrozil)
  • medicines used to treat heartburn or stomach ulcers (eg cimetidine)
  • medicines used to treat HIV and AIDS (eg ritonavir, saquinavir, indinavir, nelfinavir, efavirenz, and nevirapine)
  • a drug called clopidogrel used to prevent blood clots.

Pregnancy, breastfeeding, and fertility

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

Women of childbearing potential should use effective contraception during and up to one month after treatment with Abraxane.

You should not breast-feed while taking Abraxane as it is unknown whether the active substance paclitaxel passes into breast milk.

Male patients should use effective contraception and avoid making women pregnant during and up to six months after treatment. Male patients may also consult sperm preservation prior to treatment, as treatment with Abraxane may lead to irreversible infertility.

Talk to your doctor before taking this medicine.

Driving and using machines

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

If you are taking any other medicines as part of your treatment, you should consult your doctor about driving and using machines.

Abraxane contains sodium

Each ml of Abraxane contains approximately 4.2 mg of sodium. You should keep this in mind if you are prescribed a low-salt diet.

3. How to use Abraxane

Abraxane is given to you by a doctor or nurse with an intravenous drip into a vein. The dose you receive is based on your body surface area and your blood test results. The usual dose for breast cancer is 260 mg / m 2 body surface area given for 30 minutes. The usual dose for advanced pancreatic cancer is 125 mg / m 2 body surface area given for 30 minutes. The usual dose for non-small cell lung cancer is 100 mg / m 2 body surface area given over a 30-minute period.

How often will you receive Abraxane?

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

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

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

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

4. Possible side effects

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

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

  • Hair loss (most cases occurred within one month after starting treatment with Abraxane. When it does occur, hair loss is pronounced [over 50%] in most patients)
  • Rash
  • An abnormal decrease in the number of different types of white blood cells ( neutrophils , lymphocytes, or leukocytes ) in the blood
  • Lack of red blood cells
  • Reduction in the number of platelets in the blood
  • Effects on peripheral nerves (pain, numbness, tingling, or loss of sensation)
  • Pain in a joint or joints
  • Muscle pain
  • Nausea, diarrhea, constipation, soreness in the mouth, loss of appetite
  • Vomiting
  • Weakness and fatigue, fever
  • Dehydration, taste changes, weight loss
  • Low levels of potassium in the blood
  • Depression, sleep problems
  • Headache
  • Overindulge
  • Hard to breathe
  • Dizziness
  • Swollen mucous membranes and soft parts
  • Elevated liver function tests
  • Pain in arms and legs
  • Cough
  • Stomach pain
  • Nosebleed

Common side effects can affect up to 1 in 10 people:

  • Itching, dry skin, nail problems
  • Infection, fever with a decreased number of a white blood cell type ( neutrophils ) in the blood, redness, cold sores, severe infection in the blood that can be caused by a decreased number of white blood cells
  • Reduced number of all blood cell s
  • Chest or neck pain
  • Indigestion, feeling of discomfort in the abdomen
  • Nasal congestion
  • Back pain, skeletal pain
  • Decreased muscle coordination and difficulty reading, increased or decreased tear formation, eyelash waste
  • Changes in heart rate or heart rate, heart failure
  • Lowered or increased blood pressure
  • Redness or swelling at the place where the needle was inserted into the body
  • Anxiety
  • Infection of the lungs
  • Urinary tract infection
  • Intestinal obstruction, inflammation of the colon, inflammation of the bile ducts
  • Acute renal failure
  • Increased levels of bilirubin in the blood
  • Coughing up of blood
  • Dry mouth, difficulty swallowing
  • Muscle weakness
  • Tamsyn

Uncommon side effects may affect up to 1 in 100 people:

  • Increased weight, increased level of lactate dehydrogenase in the blood, decreased kidney function, increased blood sugar, increased level of phosphorus in the blood
  • Impaired reflexes or lack of reflexes, involuntary movements, pain along a nerve, fainting, dizziness when getting up, tremors, facial paralysis
  • Irritated eyes, painful eyes, red eyes, itchy eyes, double vision, impaired vision or seeing flashing light, blurred vision due to swelling of the retina (cystoid macular edema)
  • Ear pain, ringing in the ears
  • Cough with mucus, shortness of breath when walking or walking upstairs, runny nose or dry nose, decreased breathing noise, water in the lungs, loss of voice, blood clot in the lung, dryness in the throat
  • Gases, stomach cramps, painful or sore gums, rectal bleeding
  • Pain when urinating, frequent urination, blood in the urine, inability to hold urine
  • Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin if exposed to sunlight, discoloration of the skin, increased sweating, night sweats, white areas of the skin, sores, swollen face
  • Decreased level of phosphorus in the blood, accumulation of fluid in the body, low albumin value in the blood, increased thirst, decreased level of calcium in the blood, decreased blood sugar, decreased level of sodium in the blood
  • Pain and swelling in the nose, skin infections, infection due to catheter lead
  • Bruises
  • Pain at the tumor site, death from tumor
  • Reduced blood pressure when standing up, cold hands and feet
  • Difficulty walking, swelling
  • Allergic reaction
  • Decreased liver function, increased size of the liver
  • Chest pain
  • Restlessness
  • Minor bleeding in the skin due to blood clotting
  • A condition that involves the breakdown of red blood cells and acute renal failure

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

  • Skin reaction to another agent or pneumonia after irradiation
  • Blood clotting
  • Very low heart rate, heart attack
  • Leakage of drugs outside the vein
  • Irregular conduction of electrical impulses in the heart (atrioventricular block)

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

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

No known frequency (cannot be calculated from the available data) 

  • Hardening/thickening of the skin ( scleroderma )

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

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 vial after EXP. The expiration date is the last day of the specified month.

Unopened vials: Keep the vial in the outer carton. Sensitive to light.

After the first reconstitution, the suspension should be used immediately. If the suspension is not used immediately, it can be stored in a refrigerator (2 ° C-8 ° C) for up to 24 hours in the vial, provided that the vial is in the outer carton to protect it from light.

Prepared suspension in infusion bag can be stored in a refrigerator (2 ° C-8 ° C) for up to 24 hours protected from light.

The total combined storage time for the reconstituted product in the vial and in the infusion bag is 24 hours for cold storage and protection from light. This can be followed by storage in the infusion bag for 4 hours at a maximum of 25 ° C.

Physicians or pharmacists are responsible for disposing of unused Abraxane properly.

6. Contents of the packaging and other information

Content declaration

The active substance is paclitaxel.

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

After reconstitution, each ml of suspension contains 5 mg of paclitaxel in the form of albumin-bound nanoparticles.

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

What the medicine looks like and the contents of the pack

Abraxane is a white-yellow powder for infusion, suspension . Abraxane is supplied in vials of glass containing 100 mg or 250 mg of paclitaxel in the form of albumin-bound nanoparticles.

Each pack contains 1 vial.

Marketing Authorisation Holder

Celgene Europe BV

Winthontlaan 6 N

3526 KV Utrecht

Netherlands

Manufacturer

Celgene Distribution BV

Winthontlaan 6 N

3526 KV Utrecht

Netherlands

For further information on this medicine, please contact the Marketing Authorization Holder.

This leaflet was last modified 10/2020

Other sources of information

Further information on this medicine is available on the European Medicines Agency

Healthcare professionals

The following information is intended for healthcare professionals only:

Instructions for preparation, handling, and waste disposal

Precautions for preparation and administration

Paclitaxel is a cytotoxic anticancer drug and as with other potentially toxic compounds, caution should be exercised when administering Abraxane. The use of gloves, goggles, and protective clothing is recommended. If the skin comes in contact with suspension one, the skin should be rinsed off immediately and washed thoroughly with soap and water. If mucous membranes come in contact with suspension one, the mucous membranes should be rinsed thoroughly with water. Abraxane should only be prepared and administered by personnel trained in the handling of cytotoxic agents. Pregnant staff should not handle Abraxane.

Due to the possibility of extravasation, the infusion site should be closely monitored for possible infiltration during the administration of the drug. If infusion one of Abraxane is limited to 30 minutes as directed, the likelihood of infusion-related reactions decreases.

Preparation and administration of the product:

Abraxane should only be given under the supervision of a qualified oncologist in a department specializing in chemotherapy.

Abraxane is supplied as a sterile, lyophilized powder for reconstitution before use. After reconstitution, each ml of suspension contains 5 mg of paclitaxel as albumin-bound nanoparticles.

Reconstituted Abraxane suspension is administered intravenously using an infusion set with a 15 filter.

Preparation of 100 mg:

Using a sterile syringe, slowly inject 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion into the 100 mg Abraxane vial for at least 1 minute.

Preparation of 250 mg:

Using a sterile syringe, slowly inject 50 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion into the 250 mg Abraxane vial for at least 1 minute.

The solution should be directed towards the inner wall of the bottle. The solution must not be injected directly onto the powder, as this will lead to foaming.

When the additive is ready, the bottle should stand for at least 5 minutes to allow the powder to soak properly. Thereafter, the vial should be gently and slowly rotated and/or inverted for at least 2 minutes, until all the powder is completely dissolved. The formation of foam must be avoided. If foaming or lumps appear, the solution must stand for at least 15 minutes until the foam disappears.

The reconstituted suspension should be milky and homogeneous with no visible precipitate. Some settings of the reconstituted suspension may occur. If precipitate lumps appear, carefully invert the bottle again to ensure that the powder is completely dissolved before use.

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

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

The use of medical devices containing silicone oil as lubricants (ie syringes and IV bags) to reconstitute and administer Abraxane may lead to the formation of proteinaceous filaments. Administer Abraxane using an infusion set with a 15 filter to avoid administering these threads. Using a 15 filter removes threads and does not change the physical or chemical properties of the reconstituted product.

Using a filter with a pore size of less than 15 µm may cause the filter to become blocked.

It is not necessary to use special solution containers or administration kits without DEHP to prepare and administer Abraxane.

After administration, it is recommended that the intravenous infusion be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection to ensure that the full dose is administered.

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, as long as the vial is stored in the outer carton. Sensitive to light. Neither freezing nor cooling adversely affects the stability of the product. No special temperature instructions.

Stability of the reconstituted solution for infusion in a vial

Chemical and physical stability of the constituted suspension a demonstrated for 24 hours at 2 ° C-8 ° C in the original package, protected from light.

The shelf life of reconstituted infusion fluid in the infusion bag

Chemical and physical in-use stability has been demonstrated for the reconstituted suspension for 24 hours at 2 ° C – 8 ° C, followed by 4 hours at 25 ° C, protected from light.

From a microbiological perspective, the reconstituted suspension should be used immediately after preparation and filing of the infusion bags, unless the method of preparation and filing of the infusion bag excludes the risk of microbial contamination.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

The total combined storage time for the reconstituted product in the vial and in the infusion bag is 24 hours for cold storage and protection from light. This can be followed by storage in the infusion bag for 4 hours at a maximum of 25 ° C

Muhammad Nadeem

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