Abraxane (Paclitaxel)

Abraxane 5 mg/ml powder for suspension for infusion

Paclitaxel

WHAT ABRAXANE IS AND WHAT IT IS USED FOR

Abraxane is a medicine containing paclitaxel albumin. Albumin is a part of human blood. Paclitaxel belongs to a group of medicines called taxanes used to treat cancers.

Abraxane is used for the treatment of breast cancer when other therapies have been tried but have not worked and if you are unsuitable for anthracycline containing treatments.

BEFORE YOU USE ABRAXANE

Do not use Abraxane

• if you are allergic (hypersensitive) to paclitaxel or any of the other ingredients of Abraxane;
• if you are breastfeeding;
• if you have a low white blood cell count (baseline neutrophil counts <1.5 x 10⁹/1 – your doctor will advise you on this).

Take special care with Abraxane

• if you have poor kidney function;
• if you experience numbness, tingling, pricking sensations, sensitivity to touch, or muscle weakness;
• if you have severe liver problems;
• if you have heart problems.

If you experience any of these conditions your doctor may wish to stop treatment or reduce the dose.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, because they could interact with Abraxane.

Using Abraxane with food and drink

Abraxane is unaffected by food and drink.

Pregnancy and breast-feeding

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. 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.

It is not known if paclitaxel passes into breast milk. Because of the possibility of harm to the infant, breast-feeding must be discontinued for the duration of treatment.

Ask your doctor for advice before taking this medicine.

Driving and using machines

Abraxane may cause side effects such as tiredness (very common) and dizziness (common) that may affect your ability to drive and use machinery. If you experience these symptoms, do not drive or operate machinery until they have fully resolved.

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

Important information about some of the ingredients of Abraxane

This medicine contains approximately 425 mg sodium per dose. This should be taken into consideration by patients on a controlled sodium diet.

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 260 mg/m² of body surface area.

How often will you receive Abraxane?

Abraxane is usually given every three weeks.

How long will it take to give you your intravenous drip?

Abraxane is given over a 30 minute period.

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

POSSIBLE SIDE EFFECTS

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

The frequency of possible side effects listed below is defined using the following convention:

• very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100)
• uncommon (affects 1 to 10 users in 1,000)
• rare (affects 1 to 10 users in 10,000)
• very rare (affects less than 1 user in 10,000)
• not known (frequency cannot be estimated from the available data).

The very common side effects are: Loss of hair, rash

Abnormal decrease in the number of neutrophils in the blood Decrease in the number of white blood cells in the blood Deficiency of red blood cells

Reduction in the number of lymphocytes in the blood Reduction in the number of platelets in the blood Effect of peripheral nerves (pain, and numbness) Pain in a joint or joints Pain in the muscles

Nausea, diarrhoea, constipation, sore mouth, loss of appetite Vomiting Weakness and tiredness, fever

The common side effects are:

• Itching, dry skin, nail disorder
• Infection, fever with decrease in the number of neutrophils in the blood, flushing
• Chest, throat or abdominal pain, headache
• Indigestion, abdominal discomfort
• Difficulty in breathing
• Dehydration, taste disturbance, weight loss, hypokalaemia
• Pain in extremities, back or limbs, bone pain, muscle cramps
• Dizziness, diminished muscular coordination or difficulty in reading, increased or decreased
• tears, loss of eyelashes
• Changes in heart rate or rhythm
• Swelling of mucosal and soft tissues
• Sleep problems, depression, anxiety
• Increased liver function tests

The uncommon side effects are:

• Increased blood pressure, increased weight, increased lactate dehydrogenase in the blood, decreased kidney function, increased blood sugar, increased phosphorus in the blood, decreased potassium in the blood
• Nerve disorder, decreased or lack of reflexes, involuntary movements, pain along a nerve, loss of feeling, fainting, dizziness when standing up, painful numbness or tingling, shaking
• Irritated eyes, painful eyes, red eyes, itchy eyes, blurred or double vision, reduced vision, or seeing flashing lights
• Ear pain, ringing in your ears
• Coughing with phlegm, shortness of breath when walking or climbing stairs, stuffy nose, runny nose, or dry nose, decreased breath sounds, water on the lung, loss of voice, difficulty breathing, blood clot in the lung
• Difficulty swallowing, gas, dry mouth, loose stools, heartburn, stomach cramps, painful or sore mouth and 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, red rash, itchy rash, increased sweating, night sweats, white areas on the skin, less hair, overall itching, 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
• Thrush, pain and swelling in the nose and throat, skin infections, infection in the lungs, infection due to catheter line, infection, redness or swelling at the site where the needle entered the body
• Bruising
• Pain at site of tumour, death of the tumour
• Decreased blood pressure, decreased blood pressure when standing up, coldness in your hands and feet
• Chest pain or heaviness, difficulty walking, swelling
• Allergic reaction
• Decreased liver function, increased size of liver
• Pain in the breast
• Restlessness

The rare side effects are:

• Reduced blood cells
• Lung infection
• Skin reaction to another agent or lung inflammation following radiation
• Blood clot
• Very slow pulse, heart attack, heart failure.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

HOW TO STORE ABRAXANE

Keep out of the reach and sight of children.

Do not use Abraxane 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: This medicine does not require any special temperature storage conditions. 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 25°C.

FURTHER INFORMATION

What Abraxane contains

• The active substance is paclitaxel. Each vial contains 100 mg of paclitaxel (as paclitaxel albumin).
• After reconstitution, each ml of suspension contains 5 mg of paclitaxel.
• 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 available in glass vials containing 100 mg paclitaxel. Each pack contains 1 vial.

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.

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.

Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should be injected into a 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. If precipitates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use. Some settling of the reconstituted suspension may occur. Complete resuspension should be ensured by mild agitation of the vial before use.

If precipitates are observed, the reconstituted suspension should be discarded.

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, polyvinyl chloride (PVC) type IV bag. The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions. In-line filters should not be used.

Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

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.