Lipaxol

Paclitaxel

Chemical

Injectable

Dosage form :

Vials

Doses :

30/100/150/300 mg

Short Description:

Lipaxol contains the active substance paclitaxel. Lipaxol is a taxoid chemotherapeutic agent used as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary, and other various cancers including breast and lung cancer

Product Introduction

What Lipaxol is and what it is used for?

The name of your medicine is Lipaxol. Lipaxol belongs to a group of anti-cancer medicines called taxanes. These agents inhibit the growth of cancer cells. Lipaxol is used to treat:

Ovarian cancer

As first therapy (after initial surgery in combination with the platinum-containing medicine cisplatin).
After standard platinum-containing medicines have been tried but did not work.

Breast cancer

As first therapy for advanced disease or disease which has spread to other parts of the body (metastatic disease). Lipaxol is either combined with an anthracycline (e.g. doxorubicin) or with a medicine called trastuzumab (for patients for whom anthracycline is not suitable and whose cancer cells have a protein on their surface called her 2, see package leaflet of trastuzumab).
After initial surgery following treatment with anthracycline and cyclophosphamide (AC) as an additional treatment.
As a second-line treatment for patients who have not responded to standard treatments using anthracyclines, or for whom such treatment should not be used.

Advanced non-small-cell lung cancer

In combination with cisplatin, when surgery and/or radiation therapy aren’t suitable.

AIDS-related Kaposi’s sarcoma

Where another treatment (i.e. liposomal anthracyclines) has been tried but did not work.

Before you take Lipaxol

Do not take Lipaxol

If you are allergic (hypersensitive) to paclitaxel or to any of the other ingredients of Lipaxol listed in section 6.
If you are breast-feeding.
If you have too few white blood cells count (baseline neutrophil counts <1.5 x 10 9/ L – your doctor will advise you on this) in your blood. Your doctor will take blood samples to check this.
If you have a serious and uncontrolled infection and Lipaxol is used to treat kaposi’s sarcoma.

If any of these apply to you, talk to your doctor before starting treatment with Lipaxol.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Lipaxol. To minimize allergic reactions, you will be given other medicines before you receive Lipaxol.

If you experience severe allergic reactions (for example difficulty in breathing, shortness of breath, chest tightness, drop in blood pressure, dizziness, light headedness, skin reactions such as rash or swelling).
If you have fever, severe chills, sore throat or mouth ulcers (signs of bone marrow suppression).
If you have numbness, tingling, pricking sensations, sensitivity to touch, or weakness of the arms and legs (signs of peripheral neuropathy); a dose reduction of Lipaxol may be necessary.
- If you have severe liver problems; in that case the use of Lipaxol is not recommended.
- If you have heart conduction problems.
- If you develop severe or persistent diarrhea, with fever and stomach pain, during or shortly after the treatment with Lipaxol. Your colon could be inflamed (pseudomembranous colitis).
- If you had previous radiation to your chest (because it may increase the risk of lung inflammation).
- If you have a sore or red mouth (signs of mucositis) and are treated for Kaposi’s Sarcoma, you may need a lower dose.
Tell your doctor immediately if any of these apply to you.

Lipaxol should always be administered into veins. Administration of Lipaxol in the arteries can cause inflammation of the arteries, and you can suffer from pain, swelling, redness and heat.

Children and adolescents

This medicine is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.

Other medicines and Lipaxol

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Speak to your doctor when taking Lipaxol 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

Lipaxol must NOT be administered if you are pregnant unless clearly indicated by your doctor.

You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because Lipaxol may be harmful for the unborn baby. If pregnancy occurs during your treatment or within the 6 months after treatment has finished, you must immediately inform your doctor.

You must not breast-feed while you are treated with Lipaxol, because it is not known if Lipaxol passes into breast milk. Due to the possibility of harm to the infant stop breast-feeding and do not restart breast-feeding unless your doctor has allowed you to.

If you are a man being treated with Lipaxol you are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because Lipaxol may alter male fertility.

Driving and using machines

Lipaxol 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.

This medicine contains alcohol. Therefore, it may be unwise to drive immediately after a course of treatment.

Lipaxol contains alcohol (approximately 50% ethanol)

Harmful for those suffering from alcoholism.

To be taken into the account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

The amount of alcohol in this medicinal product may alter the effects of other medicines.

Lipaxol contains caster oil (approximately 50%)

Lipaxol contains polyoxyl 35 castor oil that may cause severe allergic reactions. If you are allergic to castor oil, talk to your doctor before you receive Lipaxol.

How to take Lipaxol?

To minimize allergic reactions, you will be given other medicines before you receive Lipaxol.

These medicines can be given as either tablets or infusion into a vein or both.

You will receive Lipaxol as a drip into one of your veins (by intravenous infusion), through an in-line filter. Lipaxol will be administered to you by a healthcare professional. He or she shall prepare the solution for infusion before it is given to you. The dose you receive will also depend on results of your blood tests. Depending on the type and severity of the cancer you will receive Lipaxol either alone or in combination with another anticancer agent.

Lipaxol should always be administered into one of your veins over a period of 3 or 24 hours.

It is usually given every 2 or 3 weeks, unless your doctor decides otherwise. Your doctor will inform you about the number of courses of Lipaxol you need to receive.

The recommended doses for the intravenous infusion of Lipaxol are as follows:

First-line ovarian carcinoma: 135 mg/m2 over 24 hours, followed by cisplatin 75 mg/m2 or 175 mg/m2 over 3 hours, followed by cisplatin 75 mg/m2, every 3 weeks
Second-line ovarian carcinoma: 175 mg/m2 over 3 hours, every 3 weeks
Adjuvant breast carcinoma: 175 mg/m2 over 3 hours; following anthracycline and cyclophosphamide (AC) therapy, every 3 weeks
First-line breast carcinoma (with doxorubicin): 220 mg/m2 over 3 hours, 24 hours after doxorubicin (50 mg/m2), every 3 weeks
First-line breast carcinoma (with trastuzumab): 175 mg/m2 over 3 hours, after trastuzumab, every 3 weeks
Second-line breast carcinoma: 175 mg/m2 over 3 hours, every 3 weeks
Advanced Non- small cell lung carcinoma: 175 mg/m2 over 3 hours, followed by cisplatin 80 mg/m2, every 3 weeks
AIDS-related Kaposi’s sarcoma: 100 mg/m2 over 3 hours, every 2 weeks

Do not re-administer Lipaxol until the neutrophil count is ≥ 1,500/mm³ (≥ 1,000/mm³ for Kaposi’s sarcoma patients) and the platelet count is ≥ 100,000/mm³ (≥ 75,000/mm³ for Kaposi’s sarcoma patients).

Patients who experience severe neutropenia (neutrophil count < 500/mm³ for a week or longer) or severe peripheral neuropathy should receive a dose reduction of 20% for subsequent courses (25% for Kaposi’s sarcoma patients).

Patients with severe hepatic impairment should not be treated with Lipaxol.

The following information is intended for healthcare professionals only:

Preparation of infusion solutions:

Containers and infusion sets used with Lipaxol must be DEHP-free. This will minimize patient exposure to the plasticizer DEHP [di-(2-ethylhexyl) phthalate], which may leach from PVC infusion containers or sets. Use of filter devices (e.g. IVEX-2) which incorporate short inlet and/or outlet plasticized PVC tubing has not resulted in significant leaching of DEHP.

Take care when handling Lipaxol as with all antineoplastic agents. Always wear adequate protective gloves when handling vials containing Lipaxol. Dilution should be performed under aseptic conditions by trained personnel in a designated area. In the event of contact with the skin, wash the area with soap and water. In the event of contact with the mucous membranes, flush thoroughly with water.

Do not use the Chemo-Dispensing Pin device or similar devices with spikes since they can cause the vial stopper to collapse, resulting in loss of sterile integrity.

Before administration, the Lipaxol must be further diluted with either:

0.9% Sodium Chloride Injection
5 % Dextrose Injection
5% Dextrose and 0.9% Sodium Chloride injection
5% Dextrose in Ringer’s Injection

The final infusion concentration of Lipaxol must range between 0.3 mg/ml and 1.2 mg/ml. Pre-medicate all patients with corticosteroids, antihistamines and H2 antagonists prior to administration.

Avoid precipitation of the infusion solution.

Use as soon as possible after dilution.

Avoid excessive agitation, vibration or shaking.

Flush the infusion sets thoroughly before use.

Regularly inspect the appearance of the infusion and stop the infusion if precipitation is present.

Chemical and physical in-use stability of the diluted solution has been demonstrated at 5° and at 25°C for 7 days when diluted in 5% Dextrose solution, and for 14 days when diluted in 0.9% Sodium Chloride Injection. From a microbiological point of view, the diluted product should be used immediately or maintained at 2 to 8°C for a maximum of 24 hours.

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

Possible side effects

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

Tell your doctor immediately if you notice any signs of allergic reactions. These may include one or more of the following:

Flushing
Skin reactions
Itching
Chest tightness
Shortness or difficulty in breathing
Swelling

These can all be signs of serious side effects.

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

Minor allergic reactions such as flushing, rash, itching
Infections; mainly upper respiratory infection, urinary tract infection
Shortness of breath
Sore throat or mouth ulcers, sore and red mouth, diarrhea, feeling or being sick (nausea, vomiting)
Loss of hair is pronounced (over 50%) in the majority of patients
Pain in the muscles, cramps, pain in the joints
Fever, severe chills, headache, dizziness, tiredness, looking pale, bleeding, bruising more easily than normal
Numbness, tingling or weakness in arms and legs (all symptoms of peripheral neuropathy)
Tests may show reduction of blood platelet count, white or red blood cells count and low blood pressure

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

Temporary mild nail change and skin changes, reactions at injection sites (localized swelling, pain, and redness of the skin)
Tests may show slower heart rate, severe elevation in liver enzymes (alkaline phosphatase and AST – SGOT)

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

Shock due to infections (known as ‘septic shock’)
Palpitations, cardiac dysfunction (AV block), rapid beating of the heart, heart attack, respiratory distress
Fatigue, sweating, fainting (syncope), significant allergic reactions, phlebitis (inflammation of a vein), swelling of the face, lips, mouth, tongue or throat
Back pain, chest pain, pain around hands and feet, chills, abdominal (tummy) pain
Tests may show severe elevation of bilirubin (jaundice), high blood pressure, and blood clot

Rare side effects (may affect up to 1 in 1000 people):

Heart failure
Shortage of white blood cells with fever and increased risk of infection (febrile neutropenia)
Affection of nerves with feeling of weakness in muscles of arms and legs (motor neuropathy)
Shortness of breath, pulmonary embolism, lung fibrosis, interstitial pneumonia, dyspnea, pleural effusion
Bowel obstruction, bowel perforation, inflammation of colon (ischemic colitis), inflammation of the pancreas (pancreatitis)
Pruritus, rash, skin redness (erythema)
Blood poisoning (sepsis), peritonitis
Pyrexia, dehydration, asthenia, edema, malaise
Serious and potentially fatal hypersensitivity reactions (anaphylactic reactions)
Tests may show increase in blood creatinine indicating renal function impairment

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

Irregular rapid heart rhythm (atrial fibrillation, supraventricular tachycardia)
Sudden disorder in blood forming cells (acute myeloid leukemia, myelodysplastic syndrome)
Optic nerve and/or visual disturbances (scintillating scotomata)
Hearing loss or reduction (ototoxicity), ringing in the ears (tinnitus), vertigo
Blood clot in a blood vessel of abdomen and bowel (mesenteric thrombosis), inflammation of colon sometimes with persistent severe diarrhea (pseudomembranous colitis, neutropenic colitis), dropsy (ascites), esophagitis, constipation
Serious hypersensitivity reactions including fever, skin redness, pain in joints and/or inflammation of the eye (Stevens-Johnson syndrome), local peeling of the skin (epidermal necrolysis), redness with irregular red (exudative) spots (erythema multiforme), inflammation of the skin with blisters and peeling (exfoliative dermatitis), urticaria, loose nails (patients on therapy should wear sun protection on hands and feet)
Loss of appetite (anorexia)
Serious and potentially fatal hypersensitivity reactions with shock (anaphylactic shock)
Disturbed liver function (hepatic necrosis, hepatic encephalopathy (both with reported cases of fatal outcome))
Confusional state
Cough

Not known side effects (the frequency cannot be determined based on the available data):

Phlebitis
Tumor lysis syndrome
Systemic lupus erythematosus
Hardening/ thickening of the skin

(scleroderma)

Macular edema, photopsia, vitreous floaters
Disseminated intravascular coagulation (DIC), a serious condition that makes people bleed too easily, get blood clots too easily, or both

How to store Lipaxol?

Keep out of the reach of children.

Store below 25°C. Keep vial in outer carton in order to protect from light.

The diluted product should be used immediately. If not used immediately, store in a refrigerator (2 to 8°C) for no more than 24 hours.

Do not use this medicine if you notice a cloudy solution or an insoluble precipitate.

Do not use this medicine after the expiry date which is stated on the label and carton.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Lipaxol contains?

The active substance of this medicine is paclitaxel. Each ml of concentrate for solution for infusion contains 6 mg of Paclitaxel.

Each vial contains 5, 16.7, 25 and 50 ml (equivalent to 30, 100, 150 and 300 mg of paclitaxel respectively).

The other ingredients are polyoxyl 35 castor oil, anhydrous citric acid and ethanol, anhydrous.

What Lipaxol looks like and contents of the pack?

Lipaxol is a clear colorless to slightly yellow viscous solution free from visible particles.

Lipaxol

Paclitaxel

Category:

Chemical

Injectable

Dosage form :

Vials

Doses :

30/100/150/300 mg

Short Description:

Lipaxol contains the active substance paclitaxel. Lipaxol is a taxoid chemotherapeutic agent used as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary, and other various cancers including breast and lung cancer

Product Introduction

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