Paclitaxel Injection

Side effects of Cansure (260mg)

• Heart  -  Abnormal ECG, high blood pressure and slow heart rate.
• Central Nervous System  -  Nerve damage.
• Skin  -  Hair loss.
• Gastrointestinal  -  Nausea, vomiting, and diarrhea.
• Blood  -  Anemia, decrease in white blood cells, platelets and bleeding.
• Liver  -  Elevated liver enzyme levels.
• Hypersensitivity  -  Severe allergic reactions such as rash, hives, trouble in breathing, etc.
• Eye - Cystoid macular edema (CME).
• Local  -  Injection site reaction.
• Musculoskeletal  -  Muscle and joint pain.

• Miscellaneous  -  Bone marrow infections.

Dosage & When it is to be taken (Indications)
Adult- IV- The recommended dose is 135 to 175 mg/m2, over 3 hours every 3 weeks for 4 courses.

How to use Cansure (260mg)?
It comes as a solution for injection to be administered by a healthcare provider into the vein.

When is Cansure (260mg) not to be taken? (Contraindications)
Contraindicated in patients with extremely low white blood cell counts and hypersensitivity.

Warnings and Precautions for Cansure (260mg)

• Caution should be exercised in patients with history of viral infection, HIV infection, heart, liver or kidney problems, bone marrow depression, any allergy, who are taking other medications, elderly, children, during pregnancy and breastfeeding.
• It may cause dizziness or vision changes, do not drive a car or operate machinery while taking this medication.
• Avoid alcohol consumption.
• It may reduce platelet counts; avoid injury or bruising.

Description :

• Paclitaxel Injection is a clear, colorless to slightly yellow viscous solution. It is supplied as anonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel, 527 mg of polyoxyl 35 castor oil, NF, 2 mg of anhydrous citric acid, USP and 49.7% (v/v) dehydrated alcohol, USP.
• Paclitaxel is a natural product with antitumor activity. Paclitaxel is obtained via a semi-synthetic process from Taxus baccata. The chemical name for paclitaxel is 5β, 20-Epoxy-1,2α,4,7β,10β,13α- hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3- phenylisoserine

WARNING

• TAXOL® (paclitaxel) should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
• Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in 2 to 4% of patients receiving TAXOL in clinical trials. Fatal reactions have occurred in patients despite premedication. All patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists.Patients who experience severe hypersensitivity reactions to TAXOL should not be rechallenged with the drug.

Indications:

• Paclitaxel Injection is indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As first- line therapy, paclitaxel is indicated in combination with cisplatin.
• Paclitaxel Injection is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. In the clinical trial, there was an overall favorable effect on disease-free and overall survival in the total population of patients with receptor-positive and receptor-negative tumors, but the benefit has been specifically demonstrated by available data (median follow-up 30 months) only in the patients with estrogen and progesterone receptor negative tumors.
• Paclitaxel Injection is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

Dosage and Administration

Note:

• Contact of the undiluted concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP [di-(2- ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted paclitaxel injection solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
• All patients should be premedicated prior to paclitaxel injection administration in order to prevent severe hypersensitivity reactions. Such premedication may consist of dexamethasone 20 mg PO administered approximately 12 and 6 hours before paclitaxel injection, diphenhydramine (or its equivalent) 50 mg IV 30 to 60 minutes prior to paclitaxel injection, and cimetidine (300 mg) or ranitidine (50 mg) IV 30 to 60 minutes before paclitaxel injection.

Storage : Stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in original carton.

Qualitative and quantitative composition

• 1 ml of concentrate for solution for infusion contains 6 mg paclitaxel.
• Each 5 ml vial contains 30 mg of paclitaxel
• Each 16.7 ml vial contains 100 mg of paclitaxel
• Each 25 ml vial contains 150 mg of paclitaxel
• Each 50 ml vial contains 300 mg of paclitaxel
• Excipients with known effect:
• ethanol, 393 mg per ml
• macrogolglycerol ricinoleate (polyoxyl castor oil), 527 mg per ml
• For the full list of excipients, see section 6.1.

Pharmaceutical form

• Concentrate for solution for infusion

• A clear, colourless to slightly yellow, viscous solution.