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Indications & Uses
Pacli is indicated for:
Pharmacology
Paclitaxel is a novel anti-microtubule agent. It promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability blocks the normal dynamic reorganization of the microtubule network, a process the cell depends on for vital interphase and mitotic functions. Paclitaxel also induces abnormal arrays or "bundles" of microtubules throughout the cell cycle, along with multiple asters of microtubules during mitosis. After intravenous administration, plasma concentrations of paclitaxel decline in a biphasic manner. The initial rapid decline reflects distribution into the peripheral compartment together with elimination of the drug, while the later, slower phase is due in part to a relatively slow efflux of paclitaxel back out of that peripheral compartment.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
All patients should be given premedication before paclitaxel is started, to prevent severe hypersensitivity reactions. The premedication may include dexamethasone 20 mg by mouth (PO), taken about 12 and 6 hours before paclitaxel. Diphenhydramine (or an equivalent) 50 mg IV is given 30 to 60 minutes before paclitaxel, and cimetidine (300 mg) or ranitidine (50 mg) IV is given 30 to 60 minutes before paclitaxel too.
First-line treatment of ovarian cancer: Other medicine regimens with paclitaxel are still being studied, but a combination of paclitaxel and cisplatin is the recommended choice. Two dosages are used, depending on how long the infusion runs. In the first, 175 mg/m2 of paclitaxel is given as an intravenous infusion over three hours, followed by 75 mg/m2 of cisplatin, and the treatment is repeated every 3 weeks. In the second, 135 mg/m2 of paclitaxel is given as an intravenous infusion over 24 hours, followed by 75 mg/m2 of cisplatin, again repeated every 3 weeks.
Second-line treatment of ovarian cancer: The recommended dose is 175 mg/m2 given over 3 hours, with a 3-week gap between courses.
Adjuvant chemotherapy in breast carcinoma: The recommended dose is 175 mg/m2 given over 3 hours every 3 weeks for four courses, after AC therapy.
First-line chemotherapy of breast carcinoma: When paclitaxel is used with doxorubicin (50 mg/m2), paclitaxel is given 24 hours after the doxorubicin. The recommended dose is 220 mg/m2 given intravenously over 3 hours, with a 3-week gap between courses. When paclitaxel is used with trastuzumab, the recommended dose is 175 mg/m2 given intravenously over 3 hours, with a 3-week gap between courses. The paclitaxel infusion can start the day after the first trastuzumab dose, or straight after later trastuzumab doses if the previous one was well tolerated.
Second-line chemotherapy of breast carcinoma: The recommended dose is 175 mg/m2 given over 3 hours, with a 3-week gap between courses.
Advanced non-small-cell lung cancer: The recommended dose is 175 mg/m2 given over 3 hours, followed by 80 mg/m2 of cisplatin, with a 3-week gap between courses.
Treatment of AIDS-related KS: The recommended dose is 100 mg/m2 given as a 3-hour intravenous infusion every two weeks.
Dose adjustment: Later doses should be based on how well each patient tolerates the medicine. Do not give paclitaxel again until the neutrophil count is above 1.5 x 109/1 (above 1 x 109/1 for KS patients) and the platelet count is above 100 x 109/1 (above 75 x 109/1 for KS patients).
Side Effects
Common side effects include low blood counts, which raise the risk of infection, anaemia or bleeding. Hair loss is also common. Paclitaxel can cause pain in the joints and muscles (arthralgias and myalgias), and numbness or tingling in the hands and feet (peripheral neuropathy) is frequent too. Nausea is common, and vomiting is usually mild. Diarrhoea and mouth sores can happen as well. Some people have an allergic-type reaction after Paxel is given. This can cause fever, facial flushing, chills, shortness of breath or hives. Rare side effects include swelling of the feet or ankles (oedema), liver problems and low blood pressure. The skin over an area that had radiation treatment before may darken.
Cautions & Contraindications
Warnings & Precautions
Paxel should only be given under the supervision of a physician experienced in using cancer chemotherapy medicines. Because serious hypersensitivity reactions can occur, suitable supportive equipment must be on hand. As extravasation is possible, the infusion site should be watched closely for any sign of infiltration while the drug is being given. When Paxel is combined with cisplatin, Paxel should be given first. Serious hypersensitivity reactions, marked by breathing difficulty and low blood pressure needing treatment, angioedema, and widespread urticaria, have occurred in fewer than 1% of patients who received Paxel after adequate premedication. Fatal hypersensitivity reactions have occurred in some patients even with premedication. These reactions are probably histamine-mediated. If a severe hypersensitivity reaction occurs, the Paxel infusion must be stopped at once. Bone marrow suppression, mainly neutropenia, is the dose-limiting toxicity. The lowest neutrophil counts occurred at a median of 11 days. Blood counts should be checked frequently. Patients should not be treated again until the neutrophil count is at or above 1.5 x 109/l (at or above 1 x 109/l for KS patients) and the platelet count has recovered to at or above 100 x 109/l (at or above 75 x 109/l for KS patients). Severe abnormalities of cardiac conduction have rarely been reported with Paxel used alone. If a patient develops significant conduction abnormalities while receiving Paxel, appropriate treatment should be given, and continuous cardiac monitoring should be carried out during any later therapy with Paxel.
Contraindications
Paclitaxel must not be given to patients who have had severe hypersensitivity reactions to paclitaxel or to macrogolglycerol ricinoleate (polyoxyl castor oil). It is also contraindicated during lactation. Paclitaxel should not be used in patients whose baseline neutrophil count is below 1.5x109/l (below 1x109/l for KS patients) or whose platelet count is below 100x109/l (below 75x109/l for KS patients). In KS, paclitaxel is further contraindicated in patients with concurrent, serious, uncontrolled infections. Patients with severe hepatic impairment must not be treated with paclitaxel.
Pregnancy & Breastfeeding
Pregnancy Category D. There isn't enough evidence from human studies to confirm the effects of paclitaxel in pregnancy, but like other cytotoxic drugs, it may harm the unborn baby if taken while pregnant. Paclitaxel should not be used while breastfeeding.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
If a patient has severe neutropenia (neutrophil count <0.5 x 109/1 for a minimum of 7 days) or severe peripheral neuropathy, the dose for the following courses should be reduced by 20%. For KS patients the reduction is 25%.
Patients with hepatic impairment: there isn't enough data to recommend any dose change in mild to moderate hepatic impairment. Patients with severe hepatic impairment must not be treated with Paclitaxel AqVida.
Pediatric use: Paclitaxel AqVida isn't recommended in children below 18 years, because there is no data on its safety and efficacy.
Overdose
There is no known antidote for an overdose of Paclitaxel AqVida. If one happens, the patient should be watched closely. Treatment should aim at the toxicities most likely to appear, which are bone marrow suppression, peripheral neurotoxicity and mucositis. In children, an overdose may also bring acute ethanol toxicity.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Paclitaxel in a dry place, below 30°C, and keep it away from light. Keep it out of the reach of children. Only a freshly prepared solution should be used.
Drug Interactions
Common questions about Pacli 6 mg/ml
What is Pacli 6 mg/ml IV Infusion?
Pacli 6 mg/ml IV Infusion is a medicine that contains Paclitaxel. It is made by Beximco Pharmaceuticals Ltd. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Pacli used for?
Pacli is used for: Cancer.
What are the side effects of Pacli?
Common side effects include low blood counts, which raise the risk of infection, anaemia or bleeding. Hair loss is also common.
Can I take Pacli during pregnancy or while breastfeeding?
Pregnancy Category D. There isn't enough evidence from human studies to confirm the effects of paclitaxel in pregnancy, but like other cytotoxic drugs, it may harm the unborn baby if taken while pregnant. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Pacli?
There is no known antidote for an overdose of Paclitaxel AqVida. If one happens, the patient should be watched closely. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Pacli?
Store Paclitaxel in a dry place, below 30°C, and keep it away from light. Keep it out of the reach of children.
Can I take other medicines with Pacli?
Some medicines can interact with Paclitaxel, for example: Carbamazepine, Rifampicin, Nevirapine, Efavirenz, Phenytoin, Sorafenib Tosylate. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Pacli?
Pacli is a prescription (Rx) medicine. Take it as your doctor advises.