Introduction
Paxel 100 is an anti-cancer medication used for the treatment of breast cancer, pancreatic cancer and non-small cell lung cancer.
It is given as an injection by a qualified medical professional. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to.
Some common side effects of this medicine include nausea, vomiting, and weakness. It may also cause serious side effects such as swelling of hands, lips, hair loss, and weight gain. To reduce these side effects your doctor may suggest some medication along with it. But, inform your doctor if you notice unexplained bruising or bleeding, sore throat, mouth ulcers, high temperature (fever). This medicine may reduce the number of blood cells (decrease red blood and white blood cells) in your blood, thereby, increasing the susceptibility to infections. Regular blood tests are required to check your blood cells and liver function.
Before taking it, tell your doctor if you have heart disease, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your doctor know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. The use of effective contraception by both males and females during treatment is important to avoid pregnancy.
Uses of Paxel 100
- Breast cancer
- Non-small cell lung cancer
- Pancreatic cancer
Side effects of Paxel 100
Common
- Nausea
- Vomiting
- Weakness
- Low blood platelets
- Rash
- Upper respiratory tract infection
- Urinary tract infection
- Bleeding
- Anemia (low number of red blood cells)
- Flushing (sense of warmth in the face, ears, neck and trunk)
- Hair loss
- Decreased blood pressure
- Peripheral neuropathy (tingling and numbness of feet and hand)
- Diarrhea
- Decreased white blood cell count (neutrophils)
How to use Paxel 100
Your doctor or nurse will give you this medicine. Kindly do not self administer.
How Paxel 100 works
Paxel 100 is an anticancer medication. It works by interfering with the microtubule structures which help the cancer cells to divide and multiply. This slows the growth of cancer cells and eventually kills them.
Indication
Ovarian carcinoma, Breast cancer, Lung cancer, Kaposi's sarcoma
Administration
Reconstitution: Paclitaxel must be diluted before infusion. It can be diluted in 0.9% sodium chloride inj, 5% dextrose inj, 5% dextrose and 0.9% sodium chloride inj or 5% dextrose in lactated Ringer's inj to a concentration of 0.3-1.2 mg/ml.
Adult Dose
Intravenous
Ovarian carcinoma
Adult: Primary treatment (in combination with cisplatin or carboplatin): 135 mg/m2 infused over 24 hr followed by cisplatin and repeated at 3 wk intervals.
Secondary treatment (as single agent): 135 or 175 mg/m2 infused over 3 hr once every 3 wk.
Breast cancer
Adult: Adjuvant therapy; 2nd line monotherapy or 1st line treatment with trastuzumab: 175 mg/m2 infused over 3 hr once every 3 wk for 4 courses; when used with trastuzumab, dose should be given the day after the 1st dose of trastuzumab or immediately after subsequent doses if well-tolerated.
1st line with doxorubicin: 220 mg/m2 over 3 hr every 3 wk, dose to be administered 24 hr after doxorubicin.
Advanced non-small cell lung cancer
Adult: 135 mg/m2 over 24 hr or 175 mg/m2 over 3 hr, followed by cisplatin and repeated at 3 wk intervals.
AIDS-related Kaposi's sarcoma
Adult: 135 mg/m2 over 3 hr every 3 wk. Alternatively, 100 mg/m2 over 3 hr every 2 wk especially in patients with poor performance status.
Hepatic Impairment
With solid carcinomas and not Kaposi sarcoma
24-hr infusion
AST/ALT <2 x ULN and bilirubin ?1.5 mg/dL: 135 mg/m² over 24 hr
AST/ALT 2-<10 x ULN and bilirubin ?1.5 mg/dL: 100 mg/m² over 24 hr
AST/ALT <10 x ULN and bilirubin 1.6-7.5 mg/dL: 50 mg/m² over 24 hr
AST/ALT ?10 x ULN OR bilirubin >7.5 mg/dL: Do not administer
3-hr infusion
AST/ALT <10 x ULN and bilirubin <1.25 x ULN: 175 mg/m² over 3 hr
AST/ALT <10 x ULN and bilirubin 1.26-2 x ULN: 135 mg/m² over 3 hr
AST/ALT <10 x ULN and bilirubin 2.01-5 x ULN: 90 mg/m² over 3 hr
AST/ALT ?10 x ULN OR bilirubin >5 x ULN: Do not administer
Child Dose
Safety and efficacy not established
Contraindication
History of hypersensitivity (especially macrogol glycerol ricinolate). Patients with baseline neutropenia of <1500 cells/mm3 (<1000 cells/mm3 for kaposi's sarcoma). Pregnancy and lactation. In kaposi's sarcoma, contraindicated in patients with concurrent, serious, uncontrolled infections.
Mode of Action
Paclitaxel promotes microtubule formation by enhancing the action of tubulin dimers, stabilising existing microtubules and preventing their disassembly, thereby disrupting normal cell division in the late G2 mitotic phase of the cell cycle. This results in the inhibition of cell replication.
Precaution
Bone marrow suppression during therapy. Monitor cardiac function if conduction abnormalities result. Premedicaton (with corticosteroid, antihistamine and histamine H2-receptor antagonist) may be required to reduce risk of hypersensitivity reaction. Discontinue, if severe reactions e.g. hypotension, dyspnoea, angioedema or urticaria occur. Caution in patients with moderate hepatic impairment. Monitor for reactions of admin. Safety and efficacy in paediatric patients have not been established. Administer before platinum derivatives (cisplatin, carboplatin) if used in combination. Hazardous agent; use appropriate precautions for handling and disposal.
Lactation: not known if excreted in breast milk, do not nurse
Side Effect
>10%
Neutropenia (78-100%),Alopecia (55-96%),Anemia (47-96%),Arthralgia/myalgia (93%),Diarrhea (90%),Leukopenia (90%),Nausea/vomiting (9-88%),Opportunistic infections (76%),Peripheral neuropathy (42-79%),Thrombocytopenia (4-68%),Mucositis (5-45%),Hypersensitivity (2-45%),Renal impairment (34%),Hypotension (17%)
1-10%
Bradycardia (3%)
<1%
Grand mal seizures,Cardiac conduction abnormalities
Frequency Not Defined
Pyrexia,Dehydration,Pancytopenia,Congestive heart failure,Left ventricular dysfunction,Stevens-Johnson syndrome, toxic epidermal necrolysis, and extravasation
Potentially Fatal: Infections and infestations leading to death e.g. pneumonia and peritonitis.
Interaction
Myelosuppression was more profound when given after cisplatin than with the alternate sequence (e.g., paclitaxel before cisplatin). CYP2C8 inducers e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, rifapentine, and secobarbital may reduce levels or effects. CYP2C8 inhibitors e.g. gemfibrozil, ketoconazole, montelukast, and ritonavir may increase levels or effects. CYP3A4 inducers e.g. aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins may decrease the levels or effects.
CYP3A4 inhibitors e.g. azole antifungals, clarithromycin, diclofenac, doxycycline, erythromycin, imatinib, isoniazid, nefazodone, nicardipine, propofol, protease inhibitors, quinidine, telithromycin, and verapamil may increase levels or effects. May increase anthracycline (eg doxorubicin, epirubicin) levels or toxicity; admin of anthracycline at least 24 hr prior to paclitaxel may reduce interaction. May decrease the absorption of cardiac glycosides (may only affect digoxin tablets); levels should be monitored.