Instructions for use
Dosage form
Concentrate for solution for infusion, 300 mg/50 ml.
Compound
1 ml of the drug contains:
- active substance — paclitaxel 6.00 mg,
- excipients: anhydrous ethanol, macroglycerol ricinoleate, anhydrous citric acid.
Description
A transparent, colorless or slightly yellowish viscous solution without foreign particles.
Pharmacotherapeutic group
Antitumor drugs.
Alkaloids of plant origin. Taxanes. Paclitaxel.
Indications
Ovarian cancer
- First-line therapy in combination with platinum antineoplastic agents in patients with advanced ovarian cancer or residual tumor (>1 cm) after initial laparotomy;
- second-line therapy in patients with metastatic ovarian cancer after standard therapy has not led to a positive result.
Mammary cancer
- adjuvant therapy in patients with metastases in the lymph nodes after standard combination chemotherapy;
- first-line therapy in patients with late-stage cancer or metastatic cancer after disease relapse within 6 months after the start of adjuvant therapy with anthracycline drugs, in the absence of contraindications for their use;
- first-line therapy in patients with late-stage or metastatic breast cancer in combination with anthracycline drugs in the absence of contraindications for their use, or in combination with trastuzumab in patients with immunohistochemically confirmed 2+ or 3+ HER-2 levels;
- Second-line therapy in patients with advanced or metastatic cancer who have progressed after combination chemotherapy. Previous therapy should include anthracycline drugs in the absence of contraindications for their use.
Non-small cell lung cancer
First-line therapy in combination with cisplatin or as monotherapy in patients who are not planned for surgery and/or radiation therapy.
Kaposi’s sarcoma due to AIDS
Contraindications
Side effects of paclitaxel are generally the same in frequency and severity when treating ovarian cancer, breast cancer, non-small cell lung cancer, or Kaposi’s sarcoma. However, in patients with Kaposi’s sarcoma caused by AIDS, when using the drug, infections (including opportunistic ones), suppression of hematopoiesis, and febrile neutropenia are observed more often than usual and are more severe.
Side effects with monotherapy:
The incidence of side effects is given in accordance with the following scale: very often (≥10), often (≥100, but ˂ 1/10), infrequently (≥1000, but ˂ 1/100), rarely (≥10,000, but ˂ 1 /1000), very rare (˂ 10000), frequency unknown (cannot be estimated using available data).
From the hematopoietic organs: very often — myelosuppression, neutropenia, anemia, thrombocytopenia, leukopenia, fever, bleeding; rarely* — febrile neutropenia; very rarely* — acute myeloid leukemia, myelodysplastic syndrome; frequency unknown — disseminated intravascular coagulation syndrome
From the immune system: very often — minor hypersensitivity reactions, mainly manifested in the form of hyperemia (“flushes”) and skin rash; uncommon — severe hypersensitivity reactions requiring treatment (for example, decreased blood pressure (BP), angioedema, respiratory dysfunction, generalized urticaria, edema, back pain, chills, tachycardia, abdominal pain, pain in the extremities, profuse sweating) ; rarely* — anaphylactic reactions (including fatal ones); very rarely* — anaphylactic shock.
From the nervous system: very often — neurotoxicity (mainly peripheral neuropathy); rarely* — motor neuropathy (leading to slight weakness of the limbs); very rarely* — confusion, autonomic neuropathy, manifested by paralytic ileus and orthostatic hypotension, grand mal seizures, convulsions, encephalopathy, dizziness, headache, ataxia.
From the cardiovascular system: very often — changes in the ECG, decreased blood pressure; often — bradycardia; uncommon — increased blood pressure, thrombosis, thrombophlebitis, cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, atrioventricular block and fainting, myocardial infarction; rarely — heart failure; very rarely* — atrial fibrillation, supraventricular tachycardia, shock.
From the respiratory system: rarely* — shortness of breath, pleural effusion, respiratory failure, interstitial pneumonia, pulmonary fibrosis, pulmonary embolism; very rarely* — cough.
From the gastrointestinal tract: very often — nausea, vomiting, diarrhea, mucositis; rarely* — intestinal obstruction, intestinal perforation, ischemic colitis, pancreatitis; very rarely* — thrombosis of the mesenteric artery AI, pseudomembranous colitis, neutropenic colitis, esophagitis, constipation, ascites, anorexia.
From the liver and biliary tract: very rarely* — hepatonecrosis (fatal), hepatic encephalopathy (fatal).
From the organ of vision: very rarely* — reversible damage to the optic nerve and/or visual impairment (atrial scotoma or ocular migraine); frequency unknown* — macular edema, photopsia, destruction of the vitreous body of the eye.
From the organ of hearing: very rarely* — hearing loss, tinnitus, vertigo (vestibular vertigo), ototoxicity.
From the skin and subcutaneous tissues: very often — alopecia; often — temporary minor changes in the skin and nails; rarely* — itching, rash, erythema, phlebitis, inflammation of subcutaneous fat, skin exfoliation, skin necrosis and fibrosis, skin lesions resembling the effects of radiation therapy; very rarely* — Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme exudative, exfoliative dermatitis, urticaria, onycholysis; frequency unknown* — scleroderma, cutaneous lupus erythematosus, palmoplantar erythrodysesthesia syndrome.
From the musculoskeletal system: very often — arthralgia, myalgia; frequency unknown* — systemic lupus erythematosus.
Local reactions: often — local swelling, pain, erythema, induration.
From laboratory parameters: often — increased activity of aspartate aminotransfer (AST), increased activity of alkaline phosphatase; uncommon — increased bilirubin concentration;rarely* — increased serum creatinine concentration.
Other: very often — secondary infections (in isolated cases — fatal); uncommon — septic shock; rarely* — pneumonia, sepsis, peritonitis, asthenia, general malaise, fever, dehydration, peripheral edema; frequency unknown* — tumor lysis syndrome.
Side effects with combination therapy:
Paclitaxel Paclikast + cisplatin for 1st line treatment of ovarian cancer
The incidence and severity of neurotoxicity, arthralgia/myalgia and hypersensitivity are higher compared to cyclophosphamide and cisplatin therapy. On the contrary, manifestations of myelosuppression are observed less frequently and are less pronounced than with the use of cyclophosphamide and cisplatin.
Manifestations of severe neurotoxicity when used in combination with cisplatin at a dose of 75 mg/m2 are observed less frequently when using Paclitaxel-Teva at a dose of 135 mg/m2 as a 24-hour infusion than when administered at a dose of 175 mg/ml2 as a 3-hour infusion. hourly infusion.
Paclitaxel Paclikast + trastuzumab for the treatment of breast cancer
When using Paclitaxel Paclikast in combination with trastuzumab for first-line treatment of metastatic breast cancer, the following side effects were observed more often than with Paclitaxel Paclikast monotherapy: heart failure, infections, chills, fever, cough, rash, arthralgia, tachycardia, diarrhea , increased blood pressure, nosebleeds, acne, herpetic rashes, accidental injuries, insomnia, rhinitis, sinusitis, reactions at the injection site.
The use of the drug Paclitaxel Paclikast in combination with trastuzumam in 2nd line therapy (after anthracycline drugs) led to an increase in the frequency and severity of cardiac events (in rare cases with fatal outcome) compared with monotherapy with Paclitaxel-Teva. In most cases, side effects were reversible after appropriate treatment.
The drug Paclitaxel Paclikast + doxorubicin for the treatment of breast cancer
Cases of congestive heart failure have been reported in patients who have not previously received chemotherapy. In patients who had previously received courses of chemotherapy, especially with the use of anthracyclines, cardiac dysfunction, a decrease in left ventricular ejection fraction, and insufficiency of ventricular function were often observed. In rare cases, myocardial infarction has been reported.
Paclitaxel Paclikast + radiation therapy
Cases of radiation pneumonitis have been reported in patients receiving paclitaxel and radiation therapy concomitantly.
*Note: Post-marketing data on side effects are indicated with an asterisk.
Manufacturer
Aprazer.
Best before date
2 years
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