DRUGS & SUPPLEMENTS
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Fytop capsules are indicated in the management of the following neoplasms:
Fytop capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.
Fytop capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to Fytop or any component of the formulation.
Patients being treated with Fytop must be frequently observed for myelosuppression both during and after therapy. Myelosuppression resulting in death has been reported. Dose-limiting bone marrow suppression is the most significant toxicity associated with Fytop therapy. Therefore, the following studies should be obtained at the start of therapy and prior to each subsequent cycle of Fytop: platelet count, hemoglobin, white blood cell count and differential. The occurrence of a platelet count below 50,000/mm3 or an absolute neutrophil count below 500/mm3 is an indication to withhold further therapy until the blood counts have sufficiently recovered.
Fytop can cause fetal harm when administered to a pregnant woman. Fytop has been shown to be teratogenic in mice and rats.
In rats, an intravenous Fytop dose of 0.4 mg/kg/day (about 1/20th of the human dose on a mg/m2 basis) during organogenesis caused maternal toxicity, embryotoxicity, and teratogenicity (skeletal abnormalities, exencephaly, encephalocele and anophthalmia); higher doses of 1.2 mg/kg/day and 3.6 mg/kg/day (about 1/7th and 1/2 of human dose on a mg/m2 basis) resulted in 90% and 100% embryonic resorptions. In mice, a single 1.0 mg/kg (1/16th of human dose on a mg/m2 basis) dose of Fytop administered intraperitoneally on days 6, 7 or 8 of gestation caused embryotoxicity, cranial abnormalities, and major skeletal malformations. An I.P. dose of 1.5 mg/kg (about 1/10th of human dose on a mg/m2 basis) on day 7 of gestation caused an increase in the incidence of intrauterine death and fetal malformations and a significant decrease in the average fetal body weight.
Women of childbearing potential should be advised to avoid becoming pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be warned of the potential hazard to the fetus.
Fytop should be considered a potential carcinogen in humans. The occurrence of acute leukemia with or without a preleukemic phase has been reported in rare instances in patients treated with Fytop alone or in association with other neoplastic agents. The risk of development of a preleukemic or leukemic syndrome is unclear. Carcinogenicity tests with Fytop have not been conducted in laboratory animals.
In all instances where the use of Fytop is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions. Most such adverse reactions are reversible if detected early. If severe reactions occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken according to the clinical judgment of the physician. Reinstitution of Fytop therapy should be carried out with caution, and with adequate consideration of the further need for the drug and alertness as to possible recurrence of toxicity.
Patients with low serum albumin may be at an increased risk for Fytop associated toxicities.
High-dose cyclosporin A resulting in concentrations above 2000 ng/mL administered with oral Fytop has led to an 80% increase in Fytop exposure with a 38% decrease in total body clearance of Fytop compared to Fytop alone.
Periodic complete blood counts should be done during the course of Fytop treatment. They should be performed prior to each cycle of therapy and at appropriate intervals during and after therapy. At least one determination should be done prior to each dose of Fytop.
In patients with impaired renal function, the following initial dose modification should be considered based on measured creatinine clearance:
Measured Creatinine Clearance
> 50 mL/min
15 to 50 mL/min
100% of dose
75% of dose
Subsequent Fytop dosing should be based on patient tolerance and clinical effect.
Data are not available in patients with creatinine clearances < 15 mL/min and further dose reduction should be considered in these patients.
Fytop has been shown to be mutagenic in Ames assay.
Treatment of Swiss-Albino mice with 1.5 mg/kg I.P. of Fytop on day 7 of gestation increased the incidence of intrauterine death and fetal malformations as well as significantly decreased the average fetal body weight. Maternal weight gain was not affected.
Irreversible testicular atrophy was present in rats treated with Fytop intravenously for 30 days at 0.5 mg/kg/day (about 1/16th of the human dose on a mg/m2 basis).
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Fytop, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
Of more than 600 patients in four clinical studies in the NDA databases who received Fytop or Fytop phosphate in combination with other chemotherapeutic agents for the treatment of small cell lung cancer (SCLC), about one-third were older than 65 years. When advanced age was determined to be a prognostic factor for response or survival in these studies, comparisons between treatment groups were performed for the elderly subset. In the one study (etoposide in combination with cyclophosphamide and vincristine compared with cyclophosphamide and vincristine or cyclophosphamide, vincristine and doxorubicin) where age was a significant prognostic factor for survival, a survival benefit for elderly patients was observed for the Fytop regimen compared with the control regimens. No differences in myelosuppression were seen between elderly and younger patients in these studies except for an increased frequency of WHO Grade III or IV leukopenia among elderly patients in a study of Fytop phosphate or Fytop in combination with cisplatin. Elderly patients in this study also had more anorexia, mucositis, dehydration, somnolence and elevated BUN levels than younger patients.
In five single-agent studies of Fytop phosphate in patients with a variety of tumor types, 34% of patients were age 65 years or more. WHO Grade III or IV leukopenia, granulocytopenia and asthenia were more frequent among elderly patients.
Post-marketing experience also suggests that elderly patients may be more sensitive to some of the known adverse effects of Fytop, including myelosuppression, gastrointestinal effects, infectious complications and alopecia.
Although some minor differences in pharmacokinetic parameters between elderly and nonelderly patients have been observed, these differences were not considered clinically significant.
Fytop and its metabolites are known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
The following data on adverse reactions are based on both oral and intravenous administration of Fytop as a single agent, using several different dose schedules for treatment of a wide variety of malignancies.
Myelosuppression is dose related and dose limiting, with granulocyte nadirs occurring 7 to 14 days after drug administration and platelet nadirs occurring 9 to 16 days after drug administration. Bone marrow recovery is usually complete by day 20, and no cumulative toxicity has been reported. Fever and infection have also been reported in patients with neutropenia. Death associated with myelosuppression has been reported.
The occurrence of acute leukemia with or without a preleukemic phase has been reported rarely in patients treated with Fytop in association with other antineoplastic agents.
Nausea and vomiting are the major gastrointestinal toxicities. The severity of such nausea and vomiting is generally mild to moderate with treatment discontinuation required in 1% of patients. Nausea and vomiting can usually be controlled with standard antiemetic therapy. Mild to severe mucositis/esophagitis may occur. Gastrointestinal toxicities are slightly more frequent after oral administration than after intravenous infusion.
Transient hypotension following rapid intravenous administration has been reported in 1% to 2% of patients. It has not been associated with cardiac toxicity or electrocardiographic changes. No delayed hypotension has been noted. To prevent this rare occurrence, it is recommended that Fytop be administered by slow intravenous infusion over a 30- to 60-minute period. If hypotension occurs, it usually responds to cessation of the infusion and administration of fluids or other supportive therapy as appropriate. When restarting the infusion, a slower administration rate should be used.
Anaphylactic-like reactions characterized by chills, fever, tachycardia, bronchospasm, dyspnea and/or hypotension have been reported to occur in 0.7% to 2% of patients receiving intravenous Fytop and in less than 1% of the patients treated with the oral capsules. These reactions have usually responded promptly to the cessation of the infusion and administration of pressor agents, corticosteroids, antihistamines or volume expanders as appropriate; however, the reactions can be fatal. Hypertension and/or flushing have also been reported. Blood pressure usually normalizes within a few hours after cessation of the infusion. Anaphylactic-like reactions have occurred during the initial infusion of Fytop.
Facial/tongue swelling, coughing, diaphoresis, cyanosis, tightness in throat, laryngospasm, back pain and/or loss of consciousness have sometimes occurred in association with the above reactions. In addition, an apparent hypersensitivity-associated apnea has been reported rarely.
Rash, urticaria, and/or pruritus have infrequently been reported at recommended doses. At investigational doses, a generalized pruritic erythematous maculopapular rash, consistent with perivasculitis, has been reported.
Reversible alopecia, sometimes progressing to total baldness, was observed in up to 66% of patients.
The following adverse reactions have been infrequently reported: abdominal pain, aftertaste, constipation, dysphagia, asthenia, fatigue, malaise, somnolence, transient cortical blindness, optic neuritis, interstitial pneumonitis/pulmonary fibrosis, fever, seizure (occasionally associated with allergic reactions), Stevens-Johnson Syndrome, and toxic epidermal necrolysis, pigmentation, and a single report of radiation recall dermatitis.
Hepatic toxicity, generally in patients receiving higher doses of the drug than those recommended, has been reported with Fytop. Metabolic acidosis has also been reported in patients receiving higher doses.
The incidences of adverse reactions in the table that follows are derived from multiple data bases from studies in 2,081 patients when Fytop was used either orally or by injection as a single agent.
ADVERSE DRUG EFFECT
PERCENT RANGE OF REPORTED INCIDENCE
Leukopenia (less than 1,000 WBC/mm3)
Leukopenia (less than 4,000 WBC/mm3)
Thrombocytopenia (less than 50,000 platelets/mm3)
Thrombocytopenia (less than 100,000 platelets/mm3)
3 to 17
60 to 91
1 to 20
22 to 41
0 to 33
Nausea and vomiting
31 to 43
0 to 2
10 to 13
1 to 13
1 to 6
0 to 3
8 to 66
1 to 2
1 to 2
1 to 2
No proven antidotes have been established for Fytop overdosage.
In small cell lung cancer, the recommended dose of Fytop capsules is two times the IV dose rounded to the nearest 50 mg.
The dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior x-ray therapy or chemotherapy which may have compromised bone marrow reserve.
Fytop capsules must be stored under refrigeration 2° to 8°C (36° to 46°F). The capsules are stable for 36 months under such refrigeration conditions.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published1-8. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Fytop Capsules, USP are available containing 50 mg of Fytop, USP.
The 50 mg capsule is an opaque dark pink, soft gelatin capsule printed with E50 in black ink. They are available as follows:
20 Capsules - Unit Dose
Capsules are to be stored under refrigeration, between 2° to 8°C (36° to 46°F).
Protect from freezing.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Catalent Germany Eberbach GmbH
Depending on the reaction of the Fytop after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Fytop not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Fytop addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology