What happens if I overdose Filcad?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Filcad:
Store Filcad in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. If accidentally frozen, allow the medicine to thaw at room temperature. If frozen more than once, the medicine should be thrown away. If Filcad is left at room temperature for more than 24 hours, it should be discarded. Keep Filcad out of the reach of children and away from pets.
Overdose of Filcad in details
In cancer patients receiving Filcad as an adjunct to myelosuppressive chemotherapy, it is recommended to avoid the potential risk of excessive leukocytosis, that Filcad therapy be discontinued if ANC surpasses 10,000/mm3 after the chemotherapy-induced ANC nadir has occurred. Doses of Filcad that increase the ANC beyond 10,000/mm3 may not result in any additional clinical benefit. Maximum tolerated dose of Filcad has not been determined. Efficacy has been observed at doses of 4-8 mcg/kg/day in nonmyeloblative chemotherapy. Patients in BMT have received up to 138 mcg/kg/day without toxic effects, although there was a flattening of the dose response of above daily doses of >10 mcg/kg/day.
What should I avoid while taking Filcad?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Filcad warnings
5.1 Splenic Rupture
Splenic rupture, including fatal cases, has been reported following the administration of Filcad. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
5.2 Acute Respiratory Distress Syndrome
Acute respiratory distress syndrome (ARDS) has been reported in patients receiving Filcad. Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue Filcad in patients with ARDS.
5.3 Serious Allergic Reactions
Serious allergic reactions, including anaphylaxis, have been reported in patients receiving Filcad. The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving Filcad can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Filcad in patients with serious allergic reactions. Filcad is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as Filcad or pegfilgrastim.
5.4 Sickle Cell Disorders
Sickle cell crisis, in some cases fatal, has been reported with the use of Filcad in patients with sickle cell trait or sickle cell disease.
5.5 Glomerulonephritis
Glomerulonephritis has occurred in patients receiving Filcad. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of Filcad. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Filcad.
5.6 Alveolar Hemorrhage and Hemoptysis
Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization have been reported in Filcad-treated healthy donors undergoing peripheral blood progenitor cell (PBPC) collection mobilization. Hemoptysis resolved with discontinuation of Filcad. The use of Filcad for PBPC mobilization in healthy donors is not an approved indication.
5.7 Capillary Leak Syndrome
Capillary leak syndrome (CLS) has been reported after G-CSF administration, including Filcad, and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
5.8 Patients with Severe Chronic Neutropenia
Confirm the diagnosis of SCN before initiating Filcad therapy.
Myelodysplastic syndrome (MDS) and acute myelogenous leukemia (AML) have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with Filcad for SCN. Based on available data including a postmarketing surveillance study, the risk of developing MDS and AML appears to be confined to the subset of patients with congenital neutropenia. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of Filcad on the development of abnormal cytogenetics and the effect of continued Filcad administration in patients with abnormal cytogenetics or MDS are unknown. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing Filcad should be carefully considered.
5.9 Thrombocytopenia
Thrombocytopenia has been reported in patients receiving Filcad. Monitor platelet counts.
5.10 Leukocytosis
Patients with Cancer Receiving Myelosuppressive Chemotherapy
White blood cell counts of 100‚000/mm3 or greater were observed in approximately 2% of patients receiving Filcad at dosages above 5 mcg/kg/day. In patients with cancer receiving Filcad as an adjunct to myelosuppressive chemotherapy‚ to avoid the potential risks of excessive leukocytosis‚ it is recommended that Filcad therapy be discontinued if the ANC surpasses 10‚000/mm3 after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy. Dosages of Filcad that increase the ANC beyond 10‚000/mm3 may not result in any additional clinical benefit. In patients with cancer receiving myelosuppressive chemotherapy‚ discontinuation of Filcad therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days.
Peripheral Blood Progenitor Cell Collection and Therapy
During the period of administration of Filcad for PBPC mobilization in patients with cancer, discontinue Filcad if the leukocyte count rises to > 100,000/mm3.
5.11 Cutaneous Vasculitis
Cutaneous vasculitis has been reported in patients treated with Filcad. In most cases‚ the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with SCN receiving long-term Filcad therapy. Hold Filcad therapy in patients with cutaneous vasculitis. Filcad may be started at a reduced dose when the symptoms resolve and the ANC has decreased.
5.12 Potential Effect on Malignant Cells
Filcad is a growth factor that primarily stimulates neutrophils. The granulocyte-colony-stimulating factor (G-CSF) receptor through which Filcad acts has also been found on tumor cell lines. The possibility that Filcad acts as a growth factor for any tumor type cannot be excluded. The safety of Filcad in chronic myeloid leukemia (CML) and myelodysplasia has not been established.
When Filcad is used to mobilize PBPC‚ tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of reinfusion of tumor cells has not been well studied‚ and the limited data available are inconclusive.
5.13 Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended
The safety and efficacy of Filcad given simultaneously with cytotoxic chemotherapy have not been established. Because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy‚ do not use Filcad in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy.
The safety and efficacy of Filcad have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of Filcad with chemotherapy and radiation therapy.
5.14 Nuclear Imaging
Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes. This should be considered when interpreting bone-imaging results.
What should I discuss with my healthcare provider before taking Filcad?
Some medical conditions may interact with Filcad. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you think you may be pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are undergoing chemotherapy or radiation therapy
- if you have leukemia, other blood disorders (eg, myelodysplastic syndrome), an infection of the blood or tissue, or sickle cell disease
Some MEDICINES MAY INTERACT with Filcad. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Lithium because it may increase the risk of Filcad's side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if Filcad may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Filcad precautions
Simultaneous Use with Chemotherapy and Radiation Therapy: The safety and efficacy of Filcad given simultaneously with cytotoxic chemotherapy have not been established. Because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, do not use Filcad in the period 24 hrs before or until 24 hrs after the administration of cytotoxic chemotherapy.
The efficacy of Filcad has not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression (eg, nitrosoureas) or with mitomycin-C or with myelosuppressive doses of antimetabolites eg, 5-fluorouracil.
The safety and efficacy have not been evaluated in patients receiving concurrent radiation therapy; hence, simultaneous use of Filcad with chemotherapy and radiation therapy should be avoided.
Potential Effects on Malignant Cells: Filcad is a growth factor that primarily stimulates neutrophils. However, the possibility that the Filcad can act as a growth factor for any tumour type cannot be excluded. In randomized study evaluating the effects of Filcad vs placebo in patients undergoing remission induction for AML, there was no significant difference in remission rates, disease free or overall survival. When Filcad was used to mobilize peripheral blood progenitor cells, tumor cells may be released from the marrow or subsequently collected in the leukapheresis product. The effect of reinfusion of tumor cells has not been well studied and the limited data available are inconclusive.
Cancer Patients Receiving Myelosuppressive Chemotherapy: WBC counts of ≥100,000/mm3 were observed in approximately 2% of patients receiving Filcad at doses >5 mcg/kg/day. There were no reports of adverse events associated with this degree of leukocytes.
Premature Discontinuation of Filcad Therapy: A transient increase in neutrophil counts is typically seen 1-2 days after initiation of Filcad therapy. However, for sustained therapeutic response, Filcad should be continued following chemotherapy until the post nadir ANC reaches 10,000/mm3. Therefore, the premature discontinuation of Filcad therapy, prior to the time of recovery from the expected neutrophils nadir, is generally not recommended.
Laboratory Monitoring: Complete blood counts including white blood cells with differential and platelets should initially be monitored 2 or 3 times per week.
Carcinogenicity, Mutagenicity & Impairment of Fertility: The carcinogenic potential of Filcad has not been studied. Filcad fails to induce bacterial gene mutations in either the presence or absence of a drug metabolizing enzyme system. Filcad had no observed effect on the fertility of male or female rats or on gestation at doses up to 500 mcg/kg.
Use in pregnancy & lactation: Pregnancy Category C: Filcad has been shown to have adverse effect in pregnant rabbits when given in doses of 2-10 times the human dose. Since there are no adequate and well-controlled studies in pregnant women, the effect if any, of Filcad on the developing fetus or the reproductive capacity of the mother is unknown. Filcad should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Filcad is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Filcad is administered to nursing women.
What happens if I miss a dose of Filcad?
Use the missed dose as soon as you remember, but not within the 24-hour period before or after you receive chemotherapy treatment. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
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Information checked by Dr. Sachin Kumar, MD Pharmacology
