Testosterone cypionate does not increase the incidence of adverse reactions to cytotoxic chemotherapy. Adverse events observed with equal frequency in patients treated with and placebo / chemotherapy.
Body as a whole: often – fatigue, generalized weakness, inflammation of mucous membranes (mucositis), anorexia; infrequently – nonspecific pain; rarely – worsening of rheumatoid arthritis.
Musculoskeletal System: often – pain in the chest, bone pain (especially in the bones active hematopoiesis) and muscles (weak or moderate (10%), sometimes severe (3%), which in most cases cropped conventional analgesics).
Gastrointestinal tract: often – nausea, vomiting; often – constipation, diarrhea.
Cardiovascular system: in rare cases – transient hypotension, not requiring medical correction, vascular disorders (venookklyuzionnaya disease, disorders associated with a change in the fluid content in the body, in patients treated with high-dose testosterone cypionate chemotherapy followed by autologous bone marrow transplantation; communication with receiving has not been established).
Respiratory system: often – cough, sore throat; rarely – pulmonary infiltrates, interstitial pneumonia, pulmonary edema, and in rare cases with unfavorable outcome of respiratory failure or adult respiratory distress syndrome (can be fatal).
Skin and subcutaneous fat: often – alopecia, skin rash; rarely – Sweet’s syndrome (febrile acute dermatosis, a significant proportion of these patients suffered from leukemia, which is often accompanied by the development of Sweet’s syndrome, so that the connection with the reception of has not been established), cutaneous vasculitis (development mechanism in patients receiving , is not known ).
Nervous system: often – headache.
Immune system: rare – allergic reactions. About half of allergic reactions associated with the administration of the first dose, more often – after / in the drug. Sometimes resumption of treatment is accompanied by a relapse of symptoms.
Genito-urinary system: rarely – a violation of urination (dysuria generally mild to moderate).
Laboratory findings: very often – increasing the activity of lactate dehydrogenase, alkaline phosphatase, g-glutamyl transferase, an increase in serum uric acid concentration (reversible dose-related changes are usually mild or moderate).
Patients with HIV infection
Musculoskeletal system: very often – pain in bones and muscles (myalgia), mainly mild or moderate (frequency similar to that of patients with oncological diseases).
Blood and lymphatic system: often – splenomegaly (linked to drug intake at least 3% of cases; in all cases, physical examination, there was a slight or moderate degree of splenomegaly with a favorable clinical course, been no cases of hypersplenism, splenectomy was not carried out in any case). Splenomegaly often occurs in patients suffering from HIV infection, as well as varying degrees of symptoms occurs in most patients with AIDS; in such cases the connection with the reception of has not been established.
Healthy donors (allogeneic PBSC mobilization)
Body as a whole: . Rarely – worsening of rheumatoid arthritis Musculoskeletal System: often – pain in the bones and muscles, mainly mild or moderate. Respiratory system: rare – hemoptysis, pulmonary infiltrates. The nervous system: very often – headache . immune system: . rare – severe allergic reaction Blood and lymphatic system: very often – leukocytosis (more than 50 x 10 9 / l) was observed in 41% of healthy donors, transient thrombocytopenia (less than 100 x 10 9 / l) was observed in 35% healthy donors; often – splenomegaly (without clinical signs); seldom – disorders of the spleen function. Laboratory tests: often – a transient slight increase in lactate dehydrogenase, alkaline phosphatase; infrequently – a slight increase in the activity of aspartate aminotransferase (AST) (no clinical sequelae), hyperuricemia.
Patients with TXH
The frequency of adverse events while taking the drug patients with TXH decreases over time.
Body as a whole: often – reactions (including pain) at the injection site (less than 2% of patients), arthralgia (less than 2% of patients). Musculoskeletal System: often – pain in bones and muscles; . often – osteoporosis (less than 2% of patients) Gastrointestinal tract: often – diarrhea (usually after the start of therapy), hepatomegaly (less than 2% of patients). Skin and subcutaneous fat: often – alopecia (less than . 2% of patients), rash (less than 2% of patients) cutaneous vasculitis (2% of patients) Nervous system: often – headache (less than 2% of patients, usually after the beginning of therapy). Blood and lymphatic system : often – anemia, splenomegaly (in some cases can progress); often – thrombocytopenia; seldom – disorders of the spleen function. Also identified cases of epistaxis. Genito-urinary system:rarely – hematuria, proteinuria. Laboratory findings: very often – transient increase in lactate dehydrogenase, alkaline phosphatase, without clinical manifestations, moderate transient hypoglycemia after eating, hyperuricemia.
Postmarketing use of the drug
Immune system: In rare cases, the allergic reactions, including anaphylaxis, skin rash, hives, which can develop at the start of therapy or during subsequent treatment filgrastim. In some cases, accompanied by a resumption of treatment a relapse of symptoms, suggesting a relationship between the drug and the adverse event.
With the development of a serious allergic reaction filgrastim therapy should be discontinued.
In patients receiving filgrastim described isolated cases of sickle cell crises, some – with a fatal outcome (see “Precautions” section.).
In patients receiving G-CSF (filgrastim) describes individual cases splenic rupture in healthy donors and patients with cancer (see. “Safety Precautions” section).
Described rare cases (more than or equal to 0.01% and less than 0.1%) Sweet’s syndrome (acute febrile dermatosis).
Patients with cancer in patients receiving filgrastim individual cases described of pseudogout (chondrocalcinosis).
Laboratory parameters: in patients receiving cytotoxic filgrastim after chemotherapy, there was a reversible increase in the concentration of uric acid in serum, activity of alkaline phosphatase and lactate dehydrogenase without clinical signs (generally mild or moderate).
Interaction with other drugs
Safety and efficacy of administration of on the same day as myelosuppressive cytotoxic chemotherapy drugs, have not been established. In view of the sensitivity of rapidly dividing myeloid cells to myelosuppressive cytotoxic chemotherapy, prescribe testosterone cypionate before or after the administration of these drugs is not recommended in the range of 24 hours. When concomitant administration of the drug and fluorouracil severity of neutropenia may be exacerbated. Possible interactions with other hematopoietic growth factors and cytokines is unknown.
Given that lithium promotes the release of neutrophils, may increase the action of the drug Neupogen ® with combined appointment, but such studies have not been conducted.
Increased haematopoietic activity of the bone marrow in response to growth factor treatment results in a transient positive bone imaging changes during that should be taken into account when interpreting the results.
Because of the incompatibility of the pharmaceutical should not be mixed with sodium chloride 0.9%.
Features of the drug by pregnant women, women during the period of breastfeeding, children and adults with chronic diseases
Pregnancy and lactation
The drug category C.
Security has not been established for pregnant women. Perhaps the passage of the drug through the placental barrier in women. In animal studies, reproductive toxicity was identified. In appointing the drug pregnant should be related to the expected therapeutic effect of the possible risk to the fetus.
In studies in rats of both sexes were not observed any influence on the fertility and pregnancy when applying filgrastim at doses up to 500 mg / kg.
In studies on rats and rabbits did not have a teratogenic effect. In rabbits, there was an increased incidence of miscarriage, but fetal abnormalities were noted.
It is not known whether passes into breast milk. Use in nursing mothers is not recommended.
The study involved a small number of elderly patients, special studies of this group of patients have not been conducted. Specific recommendations for elderly patients are missing.
Evaluation of safety and efficacy of testosterone cypionate in over 60 years has not been evaluated healthy donors.
Standard regimens of cytotoxic chemotherapy: the safety profile and efficacy of the drug in children receiving cytotoxic chemotherapy, did not differ from those of adults.
Patients after myelosuppressive or myeloablative therapy followed by autologous transfusion PSCC: assessment of safety and efficacy of in healthy donors under the age of 16 years has not been evaluated.
Patients with TXH and cancer: efficacy and safety of in infants suffering TXH not installed.
Severe congenital, periodic or idiopathic neutropenia (ANC less than or equal to 0.5 x 10 9 / l) is an indication for prolonged use of the drug Neupogen ® in children with severe or recurrent infections history to increase the number of neutrophils, as well as to reduce the frequency and duration of complications associated with infection (see. “readings” section).
In clinical trials, efficacy was proven in patients under the age of 18 years TXH and cancer. The safety profile of the drug in children for the treatment of TXH not differ from that in adults.
Dosing recommendations for pediatric patients are the same as for adults receiving myelosuppressive cytotoxic chemotherapy.
Patients with renal or hepatic insufficiency
No dose adjustment is required in patients with severe renal or hepatic impairment, as their pharmacokinetic and pharmacodynamic indices were similar to those of healthy volunteers.
Filgrastim – highly purified non-glycosylated protein consisting of 175 amino acids. It is produced strain K12 Escherichia coli, in which the gene introduced by genetic engineering techniques gene granulocyte colony stimulating factor (G-CSF), human.
The human G-CSF – glycoprotein that regulates the formation of functionally active neutrophils and their exit into the blood from bone marrow.
After the treatment, the number of neutrophils in the peripheral blood is reduced by 50% within 1-2 days and returned to normal levels over the next 1-7 days.
Neupogen ® significantly reduces the frequency, severity and duration of neutropenia and febrile neutropenia, reducing the need for and duration of inpatient treatment in patients receiving chemotherapy with cytostatics or myeloablative therapy followed by bone marrow transplantation.
Patients receiving and cytotoxic chemotherapy, require lower doses of antibiotics compared to patients receiving cytotoxic chemotherapy only.
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