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Examiné médicalement par Kovalenko Svetlana Olegovna, Pharmacie Dernière mise à jour le 05.04.2022
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L'injection d'Oнкокристин (Онкокристин) est indiquée en leucémie aiguë.
L'injection d'Онкокристин (Онкокристин) s'est également avérée utile en association avec d'autres agents oncolytiques de la maladie de Hodgkin, des lymphomes malins non hodgkiniens (lymphocytaire, mixte, histiocytaire, indifférencié, nodulaire et diffus).
Cette préparation est destinée à un usage intraveineux uniquement (voir AVERTISSEMENTS).
La neurotoxicité semble être liée à la dose. Des soins extrêmes doivent être utilisés pour calculer et administrer la dose de Injection d'Oнкокристин, USP (Онкокристин) car un surdosage peut avoir une issue très grave ou fatale.
Informations spéciales de distribution: QUAND DÉPENSANT L'INJECTION DE Онкокристин (Онкокристин), UTILISER DANS UN AUTRE CONTENANT ORIGINAL, IL EST IMPERATIF QU'IL SOIT EMBALLÉ DANS LA SURVEILLANCE FOURNIE QUI ÉTAIT LE DÉCLARATION SUIVANT: «NE PAS. Une seringue contenant une dose spécifique doit être étiquetée, à l'aide de l'autocollant auxiliaire fourni, pour indiquer: «FATAL SI DONNÉ INTRATHÉQUELLEMENT. POUR UNE UTILISATION INTRAVEULE UNIQUEMENT. »
La concentration d'injection d'Oнкокристин, USP (Онкокристин) est de 1 mg / ml. N'ajoutez pas de liquide supplémentaire au flacon avant le retrait de la dose. Retirez la solution de l'injection de Онкокристин, USP (Онкокристин) dans une seringue sèche précise, en mesurant soigneusement la dose. N'ajoutez pas de liquide supplémentaire au flacon pour tenter de le vider complètement.
Attention: Il est extrêmement important que l'aiguille intraveineuse ou le cathéter soit correctement positionné avant l'injection de vincristine. Les fuites dans les tissus environnants pendant l'administration intraveineuse de l'injection de Онкокристин, USP (Онкокристин) peuvent provoquer une irritation considérable. En cas d'extravasation, l'injection doit être interrompue immédiatement et toute portion restante de la dose doit ensuite être introduite dans une autre veine. L'injection locale d'hyaluronidase et l'application de chaleur modérée dans la zone de fuite aideront à disperser le médicament et peuvent minimiser l'inconfort et la possibilité de cellulite.
L'injection de Онкокристин, USP (Онкокристин) doit être administrée via une aiguille ou un cathéter intraveineux intact et fluide. Il faut veiller à ce qu'il n'y ait pas de fuite ou de gonflement pendant l'administration (voir AVERTISSEMENTS EN BOÎTE).
La solution peut être injectée soit directement dans une veine, soit dans le tube d'une perfusion intraveineuse en cours d'exécution (voir Interactions médicamenteuses au dessous de). L'injection de Онкокристин Injection, USP (Онкокристин) doit être effectuée dans la minute.
Le médicament est administré par voie intraveineuse à intervalles hebdomadaires.
La dose habituelle d'injection d'Oнкокристин, USP (Онкокристин) pour les patients pédiatriques est de 1,5 à 2 mg / m². Pour les patients pédiatriques pesant 10 kg ou moins, la dose initiale doit être de 0,05 mg / kg, administrée une fois par semaine. La dose habituelle d'injection de sulfate de Vincristine, USP pour les adultes est de 1,4 mg / m². Une réduction de 50% de la dose d'injection d'Онкокристин, USP (Онкокристин) est recommandée pour les patients ayant une valeur de bilirubine sérique directe supérieure à 3 mg / 100 ml
L'injection d'Oнкокристин, USP (Онкокристин) ne doit pas être administrée aux patients pendant qu'ils reçoivent une radiothérapie par des ports qui incluent le foie. Lorsque l'injection de Онкокристин (Онкокристин), l'USP est utilisé en association avec la L-asparaginase, l'injection de Онкокристин, l'USP (Онкокристин) doit être administré 12 à 24 heures avant l'administration de l'enzyme.
Interactions médicamenteuses - L'injection d'Oнкокристин, USP (Онкокристин) ne doit pas être diluée dans des solutions qui augmentent ou abaissent le pH en dehors de la plage de 3,5 à 5,5. Il ne doit pas être mélangé avec autre chose que de la solution saline ou du glucose dans l'eau.
Chaque fois que la solution et le récipient le permettent, les produits médicamenteux parentéraux doivent être inspectés visuellement à la recherche de particules et de décoloration avant l'administration.
Manipulation et élimination - Des procédures de manipulation et d'élimination appropriées des médicaments anticancéreux doivent être envisagées. Plusieurs lignes directrices à ce sujet ont été publiées. 1-7 Il n'est pas généralement admis que toutes les procédures recommandées dans les lignes directrices sont nécessaires ou appropriées.
Les patients atteints de la forme démyélinisante du syndrome de Charcot-Marie-Tooth ne doivent pas recevoir d'injection d'Онкокристин (Онкокристин). Une attention particulière doit être accordée aux conditions énumérées sous Avertissement et Précautions.
WARNINGS
This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of Онкокристин injection. The intrathecal administration of Онкокристин injection (Онкокристин) usually results in death. Syringes containing this product should be labeled, using the auxiliary sticker provided, to state “FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY.”
Extemporaneously prepared syringes containing this product must be packaged in an overwrap which is labeled “DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION. FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY.”
Treatment of patients following intrathecal administration of Онкокристин injection has included immediate removal of spinal fluid and flushing with Lactated Ringer's, as well as other solutions and has not prevented ascending paralysis and death. In one case, progressive paralysis in an adult was arrested by the following treatment initiated immediately after the intrathecal injection:
- As much spinal fluid was removed as could be safely done through lumbar access.
- The subarachnoid space was flushed with Lactated Ringer's solution infused continuously through a catheter in a cerebral lateral ventricle at the rate of 150 mL/h. The fluid was removed through a lumbar access.
- As soon as fresh frozen plasma became available, the fresh frozen plasma, 25 mL, diluted in 1 L of Lactated Ringer's solution was infused through the cerebral ventricular catheter at the rate of 75 mL/h with removal through the lumbar access. The rate of infusion was adjusted to maintain a protein level in the spinal fluid of 150 mg/dL.
- Glutamic acid, 10 g, was given intravenously over 24 hours followed by 500 mg 3 times daily by mouth for 1 month or until neurological dysfunction stabilized. The role of glutamic acid in this treatment is not certain and may not be essential.
Pregnancy Category D - Онкокристин can cause fetal harm when administered to a pregnant woman. When pregnant mice and hamsters were given doses of Онкокристин that caused resorption of 23% to 85% of fetuses, fetal malformations were produced in those that survived. Five monkeys were given single doses of Онкокристин between days 27 and 34 of their pregnancies; 3 of the fetuses were normal at term, and 2 viable fetuses had grossly evident malformations at term. In several animal species, Онкокристин can induce teratogenesis as well as embryo death at doses that are nontoxic to the pregnant animal. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while receiving this drug, she should be apprised of the potential hazard to the fetus. Women of child-bearing potential should be advised to avoid becoming pregnant.
PRECAUTIONS
General - Acute uric acid nephropathy, which may occur after the administration of oncolytic agents, has also been reported with Онкокристин. In the presence of leukopenia or a complicating infection, administration of the next dose of Онкокристин injection (Онкокристин) warrants careful consideration.
If central nervous system leukemia is diagnosed, additional agents may be required, because vincristine does not appear to cross the blood-brain barrier in adequate amounts.
Particular attention should be given to dosage and neurologic side effects if Онкокристин injection (Онкокристин) is administered to patients with preexisting neuromuscular disease and when other drugs with neurotoxic potential are also being used.
Acute shortness of breath and severe broncospasm have been reported following the administration of vinca alkaloids. These reactions have been encountered most frequently when the vinca alkaloid was used in combination with mitomycin-C and may require aggressive treatment, particularly when there is preexisting pulmonary dysfunction. The onset of these reactions may occur minutes to several hours after the vinca alkaloid is injected and may occur up to 2 weeks following the dose of mitomycin. Progressive dyspnea requiring chronic therapy may occur. Онкокристин should not be readministered.
Care must be taken to avoid contamination of the eye with concentration of Онкокристин injection (Онкокристин) used clinically. If accidental contamination occurs severe irritation (or, if the drug was delivered under pressure, even corneal ulceration) may result. The eye should be washed immediately and thoroughly.
Laboratory Tests - Because dose-limiting clinical toxicity is manifested as neurotoxicity clinical evaluation (e.g., history, physical examination) is necessary to detect the need for dosage modification. Following administration of Онкокристин injection (Онкокристин) , some individuals may have a fall in the white blood cell count or platelet count, particularly when previous therapy or the disease itself has reduced bone-marrow function. Therefore, a complete blood count should be done before administration of each dose. Acute elevation of serum uric acid may also occur during induction of remission in acute leukemia; thus, such levels should be determined frequently during the first 3 to 4 weeks of treatment or appropriate measures taken to prevent uric acid nephropathy. The laboratory performing these tests should be consulted for its range of normal values.
Carcinogenesis, Mutagenesis, Impairment of Fertility- Neither in vivo nor in vitro laboratory tests have conclusively demonstrated the mutagenicity of this product. Fertility following treatment with vincristine sulfate alone for malignant disease has not been studied in humans. Clinical reports of both male and female patients who received multiple-agent chemotherapy that included Онкокристин indicate that azoospermia and amenorrhea can occur in postpubertal patients. Recovery occurred many months after completion of chemotherapy in some but not all patients. When the same treatment is administered to prepubertal patients, permanent azoospermia and amenorrhea are much less likely.
Patients who received chemotherapy with Онкокристин in combination with anti-cancer drugs known to be carcinogenic have developed second malignancies. The contributing role of Онкокристин in this development has not been determined. No evidence of carcinogenicity was found following intraperitoneal administration of Онкокристин in rats and mice, although this study was limited.
Usage in Pregnancy - Pregnancy Category D. See WARNINGS.
Nursing Mothers- 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 due to Онкокристин in nursing infants, a decision should be made either to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Pediatric Use - See DOSAGE AND ADMINISTRATION section.
Prior to the use of this drug, patients and/or their parents/guardian should be advised of the possibility of untoward symptoms.
In general, adverse reactions are reversible and are related to dosage. The most common adverse reaction is hair loss; the most troublesome adverse reactions are neuromuscular in origin.
When single, weekly doses of the drug are employed, the adverse reactions of leukopenia, neuritic pain, and constipation occur but are usually of short duration (ie., less than 7 days). When the dosage is reduced, these reactions may lessen or disappear. The severity of such reactions seems to increase when the calculated amount of drug is given in divided doses. Other adverse reactions, such as hair loss, sensory loss, paresthesia, difficulty in walking, slapping gait, loss of deep-tendon reflexes, and muscle wasting, may persist for at least as long as therapy is continued. Generalized sensorimotor dysfunction may become progressively more severe with continued treatment. Although most such symptoms usually disappear by about the sixth week after discontinuance of treatment, some neuromuscular difficulties may persist for prolonged periods in some patients. Regrowth of hair may occur while maintenance therapy walking, slapping gait, loss of deep-tendon reflexes, and muscle wasting, may persist for at least as long as therapy is continued. Generalized sensorimotor dysfunction may become progressively more severe with continued treatment.
Although most such symptoms usually disappear by about the sixth week after discontinuance of treatment, some neuromuscular difficulties may persist for prolonged periods in some patients. Regrowth of hair may occur while maintenance therapy continues.
The following adverse reactions have been reported:
Hepatic veno-occlusive disease has been reported in patients receiving vincristine, particularly in pediatric patients, as part of standard combination chemotherapy regimens. Some of the patients had fatal outcomes; some who survived had undergone liver transplantation.
Hypersensitivity - Rare cases of allergic-type reactions, such as anaphylaxis, rash and edema, that are temporally related to vincristine therapy have been reported in patients receiving vincristine as a part of multidrug chemotherapy regimens.
Gastrointestinal - Constipation, abdominal cramps, weight loss, nausea, vomiting, oral ulceration, diarrhea, paralytic ileus, intestinal necrosis and/or perforation, and anorexia have occurred. Constipation may take the form of upper-colon impaction, and, on physical examination, the rectum may be empty. Colicky abdominal pain coupled with an empty rectum may mislead the physician. A flat film of the abdomen is useful in demonstrating this condition. All cases have responded to high enemas and laxatives. A routine prophylactic regimen against constipation is recommended for all patients receiving Онкокристин injection (Онкокристин). Paralytic ileus (which mimics the “surgical abdomen”) may occur, particularly in young pediatric patients. The ileus will reverse itself with temporary discontinuance of Онкокристин injection (Онкокристин) and with symptomatic care.
Genitourinary-Polyuria, dysuria, and urinary retention due to bladder atony have occurred. Other drugs known to cause urinary retention (particularly in the elderly) should, if possible, be discontinued for the first few days following administration of Онкокристин injection (Онкокристин).
Cardiovascular - Hypertension and hypotension have occurred. Chemotherapy combinations that have included Онкокристин, when given to patients previously treated with mediastinal radiation, have been associated with coronary artery disease and myocardial infarction. Causality has not been established.
Neurologic - Frequently, there is a sequence to the development of neuromuscular side effects. Initially, only sensory impairment and paresthesia may be encountered. With continued treatment, neuritic pain and, later, motor difficulties may occur. There have been no reports of any agent that can reverse the neuromuscular manifestations that may accompany therapy with Онкокристин.
Loss of deep-tendon reflexes, foot drop, ataxia, and paralysis have been reported with continued administration. Cranial nerve manifestations, such as isolated paresis and/or paralysis of muscles controlled by cranial motor nerves including potentially life-threatening bilateral vocal cord paralysis, may occur in the absence of motor impairment elsewhere; extraocular and laryngeal muscles are those most commonly involved. Jaw pain, pharyngeal pain, parotid gland pain, bone pain, back pain, limb pain, and myalgias have been reported; pain in these areas may be severe. Convulsions, frequently with hypertension, have been reported in a few patients receiving Онкокристин. Several instances of convulsions followed by coma have been reported in pediatric patients. Transient cortical blindness and optic atrophy with blindness have been reported. Treatment with vinca alkaloids has resulted in both vestibular and auditory damage to the eighth cranial nerve. Manifestations include partial or total deafness which may be temporary or permanent, and difficulties with balance including dizziness, nystagmus, and vertigo. Particular caution is warranted when vincristine is used in combination with other agents known to be ototoxic such as the platinum-containing oncolytics.
Pulmonary - See PRECAUTIONS.
Endocrine - Rare occurrences of a syndrome attributable to inappropriate antidiuretic hormone secretion have been observed in patients treated with vincristine sulfate. This syndrome is characterized by high urinary sodium excretion in the presence of hyponatremia; renal or adrenal disease, hypotension, dehydration, azotemia, and clinical edema are absent. With fluid deprivation, improvement occurs in the hyponatremia and in the renal loss of sodium.
Hematologic - Онкокристин injection (Онкокристин) does not appear to have any constant or significant effect on platelets or red blood cells. Serious bone-marrow depression is usually not a major dose-limiting event. However, anemia, leukopenia, and thrombocytopenia have been reported. Thrombocytopenia, if present when therapy with Онкокристин injection (Онкокристин) is begun, may actually improve before the appearance of bone marrow remission.
Skin - Alopecia and rash have been reported.
Other - Fever and headache have occurred.
Les effets secondaires suite à l'utilisation de l'injection d'Oнкокристин (Онкокристин) sont liés à la dose. Chez les patients pédiatriques de moins de 13 ans, le décès est survenu à la suite de doses d'Онкокристин qui étaient 10 fois supérieures à celles recommandées pour le traitement. Des symptômes graves peuvent survenir dans ce groupe de patients après des doses de 3 à 4 mg / m². On peut s'attendre à ce que les adultes présentent des symptômes graves après des doses uniques de 3 mg / m² ou plus (voir RÉACTIONS INDÉSIRABLES). Par conséquent, après l'administration de doses supérieures à celles recommandées, les patients peuvent ressentir des effets secondaires exagérés. Les soins de soutien devraient inclure les éléments suivants: (1) prévention des effets secondaires résultant du syndrome de sécrétion inappropriée d'hormones antidiurétiques (le traitement préventif comprendrait la restriction de l'apport hydrique et peut-être l'administration d'un diurétique affectant la fonction de la boucle de Henle et du tubule distal) (2) administration d'anticonvulsivants; (3) utilisation de lavements ou de cathartique pour prévenir l'iléus (dans certains cas, une décompression du tractus gastro-intestinal peut être nécessaire) (4) surveiller le système cardiovasculaire; (5) déterminer la numération sanguine quotidienne pour obtenir des conseils sur les exigences de transfusion.
On a observé que l'acide folinique a un effet protecteur chez les souris normales qui ont reçu des doses létales d'Онкокристин (Cancer Res 1963; 23: 1390). Les rapports de cas isolés suggèrent que l'acide folinique peut être utile pour traiter les humains qui ont reçu une surdose d'Онкокристин. Il est suggéré que 100 mg d'acide folinique soient administrés par voie intraveineuse toutes les 3 heures pendant 24 heures, puis toutes les 6 heures pendant au moins 48 heures. Théoriquement (sur la base des données pharmacocinétiques), les niveaux de tissus de Онкокристин devraient rester significativement élevés pendant au moins 72 heures. Le traitement à l'acide folinique n'élimine pas la nécessité des mesures de soutien susmentionnées.
La majeure partie d'une dose intraveineuse de vincristine est excrétée dans la bile après une liaison tissulaire rapide (voir PHARMACOLOGIE CLINIQUE). Étant donné que seules de très petites quantités de médicament apparaissent dans le dialysat, l'hémodialyse ne sera probablement pas utile en cas de surdosage. Une augmentation de la gravité des effets secondaires peut être observée chez les patients atteints d'une maladie du foie suffisamment sévère pour diminuer l'excrétion biliaire.
Une excrétion fécale accrue de vincristine administrée par voie parentérale a été démontrée chez les chiens prétraités avec de la cholestyramine. Il n'y a pas de données cliniques publiées sur l'utilisation de la cholestyramine comme antidote chez l'homme.
Il n'y a pas de données cliniques publiées sur les conséquences de l'ingestion orale de vincristine. En cas d'ingestion orale, l'estomac doit être évacué. L'évacuation doit être suivie d'une administration orale de charbon activé et d'une cathartique.