Indications : התוויות

Therapeutic indications                                                                                Severe myelosuppression and immunosuppression must be expected particularly in                             Anaphylactic/anaphylactoid reactions have been reported in association with ifosfamide.
Testicular tumor                                                                                       patients pre-treated with and/or receiving concomitant chemotherapy/haematotoxic agents, immunosuppressants and/or radiation therapy (see section 4.5).                                             Cross-sensitivity between oxazaphosphorine cytotoxic agents has been reported.
For combination chemotherapy in patients with advanced stage II to IV tumours according to the TNM classification (seminomas and non-seminomas), which do not respond or adequately                                                                                                                          Impairment of Wound Healing respond to initial chemotherapy.                                                                       Where indicated, use of haematopoiesis-stimulating agents (colonystimulating factors and erythropoiesis-stimulating agents) may be considered to reduce the risk of myelosuppressive Cervical cancer                                                                                        complications and/or help facilitate the delivery of the intended dosing. For information on a             Ifosfamide may interfere with normal wound healing.
Palliative cisplatin/ifosfamide combination chemotherapy (without any other combination                potential interaction with G-CSF and GM-CSF (granulocyte colonystimulating factor, granulocyte partners) of cervical carcinoma, FIGO stage IV B (when curative therapy of the disease is not          macrophage colony-stimulating factor) (see section 4.5).                                                   Paravenous Administration possible with surgery or radiotherapy) – as an alternative to palliative radiotherapy.
The risk of myelosuppression is dosedependent and is increased with administration of a single             The cytotoxic effect of ifosfamide occurs after its activation, which takes place mainly in the liver.
Breast cancer                                                                                                                                                                                                     Therefore, the risk of tissue injury from accidental paravenous administration is low.
For palliative therapy in advanced, therapy-refractory or recurrent breast cancer.                     high dose compared to fractionated administration.
Non-small-cell lung cancer                                                                             The risk of myelosuppression is increased in patients with reduced renal function.                         In case of accidental paravenous administration of ifosfamide, the infusion should be stopped For mono- or combination chemotherapy of patients with inoperable or metastatic tumours.                                                                                                                          immediately, the extravascular ifosfamide solution should be aspirated with the cannula in place, Severe immunosuppression has led to serious, sometimes fatal, infections. Infections reported              and other measures should be instituted as appropriate.
Small-cell lung cancer
For combination chemotherapy.                                                                          with ifosfamide include pneumonias, as well as other bacterial, fungal, viral, and parasitic infections. Sepsis and septic shock also have been reported.                                               Use in Patients with Renal Impairment Soft-tissue sarcoma (incl. osteosarcoma and rhabdomyosarcoma)
For mono- or combination chemotherapy of rhabdomyosarcoma or osteosarcoma after failure of             Latent infections can be reactivated. In patients treated with ifosfamide, reactivation has been           In patients with renal impairment, particularly in those with severe renal impairment, decreased standard therapies. For mono- or combination chemotherapy of other soft-tissue sarcomas after          reported for various viral infections.                                                                     renal excretion may result in increased plasma levels of ifosfamide and its metabolites. This failure of surgery and radiation therapy.                                                                                                                                                                         may result in increased toxicity (e.g., neurotoxicity, nephrotoxicity, hematotoxicity) and should be Close hematologic monitoring is recommended. White blood cell count, platelet count, and                   considered when determining the dosage in such patients.
Ewing’s sarcoma                                                                                        haemoglobin levels should be obtained prior to each administration and at appropriate intervals For combination chemotherapy after failure of primary cytostatic therapy.                              after administration.                                                                                      Use in Patients with Hepatic Impairment Non-Hodgkin’s lymphoma
For combination chemotherapy in patients with highly malignant non-Hodgkin’s lymphoma which            Central Nervous System Toxicity, Neurotoxicity                                                             Hepatic impairment, particularly if severe, may be associated with decreased activation of does not respond, or only insufficiently responds, to the initial therapy. For combination therapy                                                                                                                ifosfamide. This may alter the effectiveness of ifosfamide treatment. Low serum albumin and of patients with recurrent tumours.                                                                    Administration of ifosfamide can cause CNS toxicity and other neurotoxic effects (see section              hepatic impairment are also considered risk factors for the development of CNS toxicity. Hepatic 4.8).                                                                                                      impairment may increase the formation of a metabolite that is believed to cause or contribute to Hodgkin’s lymphoma                                                                                                                                                                                                CNS toxicity and also contribute to nephrotoxicity.
For the treatment of patients with primary progressive forms and early relapse of Hodgkin’s            Ifosfamide neurotoxicity may become manifest within a few hours to a few days after first lymphoma (duration of complete remission shorter than one year) after failure of primary               administration and in most cases resolves within 48 to 72 hours of ifosfamide discontinuation.             This should be considered when selecting the dose and interpreting response to the dose chemotherapeutic or radio-chemotherapeutic treatment – as part of a recognised combination             Symptoms may persist for longer periods of time. Occasionally, recovery has been incomplete.               selected.
chemotherapy regimen, such as the MINE protocol.                                                       Fatal outcome of CNS toxicity has been reported.
4.5 Interaction with other medicinal products and other forms of interaction