Quadramet · 4.3 Contraindications · 1

HOS-083502 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In clinical studies in individuals who received Quadramet, the most frequently reported reactions were thrombocytopenia, anaemia and leukopenia. The most important serious adverse reactions associated with Quadramet are disseminated intravascular coagulation, bone marrow failure, hypersensitivity, anaphylactic reaction, intracranial haemorrhage, cerebrovascular accident and spinal cord compression. Tabulated list of adverse reactions The following table subsumes the observed reaction types and symptoms sorted by System Organ Class. The frequencies listed below are defined using the following convention: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). 5 Table 2: Adverse Reactions from clinical trials and post marketing surveillance System Organ Class Frequency Adverse reactions Blood and lymphatic system Very Common Thrombocytopenia2 disorders Anaemia2 Leukopenia2 Uncommon Disseminated intravascular coagulation2 Bone marrow failure 2 Immune system disorders Not known Hypersensitivity1 Anaphylactic reaction1 Metabolism and nutrition Uncommon Anorexia disorders Nervous system disorders Uncommon Haemorrhage intracranial Cerebrovascular accident 2 Spinal cord compression 2 Common Dizziness Gastrointestinal disorders Common Nausea Uncommon Vomiting Not known

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HOS-083498 · has-contraindication-information · PDF-Seite 3

• Hypersensitivity to the active substance (ethylenediaminetetramethylenephosphonate (EDTMP)) or similar phosphonates or to any of the excipients listed in section 6.1. • Pregnancy (See section 4.6). • Patients having received chemotherapy or hemi-body external radiation therapy in a preceding period of 6 weeks. • Concomitant use with myelotoxic chemotherapy (see section 4.5)

HOS-083497 · has-indication-information · PDF-Seite 2

Quadramet is indicated for the relief of bone pain in patients with multiple painful osteoblastic skeletal metastases which take up technetium (99mTc)-labelled bisphosphonates on bone scan. The presence of osteoblastic metastases which take up technetium (99mTc)-labelled bisphosphonates must be confirmed prior to therapy.

HOS-083500 · has-interaction-information · PDF-Seite 4

Because of the potential for additive effects on bone marrow, the treatment should not be given concurrently with chemotherapy or external beam radiation therapy. Quadramet may be given subsequent to either of these treatments after allowing for adequate marrow recovery. 4

HOS-083501 · has-pregnancy-information · PDF-Seite 5

Women of childbearing potential When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise. If in doubt about her potential pregnancy (if the woman has missed a period, if the period is very irregular, etc.), alternative techniques not using ionising radiation (if there are any) should be offered to the patient. The possibility of pregnancy must strictly be ruled out. Contraception Women of childbearing potential and men have to use effective contraception after the administration and the whole period of follow-up. Pregnancy The use of samarium (153Sm) lexidronam pentasodium is contraindicated in pregnant women (see section 4.3). Breast-feeding Before administering radiopharmaceuticals to a mother who is breastfeeding consideration should be given to the possibility of delaying the administration of radionuclide until the mother has ceased breastfeeding. There are no available clinical data relating to the excretion of Quadramet in human milk. If the administration is considered necessary, formula feeding should be substituted for breast-feeding and the expressed feeds discarded. Close contact with infants should be restricted during 48 hours. Fertility No studies on fertility have been performed.

HOS-083499 · has-warning-information · PDF-Seite 3

Potential for hypersensitivity or anaphylactic reactions If hypersensitivity or anaphylactic reactions occur, the administration of the medicinal product must be discontinued immediately and intravenous treatment initiated, if necessary. To enable immediate action in emergencies, the necessary medicinal products and equipment such as endotracheal tube and ventilator must be immediately available. Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should in every case be as low as reasonably achievable to obtain the required therapeutic effect. In patients with evidence of compromised bone marrow reserve from previous therapy or disease involvement, the use of Quadramet is not recommended unless the potential benefit of the treatment outweighs its risks. Renal impairment Careful consideration of the benefit risk ratio in these patients is required since an increased radiation exposure is possible. 3 Paediatric population For information on the use in paediatric population see section 4.2. Careful consideration of the indication is required since the effective dose per MBq is higher than in adults. It should not be used concurrently with other bisphosphonates if an interference is shown on the technetium (99mTc)-labelled bisphosphonate bone scans. Myelosuppression Treatment of patients with compromised bone marrow function is not recommended. Complete Blood Counts should be obtained within 2 weeks prior to the start of therapy. The following thresholds should be considered prior to initiating therapy: • Haemoglobin <100 g/L • Total white cell count <5 × 109/L • Absolute neutrophil count <2 x 109/L • Platelet count <100 × 109/L Patient preparation The patient should be encouraged to ingest (or receive by intravenous administration) a minimum of 500 mL of fluids prior to injection and should be encouraged to void as often as possible after injection to minimise radiation exposure to the bladder. Patients with urinary problems (obstruction or incontinence) should be catheterised after administration to minimise the risk of radioactive contamination of clothing, bed linen, and the patient's environment. Patients’ release has to be aligned with local regulations. The clearance of Quadramet being rapid, the precautions relating to the excreted urinary radioactivity has to be aligned w

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