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CYCLOPHOSPHAMIDE ACCORD is a brand name for Cyclophosphamide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Cyclophosphamide is used in combination with chemotherapy regimens or alone, depending on the indication. Cyclophosphamide is indicated in the treatment of: • Chronic Lymphocytic Leukemia (CLL) • Acute Lymphocytic Leukemia (ALL) • As conditioning for a bone marrow transplantation, in the treatment of Acute Lymphocytic…
Verbatim from this product's MHRA label. Tap a section to expand.
Cyclophosphamide should only be used by clinicians experienced in the use of cancer chemotherapy. Cyclophosphamide should only be administered where there are facilities for monitoring of clinical, biochemical and haematological parameters before, during, and after administration and under the supervision of an oncology specialist.
Posology Dosage must be individualised. Doses and duration of treatment and/or treatment intervals depend on the therapeutic indication, the scheme of a combination therapy, the patient's general state of health and organ function, and the results of laboratory monitoring (in particular, blood cell monitoring).
In combination with other cytostatics of similar toxicity, a dose reduction or extension of the therapy- free intervals may be necessary. Use of haematopoiesis stimulating agents (colony-stimulating factors and erythropoiesis-stimulating agents) may be considered to reduce the risk of myelosuppressive complications and/or help facilitate the delivery of the intended dosing.
Prior, during or immediately after the administration, adequate amounts of fluid should be ingested or infused to force diuresis in order to reduce the risk of urinary tract toxicity. Therefore, Cyclophosphamide should be administered in the morning.
See section
The frequency listing of adverse reactions reported below are derived from clinical trials and from post marketing experience.
The frequency of adverse reactions is 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.
Infections and infestations Common :
Infections1 Uncommon : Pneumonia2, sepsis1 Neoplasms, benign and malignant and unspecified (including cysts and polyps) Rare : Acute leukemia3, myelodysplastic syndrome, secondary malignancies, bladder cancer, ureteric cancer Very rare : Tumour lysis syndrome Not known : Non-Hodgkin's lymphoma, sarcoma, renal cell carcinoma, renal pelvis cancer, thyroid cancer Blood and lymphatic system disorders Very common : Myelosuppression4, leukopenia, neutropenia Common : Febrile neutropenia Uncommon : Thrombocytopenia, anaemia Very rare : Disseminated intravascular coagulation, Haemolytic uremic syndrome Not known : Agranulocytosis, Lymphopenia, Haemoglobin decreased Immune system disorders Very common : Immunosuppression Uncommon : Anaphylactic/ Anaphylactoid reaction, hypersensitivity reaction Very rare : Anaphylactic shock Endocrine disorders Rare : SIADH (syndrome of inappropriate antidiuretic hormone secretion) Not known : Water intoxication Metabolism and nutrition disorders Uncommon : Anorexia Rare : Dehydration Very rare : Hyponatremia Not known : Blood glucose increased, Blood glucose decreased Psychiatric disorders Very rare : Confusional state Nervous system disorders Uncommon : Peripheral neuropathy, polyneuropathy, neuralgia Rare : Convulsion, dizziness Very rare : Dysgeusia, hypogeusia, paresthesia Not known : Neurotoxicity5, Reversible posterior leukoencephalopathy syndrome6, encephalopathy Eye disorders Rare : Blurred vision Very rare : Visual impairment, conjunctivitis, eye oedema7 Not known : Lacrimation increased Ear and labyrinth disorders Uncommon : Deafness Not known : Tinnitus Cardiac disorders Uncommon : Heart failure8, cardiomyopathy, myocarditis, tachycardia Rare : Ventricular arrhythmia, arrhythmia, supraventricular arrhythmia Very rare : Ventricular fibrillation, angina, myocardial infarction, pericarditis, atrial fibrillation, Not known : Ventricular tachycardia, cardiogenic shock, pericardial effusion, palpitations, bradycardia, electrocardiogram QT prolonged Vascular disorders Uncommon : Flushing Rare : Haemorrhage Very rare : Thromboembolism, hypertension, hypotension Not known : Pulmonary embolism, venous thrombosis, vasculitis, peripheral ischemia.
4 It is within the responsibility of the physician to decide on the use of Cyclophosphamide according to the operative treatment guidelines.
The doses below can be regarded as general guidelines:
Hematologic and solid tumours • For daily treatment: 3 - 6 mg/kg body weight (= 120 - 240 mg/m2 body surface area), injected intravenously • For the intermittent treatment: 10 - 15 mg/kg body weight (= 400 - 600 mg/m2 body surface area), injected intravenously, with therapy-free intervals of 2 to 5 days • For high-dose intermittent treatment: 20 - 40 mg/kg body weight (= 800 - 1600 mg/m2 body surface area), injected intravenously, with therapy-free intervals of 21 to 28 days.
As preparation for a bone marrow transplantation 2 days 60 mg/kg or 4 days 50 mg/kg body weight injected intravenously. 5). Autoimmune diseases Per month 500 – 1000 mg/m2 body surface area. Patients with Hepatic Impairment Severe hepatic impairment may be associated with a decreased activation of cyclophosphamide.
This may alter the effectiveness of the Cyclophosphamide treatment and should be considered when selecting the dose and estimating response to the medicinal product. 4). The dose must be reduced in patients with severe hepatic impairment.
086 mmol/l). Patients with Renal Impairment In patients with renal impairment, particularly in patients with severe impairment, decreased renal excretion may result in increased plasma levels of cyclophosphamide and its metabolites.
This may result in increased toxicity and should be considered when determining the dosage in such patients. 4). A dose reduction of 50% for a glomerular filtration rate below 10 mL/minute is recommended. Cyclophosphamide and its metabolites are dialyzable, although there may be differences in clearance depending upon the dialysis system being used.
1; • acute infections; • bone marrow aplasia or bone marrow depression prior to treatment; • urinary tract infection; • acute urothelial toxicity following cytotoxic chemotherapy or radiation therapy; • urinary outflow obstruction.
6) Cyclophosphamide should not be used in the management of non-malignant disease, except for immunosuppression in life-threatening situations.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Respiratory, thoracic and mediastinal disorders8, 9 Very rare :
Acute respiratory distress syndrome (ARDS), chronic pulmonary interstitial fibrosis, pulmonary oedema, bronchospasm, dyspnoea, hypoxia, cough Not known : Pulmonary veno-occlusive disease, alveolitis allergic, pneumonitis, nasal congestion, oropharyngeal pain, rhinorrhoea, sneezing, Obliterative bronchiolitis, Pleural effusion Gastrointestinal disorders Common : Mucosal inflammation Very rare : Haemorrhagic enterocolitis, acute pancreatitis, ascites, stomatitis, diarrhoea, vomiting, constipation, nausea Not known : Gastrointestinal haemorrhage, Cecitis, colitis, enteritis, abdominal pain, inflammation of parotid salivary glands Hepatobiliary disorders Common : Hepatic function abnormal Rare : Hepatitis Very rare : Veno-occlusive liver disease, hepatomegaly, Jaundice Not known : Cholestatic hepatitis, hepatotoxicity10 Skin and subcutaneous tissue disorders Very common : Alopecia11, Rare : Rash, Dermatitis, Nail discolouration, Skin discolouration12 Very rare : Stevens-Johnson syndrome, toxic epidermal necrolysis, radiation erythaema, pruritus (including inflammatory itching) Not known : Erythema multiforme, palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome), urticaria, erythema, facial swelling, hyperhidrosis Musculoskeletal and connective tissue disorders Very rare : Rhabdomyolysis, cramps Not known : Scleroderma, muscle spasms, myalgia, arthralgia Renal and urinary tract disorders Very common : Cystitis, microhaematuria Common : Haemorrhagic cystitis, macrohematuria Very rare : Sub urethral haemorrhage, bladder wall oedema, fibrosis and bladder sclerosis, renal failure, renal impairment, blood creatinine increased, Renal tubular necrosis.
Not known :
Renal tubular disorder, nephropathy toxic, haemorrhagic urethritis, bladder contracture, nephrogenic diabetes insipidus, atypical urinary bladder epithelial cells, blood urea nitrogen increased Pregnancy, puerperium and perinatal conditions Not known : Premature labour Reproductive system and breast disorders Common : Impairment of spermatogenesis Uncommon : Ovulation disorder (rarely irreversible) Rare : Amenorrhea13, azoospermia/asperima13, oligospermia13 Not known : Infertility, ovarian failure, oligomenorrhea, testicular atrophy, Congenital, familial and genetic disorders Not Known : Intra-uterine death, foetal malformation, foetal growth retardation, foetal toxicity, Carcinogenic effect on offspring General disorders and administrative site conditions Very common : Fever Common : Chills, asthenia, malaise, Rare : Chest pain Very rare : Headache, pain, multiorgan failure, injection/infusion site reactions (thrombosis, necrosis, phlebitis, inflammation, pain, swelling, erythema) Investigations Uncommon : Blood lactate dehydrogenase increased, C-reactive protein increased, ECG changes, decreased left ventricle ejection fraction (LVEF), Lower levels of female sex hormones Very rare : Weight gain Not known : Blood oestrogen level decreased, Blood gonadotropin level increased 1An increased risk for and severity of pneumonias (including fatal outcomes), other bacterial, fungal, viral, protozoal, and parasitic infections; reactivation of latent infections, including viral hepatitis, tuberculosis, JC virus with progressive multifocal leukoencephalopathy (including fatal outcomes), pneumocystis jiroveci, herpes zoster, […]
In patients requiring dialysis, consistent interval between dialysis cycles and Cyclophosphamide administration should be considered. 4. Elderly patients In elderly patients, monitoring for toxicities and the need for dose adjustment should reflect the higher frequency of decreased hepatic, renal or cardiac function, or other organ function and concomitant diseases or other drug therapy in this population.
Paediatric population Cyclophosphamide has been administered to children. The safety profile of cyclophosphamide in paediatric patients is similar to that of the adult population. Dose modification due to myelosuppression A leukocyte and platelet count should be regularly performed during treatment with cyclophosphamide.
It is recommended to adjust the dose, if required, if signs of myelosuppression become evident. Please refer to the table below. Urinary sediment should also be checked regularly for the presence of erythrocytes. Leukocyte count [μl] Platelet count [μl] Dosage >4000 >100 000 100% of the planned dose 2500 - 4000 50 000 - 100 000 50% of the planned dose <2500 <50 000 Omit until values normalise or decide individually In combination therapy further dose reductions may have to be considered.
Method of administration Cyclophosphamide is inert until activated by enzymes in the liver. However, as with all cytotoxic agents, it is recommended that reconstitution should be performed by trained personnel, in a designated area.
Precaution to be taken before handling or administering the product Those handling the preparation should wear protective gloves. Care should be taken to avoid splashing material into the eyes. The material should not be handled by women who are pregnant or who are breast-feeding.
The choice of solvent for reconstituting Cyclophosphamide depends on the route of administration to be used.
Infusion:
Intravenous administration should preferably be conducted as an infusion. 9% sterile sodium chloride solution or 5% glucose solution. 6. 9% sterile sodium chloride solution. 9% sterile sodium chloride solution is suitable for bolus injection.
Cyclophosphamide reconstituted in water is hypotonic and should not be injected directly. 6. g. facial swelling, headache, nasal congestion, scalp burning), cyclophosphamide should be injected or infused very slowly. Duration of the infusion (ranging from 30 minutes to 2 hours) should be appropriate for the volume and type of carrier fluid to be infused.
Before intravenous use, the substance must be completely dissolved. Drug products for intravenous use must be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.
1; • acute infections; • bone marrow aplasia or bone marrow depression prior to treatment; • urinary tract infection; • acute urothelial toxicity following cytotoxic chemotherapy or radiation therapy; • urinary outflow obstruction.
6) Cyclophosphamide should not be used in the management of non-malignant disease, except for […]