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Neofordex is a brand name for Dexamethasone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Neofordex is indicated in adults for the treatment of symptomatic multiple myeloma in combination with other medicinal products.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma. Posology The dose and administration frequency varies with the therapeutic protocol and the associated treatment(s).
Neofordex administration should follow instructions for dexamethasone administration when described in the Summary of Product Characteristics of the associated treatment(s). If this is not the case, local or international treatment protocols and guidelines should be followed.
Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient. The usual posology of dexamethasone is 40 mg once per day of administration. At the end of dexamethasone treatment, the dose should be tapered in a stepwise fashion until a complete stop.
Missed dose The tablet should be taken immediately if the dose was missed for less than 12 hours. The next tablet should be taken at the usual time, if the dose was missed for more than 12 hours. In case of a missed dose, a double dose must not be taken.
Special population Elderly 3 In elderly and/or frail patients, where the dose needs to be reduced, it can be decided to prescribe another product containing a lower dose of dexamethasone, according to the appropriate treatment regimen.
2). 4). Paediatric population There is no relevant use of Neofordex in the paediatric population for the indication of multiple myeloma. Method of administration Oral use. In order to minimise insomnia, the tablet should preferably be taken in the morning.
Tablets should be kept in the blister package until administration. g. for use in multi-compartment compliance aids.
Summary of the safety profile Adverse reactions to Neofordex correspond to the predictable safety profile of glucocorticoids. Hyperglycaemia, insomnia, muscle pain and weakness, asthenia, fatigue, oedema and weight increase occur very commonly.
4). 4). 4). Tabulated list of adverse reactions The adverse reactions observed in patients treated with dexamethasone are listed below by system organ class and frequency. Frequencies are defined as: 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 including isolated reports), not known (cannot be estimated from the available data).
System organ class Adverse reactions Infections and infestations Common:
Pneumonia, herpes zoster, upper respiratory tract infection, lower respiratory tract infection, oral candidiasis, oral fungal infection, urinary tract infection, herpes simplex, candida infection; Not known: Infection, sepsis.
Blood and the lymphatic system disorders Common:
Neutropenia, anaemia, thrombocytopenia, lymphopenia, leukopenia, leukocytosis; Uncommon: Febrile neutropenia, pancytopenia, coagulopathy.
Endocrine disorders Common:
Cushing’s syndrome; Uncommon: Hypothyroidism; Not known: Adrenal atrophy, steroid withdrawal syndrome, adrenal insufficiency, hirsutism, menstrual irregularity.
Metabolism and nutrition disorders Very common:
Hyperglycaemia; Common: Hypokalaemia, diabetes mellitus, anorexia, increased or decreased appetite, hypoalbuminaemia, fluid retention, hyperuricaemia; Uncommon: Dehydration, hypocalcaemia, hypomagnesemia; Not known: Glucose tolerance impaired, sodium retention, metabolic alkalosis.
Dexamethasone is a high-dose glucocorticoid. This should be taken into consideration in the surveillance of the patient. The benefit from dexamethasone treatment should be carefully and continuously weighed against actual and potential risks.
Risk of infection Treatment with high-dose dexamethasone increases the risk of developing serious infections, in particular due to bacteria, yeasts and/or parasites. Such infections can also be caused by microorganisms that rarely cause disease under normal circumstances (opportunistic infections).
Signs of a developing infection may be masked by dexamethasone therapy. Before the start of treatment, any source of infection, especially tuberculosis, should be removed. During treatment, patients should be closely monitored for the appearance of infections.
In particular, pneumonia occurs commonly. Patients should be informed of the signs and symptoms of pneumonia and be advised to seek medical attention in case of their appearance. In case of active infectious disease, appropriate anti-infective treatment must be added to the treatment with dexamethasone.
In cases of prior tuberculosis with major radiological sequelae or if it is not certain that a full 6-month rifampicin treatment course has been followed, a prophylactic anti-tuberculosis treatment is required. 4 There is a risk of severe strongyloidiasis.
Patients from endemic areas (tropical and sub-tropical regions, southern Europe) should have a stool examination and if required an eradication of the parasite before initiating dexamethasone treatment. Certain viral diseases (varicella, measles) can be aggravated in patients receiving glucocorticoid treatment or who have received glucocorticoid treatment within the previous 3 months.
Patients must avoid contact with subjects with chickenpox or measles. Immunocompromised patients who have not previously had chickenpox or measles are particularly at risk. If such patients have been in contact with people with chickenpox or measles, a preventive treatment with intravenous normal immunoglobulin or passive immunisation with varicella zoster immunoglobulin (VZIG) must be started as appropriate.
1. Active viral disease (especially viral hepatitis, herpes, varicella, shingles). Uncontrolled psychoses. When dexamethasone is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dexamethasone in European Union.
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Psychiatric disorders Very common:
Insomnia; Common: Depression, anxiety, aggression, confusional state, irritability, nervousness, mood alteration, agitation, euphoric mood; Uncommon: Mood swings, hallucinations; Not known: Mania, psychosis, behavioural disturbance.
11 Nervous system disorders Common: Peripheral neuropathy, dizziness, psychomotor hyperactivity, disturbance in attention, memory impairment, tremor, paraesthesia, headache, ageusia, dysgeusia, somnolence, lethargy, balance impaired, dysphonia; Uncommon: Cerebrovascular accident, transient ischaemic attack, amnesia, coordination abnormal, ataxia, syncope; Not known: Convulsions.
Eye disorders Common:
Vision blurred, cataract; Uncommon: Conjunctivitis, increased lacrimation; Not known: Chorioretinopathy, glaucoma.
Ear and labyrinth disorders Common:
Vertigo.
Cardiac disorders Common:
Atrial fibrillation, supraventricular extrasystoles, tachycardia, palpitations; Uncommon: Myocardial ischaemia, bradycardia; Not known: Congestive heart failure.
Vascular disorders Common:
Venous thromboembolic reactions, predominantly deep vein thrombosis and pulmonary embolism, hypertension, hypotension, flushing, blood pressure increased, diastolic blood pressure decreased; Not known: Purpura, bruising.
Respiratory, thoracic, or mediastinal disorders Common:
Bronchitis, cough, dyspnoea, pharyngolaryngeal pain, hoarseness, hiccough.
Gastrointestinal disorders Very Common:
Constipation; Common: Vomiting, diarrhoea, nausea, dyspepsia, stomatitis, gastritis, abdominal pain, dry mouth, abdominal distension, flatulence; Not known: Pancreatitis, gastrointestinal perforation, gastrointestinal haemorrhage, gastrointestinal ulcer.
Hepatobiliary disorders Common:
Liver function tests abnormal, alanine aminotransferase increased.
Skin and subcutaneous tissue disorders Common:
Rash, erythema, hyperhidrosis, pruritus, dry skin, alopecia; Uncommon: Urticaria; Not known: Skin atrophy, acne.
Musculoskeletal and connective tissue disorders Very common:
Muscular weakness, muscle cramps; Common: Myopathy, musculoskeletal pain, arthralgia, pain in extremity; Not known: Pathological fracture, osteonecrosis, osteoporosis, tendon rupture.
Renal and urinary disorders Common:
Pollakiuria; Uncommon: Renal failure.
General disorders and administration site conditions Very common:
Fatigue, asthenia, oedema (including peripheral and facial oedema); Common: Pain, mucosal inflammation, pyrexia, chills, malaise; Not known: Impaired healing.
Investigations Common:
Weight decreased, weight increased. Description of selected adverse reactions Prior to the use of Neofordex in combination with any other medicinal product, reference should be made to the Summary of Product Characteristics of that product.
The incidence rate of certain adverse reactions varies depending on the combination treatment used. 6% in placebo/dexamethasone-treated patients). 0% in placebo/dexamethasone treated patients). A similar incidence of high-grade neutropenia was reported in newly diagnosed patients treated with the combination of lenalidomide and dexamethasone.
5% of patients who received high dose dexamethasone (HD-Dex). 7% of patients who received Pom + […]
Exposed patients should be advised to seek medical attention without delay. 5). Vaccinations with inactivated vaccines are usually possible. However, the immune response and hence the effect of the vaccination can be diminished by high glucocorticoid doses.
Interference with laboratory tests Dexamethasone can suppress skin reaction to allergy testing. It can also affect the nitro blue tetrazolium (NBT) test for bacterial infections and cause false-negative results. 8). Symptoms typically emerge within a few days or weeks of starting the treatment.
5 for pharmacokinetic interactions that can increase the risk of adverse reactions), although dose levels do not allow prediction of the onset, type severity or duration of reactions. Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary.
Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected. Patients/carers should also be alert to possible psychiatric disturbances that may occur either during, or immediately after, dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Particular care is required when considering the use of systemic corticosteroids in patients with existing or previous history of severe affective disorders in themselves or in their first degree relatives. These would include depressive or manic-depressive illness and previous steroid psychoses.
Insomnia may be minimised by administering Neofordex in the morning. Tumour lysis syndrome In post marketing experience tumour lysis syndrome (TLS) has been reported in patients with haematological malignancies following the use of dexamethasone alone or in combination with other chemotherapeutic agents.
Patient at high risk of TLS, such as patients with high proliferative rate, high tumour burden, and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precaution taken. Gastrointestinal disorders Treatment for active gastric or duodenal ulceration should be commenced prior to initiation of corticosteroids.
Appropriate prophylaxis should be considered for patients with a previous history of, or risk factors for, gastric or duodenal ulceration, haemorrhage or perforation. Patients should be monitored clinically, including by endoscopy. 5 Eye disorders Systemic treatment with glucocorticoids can induce chorioretinopathy which may result in impaired vision including loss of vision.
Prolonged use of corticosteroids may produce subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Particular care is needed when treating patients with glaucoma (or family history of glaucoma) as well as when treating patients with ocular herpes simplex, because of possible corneal perforation.
Tendonitis Corticosteroids can favour the development of tendonitis and, in exceptional cases, rupture of the affected tendon. This risk is increased by concomitant use of fluoroquinolones and in patients undergoing dialysis with secondary hyperparathyroidism or after renal transplantation.
Pheochromocytoma crisis Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an […]