ADOPORT 2 mg

Generic drug of the therapeutic class: Immunology
Active ingredients: Tacrolimus
laboratory: Sandoz

Indication

Prevention of graft rejection in hepatic, renal or cardiac transplant patients.

Treatment of allograft rejection resistant to treatment with other immunosuppressive drugs.

Dosage ADOPORT 2 mg granule boast 50

Prevention of graft rejection in hepatic, renal or cardiac transplant patients.

Treatment of allograft rejection resistant to treatment with other immunosuppressive drugs.

Against indications

To hypersensitivity to tacrolimus or other macrolides.

Hypersensitivity to any of the excipients.

Adoport side effects

The pattern of undesirable effects associated with immunosuppressive therapy is often difficult to establish because of the underlying pathology and concomitant use of many other drugs.

Most of the undesirable effects listed below are reversible and / or respond to a reduction in dosage. Oral administration appears to be associated with a lower incidence of undesirable effects than intravenous administration. Undesirable effects are presented below in order of decreasing frequency of occurrence: very common (≥1 / 10); frequent (≥ 1/100, <1/10); not very frequent (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000), undetermined frequency (can not be estimated from the available data).

Infections and infestations

As with other potent immunosuppressants, patients receiving tacrolimus frequently have an increased risk of infections (viral, bacterial, fungal, protozoal). The evolution of preexisting infectious diseases can be aggravated. Generalized or localized infections can develop.

Cases of BK virus disease and progressive multifocal leukoencephalitis (PML) have been reported in patients treated with immunosuppressants, including tacrolimus.

Benign, malignant and unstated tumors (including cysts and polyps)

Patients receiving immunosuppressive therapy have an increased risk of developing malignant tumors. Both benign and malignant tumors, including EBV-associated lymphoproliferative syndromes and cutaneous cancers, have been described in connection with tacrolimus therapy.

Hematological and lymphatic system disorders

Frequencies: anemia, leukopenia, thrombocytopenia, hyperleucocytosis, erythrocytic abnormalities.

Few: coagulopathies, bleeding and bleeding time abnormalities, pancytopenia, neutropenia.

Rare: Idiopathic thrombocytopenic purpura, hypoprothrombinemia.

Immune system disorders

Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see Warnings and Precautions section ).

Endocrine disorders

Rare: hirsutism.

Metabolism and nutrition disorders

Very frequent: hyperglycemia, diabetes, hyperkalemia.

Frequencies: hypomagnesaemia, hypophosphatemia, hypokalemia, hypocalcaemia, hyponatremia, fluid overload, hyperuricemia, decreased appetite, anorexia, metabolic acidosis, hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, other electrolytic abnormalities.

Few frequent: dehydration, hypoprotÚinà © mie, hyperphosphatà © mie, hypoglycà m mie.

Psychiatric disorders

Very frequent: insomnia.

Frequencies: signs of anxiety, confusion and disorientation, depression, depressive mood, mood disorders, nightmares, hallucinations, mental disorders.

Few frequent: psychotic disorders.

Nervous System Affections

Very frequent: tremors, cephalÚes.

Frequencies: convulsions, disturbances of consciousness, paresthesias and dysesthesias, peripheral neuropathies, vertigo, alteration of the writing, disorders of the nervous system.

Frequent: coma, hemorrhages of the central nervous system and cerebral vascular accidents, paralysis and paresis, encephalopathy, disorders of speech and language, amnesia.

Rare: hypertonia.

Very rare: myasthenia.

Eye disorders

Frequent: blurred vision, photophobia, eye disorders.

Not very common: cataract.

Rare: that's right.

Affections of the ear and labyrinth

Frequencies: tinnitus.

Few: hypoacusis.

Rare: neurosensory deafness.

Very rare: hearing disorders.

Heart conditions

Frequencies: ischemic coronary artery disease, tachycardia.

Uncommon: ventricular arrhythmias and heart failure, heart failure, cardiomyopathies, ventricular hypertrophy, supraventricular arrhythmias, palpitations, ECG abnormalities, pulse and heart rate abnormalities.

Rare: peach necklaces.

Very rare: abnormalities of the echocardiogram.

Vascular disorders

Very often: hypertension.

Frequencies: hemorrhages, thromboembolic and ischemic events, peripheral vascular disease, hypotensive vascular disorders.

Few: infarction, deep vein thrombosis of a limb, collapse.

Respiratory, thoracic and mediastinal disorders

Frequencies: dyspnea, pulmonary parenchymal affections, pleural effusion, pharyngitis, coughing, congestion and nasal inflammation.

Not very frequent: respiratory failure, respiratory tract disease, asthma.

Rare: acute respiratory distress syndrome.

Gastrointestinal disorders

Very common: diarrheas, nausea.

Frequent: gastrointestinal inflammation, ulceration and perforation of the digestive tract, gastrointestinal bleeding, stomatitis and ulceration, ascites, vomiting, gastrointestinal and abdominal pain, dyspeptic signs and symptoms, constipation, flatulence, metastasis and bloating, stool soft, gastrointestinal signs and symptoms.

Few frequent: paralytic ileus, peritonitis, acute and chronic pancreatitis, hyperamylasemia, gastroesophageal reflux, alteration of gastric emptying.

Rare: subtle, pancreatic pseudocyst.

Hospital diseases

Frequencies: liver enzymes and function abnormalities, cholestasis and jaundice, hepatocellular lesions and hepatitis, cholangitis.

Rare: thrombosis of the hepatic artery, hepatic veno-occlusive disease.

Very rare: hepatic insufficiency, stenosis of the bile ducts.

Skin and subcutaneous tissue disorders

Frequencies: pruritus, rash, alopecia, acne, hypersudation.

Frequent: dermatitis, photosensitivity.

Rare: bullous erythroderma with epidermolysis (Lyell's syndrome).

Very rare: Stevens-Johnson syndrome.

Musculoskeletal and systemic disorders

Frequent: arthralgia, muscle cramps, pain in the limbs, back pain.

Few frequent: joint disorders.

Renal and urinary disorders

Very common: abnormalities of the renal function.

Frequencies: renal insufficiency, acute renal failure, oliguria, renal tubular necrosis, toxic nephropathy, urinary disorders, vesical and ureteral symptoms.

Not very frequent: anuria, hemolytic and uremic syndrome.

Very rare: nephropathy, hemorrhagic cystitis.

Disorders of reproductive organs and breast

Few frequent: dysmenorrhea and bleeding utèrins.

General disorders and administration site abnormalities

Frequencies: asthenia, fever, oedema, pain and gout, increased alkaline blood phosphatase, weight gain, alteration of body temperature perception.

Little frequent: multivisceral failure, flu-like status, intolerance to hot and cold, chest tightness sensation, feeling of being anxious, feeling of not being in his normal state, increase of lactate dehydrogenase of blood, loss of weight.

Rare: thirst, falls, tightness of the chest, decreased mobility, ulcers.

Very rare: increase in adipose tissue.

Lesions, poisoning and complications related to procedures

Frequent: primary graft dysfunction.

Drug errors, including inadvertent, unintentional or uncontrolled substitution between "immediate release" and "prolonged release" formulations containing tacrolimus, have been observed. As a result of these errors, a number of cases of rejection of the transplant organ have been reported (frequency can not be estimated on the basis of available data).

Declaration of suspected undesirable effects

The declaration of undesirable effects suspected after authorization of the drug is important. It allows continuous monitoring of the beneficial / risk ratio of the drug. Healthcare professionals declare any suspected adverse effects via the national system of declaration: National Agency for the Safety of Medicines and Health Products (ANSM) and the Network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.