Treatment of patients with chronic immune (idiopathic) thrombocytopenic purpura at the age of one year who cannot be treated with other medications (for example, corticosteroids, immunoglobulins). Treatment of thrombocytopenia in adult patients with chronic viral hepatitis C, if the degree of thrombocytopenia is the main factor preventing or limiting the ability to continue optimal interferon-based therapy. Treatment of adult patients with severe acquired aplastic anemia (TAA) who have not undergone prior immunosuppressive therapy or are difficult to treat and are not suitable for hematopoietic stem cell transplantation.
active substance: eltrombopag;
1 tablet contains 25 mg of eltrombopagu (in the form of eltrombopagu olamine)
excipients: magnesium stearate, lures (E 421), microcrystalline cellulose, povidone K30, sodium starch (type A); Opadry White YS-1-7706-G coating: hypromellose, macrogol 400, titanium dioxide (E 171), polysorbate 80 (for 25 mg tablets) Opadry Brown 03B26716 coating: hypromellose, titanium dioxide (E 171), macrogol 400, iron yellow oxide (E172), iron oxide red (E172) (for tablets of 50 mg).
Pharmacological properties Revolad
Thrombopoietin is the main cytokine involved in the regulation of megakaryopoiesis and platelet formation and is an endogenous ligand for thrombopoietin receptors. Eltrombopag interacts with the transmembrane domain of human thrombopoietin receptors and initiates a cascade of signals similar, but not identical to those triggered by endogenous thrombopoietin, inducing proliferation and differentiation of megakaryocytes from progenitor cells in the bone marrow.
- Treatment of patients with chronic immune (idiopathic) thrombocytopenic purpura over one year of age who are not being treated with other drugs (eg, corticosteroids, immunoglobulins).
- Treatment of thrombocytopenia in adult patients with chronic viral hepatitis C, if the degree of thrombocytopenia is a major factor preventing the initiation or limitation of the continuation of optimal interferon-based therapy.
- Treatment of adult patients with acquired severe aplastic anemia (TAA) who have not undergone prior immunosuppressive therapy or who have undergone prior treatment and are not suitable for hematopoietic stem cell transplantation.
Hypersensitivity to eltrombopag or any other component of the drug.
Method of application and dosage
Eltrombopag treatment should be initiated and supervised by a physician experienced in the management of haematological diseases or chronic hepatitis C and its complications.
The dosing regimen is individual and is based on the number of platelets in each patient. The goal of eltrombopag treatment is not to normalize platelet counts.
Treatment of patients with chronic idiopathic thrombocytopenic purpura (ITP).
A minimum effective dose of eltrombopag should be used to achieve and maintain a platelet count ≥ 50,000 / μl. Dose adjustment is based on changes in platelet count. Eltrombopag should not be used to normalize platelet counts. In clinical trials, an increase in platelet count was observed within 1-2 weeks after the start of eltrombopag therapy and a decrease in platelet count was observed within 1-2 weeks after discontinuation of the drug.
- Adult patients and children aged 6 to 17 years
The recommended starting dose of eltrombopag is 50 mg once daily. Treatment of patients of East Asian descent should begin with a reduced dose of 25 mg once daily.
- Children aged 1 to 5 years
The recommended starting dose of eltrombopag is 25 mg once daily.
In clinical trials involving patients with ITP, there was one case of overdose when the patient took 5000 mg of eltrombopag. Reports of adverse reactions included moderate rash, transient bradycardia, fatigue, and elevated transaminases. The level of liver enzymes, measured between the 2nd and 18th day after overdose, increased 1.6 times above the upper limit of normal for AST, 3.9 times – for ALT and 2.4 times – for total bilirubin. The platelet count was 672,000 / μl on the 18th day after overdose, the maximum platelet count was 929,000 / μl. All side effects passed without treatment without complications.
As a result of an overdose, the platelet count may increase excessively and cause thrombotic / thromboembolic complications. In case of overdose, oral preparations of metals containing cations, such as calcium, aluminum or magnesium, should be taken to form chelated combinations with eltrombopag and to limit its absorption. Platelet levels should be closely monitored. Eltrombopag treatment can be re-initiated according to the above recommendations.
Because eltrombopag is not excreted by the kidneys in large quantities and is highly bound to plasma proteins, hemodialysis will not be an effective method of eliminating eltrombopag.
- Infections and invasions: nasopharyngitis, upper respiratory tract infections: rhinitis, pharyngitis, urinary tract infections, influenza, oral herpes, pneumonia, sinusitis, tonsillitis, respiratory infections, gingivitis, skin infections, malignancies and benign tumors ), rectosigmoid cancer.
- From the blood and lymphatic system: anemia, anisocytosis, eosinophilia, hemolytic anemia, leukocytosis, myelocytosis, thrombocytopenia, increased hemoglobin, increased levels of rod-shaped neutrophils, decreased hemoglobin, decreased myelocytes, t myelocytes,
- From the immune system: hypersensitivity.
- From the metabolism: anorexia, hypokalemia, loss of appetite, gout, hypocalcemia, increased levels of uric acid in the blood.
- From the psyche: sleep disorders, depression, apathy, mood swings, tearfulness.
- From the nervous system: paresthesia, hypoaesthesia, drowsiness, migraine, tremor, imbalance, dysesthesia, hemiparesis, migraine with aura, peripheral neuropathy, peripheral sensory neuropathy, speech disorders, toxic neuropathy, vascular headache.
- On the part of the visual organs: dry eyes, blurred vision, lenticular turbidity, astigmatism, cortical cataract, eye pain, increased tearing, retinal hemorrhage, retinal pigment epitheliopathy, decreased visual acuity, impaired visual acuity, visual acuity, testicular dysfunction, ‘junctivitis.
- From the hearing organs: ear pain, vertigo.
- From the cardiovascular system: tachycardia, acute myocardial infarction, cardiovascular disorders, cyanosis, sinus tachycardia, QT prolongation on the electrocardiogram, deep vein thrombosis, embolism, hot flushes, superficial venous thrombophlebitis, superficial veins.
- From the respiratory system: cough, oropharyngeal pain, rhinorrhea, pulmonary embolism, pulmonary infarction, nasal discomfort, blistering and pain in the oropharynx, complications from the nasal sinuses, sleep apnea syndrome.
- From the gastrointestinal tract: nausea, diarrhea (very common – in children with ITP), ulcerative stomatitis, toothache, dry mouth, vomiting, abdominal pain, glossodynia, bleeding in the mouth, abdominal pain, faecal discoloration, bloating , food poisoning, frequent defecation, hematemesis, oral discomfort.
- From the liver and biliary tract: increased levels of alanine aminotransferase *, aspartate aminotransferase * and blood bilirubin, liver dysfunction, cholestasis, liver damage, hepatitis, drug-induced liver damage
- From the skin and subcutaneous tissue: rash, alopecia, hyperhidrosis, generalized itching, urticaria, dermatosis, petechiae, cold sweats, erythema, melanosis, pigmentation disorders, skin discoloration, skin peeling.
- From the musculoskeletal system and connective tissue: myalgia, muscle cramps, bone pain, back pain, musculoskeletal pain, muscle weakness.
- From the urinary system: renal failure, leukocyturia, lupus nephritis, nocturia, proteinuria, increased levels of urea and creatinine in the blood, increased protein / creatinine in the urine.
- From the reproductive system: menorrhagia.
- General disorders: chest pain, fever, hemorrhage at the puncture site, asthenia, anxiety, inflammation of wounds, malaise, pyrexia, foreign body sensation.
- Laboratory data: increase in blood albumin, increase in alkaline blood phosphatase, increase in total protein level, decrease in blood albumin, increase in urine pH.
Storage conditions Revolad
Store below 30 ° C. Keep out of reach of children.