However, cataracts were not observed in juvenile rats given tolerated doses at 5 times the human clinical exposure in paediatric ITP patients, based on AUC. methotrexate) and BCRP (e.g. Relispas Tablet may also be used for purposes not listed in this medication guide. Effects of eltrombopag on other medicinal products. reticulin formation and risk of bone marrow fibrosis. Eltrombopag is highly bound to human plasma proteins (>99.9%), predominantly to albumin. Five of the 6 patients treated with eltrombopag experienced the thrombotic complication at a platelet count >200,000/µl and within 30 days of the last dose of eltrombopag. Grouped term with preferred terms oliguria, renal failure and renal impairment, Iron overload, decreased appetite, hypoglycaemia, increased appetite, Dry eye, cataract, ocular icterus, vision blurred, visual impairment, vitreous floaters, Diarrhoea, nausea, gingival bleeding, abdominal pain, Oral mucosal blistering, oral pain, vomiting, abdominal discomfort, constipation, abdominal distension, dysphagia, faeces discoloured, swollen tongue, gastrointestinal motility disorder, flatulence, Blood bilirubin increased (hyperbilirubinemia), jaundice, * Cases of drug-induced liver injury have been reported in patients with ITP and HCV, Petechiae, rash, pruritus, urticaria, skin lesion, rash macular, Skin discolouration, skin hyperpigmentation, Musculosketal and connective tissue disorders, Arthralgia, pain in extremity, muscle spasms, Description of selected adverse reactions. mfine only provides reference source for common information on medicines and does not … Unbound eltrombopag (active) concentrations for this highly protein-bound medicinal product were not measured. Retinal haemorrhages, mostly Grade 1 or 2, have been reported in HCV patients receiving interferon, ribavirin and eltrombopag (2% of the eltrombopag group and 2% of the placebo group. Ans: Patients with low albumin levels (≤ 35 g/l) or MELD ≥10 had a 2-fold greater risk of TEEs than those with higher albumin levels; those aged ≥60 years had a 2-fold greater risk of TEEs compared to younger patients. However a risk for humans cannot be ruled out (see section 5.3). Platelet counts should be closely monitored and consideration given to reducing the dose or discontinuing eltrombopag treatment if the platelet count exceeds the target levels (see section 4.2). No case of TEE was identified from a clinical study in refractory SAA, however the risk of these events cannot be excluded in this patient population due to the limited number of exposed patients. Aluminum blisters (PA/Alu/PVC/Alu) in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets. Median platelet counts at 1, 2, 3, 4, 5, 6 and 7 years on study were 85,000/μl, 85,000/μl, 105,000/μl, 64,000/μl, 75,000/μl, 119,000/μl and 76,000/μl, respectively. Also view other alternatives Call 040 - 67006700 for help. It allows continued monitoring of the benefit/risk balance of the medicinal product. The effectiveness and safety of Revolade have not been established for the treatment of thrombocytopenia due to MDS. RevoTile can be installed over almost any existing surface, eliminating the expense and mess of demolition. It is manufactured by Eris Life Sciences. Eltrombopag must not be used to normalise platelet counts. The dose regimen of concomitant ITP medicinal products should be modified, as medically appropriate, to avoid excessive increases in platelet counts during therapy with eltrombopag. Treatment: Revoldade 50mg tablet is used for low platelet count due to ITP or HCV infection. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Date of first authorisation: 11 March 2010. • accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation. Eighty-six percent of patients were RBC transfusion dependent, and 91% were platelet transfusion dependent. Eltrombopag is metabolised through multiple pathways including CYP1A2, CYP2C8, UGT1A1, and UGT1A3 (see section 5.2). Increase of alanine aminotransferase and aspartate aminotransferase may occur simultaneously, although at a lower frequency. Patients with low albumin levels (≤35 g/l) or MELD ≥10 had a 2-fold greater risk of TEEs than those with higher albumin levels; those aged ≥60 years had a 2-fold greater risk of TEEs compared to younger patients. Clinically significant drug interactions involving glucuronidation are not anticipated due to limited contribution of individual UGT enzymes in the glucuronidation of eltrombopag. The dose of eltrombopag could be adjusted based on individual platelet counts. Table 1 Dose adjustments of eltrombopag in ITP patients, <50,000/µl following at least 2 weeks of therapy. Prescription/Non prescription: The above warnings and precautions for ITP also apply to the paediatric population. Based on estimates from the population pharmacokinetic analysis, Asian patients had approximately 55% higher plasma eltrombopag AUC(0-) values as compared to patients of other races who were predominantly Caucasian (see section 4.2). Eltrombopag is absorbed with a peak concentration occurring 2 to 6 hours after oral administration. topotecan and methotrexate) substrates should be undertaken with caution (see section 5.2). ENABLE 1 utilised peginterferon alfa-2a plus ribavirin for antiviral treatment and ENABLE 2 utilised peginterferon alfa-2b plus ribavirin. Based on estimates from the population pharmacokinetic analysis, Asian ITP patients had approximately 49% higher plasma eltrombopag AUC(0-) values as compared to non-Asian patients who were predominantly Caucasian (see section 4.2). In controlled studies in thrombocytopenic patients with HCV (n=1,439), 38 out of 955 patients (4%) treated with eltrombopag experienced a TEE and 6 out of 484 patients (1%) in the placebo group experienced TEEs. In addition, patients could taper off concomitant ITP medicinal products and receive rescue treatments as dictated by local standard of care. Patients were permitted to reduce or discontinue baseline ITP therapy only during the open-label phase of the study and 53% (8/15) of patients were able to reduce (n=1) or discontinue (n=7) baseline ITP therapy, mainly corticosteroids, without needing rescue therapy. Following identification of a stable dose of eltrombopag, full blood count (FBC) with white blood cell count (WBC) differential should be performed monthly. Treatment-related cataracts were detected in rodents and were dose and time-dependent. Eltrombopag treatment should be terminated when antiviral therapy is discontinued unless otherwise justified. Severe aplastic anaemia in adult patients. In studies utilising human liver microsomes, eltrombopag (up to 100 μM) showed no in vitro inhibition of the CYP450 enzymes 1A2, 2A6, 2C19, 2D6, 2E1, 3A4/5, and 4A9/11 and was an inhibitor of CYP2C8 and CYP2C9 as measured using paclitaxel and diclofenac as the probe substrates. Eltrombopag should be discontinued if ALT levels increase (≥3 times the upper limit of normal [x ULN] in patients with normal liver function, or ≥3 x baseline or >5 x ULN, whichever is the lower, in patients with pre-treatment elevations in transaminases) and are: • accompanied by increased direct bilirubin, or. REVATIO (sildenafil) Tablets: REVATIO is formulated as white, film-coated round tablets for oral administration. When suggestions are available use up and down arrows to review and ENTER to select. The information provided here is accurate, up-to-date and complete, however, it should not be treated as a substitute for professional medical advice, diagnosis or treatment. Revlin M Tablet may also be used for purposes not listed in this medication guide. In the single-arm phase II monotherapy refractory SAA study, concurrent ALT or AST >3 x ULN with total (indirect) bilirubin >1.5 x ULN were reported in 5% of patients. The most common adverse reactions occurring in at least 10% of patients included headache, anaemia, decreased appetite, cough, nausea, diarrhoea, hyperbilirubinaemia, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza-like illness, asthenia, chills and oedema. In certain people, it can induce allergies. This medicinal product does not require any special storage conditions. The dose of eltrombopag should be adjusted in 25 mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics. In both HCV studies, a significantly greater proportion of patients treated with eltrombopag (n=201, 21%) achieved SVR compared to those treated with placebo (n=65, 13%) (see Table 7). Nine of these patients achieved a multi-lineage response, 4 of the 9 remain on treatment and 5 tapered off treatment with eltrombopag and maintained the response (median follow up: 20.6 months, range: 5.7 to 22.5 months). Plasma eltrombopag concentration-time data collected in 590 patients with HCV enrolled in phase III studies TPL103922/ENABLE 1 and TPL108390/ENABLE 2 were combined with data from patients with HCV enrolled in the phase II study TPL102357 and healthy adult patients in a population PK analysis. In vitro studies suggest that CYP1A2 and CYP2C8 are responsible for oxidative metabolism of eltrombopag. For TPO-R agonists there is a concern that they may stimulate the progression of existing haematopoietic malignancies such as MDS. Overview Information Choline is similar to the B vitamins.It can be made in the liver.It is also found in foods such as liver, muscle meats, fish, nuts, beans, peas, spinach, wheat germ, and eggs. Compared to healthy volunteers, patients with mild hepatic impairment had approximately 111% (95% CI: 45% to 283%) higher plasma eltrombopag AUC(0-) values and patients with moderate hepatic impairment had approximately 183% (95% CI: 90% to 459%) higher plasma eltrombopag AUC(0-) values. The non-medicinal components include cornstarch, iron oxide yellow, iron oxide red, lactose, potato starch, magnesium stearate, and talc. It is also prescribed for absence of infantile spasms. The co-administration of 600 mg ciclosporin decreased the Cmax and the AUCinf of eltrombopag by 39% and 24%, respectively. Packaging Size: 7 tablets in 1 strip. By continuing to browse the site you are agreeing to our policy on the use of cookies. The respective interferon summary of product characteristics should be referenced for discontinuation criteria. Administration of eltrombopag concomitantly with antacids and other products containing polyvalent cations such as dairy products and mineral supplements significantly reduces eltrombopag exposure (see section 4.2). Relispas Tablet contains Dicyclomine and Mefenamic Acid as active ingredients. Revolade is used in patients who did not respond to or had received multiple courses of immunosuppressive therapy (medicines that lower the body’s immune defences) and cannot receive haematopoietic (blood) stem cell transplantation. Wait 2 weeks to assess the effects of this and any subsequent dose adjustments. Haematological response requires dose titration, generally up to 150 mg, and may take up to 16 weeks after starting eltrombopag (see section 5.1). The remaining 10 patients had insufficient platelet response to prior therapies. Medicinal products used in the treatment of ITP in combination with eltrombopag in clinical studies included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. Eltrombopag is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease in preparation for invasive procedures. Revital H, the leading brand from Sun Pharma Consumer Healthcare, is one of the most trusted brands amongst millions of consumers. It is advised that the doses are taken exactly when they are supposed to be taken to ensure that the medicine works effectively. Eltrombopag is a substrate for BCRP, but is not a substrate for P-glycoprotein or OATP1B1. Renal effects were not observed in rats after 28 weeks or in dogs after 52 weeks at exposures 4 and 2 times the human clinical exposure in adult ITP patients and 3 and 2 times the human clinical exposure in paediatric ITP patients at 75 mg/day and 2 times and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC. Overall, total bilirubin ≥1.5 x ULN was reported in 76% and 50% of the eltrombopag and placebo groups, respectively. Unchanged parent compound (eltrombopag) is not detected in urine. Administration of eltrombopag 75 mg once daily for 5 days with a single 10 mg dose of the OATP1B1 and BCRP substrate rosuvastatin to 39 healthy adult subjects increased plasma rosuvastatin Cmax 103% (90% confidence interval [CI]: 82%, 126%) and AUC0-∞ 55% (90% CI: 42%, 69%). Over 50% of responders who were transfusion-dependent at baseline, had >80% reduction in both platelet and RBC transfusion requirements compared to baseline. Following administration of a single 50 mg dose, the AUC0-∞ of eltrombopag was 32% to 36% lower in patients with mild to moderate renal impairment, and 60% lower in patients with severe renal impairment compared with healthy volunteers. Unbound eltrombopag (active) concentrations for this highly protein-bound medicinal product were not measured. At baseline, more than 70% of ITP patients in each treatment group reported any bleeding (WHO Grades 1-4) and more than 20% reported clinically significant bleeding (WHO Grades 2-4), respectively. 288 talking about this. It is used to treat status epilepticus. Fifty-four percent of the eltrombopag-treated patients and 13% of placebo-treated patients achieved this level of response after 6 weeks of treatment. The most common adverse reactions in paediatric ITP patients 1 year and older (≥3% and greater than placebo) were upper respiratory tract infection, nasopharyngitis, cough, pyrexia, abdominal pain, oropharyngeal pain, toothache and rhinorrhoea. Addictive medicines are classified under schedule H or X in India by the government. The proportion of eltrombopag-treated patients with any bleeding (Grades 1-4) and clinically significant bleeding (Grades 2-4) was reduced from baseline by approximately 50% from Day 15 to the end of treatment throughout the 6-month treatment period. Revolade 25 mg Tablet Uses. The corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): 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); not known (cannot be estimated from the available data). Haematological response was defined as meeting one or more of the following criteria: 1) platelet count increases to 20,000/µl above baseline or stable platelet counts with transfusion independence for a minimum of 8 weeks; 2) haemoglobin increase by >1.5g/dl, or a reduction in ≥4 units of red blood cell (RBC) transfusions for 8 consecutive weeks; 3) absolute neutrophil count (ANC) increase of 100% or an ANC increase >0.5 x 109/l. Progression to MDS/AML in patients with hepatic impairment ( see section 5.2 ) most reactions. Starch, magnesium, aluminium, selenium and zinc ) ( see section 5.3 ) free! Available use up and log in in accordance with dosing and administration recommendations ( see subsection... Bcrp, but is not recommended for use in children under the age of year. To occur in SAA patients agonists there is a daily dose by 50 % was recommended dosage until seizures controlled. 2:1 eltrombopag ( n=76 ) to placebo ( n=38 ) in both studies were! 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