PharmAlert.net

PharmAlert Xagena

XagenaNewsletter
Medical Meeting
Xagena Mappa
Reumabase.it

Eltrombopag for the treatment of thrombocytopenia and severe aplastic anemia: important safety information


Eltrombopag ( United States: Promacta; Europe: Revolade ), in addition to the approval for severe aplastic anemia in the U.S., is indicated for the treatment of thrombocytopenia in patients with: chronic immune ( idiopathic ) thrombocytopenia ( ITP ) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Eltrombopag should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

Eltrombopag should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of Interferon-based therapy or limits the ability to maintain Interferon-based therapy. Safety and efficacy have not been established in combination with direct acting antiviral agents used without Interferon for treatment of chronic hepatitis C.

Important safety information

Warning: risk for hepatic decompensation in patients with chronic hepatitis C - In patients with chronic hepatitis C, Eltrombopag in combination with Interferon and Ribavirin may increase the risk of hepatic decompensation.

Hepatotoxicity - Eltrombopag can cause liver enzyme elevation, therefore, monitoring of liver function before and during therapy is required. If abnormalities are confirmed, monitoring of serum liver tests should continue until resolved or stabilised. Eltrombopag should be discontinued if abnormalities are progressively increasing, persistent, or accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation. Hepatotoxicity may reoccur if Eltrombopag is reinitiated.

Thrombotic / thromboembolic complications – Thrombotic / thromboembolic complications may result from increases in platelet counts with Eltrombopag. Reported thrombotic / thromboembolic complications included both venous and arterial events and were observed at low and normal platelet counts. The potential for an increased risk of thromboembolism when administering Eltrombopag to patients with known risk factors for thromboembolism should be considered. To minimise the risk for thrombotic / thromboembolic complications, Eltrombopag should not be used in an attempt to normalise platelet counts.

Cataracts - Cataracts have been reported in patients taking Eltrombopag. A baseline ocular examination should be performed prior to administration of Eltrombopag. During therapy with Eltrombopag, regularly monitoring of patients for signs and symptoms of cataracts is required.

Drug Interactions - Eltrombopag must not be taken within four hours of any medications or products containing polyvalent cations such as antacids, dairy products, and mineral supplements.

Adverse reactions - The most common adverse reactions ( 20% or more ) in a single-arm, open-label trial in 43 patients with severe aplastic anemia who received Eltrombopag were: nausea ( 33% ), fatigue ( 28% ), cough ( 23% ), diarrhoea ( 21% ), and headache ( 21% ). In this trial, patients had bone marrow aspirates evaluated for cytogenetic abnormalities. Eight patients had a new cytogenetic abnormality reported, including five patients who had complex changes in chromosome 7. If new cytogenetic abnormalities are observed, discontinuation of Eltrombopag should be considered.

The most common adverse reactions in three placebo-controlled clinical trials in chronic immune ( idiopathic ) thrombocytopenia patients ( 3% or more, and greater than placebo ) for Eltrombopag versus placebo were: nausea ( 9% vs 3% ), diarrhoea ( 9% vs 7% ), upper respiratory tract infection ( 7% vs 6% ), vomiting ( 6% vs less than 1% ), increased alanine aminotransferase ( ALT ) ( 5% vs 3% ), myalgia ( 5% vs 2% ), urinary tract infection ( 5% vs 3% ), oropharyngeal pain ( 4% vs 3% ), increased aspartate aminotransferase ( AST ) ( 4% vs 2% ), pharyngitis ( 4% vs 2% ), back pain ( 3% vs 2% ), influenza ( 3% vs 2% ), paraesthesia ( 3% vs 2% ), and rash ( 3% vs 2% ).

The most common adverse reactions in two randomised, placebo-controlled clinical trials in thrombocytopenic patients with chronic hepatitis C ( 10% or more, and greater than placebo ) for Eltrombopag versus placebo were: anaemia ( 40% vs. 35% ), pyrexia ( 30% vs. 24% ), fatigue ( 28% vs. 23% ), headache ( 21% vs. 20% ), nausea ( 19% vs. 14% ), diarrhoea ( 19% vs. 11% ), decreased appetite ( 18% vs. 14% ), influenza-like illness ( 18% vs. 16% ), asthenia ( 16% vs. 13% ), insomnia ( 16% vs. 15% ), cough ( 15% vs. 12% ), pruritus ( 15% vs. 13% ), chills ( 14% vs. 9% ), myalgia ( 12% vs. 10% ), alopecia ( 10% vs. 6% ), and peripheral oedema ( 10% vs. 5% ). ( Xagena )

Source: GSK, 2014

XagenaMedicine_2014



Indietro