ASH Clinical News July 2017 Bonus Issue | Page 8

Important Safety Information for PROMACTA ® (eltrombopag) (continued)
Thrombotic/Thromboembolic Complications
Thrombotic/thromboembolic complications may result from increases in platelet counts with PROMACTA. Reported thrombotic/
thromboembolic complications included both venous and arterial events, and were observed at low and at normal platelet counts.
Consider the potential for an increased risk of thromboembolism when administering PROMACTA to patients with known risk
factors for thromboembolism. To minimize the risk for thrombotic/thromboembolic complications, do not use PROMACTA in an
attempt to normalize platelet counts. Follow the dose-adjustment guidelines to achieve and maintain target platelet counts.
In 2 controlled clinical trials in patients with chronic hepatitis C and thrombocytopenia, 3% (31/955) treated with PROMACTA
experienced a thrombotic event compared to 1% (5/484) on placebo. The majority of events were of the portal venous system
(1% in patients treated with PROMACTA vs <1% for placebo).
In a controlled trial in patients with chronic liver disease undergoing elective invasive procedures (N=292), 7 thrombotic
complications (6 patients) were reported within the group that received PROMACTA and 3 thrombotic complications (2 patients)
within the placebo group. All of the thrombotic complications reported in the group that received PROMACTA were portal vein
thrombosis, with thrombotic complications occurring in 5 of the 6 patients at a platelet count above 200 × 10 9 /L. PROMACTA is
not indicated for the treatment of thrombocytopenia in patients with chronic liver disease in preparation for invasive procedures.
Cataracts
In the 3 controlled clinical trials in chronic ITP, cataracts developed or worsened in 15 (7%) patients who received 50-mg
PROMACTA daily and 8 (7%) placebo-group patients. In the extension trial, cataracts developed or worsened in 11% of patients
who underwent ocular examination prior to therapy with PROMACTA.
Cataracts were observed in toxicology studies of eltrombopag in rodents. Perform a baseline ocular examination prior to
administration of PROMACTA and, during therapy with PROMACTA, regularly monitor patients for signs and symptoms of cataracts.
Laboratory Monitoring
In patients with chronic ITP, monitor serum liver tests. During therapy with PROMACTA, assess complete blood counts (CBCs)
with differentials, including platelet counts, weekly until a stable platelet count has been achieved. Monitor platelet counts
monthly thereafter. Obtain CBCs with differentials, including platelet counts, weekly for at least 4 weeks following discontinuation
of PROMACTA.
When switching between the oral suspension and tablet, assess platelet counts weekly for 2 weeks, then follow standard
monthly monitoring.
Drug Interactions
PROMACTA must be taken at least 2 hours before or 4 hours after any medications or products containing polyvalent cations
such as antacids, calcium-rich foods, and mineral supplements.
Adverse Reactions
The most common adverse reactions in 3 placebo-controlled clinical trials in adult patients with chronic ITP (≥3% and greater than
placebo) for PROMACTA vs placebo were nausea (9% vs 3%), diarrhea (9% vs 7%), upper respiratory tract infection (7% vs 6%),
vomiting (6% vs <1%), increased ALT (5% vs 3%), myalgia (5% vs 2%), urinary tract infection (5% vs 3%), oropharyngeal pain (4%
vs 3%), increased AST (4% vs 2%), pharyngitis (4% vs 2%), back pain (3% vs 2%), influenza (3% vs 2%), paresthesia (3% vs 2%), and
rash (3% vs 2%).
The most common adverse reactions in 2 placebo-controlled clinical trials in chronic ITP patients 1 year and older (≥3% and
greater than placebo) for PROMACTA vs placebo were upper respiratory tract infection (17% vs 6%), nasopharyngitis (12% vs 4%),
cough (9% vs 0%), diarrhea (9% vs 2%), pyrexia (9% vs 8%), rhinitis (9% vs 6%), abdominal pain (8% vs 4%), oropharyngeal pain (8%
vs 2%), toothache (6% vs 0%), ALT increased (6% vs 0%), rash (5% vs 2%), AST increased (4% vs 0%), and rhinorrhea (4% vs 0%).
Please see Important Safety Information for PROMACTA, including Boxed WARNING,
and Brief Summary of full Prescribing Information on adjacent pages.
Reference: 1. Promacta [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2017.
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936-1080 
© 2017 Novartis 
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