Important Safety Information
Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia
- In Nplate® (romiplostim) clinical trials of patients with myelodysplastic syndromes
(MDS) and severe thrombocytopenia, progression from MDS to acute myelogenous leukemia (AML) has
been observed.
- Nplate® is not indicated for the treatment of thrombocytopenia due to MDS or any
cause of thrombocytopenia other than ITP.
Thrombotic/Thromboembolic Complications
- Thrombotic/thromboembolic complications may result from increases in platelet counts with
Nplate® use. Portal vein thrombosis has been reported in patients with chronic liver
disease receiving Nplate®.
- To minimize the risk for thrombotic/thromboembolic complications, do not use Nplate® in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and
maintain a platelet count of ≥ 50 x 109/L.
Loss of Response to Nplate®
- Hyporesponsiveness or failure to maintain a platelet response with Nplate® should
prompt a search for causative factors, including neutralizing antibodies to Nplate®.
- To detect antibody formation, submit blood samples to Amgen (1‑800‑772‑64361‑800‑772‑6436). Amgen will assay these samples for antibodies to
Nplate® and thrombopoietin (TPO).
- Discontinue Nplate® if the platelet count does not increase to a level sufficient to
avoid clinically important bleeding after 4 weeks at the highest weekly dose of 10 mcg/kg.
Adverse Reactions
Adult ITP
- In the placebo-controlled trials of adult ITP patients, headache was the most commonly reported
adverse drug reaction, occurring in 35% of patients receiving Nplate® and 32% of
patients receiving placebo. Adverse drug reactions in adults with a ≥ 5% higher patient
incidence in Nplate® versus placebo were Arthralgia (26%, 20%), Dizziness (17%, 0%),
Insomnia (16%, 7%), Myalgia (14%, 2%), Pain in Extremity (13%, 5%), Abdominal Pain (11%, 0%),
Shoulder Pain (8%, 0%), Dyspepsia (7%, 0%), and Paresthesia (6%, 0%).
- The safety profile of Nplate® was similar across patients, regardless of ITP
duration. The following adverse reactions (at least 5% incidence and at least 5% more frequent
with Nplate® compared with placebo or standard of care) occurred in
Nplate® patients with ITP duration up to 12 months: bronchitis, sinusitis, vomiting,
arthralgia, myalgia, headache, dizziness, diarrhea, upper respiratory tract infection, cough,
nausea and oropharyngeal pain. The adverse reaction of thrombocytosis occurred with an incidence
of 2% in adults with ITP duration up to 12 months.
Pediatric ITP
- The most common adverse reactions experienced by ≥ 5% of patients receiving Nplate® with ≥ 5% higher incidence in the Nplate® arm across the two placebo-controlled
trials were contusion (41%), upper respiratory tract infection (31%), oropharyngeal pain (25%),
pyrexia (24%), diarrhea (20%), rash (15%), and upper abdominal pain (14%).
- In pediatric patients of age ≥ 1 year receiving Nplate® for ITP, adverse reactions
with an incidence of ≥ 25% in the two randomized trials were: contusion (41%), upper respiratory
tract infection (31%), and oropharyngeal pain (25%).
- In a long-term, single arm, open label pediatric safety study, headache occurred in 78/203 patients (38%); the incidence rates of other adverse reactions were similar to those reported in the placebo-controlled studies.
Nplate® administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of
Nplate®. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy.
INDICATIONS
Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate® is indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. Nplate® should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate® should not be used in an attempt to normalize platelet counts.
Please see full Prescribing Information and Medication Guide.
