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Nplate (Romiplostim Subcutaneous) - Side Effects and Adverse Reactions



Clinical Trials Experience

Serious adverse reactions associated with Nplate in ITP clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate discontinuation [see Warnings and Precautions (5.3, 5.4)].

The data described below reflect Nplate exposure to 271 patients with chronic ITP, aged 18 to 88, of whom 62% were female.  Nplate was studied in two randomized, placebo-controlled, double-blind studies that were identical in design, with the exception that Study 1 evaluated nonsplenectomized patients with ITP and Study 2 evaluated splenectomized patients with ITP.  Data are also reported from an open-label, single-arm study in which patients received Nplate over an extended period of time.  Overall, Nplate was administered to 114 patients for at least 52 weeks and 53 patients for at least 96 weeks.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In the placebo-controlled studies, headache was the most commonly reported adverse drug reaction, occurring in 35% of patients receiving Nplate and 32% of patients receiving placebo. Headaches were usually of mild or moderate severity.  Table 2 presents adverse drug reactions from Studies 1 and 2 with a ≥ 5% higher patient incidence in Nplate versus placebo. The majority of these adverse drug reactions were mild to moderate in severity.

Table 2. Adverse Drug Reactions Identified in Two Placebo-Controlled Studies

Preferred Term


(n = 84)



(n = 41)

 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%
 Paresthesia  6%  0%

Among 142 patients with chronic ITP who received Nplate in the single-arm extension study, the incidence rates of the adverse reactions occurred in a pattern similar to those reported in the placebo-controlled clinical studies.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Nplate.  Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Erythromelalgia
  • Hypersensitivity
  • Angioedema


As with all therapeutic proteins, patients may develop antibodies to the therapeutic protein.  Patients were screened for immunogenicity to romiplostim using a BIAcore-based biosensor immunoassay.  This assay is capable of detecting both high- and low-affinity binding antibodies that bind to romiplostim and cross-react with TPO.  The samples from patients that tested positive for binding antibodies were further evaluated for neutralizing capacity using a cell-based bioassay.

In clinical studies, the incidence of preexisting antibodies to romiplostim was 8% (43/537) and the incidence of binding antibody development during Nplate treatment was 6% (31/537).  The incidence of preexisting antibodies to endogenous TPO was 5% (29/537) and the incidence of binding antibody development to endogenous TPO during Nplate treatment was 4% (21/537).  Of the patients with positive binding antibodies that developed to romiplostim or to TPO, two (0.4%) patients had neutralizing activity to romiplostim and none had neutralizing activity to TPO.  No correlation was observed between antibody activity and clinical effectiveness or safety.

Immunogenicity assay results are highly dependent on the sensitivity and specificity of the assay used in detection and may be influenced by several factors, including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to romiplostim with the incidence of antibodies to other products may be misleading.


Below is a sample of reports where side effects / adverse reactions may be related to Nplate. The information is not vetted and should not be considered as verified clinical evidence.

Possible Nplate side effects / adverse reactions in 88 year old female

Reported by a physician from France on 2011-10-03

Patient: 88 year old female

Reactions: Phlebitis

Adverse event resulted in: hospitalization

Suspect drug(s):

Possible Nplate side effects / adverse reactions in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-03

Patient: 56 year old female

Reactions: Biopsy Bone Marrow Abnormal, Neuropathy Peripheral, Hypovitaminosis

Suspect drug(s):

Other drugs received by patient: Calcium + Vitamin D /01483701/; Reston /00000401/; Lexapro; Synthroid; Vicodin

Possible Nplate side effects / adverse reactions in 83 year old male

Reported by a physician from Netherlands on 2011-10-03

Patient: 83 year old male weighing 84.0 kg (184.8 pounds)

Reactions: Pulmonary Embolism

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):

Other drugs received by patient: Cyklokapron

See index of all Nplate side effect reports >>

Drug label data at the top of this Page last updated: 2013-05-30

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