Nplate Side Effects

Generic Name: romiplostim

Please note - some side effects for Nplate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Nplate - for the Consumer

NPlate

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using NPlate:

Dizziness; headache; indigestion; joint pain; muscle tenderness or weakness; shoulder pain; stomach pain or upset; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using NPlate:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blurred vision; chest pain; leg or arm pain; numbness or tingling of the hands and feet; one-sided weakness; severe or persistent dizziness or headache; unusual bruising or bleeding; unusual weakness or tiredness; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Nplate Side Effects - for the Professional

Nplate

Clinical Studies Experience

Serious adverse reactions associated with Nplate in clinical studies were bone marrow reticulin deposition and worsening thrombocytopenia after Nplate discontinuation [see Warnings and Precautions (5.1, 5.2)].

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 studies 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	Nplate (n = 84)	Placebo (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

Immunogenicity

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.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Headaches were usually of mild or moderate severity.

Nervous system side effects including headaches (35%), dizziness (17%), insomnia (16%), and paresthesia (6%) have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (26%) and myalgia (14%) have been reported.

Other

Other side effects have been extremity pain (13%), abdominal pain (11%), and shoulder pain (8%). Bone marrow reticulin deposition and worsening thrombocytopenia have been reported after romiplostim discontinuation.

Immunologic

In clinical studies, the incidence of preexisting antibodies to romiplostim was 8% and the incidence of binding antibody development during romiplostim treatment was 10%. The incidence of preexisting antibodies to endogenous TPO was 5% and the incidence of binding antibody development to endogenous TPO during romiplostim treatment was 5%. Of the patients with positive antibodies to romiplostim or to TPO, (0.4%) had neutralizing activity to romiplostim and none had neutralizing activity to TPO. No correlation was observed between antibody activity and clinical effectiveness or safety.

Immunologic side effects for all therapeutic proteins include the development of antibodies to the therapeutic protein.

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