Nplate (romiplostim)
Thrombopoietic Growth Factors Subcutaneous Vial (Ea)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Romiplostim, a biosynthetic (recombinant DNA-derived) Fc-peptide fusion protein, is a thrombopoietin-receptor agonist.
Romiplostim, a biosynthetic (recombinant DNA-derived) Fc-peptide fusion protein, is a thrombopoietin receptor agonist (TPO-RA). Romiplostim binds to the thrombopoietin receptor (also known as cMp1) and activates intracellular transcriptional pathways leading to increased platelet production. Romiplostim is produced by recombinant DNA technology in Escherichia coli and contains 2 identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain covalently linked at the C-terminus to a peptide containing 2 thrombopoietin receptor-binding domains.
Romiplostim has no amino acid sequence homology to endogenous thrombopoietin.
USES: This medication is used to treat a certain blood disorder (idiopathic thrombocytopenia purpura - ITP) in which the blood does not clot properly due to a lack of platelets. Platelets are a type of blood cell needed to form blood clots and prevent bleeding. Romiplostim decreases your risk of bleeding by increasing the number of platelets.
Romiplostim is also given to people whose ability to make platelets is reduced due to exposure to large amounts of radiation. Romiplostim acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets.
Generic name: romiplostim
Pronunciation: (ROE-mi-PLOE-stim)
Drug class: Thrombopoietic Growth Factors
Therapeutic class: Hematological Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Nplate
Indications
The following indications are listed for Nplate:
- Hematopoietic Syndrome Of Acute Radiation Syndrome
- Severe Thrombocytopenia In Refractory Chronic Immune Thrombocytopenia Purpura
Also known as: Bone Marrow Syndrome Of Acute Radiation Syndrome, Patient With Acute Exposure To Myelosuppressive Dose Of Radiation, Severe Thrombocytopenia In Refractory Chronic Idiopathic Thrombocytopenia Purpura.
Dosing
No dosing information is available for this tab.
No dosing information is available for this tab.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Nplate 250 Mcg Vial | Maintenance | Inject 1 mcg/kg by subcutaneous route once weekly. |
| Nplate 500 Mcg Vial | Maintenance | Inject 1 mcg/kg by subcutaneous route once weekly. |
| Nplate 125 Mcg Vial | Maintenance | Inject 1 mcg/kg by subcutaneous route once weekly. |
No dosing information is available for this tab.
Drug interactions
Romiplostim may be used with other drugs to treat immune thrombocytopenia (ITP) such as corticosteroids, danazol, azathioprine, immune globulin IV (IGIV), and Rho(D) immune globulin.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
There are no contraindication contraindications for this drug.
- Myelodysplastic syndrome
- Thromboembolic disorder
- Increased reticulin bone marrow deposition
- Thrombocytosis
Adverse reactions
The most common adverse reactions in adults receiving romiplostim in clinical studies (>=5% higher patient incidence than placebo) were arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, and paresthesia.
The most common adverse reactions in pediatric patients receiving romiplostim in clinical studies (>=25%) were contusion, upper respiratory tract infection, and oropharyngeal pain.
Less Frequent
- Increased reticulin bone marrow deposition
Rare or Very Rare
- Acute myocardial infarction
- Anaphylaxis
- Angioedema
- Erythromelalgia
- Hypersensitivity drug reaction
- Portal vein thrombosis
- Thromboembolic disorder
- Thrombotic disorder
More Frequent
- Acute abdominal pain
- Arthralgia
- Dizziness
- Dyspepsia
- Headache disorder
- Insomnia
- Myalgia
- Pain in oropharynx
- Paresthesia
- Shoulder pain
- Upper respiratory infection
Less Frequent
- Bronchitis
- Cough
- Diarrhea
- Nausea
- Pain in extremities
- Peripheral edema
- Purpura
- Sinusitis
- Skin rash
- Urticaria
- Vomiting
Precautions
No enhanced messaging available.
Safety and efficacy of romiplostim have not been established in pediatric patients <1 year of age with ITP.
The use of romiplostim in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation is based on efficacy studies conducted in animals; studies in humans could not be conducted because of ethical and feasibility reasons.
Available studies in humans are insufficient to inform a drug-associated risk if romiplostim is used during pregnancy. However, the drug may cause fetal harm based on animal studies; thrombocytosis, postimplantation loss, and increased pup mortality have been reported in animals.
It is not known if romiplostim is distributed into human milk or whether the drug has any effects on the breast-fed infant or on milk production; however, human immunoglobulin G antibody (IgG) is distributed into milk. Because of the potential for serious adverse reactions to romiplostim in nursing infants, advise women not to breast-feed during treatment with romiplostim.
No substantial differences in safety and efficacy in geriatric patients >=65 years of age relative to younger adults, but increased sensitivity cannot be ruled out.
ICD codes
| Code | Type | Description |
|---|---|---|
| Hematopoietic syndrome of acute radiation syndrome | ||
| T66.xxxA | ICD10CM | Radiation sickness, unspecified, initial encounter |
| T66.xxxD | ICD10CM | Radiation sickness, unspecified, subsequent encounter |
| Severe thrombocytopenia in refractory chronic immune thrombocytopenia purpura | ||
| D69.3 | ICD10CM | Immune thrombocytopenic purpura |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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