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Drug overview for NPLATE (romiplostim):
Generic name: ROMIPLOSTIM (ROE-mi-PLOE-stim)
Drug class: Thrombopoietic Growth Factors
Therapeutic class: Hematological Agents
Romiplostim, a biosynthetic (recombinant DNA-derived) Fc-peptide fusion protein, is a thrombopoietin-receptor agonist.
No enhanced Uses information available for this drug.
Generic name: ROMIPLOSTIM (ROE-mi-PLOE-stim)
Drug class: Thrombopoietic Growth Factors
Therapeutic class: Hematological Agents
Romiplostim, a biosynthetic (recombinant DNA-derived) Fc-peptide fusion protein, is a thrombopoietin-receptor agonist.
No enhanced Uses information available for this drug.
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The following indications for NPLATE (romiplostim) have been approved by the FDA:
Indications:
Hematopoietic syndrome of acute radiation syndrome
Severe thrombocytopenia in refractory chronic immune thrombocytopenia purpura
Professional Synonyms:
Bone marrow syndrome of acute radiation syndrome
Patient with acute exposure to myelosuppressive dose of radiation
Severe thrombocytopenia in refractory chronic idiopathic thrombocytopenia purpura
Indications:
Hematopoietic syndrome of acute radiation syndrome
Severe thrombocytopenia in refractory chronic immune thrombocytopenia purpura
Professional Synonyms:
Bone marrow syndrome of acute radiation syndrome
Patient with acute exposure to myelosuppressive dose of radiation
Severe thrombocytopenia in refractory chronic idiopathic thrombocytopenia purpura
The following dosing information is available for NPLATE (romiplostim):
The recommended initial adult dosage of romiplostim for the treatment of ITP is 1 mcg/kg weekly as a subcutaneous injection based on actual body weight. Dosage adjustments are based on platelet count monitoring. Adjust the weekly dose of romiplostim in increments of 1 mcg/kg (up to a maximum of 10 mcg/kg weekly) until the patient achieves a platelet count >=50,000/mm3.
Reduce the dosage by 1 mcg/kg weekly if the platelet count is >200,000/mm3 and <=400,000/mm3 for 2 consecutive weeks. Do not administer romiplostim if the platelet count is >400,000/mm3; assess platelet counts weekly and resume romiplostim at a dosage reduced by 1 mcg/kg weekly once the platelet count decreases to <200,000/mm3.
Romiplostim should be discontinued if, after 4 weeks of therapy at the maximum recommended dosage of 10 mcg/kg weekly, the platelet count has not increased to a level sufficient to avoid clinically important bleeding.
The recommended initial dosage of romiplostim for the treatment of ITP in pediatric patients >=1 year of age is 1 mcg/kg weekly as a subcutaneous injection based on actual body weight. Dosage adjustments are based on platelet count monitoring and changes in body weight. The manufacturer states that reassessment of body weight in pediatric patients is recommended every 12 weeks.
Adjust the weekly dose of romiplostim in increments of 1 mcg/kg (up to a maximum of 10 mcg/kg weekly) until the patient achieves a platelet count >=50,000/mm3. Reduce the dosage by 1 mcg/kg weekly if the platelet count is >200,000/mm3 and <=400,000/mm3 for 2 consecutive weeks. Do not administer romiplostim if the platelet count is >400,000/mm3; assess platelet counts weekly and resume therapy at a dosage reduced by 1 mcg/kg weekly once the platelet count decreases to <200,000/mm3.
Romiplostim should be discontinued if, after 4 weeks of therapy at the maximum recommended dosage of 10 mcg/kg weekly, the platelet count has not increased to a level sufficient to avoid clinically important bleeding.
Reduce the dosage by 1 mcg/kg weekly if the platelet count is >200,000/mm3 and <=400,000/mm3 for 2 consecutive weeks. Do not administer romiplostim if the platelet count is >400,000/mm3; assess platelet counts weekly and resume romiplostim at a dosage reduced by 1 mcg/kg weekly once the platelet count decreases to <200,000/mm3.
Romiplostim should be discontinued if, after 4 weeks of therapy at the maximum recommended dosage of 10 mcg/kg weekly, the platelet count has not increased to a level sufficient to avoid clinically important bleeding.
The recommended initial dosage of romiplostim for the treatment of ITP in pediatric patients >=1 year of age is 1 mcg/kg weekly as a subcutaneous injection based on actual body weight. Dosage adjustments are based on platelet count monitoring and changes in body weight. The manufacturer states that reassessment of body weight in pediatric patients is recommended every 12 weeks.
Adjust the weekly dose of romiplostim in increments of 1 mcg/kg (up to a maximum of 10 mcg/kg weekly) until the patient achieves a platelet count >=50,000/mm3. Reduce the dosage by 1 mcg/kg weekly if the platelet count is >200,000/mm3 and <=400,000/mm3 for 2 consecutive weeks. Do not administer romiplostim if the platelet count is >400,000/mm3; assess platelet counts weekly and resume therapy at a dosage reduced by 1 mcg/kg weekly once the platelet count decreases to <200,000/mm3.
Romiplostim should be discontinued if, after 4 weeks of therapy at the maximum recommended dosage of 10 mcg/kg weekly, the platelet count has not increased to a level sufficient to avoid clinically important bleeding.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| NPLATE 250 MCG VIAL | Maintenance | Adults inject 1 mcg/kg by subcutaneous route once weekly |
| NPLATE 500 MCG VIAL | Maintenance | Adults inject 1 mcg/kg by subcutaneous route once weekly |
| NPLATE 125 MCG VIAL | Maintenance | Adults inject 1 mcg/kg by subcutaneous route once weekly |
No generic dosing information available.
The following drug interaction information is available for NPLATE (romiplostim):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for NPLATE (romiplostim):
Drug contraindication overview.
*None.
*None.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Myelodysplastic syndrome |
| Thromboembolic disorder |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Increased reticulin bone marrow deposition |
| Thrombocytosis |
The following adverse reaction information is available for NPLATE (romiplostim):
Adverse reaction overview.
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.
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.
There are 9 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Increased reticulin bone marrow deposition |
| Rare/Very Rare |
|---|
|
Acute myocardial infarction Anaphylaxis Angioedema Erythromelalgia Hypersensitivity drug reaction Portal vein thrombosis Thromboembolic disorder Thrombotic disorder |
There are 22 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Arthralgia Dizziness Dyspepsia Headache disorder Insomnia Myalgia Pain in oropharynx Paresthesia Shoulder pain Upper respiratory infection |
Bronchitis Cough Diarrhea Nausea Pain in extremities Peripheral edema Purpura Sinusitis Skin rash Urticaria Vomiting |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for NPLATE (romiplostim):
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.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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.
The following prioritized warning is available for NPLATE (romiplostim):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for NPLATE (romiplostim)'s list of indications:
| Hematopoietic syndrome of acute radiation syndrome | |
| T66.xxxA | Radiation sickness, unspecified, initial encounter |
| T66.xxxD | Radiation sickness, unspecified, subsequent encounter |
| Severe thrombocytopenia in refractory chronic ITP | |
| D69.3 | Immune thrombocytopenic purpura |
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