Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 125mcg/vial
- 250mcg/vial
- 500mcg/vial
Chronic Immune Thrombocytopenia (ITP)
Indicated for immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
Initial
- 1 mcg/kg SC qWeek
- Use lowest dose of Nplate to achieve and maintain a platelet count ≥50 x 109/L as necessary to reduce the risk for bleeding
Dose adjustment
- Adjust weekly dose by increments of 1 mcg/kg until platelet count ≥50 x 109/L as necessary to reduce the risk for bleeding; not to exceed maximum weekly dose of 10 mcg/kg
- Median dose of 2 mcg/kg in clinical studies
Determine dose adjustment by platelet count
- Platelets <50 x 109/L: Increase by 1 mcg/kg
- Platelet >200 to ≤400 x 109/L for 2 consecutive weeks: Reduce by 1 mcg/kg
- Platelet >400 x 109/L: Do not give dose; continue weekly platelet assessment, if platelets fall to <200 x 109/L, resume at dose reduced by 1 mcg/kg
- Discontinue if platelet count does not increase to sufficient level in order to avoid clinically important bleeding after 4 weeks at 10 mcg/kg
Hematopoietic Syndrome of Acute Radiation Syndrome
Indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation
10 mcg/kg SC x 1 dose
Administer as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy)
Dosage Modifications
Renal or hepatic impairment: Not studied
Dosing Considerations
Limitations of use
- Not indicated for thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP
- Only use in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding
- Do not use as an attempt to normalize platelet counts
Monitoring parameters
-
CBC, including platelet counts
- During treatment: Obtain weekly during dose adjustment phase, and then monthly once stable dose established
- Discontinuation: Obtain weekly for at least 2 weeks following discontinuation
Aplastic Anemia (Orphan)
Orphan designation for treatment of aplastic anemia
Orphan sponsor
- Amgen Inc; One Amgen Center Drive, Mail Stop 27-2-D; Thousand Oaks, California 91320
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 125mcg/vial
- 250mcg/vial
- 500mcg/vial
Chronic Immune Thrombocytopenia
Indicated for immune thrombocytopenia (ITP) in children ≥1 year for ≥6 months who have responded insufficiently to corticosteroids, immunoglobulins, or splenectomy
Initial
- 1 mcg/kg SC qWeek
- Use actual body weight at initiation of treatment when calculating initial dose
- Use lowest dose to achieve and maintain a platelet count ≥50x 109/L as necessary to reduce the risk for bleeding
- Dose adjustments are based on changes in platelet counts and changes in body weight; reassess body weight q12Weeks
Dose adjustment
- Adjust weekly dose by increments of 1 mcg/kg until platelet count ≥50x 109/L as necessary to reduce the risk for bleeding
- Not to exceed maximum weekly dose of 10 mcg/kg
- Median dose was 5.5 mcg/kg in pediatric clinical trials
-
Determine dose adjustment by platelet count
- Platelets <50 x 109/L: Increase by 1 mcg/kg
- Platelet >200 to ≤400 x 109/L for 2 consecutive weeks: Reduce by 1 mcg/kg
- Platelet >400 x 109/L: Do not give dose; continue weekly platelet assessment, if platelets fall to <200 x 109/L, resume at dose reduced by 1 mcg/kg
Hematopoietic Syndrome of Acute Radiation Syndrome
Indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation
10 mcg/kg SC x 1 dose
Administer as soon as possible after suspected or confirmed exposure to radiation levels >2 gray (Gy)
Dosage Modifications
Renal or hepatic impairment: Not studied
Dosing Considerations
Limitations of use
- Not indicated for thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP
- Only use in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding
- Do not use as an attempt to normalize platelet counts
Monitoring parameters
-
CBC, including platelet counts
- During treatment: Obtain weekly during dose adjustment phase, and then monthly once stable dose established
- Discontinuation: Obtain weekly for at least 2 weeks following discontinuation
Adverse Effects
>10% (Adults)
Headache (35%)
Arthralgia (26%)
Dizziness (17%)
Insomnia (16%)
Myalgia (14%)
Pain in extremity (13%)
Abdominal pain (11%)
>10% (Pediatric)
Contusion (41%)
Upper respiratory tract infection (31%)
Oropharyngeal pain (25%)
Pyrexia (24%)
Diarrhea (20%)
Rash (15%)
Upper abdominal pain (14%)
1-10% (Adults)
Should pain (8%)
Dyspepsia (7%)
Paresthesia (6%)
Thrombocytosis (2%)
>5%
- Bronchitis
- Sinusitis
- Vomiting
- Arthralgia
- Myalgia
- Headache
- Dizziness
- Diarrhea
- Upper respiratory tract infection
- Cough
- Nausea
- Oropharyngeal pain
1-10% (Pediatrics)
Purpura (7%)
Peripheral swelling (7%)
Urticaria (5%)
Ear infection (5%)
Gastroenteritis (5%)
Sinusitis (5%)
Postmarketing Reports
Erythromelalgia
Hypersensitivity reactions including angioedema and anaphylaxis
Warnings
Contraindications
None
Cautions
Progression from myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML) observed in adult clinical trials; not indicated for thrombocytopenia due to MDS or any cause of thrombocytopenia other than chronic ITP
Thrombotic/thromboembolic complications may result from increased platelet counts; portal vein thrombosis reported; to minimize risk, in patients with ITP; do not use romiplostim in attempt to normalize platelet counts; follow dosage guidelines; use caution in patients with history of cerebrovascular disease
Hyporesponsiveness or failure to maintain platelet response should prompt searching for causative factors, including neutralizing antibodies to romiplostim; discontinue if platelet count does not increase to level to avoid clinically important bleeding after 4 weeks of highest weekly dose (ie, 10 mcg/kg/week)
Upon discontinuation of therapy, rebound thrombocytopenia and risk of bleeding may develop; monitor CBCs and platelet counts weekly for at least 2 weeks following discontinuation
May increase risk for bone marrow reticulin formation or progression, which may improve upon discontinuation of therapy
In absence of myelosuppression induced by acute exposure to radiation, administration might cause excessive increases in platelet counts and may cause thrombotic and thromboembolic complications
Pregnancy & Lactation
Pregnancy
Based on findings from animal reproduction studies, fetal harm may occur when administered to pregnant females
Limited available data in pregnant females are insufficient to inform a drug-associated risk of adverse developmental outcomes
Animal data
- Drug crossed placenta, and adverse fetal effects included thrombocytosis, postimplantation loss, and an increase in pup mortality
Lactation
No information available on presence of drug in human milk, effects on breastfed child, or on milk production
Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter neonatal and infant circulation in substantial amounts
Advise women not to breastfeed during treatment
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Fusion antibody-peptide that is a thrombopoietin receptor agonist; stimulates proliferation, differentiation, and activity of monocytes, neutrophils, eoxinophils, and macrophages
Absorption
Peak plasma time
- ITP: 7-50 hr
Accumulation
- ITP: None (3 mcg/kg for 6 weekly doses); unknown at higher doses
Elimination
Half-life
- ITP: 1-34 days (median: 3.5 days)
Administration
SC Preparation
Reconstitution
- Reconstitute with sterile water for injection resulting in a final volume of 500 mcg/mL; do NOT use bacteriostatic water
- 125-mcg vial (actual content is 230 mcg): Reconstitute with 0.44 mL sterile water
- 250-mcg vial (actual content is 375 mcg): Reconstitute with 0.72 mL sterile water
- 500-mcg vial (actual content is 625 mcg): Reconstitute with 1.2 mL sterile water
- Note: Actual vial content includes overfill to ensure delivery of calculated dose
- Gently swirl and invert vial to reconstitute; avoid excess or vigorous agitation; do not shake
- Generally, dissolution takes <2 minutes
- Final concentration of reconstituted vials: 500 mcg/mL
- Reconstituted solution is clear and colorless; visually inspect for particulate matter and/or discoloration; discard if particulate matter and/or discoloration is observed
Further dilute doses <23 mcg
- Further dilution required for doses <23 mcg; NOT for doses ≥23 mcg
- Reconstituted 125-mcg vial: Further dilute with 1.38 mL 0.9% NaCl
- Reconstituted 250-mcg vial: Further dilute with 2.25 mL 0.9% NaCl
- Reconstituted 500-mcg vial: Further dilute with 3.75 mL 0.9% NaCl
- Final concentration of diluted vial: 125 mcg/mL
Calculating volume
- Dose ≥23 mcg: Calculated dose/(500 mcg/mL)
- Dose <23 mcg: Calculated dose/(125 mcg/mL)
SC Administration
For SC administration only
Administer using syringe with 0.01 mL graduations
Round volume to nearest hundredth mL and verify dose
Discard any unused portion; do not pool unused portions from the vials; do not administer more than 1 dose from each vial
Storage
Protect from light
Do not shake
Unopened vials
- Refrigerate at 2-8ºC (36-46ºF) in original carton to protect from light; do not freeze
- If needed, may be stored in original carton at room temperature up to a maximum of 25ºC (77ºF) for up to 30 days; write new expiration on carton
- Once stored at room temperature, do not place back in refrigerator; if not used within 30 days, discard
Reconstituted vials
- Store in original vial at room temperature 25ºC (77ºF) OR
- Refrigerate at 2-8ºC (36-46ºF) for up to 24 hr
Diluted solution (after initial reconstitution)
- Store in syringe at room temperature 25ºC (77ºF) OR
- Refrigerate in original vial at 2-8ºC (36-46ºF) for up to 4 hr
Images
Patient Handout
romiplostim subcutaneous
ROMIPLOSTIM - INJECTION
(ROE-mi-PLOE-stim)
COMMON BRAND NAME(S): Nplate
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.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using romiplostim and each time you get a refill. If you have any questions, consult your doctor or pharmacist.This medication is given by injection under the skin by a health care professional. It is given as directed by your doctor, usually once a week. The dosage is based on your medical condition, weight, lab tests, and response to treatment.Your risk of bleeding may increase when you stop using romiplostim. Your doctor should order weekly blood tests for at least 2 weeks after your last dose. Tell your doctor right away if you develop any bleeding/bruising.When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.Tell your doctor if your condition (bleeding/bruising) lasts or gets worse.
SIDE EFFECTS: Headache, joint/muscle pain, dizziness, heartburn, abdominal pain, tingling/numbness in hands/feet, and trouble sleeping may occur. In children, fever, mouth/throat pain, diarrhea, easy bruising, or swelling hands/ankles/feet may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may rarely cause serious problems from blood clots to the heart, brain or lung (such as pulmonary embolism, stroke, heart attack), especially if your platelet counts are too high. Keep all medical/lab test appointments. Get medical help right away if you experience: sudden shortness of breath, chest/jaw/left arm pain, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, trouble speaking, weakness on one side of the body, vision problems/changes.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using romiplostim, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, other blood disorders (such as blood cancer, myelodysplastic syndrome), liver disease.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: pain/swelling/warmth in the groin/calf, sudden shortness of breath, coughing up blood, sudden dizziness/fainting, chest/jaw/left arm pain, trouble speaking, weakness on one side of the body, vision problems/changes.
NOTES: Lab and/or medical tests (such as blood and platelet counts) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised November 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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