romiplostim (Rx)

Brand and Other Names:Nplate
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

lyophilized powder for injection

  • 250mcg/vial
  • 500mcg/vial

Chronic Immune Thrombocytopenia (ITP)

Indicated for adults who have responded insufficiently to corticosteroids, immunoglobulins, or splenectomy

Initial

  • 1 mcg/kg SC qWeek  

Dose adjustment

  • Adjust weekly dose by increments of 1 mcg/kg until the patient achieves a platelet count ≥50x 10^9/L as necessary to reduce the risk for bleeding
  • Not to exceed maximum weekly dose of 10 mcg/kg
  • Most adults achieved and maintained platelets ≥50x 10^9/L with median dose of 2 mcg/kg
  • Determine dose adjustment by platelet count
    • Platelets <50x 10^9/L: Increase by 1 mcg/kg
    • Platelet >200 to ≤400x 10^9/L for 2 consecutive weeks: Reduce by 1 mcg/kg
    • Platelet >400x 10^9/L: Do not give dose; continue weekly platelet assessment, if platelets fall to <200x 10^9/L, resume at dose reduced by 1 mcg/kg

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 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

Dosage recommendations for all patients

  • Use the lowest dose to achieve and maintain a platelet count ≥50x 10^9/L as necessary to reduce the risk for bleeding
  • Administer as a weekly SC injection with dose adjustments based upon platelet count response
  • Prescribed dose may be a very small volume (eg, 0.15 mL); administer only with syringe that contains 0.01 mL graduations
  • Discontinue if the platelet count does not increase to sufficient level in order to avoid clinically important bleeding after 4 weeks at the maximum weekly dose of 10 mcg/kg

Monitoring

  • Obtain CBC, including platelet counts, weekly during dose adjustment phase, and then monthly once stable dose established
  • Obtain CBC, including platelet counts, 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

  • 250mcg/vial
  • 500mcg/vial

Chronic Immune Thrombocytopenia (ITP)

Indicated in children ≥1 year with ITP for ≥6 months who have responded insufficiently to corticosteroids, immunoglobulins, or splenectomy

Initial

  • 1 mcg/kg SC qWeek  
  • Actual body weight at initiation of treatment should always be used when calculating initial dose
  • In pediatric patients, future 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 the patient achieves a platelet count ≥50x 10^9/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 <50x 10^9/L: Increase by 1 mcg/kg
    • Platelet >200 to ≤400x 10^9/L for 2 consecutive weeks: Reduce by 1 mcg/kg
    • Platelet >400x 10^9/L: Do not give dose; continue weekly platelet assessment, if platelets fall to <200x 10^9/L, resume at dose reduced by 1 mcg/kg

Dosing Considerations

Limitations of use

  • Not indicated for thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP
  • Only 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

Dosage recommendations for all patients

  • Use the lowest dose to achieve and maintain a platelet count ≥50x 10^9/L as necessary to reduce the risk for bleeding
  • Administer as a weekly SC injection with dose adjustments based upon platelet count response
  • Prescribed dose may be a very small volume (eg, 0.15 mL); administer only with syringe that contains 0.01 mL graduations
  • Discontinue if the platelet count does not increase to sufficient level in order to avoid clinically important bleeding after 4 weeks at the maximum weekly dose of 10 mcg/kg

Monitoring

  • Obtain CBC, including platelet counts, weekly during dose adjustment phase, and then monthly once stable dose established
  • Obtain CBC, including platelet counts, weekly for at least 2 weeks following discontinuation
Next:

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

Angioedema

Previous
Next:

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, do not use romiplostim in an 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

Previous
Next:

Pregnancy & Lactation

Pregnancy

Based on findings from animal reproduction studies, therapy may cause fetal harm when administered to a pregnant woman; limited available data in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes

Animal data

  • In animal reproduction and developmental toxicity studies, drug crossed placenta, and adverse fetal effects included thrombocytosis, postimplantation loss, and an increase in pup mortality

Lactation

There is no information regarding 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; due to potential for serious adverse reactions in a breastfed child 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.

Previous
Next:

Pharmacology

Mechanism of Action

Fusion antibody-peptide that is a thrombopoietin receptor agonist; stimulates proliferation, differentiation, and activity of monocytes, neutrophils, eoxinophils, and macrophages

Pharmacokinetics

Peak plasma time: 1-3 hr (SC)

Onset: 7-14 days (increase in WBC)

Half-life elimination: 60 min (IV); 2.7 hr (SC)

Previous
Next:

Administration

SC Preparation

Reconstitution

  • Gently swirl and invert the vial to reconstitute
  • Avoid excess or vigorous agitation; do not shake
  • Generally, dissolution takes <2 minutes
  • Resulting solution should be clear and colorless; visually inspect for particulate matter and/or discoloration; do not administer if particulate matter and/or discoloration is observed
  • Initial reconstitution with designated volumes of sterile water for injection results in a concentration of 500 mcg/mL in all vial sizes
  • Do not reconstitute with bacteriostatic 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
  • Final concentration of either vial is 500 mcg/mL after reconstitution
  • Note: Actual vial content includes overfill to ensure delivery of calculated dose
  • No further dilution required for dose ≥23 mcg
  • Further dilution required for dose <23 mcg
    • Additional dilution with 0.9% NaCl is required
    • 250-mcg vial: Dilute reconstituted vial with 2.25 mL 0.9% NaCl
    • 500-mcg vial: Dilute reconstituted vial with 3.75 mL 0.9% NaCl
    • Final concentration of either vial is 125 mcg/mL after further dilution

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 2-8°C (36-46°F) in original carton to protect from light; do not freeze
  • If needed, unopened vials may be stored in the original carton at room temperature up to a maximum of 25°C (77°F) 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 25°C (77°F) OR
  • Refrigerate at 2-8°C (36-46°F) for up to 24 hr

Diluted solution (after initial reconstitution)

  • Store in syringe at room temperature 25°C (77°F) OR
  • Refrigerate in the original vial at 2-8°C (36-46°F) for up to 4 hr
Previous
Next:

Images

Previous
Next:

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Additional Offers
Email to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Email Forms to Patient

From:

To:

The recipient will receive more details and instructions to access this offer.

By clicking send, you acknowledge that you have permission to email the recipient with this information.

Previous
Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.