• Treatment of thrombocytopenia associated with chronic immune (idiopathic) thrombocytopenic purpura that has not responded to corticosteroids, immunoglobulins, or splenectomy where there is risk of bleeding.

Contraindicated in:

• None noted.

Use Cautiously in:

• Hepatic or renal impairment
• Geri: Elderly patients may be more sensitive to effects, escalate dose cautiously, consider concurrent disease states, age-related ↓ in organ function and drug therapy.
• OB: May cause fetal harm, enroll in registry; avoid use during lactation
• Pedi: Safety not established.

CNS: dizziness, insomnia, headache.

CV: THROMBOEMBOLIC EVENTS.

GI: abdominal pain, dyspepsia.

Hemat: bone marrow fibrosis, thrombosis/thromboembolism (dose related).

MS: extremity pain, myalgia, arthralgia, shoulder pain.

Neuro: paresthesia.

Misc: ANGIOEDEMA, HYPERSENSITIVITY REACTIONS.

Drug-Drug:

• Drugs affecting platelet function should be avoided

• Lyophilized powder for injection (requires reconstitution): 250 mcg/vial; 500 mcg/vial;

• SC (Adults): 1 mcg/kg weekly, ↑ by 1 mcg/kg weekly to achieve and maintain platelet count of 50 x 10⁹/L up to 10 mcg/kg.

Nplate

• Acts as thrombopoetin (TPO) receptor agonist.

• Improved platelet count with decreased sequelae of thrombocytopenia (bleeding).

Therapeutic Classification: antithrombocytopenics

Pharmacologic Classification:

Absorption: Well absorbed following subcutaneous administration.

Distribution: Binds to specific cellular receptors.

Metabolism/Excretion: Unknown.

Half-life: 1–34 days.

• Explain purpose of romiplostim to patient. Advise patient to read Medication Guide prior to initiation of therapy. If a dose is missed, contact health care professional to arrange for next dose as soon as possible.
• Instruct patient to notify health care professional of any bruising or bleeding that occurs during therapy or of any side effects that are bothersome or do not go away.
• Advise patients to avoid situations or medications that may increase the risk of bleeding.
• Rep: Advise patient to notify health care professional if pregnancy is planned or suspected. Inform pregnant patients of potential risks of therapy and encourage enrollment in pregnancy registry by calling 1-800-77-AMGEN (1-800-772-6436). Romiplostim should not be used while breastfeeding.
• Emphasize the importance or repeated lab tests. Explain that platelet count will be monitored weekly until dose is stable, then tested monthly. When romiplostim is discontinued, platelet count will be monitored for at least 2 wk to check if platelet count drops too low.

roe-mi-PLOSS-tim

NDC Code^*

• 55513- Amgen Inc
  • 55513-221- Nplate
    • 55513-221-01- 1 VIAL in 1 CARTON (55513-221-01) >.5 mL in 1 VIAL

• 55513- Amgen Inc
  • 55513-222- Nplate
    • 55513-222-01- 1 VIAL in 1 CARTON (55513-222-01) > 1 mL in 1 VIAL

• 55513- Amgen Inc
  • 55513-223- Nplate
    • 55513-223-01- 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-223-01) >.25 mL in 1 VIAL, SINGLE-DOSE