romiplostim

REMS

Immune thrombocytopenia (ITP) (children must have ITP for ≥6 mo) that has not responded to corticosteroids, immunoglobulins, or splenectomy.
Acute exposure to myelosuppressive doses of radiation.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Thrombocytopenia due to myelodysplastic syndrome (↑ risk of death and progression to acute myelogenous leukemia);
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Chronic liver disease (↑ risk of portal vein thrombosis);
Pedi: Children <1 yr (safety and effectiveness not established);
Geri: Older adults may be more sensitive to effects; escalate dose cautiously; consider concurrent disease states, age-related ↓ in organ function and drug therapy.

Adv. Reactions/Side Effects ⬆ ⬇

CV: THROMBOEMBOLIC EVENTS

GI: abdominal pain, dyspepsia

Hemat: bone marrow fibrosis, thrombocytosis

MS: extremity pain, myalgia, arthralgia, shoulder pain

Neuro: dizziness, insomnia, headache, paresthesia

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

Drugs affecting platelet function should be avoided

Availability ⬆ ⬇

Lyophilized powder for injection: 125 mcg/vial; 250 mcg/vial; 500 mcg/vial

Route/Dosage ⬆ ⬇

Immune Thrombocytopenia

SC (Adults and Children ≥1 yr): 1 mcg/kg (actual body weight) once weekly, ↑ by 1 mcg/kg (actual body weight) weekly to achieve and maintain platelet count of ≥ 50 x 10⁹/L up to 10 mcg/kg.

Hematopoietic Syndrome of Acute Radiation Syndrome

SC (Adults and Children ): 10 mcg/kg as single dose administered as soon as possible after suspected or confirmed exposure to radiation levels greater than 2 gray.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as thrombopoetin receptor agonist.

Therapeutic effects:

Improved platelet count with decreased sequelae of thrombocytopenia (bleeding).
Improved survival in patients acutely exposed to myelosuppressive doses of radiation.

Classifications ⬆ ⬇

Therapeutic Classification: antithrombocytopenics

Pharmacologic Classification: thrombopoietin receptor agonists

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following SUBQ administration.

Distribution: Binds to specific cellular receptors.

Metabolism/Excretion: Unknown.

Half-Life: 1–34 days.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	1 wk	2 wk

Patient/Family Teaching ⬆ ⬇

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.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid 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.

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Indications ⬇