romiPLOStim

(redirected from Nplate)

romiPLOStim

(roe-mi-ploss-tim) ,

Nplate

(trade name)

Classification

Therapeutic: temporary class
Pharmacologic: temporary class
Pregnancy Category: C

Indications

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.

Action

Acts as thrombopoetin (TPO) receptor agonist.

Therapeutic effects

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

Pharmacokinetics

Absorption: Well absorbed following subcutaneous administration.
Distribution: Binds to specific cellular receptors.
Metabolism and Excretion: Unknown.
Half-life: 1–34 days.

Time/action profile

ROUTEONSETPEAKDURATION
Subcutunknown1 wk2 wk

Contraindications/Precautions

Contraindicated in: None noted.
Use Cautiously in: Hepatic or renal impairment; Geriatric: Elderly patients may be more sensitive to effects, escalate dose cautiously, consider concurrent disease states, age-related ↓ in organ function and drug therapy. Obstetric: May cause fetal harm, enroll in registry; avoid use during lactation; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness (most frequent)
  • insomnia (most frequent)
  • headache

Gastrointestinal

  • abdominal pain (most frequent)
  • dyspepsia

Hematologic

  • bone marrow fibrosis
  • thrombosis/thromboembolism (dose related)

Musculoskeletal

  • extremity pain (most frequent)
  • myalgia (most frequent)
  • arthralgia
  • shoulder pain

Neurologic

  • paresthesia

Miscellaneous

  • angioedema (life-threatening)
  • hypersensitivity reactions (life-threatening)

Interactions

Drug-Drug interaction

Drugs affecting platelet function should be avoided

Route/Dosage

Subcutaneous (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.

Availability

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

Nursing implications

Nursing assessment

  • Assess for bruising and bleeding throughout therapy.
  • Lab Test Considerations: Monitor CBC, including platelet counts and peripheral blood smears, prior to, weekly until a stable platelet count (≥ 50 x 109/L for 4 wks without dose adjustment) is achieved, and at least monthly thereafter. If platelet count is <50 x 109/L, increase dose by 1 mcg/kg. If platelet count is >200 x 109/L for 2 consecutive weeks, decrease dose by 1 mcg/kg. If platelet count is >400 x 109/L, do not dose. Continue to assess platelet count weekly. When platelet count <200 x 109/L, resume romiplostim dose decreased by 1 mcg/kg. Do not administer if platelet count >400 X 109/L. Discontinue romiplostim if platelet count does not ↑ to sufficient level to avoid clinically important bleeding after 4 weeks of therapy at the maximum weekly dose of 10 mcg/kg. Continue monitoring for at least 2 wks following discontinuation. Excessive doses may increase risk of thrombolic/thromboembolic complications.
    • If platelet counts decrease following initial response, assess for formation of neutralizing antibodies. May require submitting blood samples to Amgen (1-800-772-6436) for assay.

Potential Nursing Diagnoses

Risk for injury (Indications)

Implementation

  • Do not confuse romiplostim with romidepsin.
  • Adjust dose based on platelet count. If platelet count is <50 x 109/L, increase dose by 1 mcg/kg. If platelet count is >200 x 109/L for 2 consecutive wks, reduce dose by 1 mcg/kg. If platelet count is >400 x 109/L do not dose. Continue to assess platelet count weekly. After platelet count has fallen to <200 x 109/L, resume romiplostim at a dose reduced by 1 mcg/kg.
  • Subcutaneous: Administer as a subcut injection once weekly. Diluent: Reconstitute 250 mcg vial with 0.72 mL and 500 mcg vial with 1.2 mL of preservative-free Sterile Water for Injection. Concentration: 500 mcg/mL. Gently swirl vial to reconstitute; do not shake. Dissolution usually takes less than 2 min. Injection volume may be very small; use syringe with graduations to 0.01 mL. Solution is clear and colorless; do not administer solutions that are discolored or contain a precipitate. Protect solution from light. Reconstituted solution is stable at room temperature or if refrigerated for 24 hr. Discard unused portions of single-use vial. Do not administer more than one dose from each vial.
  • Romiplostim may be used with other therapies such as corticosteroids, danazol, azathioprine, immunoglobulin IV, and anti-D immunoglobulin.

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 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 weeks to check if platelet count drops too low.

Evaluation/Desired Outcomes

  • Improved platelet count with decreased risk of bleeding. Discontinue if platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 wks at maximum weekly dose.
References in periodicals archive ?
Key data from the Nplate clinical trial program will also be presented with new insights regarding use of Nplate in treating pediatric and adult immune thrombocytopenia patients, including:
However, with doctors describing her situation as "unique" and "very tricky", her body rejected all forms of medication, except one -- the Nplate injection.
For the year, Sensipar/Mimpara sales increased 13 percent to $808 million in 2011 versus $714 million in 2010, Vectibix sales increased 12 percent to $322 million versus $288 million in 2010, and Nplate sales increased 30 percent to $297 million versus $229 million in 2010.
Other comments: Prescribers and patients must be enrolled in the Nplate Network of Experts Understanding and Supporting Nplate and Patients (NEXUS) Program to prescribe, administer, and receive romiplostim.
Nplate (romiplostim) is the first bone marrow stimulator to produce needed platelets in patients with a rare blood disorder that can lead to serious bleeding.
Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease.
Regulators extended their review of Nplate in April to analyze Amgen's safety monitoring program, and in June they delayed a decision on Glaxo and Ligand's Promacta until Sept.
0 L five-door hatchback in reasonable condition on a 1996 Nplate or pounds 7,800 for a mint condition 1.
Past product award recipients include: Prevnar 13 (Pfizer 2011), Stelara (Janssen 2011), Prolia/XGEVA (Amgen 2011), Coartem (Novartis 2010), RotaTeq (Merck 2010), xTAG (Luminex 2010), Gleevec (Novartis 2009), Nplate (Amgen 2009), Promacta (GSK 2009), Cellsearch (Veridex 2009), Isentress (Merck 2009), Selzentry (Pfizer 2008), Soliris (Alexion 2008), Infuse (Wyeth 2008), Revlimid (Celgene 2008), Januvia (Merck 2007), Chantix (Pfizer 2007), Humira (Abbott 2007) and Gardasil (Merck 2007).
Prescribing Information for Nplate has been modified to heighten awareness that use is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome.
s (Thousand Oaks CA) Nplate, an experimental biotech drug to treat a blood-clotting disorder.
Amgen today announced interim results from an international, single-arm study ("209 study") evaluating the safety and efficacy of Nplate(R) (romiplostim) in adults with primary immune thrombocytopenia (ITP) - a rare blood disorder - demonstrated that Nplate induced a rapid platelet response with a good safety profile in adult ITP patients with low platelet counts and bleeding symptoms (Abstract #0223).