Romiplate

Romiplate Uses, Dosage, Side Effects, Food Interaction and all others data.

Romiplate is a thrombopoiesis stimulating dimer Fc-peptide fusion protein (peptibody) to increase platelet production through activation of the thrombopoietin receptor. The peptibody molecule has two identical single-chain subunits, each one is made up of 269 amino acid residues. Each subunit consists of an IgG1 Fc carrier domain that is covalently attached to a polypeptide sequence that contains two binding domains to interact with thrombopoietin receptor c-Mpl. Each domain consists of 14 amino acids. Interestingly, romiplostim's amino acid sequence is not similar to that of endogenous thrombopoietin. Romiplate is produced by recombinant DNA technology in Escherichia coli. FDA approved on August 22, 2008.

Responses to platelet increase varies between patients thus indicating a need for individualization of dose. However, a dose dependent-increase in platelet counts have been observed in clinical trials. Does not affect platelet destruction.

Trade Name Romiplate
Availability Prescription only
Generic Romiplostim
Romiplostim Other Names Romiplostim
Related Drugs Nplate, Promacta, prednisone, dexamethasone, triamcinolone, Decadron
Type
Formula C2634H4086N722O790S18
Weight 59000.0 Da
Groups Approved
Therapeutic Class
Manufacturer
Available Country Japan
Last Updated: September 19, 2023 at 7:00 am
Romiplate
Romiplate

Uses

Romiplate is a fusion protein thrombopoietin (TPO) peptide analog that increases platelet counts by binding to and activating the human TPO receptor. Used to treat thrombocytopenia associated with chronic immune thrombocytopenia (ITP).

Treatment of chronic immune thrombocytopenic purpura.

Romiplate is also used to associated treatment for these conditions: Chronic immune thrombocytopenia, Refractory immune thrombocytopenia

How Romiplate works

Romiplate is a thrombopoietin receptor agonist that activates intracellular transcriptional pathways via c-Mpl to increase production of platelets. It also works similarly to thrombopoietin (TPO), an endogenous glycoprotein hormone that regulates the production of platelets in the bone marrow.

Toxicity

The most common adverse reactions (≥ 5% higher patient incidence in Nplate versus placebo) are arthralgia, dizziness, insomnia, myalgia, pain in extremity, abdominal pain, shoulder pain, dyspepsia, and paresthesia. Headache was the most commonly reported adverse reaction that did not occur at ≥ 5% higher patient incidence in Nplate versus placebo. LD50 = 980 mg/kg.

Food Interaction

No interactions found.

Volume of Distribution

In healthy volunteers, non-linear decrease in Vd with increase IV dose of romiplostim which indicates saturation of c-Mpl receptors. Vd, 0.3 μg/kg = 122 mL/kg Vd, 10 μg/kg = 48.2 mL/kg

Elimination Route

Cmax, healthy volunteers, subQ = 24-36 hours; Cmax, immune thrombocytopenia patients, subQ = 7-50 hours (median = 14 hours). Not affected by age, weight, or gender. Accumulation does not occur after six weekly doses of 3 mcg/kg romiplostim.

Half Life

Immune thrombocytopenia patients, subQ = 3.5 days (median) (range 1-34 days)

Elimination Route

Renal clearance (more dominant mode of clearance as dose increases) and
binding to c-Mpl receptors (dominant mode of clearance at low doses)

Innovators Monograph

You find simplified version here Romiplate

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