Romiplostim
- Atc Codes:B02BX04
- CAS Codes:267639-76-9
- PHARMGKB ID:267639-76-9
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Nplate; Belgium: Nplate; Bulgaria: Nplate; Czech Republic: Nplate; Denmark: Nplate; Estonia: Nplate; Finland: Nplate; France: Nplate; Germany: Nplate; Greece: Nplate; Hungary: Nplate; Ireland: Nplate; Italy: Nplate; Latvia: Nplate; Lithuania: Nplate; Luxembourg: Nplate; Malta: Nplate; Netherlands: Nplate; Poland: Nplate; Portugal: Nplate; Romania: Nplate; Slovakia: Nplate; Slovenia: Nplate; Spain: Nplate; Sweden: Nplate; UK: Nplate.
North America
Canada: Nplate; USA: Nplate.
Drug combinations
Chemistry
Romiplostim: C~2634~H~4086~N~722~O~790~S~18~. Mw: 59. L-methionyl[human immunogloblin heavy constant gamma 1-(227 C-terminal residues)-peptide (Fc fragment)] fusion protein with 41 aa peptide, (7-7′:10,10′)-bisdisulfide dimer. CAS-267639-76-9.
Pharmacologic Category
Hematopoietic Agents; Colony Stimulating Factor. (ATC-Code: B02BX04).
Mechanism of action
Increases platelet production through binding and activation of the TPO receptor, a mechanism analogous to endogenous TPO.
Therapeutic use
Treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Pregnancy and lactiation implications
May cause fetal harm. A decision should be made to discontinue therapy or nursing, taking into account importance to mother.
Unlabeled use
Contraindications
None known to date.
Warnings and precautions
Should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Should not be used in an attempt to normalize platelet counts. Increases risk for reticulin deposition within bone marrow. Discontinuation of romiplostim may result in worsened thrombocytopenia than was present prior to therapy (monitor complete blood counts including platelet counts, for at least 2 weeks following discontinuation). Excessive doses may increase platelet counts to a level that produces thrombotic/thromboembolic complications. Assess patients for the formation of neutralizing antibodies if platelet counts decrease significantly following an initial response. May increase risk for hematological malignancies, especially in patients with myelodysplastic syndrome. Monitor CBCs weekly, including platelet counts and peripheral blood smears, until a stable dose has been achieved (thereafter, monitor CBCs, including platelet counts and peripheral blood smears, at least monthly). Available only through a restricted distribution program. Discontinue romiplostim if platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of therapy at the maximum weekly dose.