"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
(romiplostim) for Subcutaneous Injection
Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody) that activates intracellular transcriptional pathways leading to increased platelet production via the TPO receptor (also known as cMpl). The peptibody molecule contains two identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain, covalently linked at the C-terminus to a peptide containing two thrombopoietin receptor-binding domains. Romiplostim has no amino acid sequence homology to endogenous TPO. Romiplostim is produced by recombinant DNA technology in Escherichia coli (E coli).
Nplate is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous injection. Two vial presentations are available, which contain a sufficient amount of active ingredient to provide either 250 mcg or 500 mcg of deliverable romiplostim, respectively. Each single-use 250 mcg vial of Nplate contains the following: 375 mcg romiplostim, 30 mg mannitol, 15 mg sucrose, 1.2 mg L-histidine, 0.03 mg polysorbate 20, and sufficient HCl to adjust the pH to a target of 5.0. Each single-use 500 mcg vial of Nplate contains the following: 625 mcg romiplostim, 50 mg mannitol, 25 mg sucrose, 1.9 mg L-histidine, 0.05 mg polysorbate 20, and sufficient HCl to adjust the pH to a target of 5.0 [see DOSAGE AND ADMINISTRATION].
What are the possible side effects of romiplostim (Nplate)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Less serious side effects may include:
- joint or muscle pain;
- pain in your arms, legs, or shoulder;
- numbness or tingly feeling;
- sleep problems (insomnia); or
- stomach pain or upset.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to...
What are the precautions when taking romiplostim (Nplate)?
Before using romiplostim, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, other blood disorders (such as blood cancer, myelodysplastic syndrome), liver disease.
Before having surgery, tell your doctor or dentist that you are using this medication.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 2/24/2014
This monograph has been modified to include the generic and brand name in many instances.
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