Romiset 250 Mg Injection
ROMISET 250MCG INJECTION is used for chronic immune thrombocytopenic purpura (ITP) patients one year of age and older who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. It contains Romiplostim which belongs to the group of medicines called Thrombopoietin receptor agonists which works by stimulating the bone marrow (part of the bone which makes blood cells) to produce more platelets. This should help to manage bruising and bleeding associated with ITP.
ROMISET 250MCG INJECTION should be used with caution in patients with thromboembolism including but not limited to inherited or acquired risk factors, advanced age, prolonged periods of immobilization, malignancies, have any clinical conditions associated with thrombocytopenia or have any renal impairment. ROMISET 250MCG INJECTION is not recommended for use in pregnant women and patients having severe to moderate liver impairment.
The safety and efficacy of ROMISET 250MCG INJECTION in children under the age of one year has not been established. The most common side effects of receiving ROMISET 250MCG INJECTION are fatigue, oedema peripheral, influenza like illness, pain, chills, injection site reaction. Consult your doctor if any of the above side effects worsen or persist for a long time.
Uses Of ROMISET 250MCG INJECTION
- It is used for chronic immune thrombocytopenic purpura (ITP) patients one year of age and older who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy
How ROMISET 250MCG INJECTION Works
ROMISET 250MCG INJECTION contains Romiplostim, an Fc-peptide fusion protein (peptibody) that signals and activates intracellular transcriptional pathways via the TPO receptor to increase platelet production. The peptibody molecule is comprised of a human immunoglobulin IgG1 Fc domain, with each single-chain subunit covalently linked at the C-terminus to a peptide chain containing 2 TPO receptor-binding domains. It has no amino acid sequence homology to endogenous TPO.
How to use ROMISET 250MCG INJECTION
ROMISET 250MCG INJECTION will be administered subcutaneously by your doctor or nurse. Self-administration of ROMISET 250MCG INJECTION is not allowed for pediatric patients.
Side Effects Of ROMISET 250MCG INJECTION
Common
- fatigue
- oedema peripheral
- influenza like illness
- pain
- asthenia
- pyrexia
- chills
- injection site reaction
- peripheral swelling
- contusion
Uncommon
- vaginal haemorrhage
- injection site haemorrhage
- chest pain
- irritability
- malaise
- face oedema
- feeling hot
- feeling jittery
- increase in blood pressure
- increase in blood lactate dehydrogenase
- increase in body temperature
- increase in weight
Warning & Precautions
Pregnancy
ContraindicatedROMISET 250MCG INJECTION is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breastfeeding
Consult your doctorIt is unknown whether ROMISET 250MCG INJECTION is excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from romiplostim therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Driving and Using Machines
Use with CautionDo not drive or handle any machines if you experience dizziness after receiving ROMISET 250MCG INJECTION.
Kidney
Use with CautionROMISET 250MCG INJECTION should be used with caution if you have renal impairment. Consult your doctor before receiving the medicine.
Liver
RiskyROMISET 250MCG INJECTION should not be used in patients with moderate to severe hepatic impairment, unless the expected benefit outweighs the identified risk of portal venous thrombosis in patients with thrombocytopenia associated to hepatic insufficiency treated with thrombopoietin (TPO) agonists. Consult your doctor before receiving the medicine.
Allergy
ContraindicatedDo not receive ROMISET 250MCG INJECTION if you are allergic to Romiplostim or any other ingredients of this medicine.
Use In Pediatrics
Consult your doctorThe safety and efficacy of ROMISET 250MCG INJECTION in children under the age of one year has not been established.
Use In Geriatrics
Use with CautionThere is no difference between safety or efficacy that have been observed in patients above 65 years of age. Dose adjustment is not required for older patients
Others
Before receiving ROMISET 250MCG INJECTION, inform your doctor if you:
- have thromboembolism including but not limited to inherited (e.g. Factor V Leiden) or acquired risk factors (e.g. ATIII deficiency, antiphospholipid syndrome), advanced age,
- have prolonged periods of immobilization
- have malignancies
- have undergone any surgery/trauma
- have any clinical conditions associated with thrombocytopenia
- are obesity
- are smoking
Interactions
A. Drug-Drug interactions:
Before receiving ROMISET 250MCG INJECTION, inform your doctor if you are taking any of the following medicine:
- Corticosteroids
- Androgenic hormones (Ex. Danazol)
- Immunosuppressants (Ex. Azathioprine)
- Intravenous immunoglobulin (IVIG), and Anti-D immunoglobulin
- Contraceptives
- Hormone replacement therapy
Overdosage:
ROMISET 250MCG INJECTION will be administered by your doctor or nurse, so it is unlikely to receive an overdose. If you experience any unusual reactions after receiving ROMISET 250MCG INJECTION, consult your doctor for advice.
Synopsis
| Drug | : | Romiplostim |
| Pharmacological Category | : | Thrombopoietin receptor agonists |
| Therapeutic Indication | : | Used for chronic immune thrombocytopenic purpura (ITP) patients one year of age and older who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy |
| Dosage Forms | : | Injection |
More Information
Storage
- Keep ROMISET 250MCG INJECTION out of reach of children
- Store in a refrigerator at 2-8°C
FAQs About ROMISET 250MCG INJECTION
Q: What is ROMISET 250MCG INJECTION used for?
A: ROMISET 250MCG INJECTION is used for chronic immune thrombocytopenic purpura (ITP) patients one year of age and older who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
Q: What if I stop receiving ROMISET 250MCG INJECTION?
A: Do not stop receiving ROMISET 250MCG INJECTION, even if you start feeling well, unless your doctor tells you. Stopping it early may increase the risk.
Q: Can ROMISET 250MCG INJECTION be used in pregnant women?
A: No. ROMISET 250MCG INJECTION is not recommended for use in pregnant women as it may affect the unborn child.
Q: What are common side effects of receiving ROMISET 250MCG INJECTION?
A: ROMISET 250MCG INJECTION may cause fatigue, oedema peripheral, influenza like illness, pain, chills, injection site reaction. Consult your doctor for advice if the above side effects persists for a longer time.
Q: What can I expect with ROMISET 250MCG INJECTION?
A: ROMISET 250MCG INJECTION is a shot (injection) given by your doctor or nurse once a week. It has no dietary restrictions and no known drug interactions. This means you do not have to change your meal schedule or other medicines.
Q: How will I receive ROMISET 250MCG INJECTION?
A: ROMISET 250MCG INJECTION is given as an injection under the skin (subcutaneous) one time each week by your healthcare provider. Your healthcare provider will check your platelet count every week and change your dose of the medicine as needed.
Q: Is there information on long-term safety for ROMISET 250MCG INJECTION?
A: The long-term safety data for ROMISET 250MCG INJECTION that side effects did not increase in frequency with longer drug exposure. The study looked at some patients from previous studies.
Q: Is ROMISET 250MCG INJECTION suitable for thrombocytopenia occuring due to Myelodysplastic syndrome (MDS)?
A: It is not approved to manage thrombocytopenia caused by Myelodysplastic syndrome (MDS) or any other cause of thrombocytopenia apart from chronic ITP.