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Introduction About ROMY INJECTION
ROMY 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.
ROMY 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. ROMY INJECTION is not recommended for use in pregnant women and patients having severe to moderate liver impairment.
The safety and efficacy of ROMY INJECTION in children under the age of one year has not been established. The most common side effects of receiving ROMY 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 ROMY 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 ROMY INJECTION Works
ROMY 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 ROMY INJECTION
ROMY INJECTION will be administered subcutaneously by your doctor or nurse. Self-administration of ROMY INJECTION is not allowed for pediatric patients.
Side Effects Of ROMY 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
ContraindicatedROMY INJECTION is not recommended during pregnancy and in women of childbearing potential not using contraception.
Breastfeeding
Consult your doctorIt is unknown whether ROMY 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 ROMY INJECTION.
Kidney
Use with CautionROMY INJECTION should be used with caution if you have renal impairment. Consult your doctor before receiving the medicine.
Liver
RiskyROMY 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 ROMY INJECTION if you are allergic to Romiplostim or any other ingredients of this medicine.
Use In Pediatrics
Consult your doctorThe safety and efficacy of ROMY 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 ROMY 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 ROMY 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:
ROMY 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 ROMY 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 ROMY INJECTION out of reach of children
- Store in a refrigerator at 2-8°C
FAQs About ROMY INJECTION
Q: What is ROMY INJECTION used for?
A: ROMY 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 ROMY INJECTION?
A: Do not stop receiving ROMY INJECTION, even if you start feeling well, unless your doctor tells you. Stopping it early may increase the risk.
Q: Can ROMY INJECTION be used in pregnant women?
A: No. ROMY INJECTION is not recommended for use in pregnant women as it may affect the unborn child.
Q: What are common side effects of receiving ROMY INJECTION?
A: ROMY 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 ROMY INJECTION?
A: ROMY 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 ROMY INJECTION?
A: ROMY 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 ROMY INJECTION?
A: The long-term safety data for ROMY INJECTION that side effects did not increase in frequency with longer drug exposure. The study looked at some patients from previous studies.
Q: Is ROMY 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.
References
- Intas pharmaceuticals. [Revised on April 10, 2019] [Accessed on August 28th 2024] https://www.intaspharma.com/wp-content/uploads/2019/09/ROMY-250%C2%B5g-VIAL-Insert_AW-QA-1909-00.pdf
- Amgen Technology. [Accessed on August 28th 2024] https://www.ema.europa.eu/en/documents/product-information/nplate-epar-product-information_en.pdf
- Nplate. [Accessed on August 28th 2024] https://www.nplate.com/faqs
Useful Diagnostic Tests
- Complete Blood Count (CBC)/ Hemogram
- Immunoglobulin M (Igm)
- Igg Total Antibody
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