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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

Warning & Precautions

Pregnancy

Contraindicated

ROMY INJECTION is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breastfeeding

Consult your doctor

It 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 Caution

Do not drive or handle any machines if you experience dizziness after receiving ROMY INJECTION.

Kidney

Use with Caution

ROMY INJECTION should be used with caution if you have renal impairment. Consult your doctor before receiving the medicine.