Romiplate: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Romiplostim

Indications/Uses

Chronic ITP adult patients who are refractory to other treatments (eg, corticosteroids, Ig). Adults w/ moderate to severe aplastic anaemia refractory to conventional therapies.

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Dosage/Direction for Use

SC Chronic ITP Initially 1 mcg/kg once wkly, increased by increments of 1 mcg/kg until platelet count ≥50 x 10⁹/L is achieved. Max: 10 mcg/kg once wkly. Aplastic anaemia Initially 10 mcg/kg once wkly, may be adjusted by increments of 5 mcg/kg. Max: 20 mcg/kg once wkly.

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Overdosage

View Romiplate overdosage for action to be taken in the event of an overdose.

Contraindications

Hypersensitivity to romiplostim or E. coli-derived proteins.

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Special Precautions

Reoccurrence of thrombocytopenia & bleeding after cessation of treatment; increased bone marrow reticulin; thrombotic/thromboembolic complications; progression of existing myelodysplastic syndrome; aplastic anaemia refractory to conventional therapy. Immunogenicity. Loss of response or failure to maintain platelet response; alterations in RBC & WBC. Perform & monitor CBC, including platelet count & peripheral blood smear prior to initiation, during dose adjustment & following discontinuation. May affect ability to drive & use machines. Not be used in moderate to severe hepatic impairment (Child-Pugh score ≥7). Renal impairment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Not recommended in childn <18 yr. Elderly ≥65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

URTI; hypersensitivity; headache. Gastroenteritis, sinusitis, bronchitis; bone marrow disorder, thrombocytopenia, anaemia; angioedema; insomnia; dizziness, migraine, paraesthesia; palpitations; flushing; pulmonary embolism; nausea, diarrhoea, abdominal pain, constipation, dyspepsia; pruritus, ecchymosis, rash; arthralgia, myalgia, muscle spasms, pain in extremity, back & bone pain; fatigue, peripheral oedema, flu-like illness, pain, asthenia, pyrexia, chills, inj site reaction; contusion.

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Drug Interactions

Concomitant use w/ corticosteroids, danazol, azathioprine, IVIg, anti-D Ig.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Romiplate detailed prescribing information

Storage

View Romiplate storage conditions for details to ensure optimal shelf-life.

Description

View Romiplate description for details of the chemical structure and excipients (inactive components).

Action

View Romiplate mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Haemostatics

ATC Classification

B02BX04 - romiplostim ; Belongs to the class of other systemic hemostatics. Used in the treatment of hemorrhage.

Regulatory Classification

Presentation/Packing

Form

Romiplate powd for inj 250 mcg

Packing/Price

1's

Romiplate

romiplostim

Manufacturer:

Kyowa Kirin

Distributor:

DKSH