Romiplate Dosage & Drug Information

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

Treatment of primary immune thrombocytopenia (ITP) in adults 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 inj ITP Initially 1 mcg/kg once wkly, may be 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 based on patient's condition. 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

Recurrence of thrombocytopenia & bleeding after discontinuation. Increased bone marrow reticulin. Thrombotic/thromboembolic complications. Progression of existing myelodysplastic syndrome. CBC including differential leukocyte count & peripheral blood smear should be tested regularly in order to assess immature cells & morphological abnormalities, as well as cytopenia. Immunogenicity. Alterations in RBC & WBC. Moderate influence on the ability to drive & use machines. Renal & hepatic impairment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Childn <18 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

URTI, hypersensitivity, headache. Reoccurrence of thrombocytopenia & bleeding after cessation of treatment, increased bone marrow reticulin, thrombotic/thromboembolic complications, progression of existing myelodysplastic syndrome to AML.

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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

P₁S₁S₃

Presentation/Packing

Form

Romiplate powd for soln for inj 250 mcg

Packing/Price

1's

Romiplate

romiplostim

Manufacturer:

Kyowa Kirin

Distributor:

DKSH

DCH Auriga - Healthcare

Four Star