Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
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1. NAME OF THE MEDICINAL PRODUCT

 Nplate® 250 micrograms powder for solution for injection

Nplate® 500 micrograms powder for solution for injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each vial contains 250 µg of romiplostim. After reconstitution, a deliverable volume of 0.5 ml solution contains 250 µg of romiplostim (500 µg/ml). An additional overfill is included in each vial to ensure that 250 µg of romiplostim can be delivered.

Each vial contains 500 µg of romiplostim. After reconstitution, a deliverable volume of 1 ml solution contains 500 µg of romiplostim (500 µg/ml). An additional overfill is included in each vial to ensure that 500 µg of romiplostim can be delivered.

Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli).

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

 Powder for solution for injection.

The powder is white.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

 Nplate is indicated for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Nplate may be considered as second line treatment for adult non-splenectomised patients where surgery is contra-indicated.

4.2 Posology and method of administration

 Treatment should remain under the supervision of a physician who is experienced in the treatment of haematological diseases.

Posology

Nplate should be administered once weekly as a subcutaneous injection.

Initial dose

The initial dose of romiplostim is 1 µg/kg based on actual body weight.

Dose calculation

Initial or subsequent once weekly dose:
 Weight* in kg x Dose in µg/kg = Individual patient dose in µg

Volume to administer:

Example:
 75 kg patient is initiated at 1 µg/kg of romiplostim.

The individual patient dose =

75 kg x 1 µg/kg = 75 µg
 
*Actual body weight at initiation of treatment should always be used when calculating dose of romiplostim. Future dose adjustments are based on changes in platelet counts o