Dose adjustments

A subject's actual body weight at initiation of therapy should be used to calculate dose. The once weekly dose of romiplostim should be increased by increments of 1 μg/kg until the patient achieves a platelet count > 50 x 109/l. Platelet counts should be assessed weekly until a stable platelet count (> 50 x 109/l for at least 4 weeks without dose adjustment) has been achieved. Platelet counts should be assessed monthly thereafter. Do not exceed a maximum once weekly dose of 10 μg/kg.

Adjust the dose as follows:

Platelet count

(x 109/l)
 Action
 
< 50
 Increase once weekly dose by 1 μg/kg
 
> 150 for two consecutive weeks
 Decrease once weekly dose by 1 μg/kg
 
> 250
 Do not administer, continue to assess the platelet count weekly

After the platelet count has fallen to < 150 x 109/l, resume dosing with once weekly dose reduced by 1 μg/kg

Due to the interindividual variable platelet response, in some patients platelet count may abruptly fall below 50 x 109/l after dose reduction or treatment discontinuation. In these cases, if clinically appropriate, higher cut-off levels of platelet count for dose reduction (200 x 109/l) and treatment interruption (400 x 109/l) may be considered according to medical judgement.

A loss of response or failure to maintain a platelet response with romiplostim within the recommended dosing range should prompt a search for causative factors (see section 4.4, loss of response to romiplostim).

Treatment discontinuation

Treatment with romiplostim should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after four weeks of romiplostim therapy at the highest weekly dose of 10 μg/kg.

Patients should be clinically eva luated periodically and continuation of treatment should be decided on an individual basis by the treating physician. The reoccurrence of thrombocytopenia is likely upon discontinuation of treatment (see section 4.4).

Method of administration

For subcutaneous use.

After reconstitution of the powder, Nplate solution for injection is administered subcutaneously. The injection volume may be very small. A syringe with graduations of 0.01 ml should be used.

For instructions on reconstitution of Nplate before administration, see section 6.6.

Elderly patients ( 65 years)

No overall differences in safety or efficacy have been observed in patients < 65 and  65 years of age (see section 5.1). Although based on these data no adjustment of the dosing regimen is required for older patients, care is advised considering the small number of elderly patients included in the clinical trials so far.

Paediatric population

Nplate is not recommended for use in children below age 18 due to insufficient data on safety or efficacy. No recommendation on a posology can be made in this population.

Hepatic Impairment

Romiplostim should not be used in patients with moderate to severe hepatic impairment (Child-Pugh score  7) unless the expected benefit outweighs the identified risk of portal venous thrombosis in patients with thrombocytopenia associated to hepatic insufficiency treated with TPO agonists (see section 4.4).

If the use of romiplostim is deemed necessary, platelet count shoul