NPLATE 250 MG 1 VIAL
Each vial contains 250 mcg of romiplostim. After reconstitution, a deliverable volume of 0.5 mL solution contains 250 mcg of romiplostim (500 mcg/mL). An additional overfill is included in each vial to ensure that 250 mcg of romiplostim can be delivered.
Nplate is indicated for the treatment of primary immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments
Fertility, pregnancy, and lactation
There is no or limited amount of data on the use of romiplostim in pregnant women.
Studies in animals have shown that romiplostim crossed the placenta and increased fetal platelet counts. Post-implantation loss and a slight increase in peri-natal pup mortality also occurred in animal studies (see section 5.3).
Romiplostim is not recommended during pregnancy and in women of childbearing potential not using contraception.
It is unknown whether romiplostim/metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from romiplostim therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
There is no data available on fertility.
No adverse effects were seen in rats given a single dose of 1,000 mcg/kg or in monkeys after repeated administration of romiplostim at 500 mcg/kg (100 or 50 times the maximum clinical dose of 10 mcg/kg, respectively).
In the event of an overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. If the platelet counts are excessively increased, discontinue Nplate and monitor platelet counts. Reinitiate treatment with Nplate in accordance with dosing and administration recommendations
There are no reviews yet.