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  • Nplate
    / Amgen


    Active Ingredient
    Romiplostim 250 mcg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 5 ml X 250 mcg

    partial basket chart 25186 14517

    Vial

    1 X 5 ml X 500 mcg

    partial basket chart

    Related information


    Dosage

    Treatment should remain under the supervision of a physician who is experienced in the treatment of hematological diseases.
    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: The volume of romiplostim to administer is calculated based on body weight, dose required, and concentration of product. For dose calculation please refer to table 1 at the attached doctor’s leaflet.
    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 10^9/l. Platelet counts should be assessed weekly until a stable platelet count (≥ 50 x 10^9/l for at least 4 weeks without dose adjustment) has been achieved. Platelet counts should be assessed monthly thereafter. A maximum once weekly dose of 10 μg/kg should not be exceeded.
    Adjust the dose as follows:
    Platelet count(x 10^9/l)< 50: Increase once weekly dose by 1 µg/kg.
    Platelet count(x 10^9/l)> 150 for two consecutive weeks: Decrease once weekly dose by 1 μg/kg.
    Platelet count(x 10^9/l)> 250: Do not administer, continue to assess the platelet count weekly. After the platelet count has fallen to < 150 x 10^9/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 10^9/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 10^9/l) and treatment interruption (400 x 10^9/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.
    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 evaluated periodically and continuation of treatment should be decided on an individual basis by the treating physician, and in non-splenectomised patients this should include evaluation relative to splenectomy. The reoccurrence of thrombocytopenia is likely upon discontinuation of treatment.
    Elderly patients (≥ 65 years): No overall differences in safety or efficacy have been observed in patients < 65 and ≥ 65 years of age. 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: The safety and efficacy of romiplostim in children aged under 18 years has not yet been established.
    Patients with 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 thrombopoietin (TPO) agonists.
    If the use of romiplostim is deemed necessary, platelet count should be closely monitored to minimise the risk of thromboembolic complications.
    Patients with renal impairment: No formal clinical trials have been conducted in these patient populations. Nplate should be used with caution in these populations.
    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. Caution should be used during preparation of Nplate in calculating the dose and reconstitution with the correct volume of sterile water for injection. If the calculated individual patient dose is less than 23 mcg, dilution with preservative-free, sterile, sodium chloride 9 mg/mL (0.9%) solution for injection is required to ensure accurate dosing. Special care should be taken to ensure that the appropriate volume of Nplate is withdrawn from the vial for subcutaneous administration – a syringe with graduations of 0.01 mL should be used.
    Self-administration of Nplate is not allowed for pediatric patients.


    Indications

    Nplate is indicated for chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients or to E. coli derived proteins.


    Special Precautions

    Traceability
    In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
    eoccurrence of thrombocytopenia and bleeding after cessation of treatment: Thrombocytopenia is likely to reoccur upon discontinuation of treatment with romiplostim. There is an increased risk of bleeding if romiplostim treatment is discontinued in the presence of anticoagulants or anti-platelet agents. Patients should be closely monitored for a decrease in platelet count and medically managed to avoid bleeding upon discontinuation of treatment with romiplostim. It is recommended that, if treatment with romiplostim is discontinued, ITP treatment be restarted according to current treatment guidelines. Additional medical management may include cessation of anticoagulant and/or antiplatelet therapy, reversal of anticoagulation, or platelet support.
    Increased bone marrow reticulin: Increased bone marrow reticulin is believed to be a result of TPO receptor stimulation, leading to an increased number of megakaryocytes in the bone marrow, which may subsequently release cytokines.
    Thrombotic/thromboembolic complications: Caution should be used when administering romiplostim to patients with known risk factors for thromboembolism including but not limited to inherited (e.g. Factor V Leiden) or acquired risk factors (e.g. ATIII deficiency, antiphospholipid syndrome), advanced age, patients with prolonged periods of immobilisation, malignancies, contraceptives and hormone replacement therapy, surgery/trauma, obesity and smoking.
    Medication Errors: Medication errors including overdose and underdose have been reported in patients receiving the drug, dose calculation and dose adjustment guidelines should be followed. In some pediatric patients, accurate dosing relies on an additional dilution step after reconstitution which may increase the risk for medication errors.
    Overdose may result in an excessive increase in platelet counts associated with thrombotic/thromboembolic complications. If the platelet counts are excessively increased, discontinue treatmen and monitor platelet counts. Reinitiate treatment in accordance with dosing and administration recommendations. Underdose may result in lower than expected platelet counts and potential for bleeding. Platelet counts should be monitored in patients receiving the drug.
    Progression of existing Myelodysplastic Syndromes (MDS): A positive benefit/risk for romiplostim is only established for the treatment of thrombocytopenia associated with chronic ITP and romiplostim must not be used in other clinical conditions associated with thrombocytopenia.
    Loss of response to romiplostim: A loss of response or failure to maintain a platelet response with romiplostim treatment within the recommended dosing range should prompt a search for causative factors, including immunogenicity and increased bone marrow reticulin (see above).
    Effects of romiplostim on red and white blood cells: Alterations in red (decrease) and white (increase) blood cell parameters have been observed in
    non-clinical toxicology studies (rat and monkey) as well as in ITP patients. Concurrent anaemia and leucocytosis (within a 4-week window) may occur in patients regardless of splenectomy status, but have been seen more often in patients who have had a prior splenectomy. Monitoring of these parameters should be considered in patients treated with romiplostim.
    See prescribing information for full details.


    Side Effects

    Very common: Hypersensitivity, upper respiratory tract infection, rhinitis, headache, oropharyngeal pain, upper abdominal pain.
    Common: Gastroenteritis, pharyngitis, conjunctivitis, ear infection, sinusitis, bronchitis, bone marrow disorder, thrombocytopenia, anemia, angioedema, insomnia, dizziness, migraine, paresthesia, palpitations, flushing, pulmonary embolism, nausea, diarrhea, abdominal pain, constipation, dyspepsia, pruritus, ecchymosis, rash, arthralgia, myalgia, muscle spasms, pain in extremity, back pain, bone pain, fatigue, edema peripheral, influenza like illness, pain, asthenia, pyrexia, chills, injection site reaction, peripheral swelling, contusion.
    See prescribing information for full details.


    Drug interactions

    No interaction studies have been performed. The potential interactions of romiplostim with co-administered medicinal products due to binding to plasma proteins remain unknown.
    Medicinal products used in the treatment of ITP in combination with romiplostim in clinical trials included corticosteroids, danazol, and/or azathioprine, intravenous immunoglobulin (IVIG), and anti-D immunoglobulin. Platelet counts should be monitored when combining romiplostim with other medicinal products for the treatment of ITP in order to avoid platelet counts outside of the recommended range.
    Corticosteroids, danazol, and azathioprine use may be reduced or discontinued when given in combination with romiplostim. Platelet counts should be monitored when reducing or discontinuing other ITP treatments in order to avoid platelet counts below the recommended range.


    Pregnancy and Lactation

    Pregnancy: There are no or limited amount of data from the use of romiplostim in pregnant women. Romiplostim is not recommended during pregnancy and in women of childbearing potential not using contraception.
    Breast-feeding: It is unknown whether romiplostim/metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from romiplostim therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
    See prescribing information for full details.


    Overdose

    In the event of 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.
    See prescribing information for full details.


    Important notes

    Storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original carton in order to protect from light.
    May be removed from the refrigerator for a period of 30 days at room temperature (up to 25°C) when stored in the original carton.
    Self-life: 5 years.


    Manufacturer
    Amgen Europe B.V., Breda, Netherlands.
    Licence holder
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