Description

The NPLATE Reconstitution Pack is an essential kit designed for the preparation and administration of Nplate® (romiplostim), a thrombopoietin receptor agonist. This medication is specifically used to manage platelet counts in patients with immune thrombocytopenia (ITP), thereby reducing the risk of bleeding. The pack is available in two strengths, containing either 250 micrograms or 500 micrograms of lyophilized powder in a single-use glass vial.

Indications

• Target Patients: Adults and children (≥1 year) with ITP who have not responded adequately to treatments such as corticosteroids, immunoglobulins, or splenectomy.
• Exclusions: Not intended for thrombocytopenia related to myelodysplastic syndrome (MDS) or other conditions.

Dosage and Administration

• Method: Administered via subcutaneous injection once weekly.
• Initial Dose: 1 microgram per kilogram of body weight.
• Adjustments: Dosing is adjusted weekly based on platelet response, with a target to maintain platelet counts at or above 50 x 10^9/L.
• Self-Administration: Possible for eligible adults with stable platelet counts, following appropriate training and approval.

Kit Components

• Vial of Nplate® powder
• Pre-filled syringe with sterile water for injection
• Plunger rod
• Sterile vial adapter
• Luer lock syringe
• Sterile safety needles
• Alcohol swabs

Reconstitution Instructions

• Use the provided sterile water for injection.
• For the 250 mcg vial, add 0.72 mL of water; for the 500 mcg vial, add 1.2 mL.
• Gently swirl until dissolved, ensuring the solution is clear and colorless.
• Use immediately or store appropriately if needed.

Storage

• Store vials and reconstituted solution at 2°C–8°C, protecting from light.
• Do not freeze; keep in original carton.
• Reconstituted solution should be used within 24 hours if refrigerated.

Contraindications and Precautions

• Contraindications: Hypersensitivity to romiplostim, E. coli-derived proteins, or excipients.
• Warnings: Monitor for thrombocytopenia recurrence, bone marrow changes, and thrombotic events.
• Use Caution: In patients with hepatic or renal impairment, and during pregnancy or breastfeeding.

Adverse Reactions

Common side effects include headache, joint and muscle pain, dizziness, insomnia, and abdominal pain. Serious risks involve hypersensitivity reactions and thrombotic events.

Handling and Disposal

• Single-use only; discard any remaining solution.
• Ensure proper disposal of all components according to local guidelines.

Additional Information

Regular blood tests are necessary to monitor treatment effects. Patients should not discontinue use without medical advice, as platelet levels may drop significantly after stopping the medication. The pack also includes a patient pack to maintain appropriate storage conditions during transport, ensuring the integrity of Nplate® is preserved.