e is a caregiver available to monitor the status of the On-body Injector for Neulasta. Approximately 27 hours after the On-body Injector for Neulasta is applied to the patient’s skin, Neulasta will be delivered over approximately 45 minutes. A healthcare provider may initiate administration with the On-body Injector for Neulasta on the same day as the administration of cytotoxic chemotherapy, as long as the On-body Injector for Neulasta delivers Neulasta no less than 24 hours after administration of cytotoxic chemotherapy.
The prefilled syringe co-packaged in Neulasta OnproTM kit must only be used with the On-body Injector for Neulasta. The prefilled syringe contains additional solution to compensate for liquid loss during delivery through the On-body Injector for Neulasta. If the prefilled syringe co-packaged in Neulasta Onpro kit is used for manual subcutaneous injection, the patient will receive an overdose. If the single-use prefilled syringe for manual use is used with the On-body Injector for Neulasta, the patient may receive less than the recommended dose.
Do not use the On-body Injector for Neulasta to deliver any other drug product except the Neulasta prefilled syringe co-packaged with the On-body Injector for Neulasta.
The On-body Injector for Neulasta should be applied to intact, non-irritated skin on the arm or abdomen.
A missed dose could occur due to an On-body Injector for Neulasta failure or leakage. If the patient misses a dose, a new dose should be administered by single prefilled syringe for manual use, as soon as possible after detection.
Refer to the Healthcare Provider Instructions for Use for the On-body Injector for Neulasta for full administration information.
2.5 Advice to Give to Patients Regarding Administration via the On-body Injector for Neulasta Advise patients to avoid activities such as traveling, driving, or operating heavy machinery during hours 26-29 following application of the On-body Injector for Neulasta (this includes the 45-minute delivery period plus an hour post-delivery). Patients should have a caregiver nearby for the first use.
Refer the patient to the dose delivery information written on the Patient Instructions for Use. Provide training to patients to ensure they understand when the dose delivery of Neulasta will begin and how to monitor the On-body Injector for Neulasta for completed delivery. Ensure patients understand how to identify signs of malfunction of On-body Injector for Neulasta [see Warnings and Precautions (5.3) and Patient Counseling Information (17)].
3 DOSAGE FORMS AND STRENGTHS
Injection: 6 mg/0.6 mL solution in a single-use prefilled syringe for manual use only.
Injection: 6 mg/0.6 mL solution in a single-use prefilled syringe co-packaged with the On-body Injector for Neulasta (Neulasta Onpro kit).
4 CONTRAINDICATIONS
Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.
5 WARNINGS AND PRECAUTIONS
5.1 Splenic Rupture Splenic rupture, including fatal cases, can occur following the administration of Neulasta. eva luate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta.
5.2 Acute Respiratory Distress Syndrome Acute respiratory distress syndrome (ARD
