KESIMPTA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 20MG/0.4ML

NOVARTIS (SINGAPORE) PTE LTD

NOVARTIS (SINGAPORE) PTE LTD

Therapeutic

Prescription Only

INJECTION, SOLUTION

**4 Dosage regimen and administration** **Dosage regimen** The recommended dose is 20 mg KESIMPTA administered by subcutaneous injection with: - initial dosing at weeks 0, 1 and 2, followed by - subsequent monthly dosing, starting at week 4. Missed Doses If an injection of KESIMPTA is missed, it should be administered as soon as possible without waiting until the next scheduled dose. Subsequent doses should be administered at the recommended intervals. **Special populations** **Renal impairment** No specific studies of ofatumumab in patients with renal impairment have been performed. Patients with mild renal impairment were included in clinical studies. There is no experience in patients with moderate and severe renal impairment. However, as ofatumumab is not excreted via urine, it is not expected that patients with renal impairment require dose modification (see section 11 Clinical pharmacology – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Hepatic impairment** No studies of ofatumumab in patients with hepatic impairment have been performed. Since hepatic metabolism of monoclonal antibodies such as ofatumumab is negligible, hepatic impairment is not expected to impact its pharmacokinetics. Therefore, it is not expected that patients with hepatic impairment require dose modification (see section 11 Clinical pharmacology – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Pediatric patients (below 18 years)** The safety and effectiveness in pediatric MS patients below the age of 18 years have not yet been studied. **Adults over 55 years old** No studies have been performed in MS patients over the age of 55 years old. Ofatumumab was studied in patients with RMS aged 18 to 55 years. Based on the limited data available, no dose adjustment is considered necessary in patients over the age of 55 years old (see section 11 Clinical pharmacology – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Method of administration** KESIMPTA is intended for patient self-administration by subcutaneous injection. The usual sites for subcutaneous injections are the abdomen, the thigh and the upper outer arm. The first injection of KESIMPTA should be performed under the guidance of a healthcare professional (see section 6 Warnings and precautions – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Comprehensive instructions for administration are provided in section 14 Pharmaceutical information – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.