KESIMPTA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 20MG/0.4ML [SIN16100P]

Product Info

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

[SIN16100P]

Indication

3 Indications

KESIMPTA is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) (refer to Section 12 Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosing

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.

Contraindications

5 Contraindications

• History of confirmed hypersensitivity to Kesimpta (see section 6 Warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Patients who are hypersensitive to ofatumumab or any ingredient in the formulation.

• Patients in a severely immunocompromised state (see section 6 Warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Severe active infection until resolution (see section 6 Warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Known active malignancy