Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Novartis South Africa (Pty) Ltd., Magwa Crescent West, Waterfall City, Jukskei View, Johannesburg, 2090
BONSPRI is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS).
The recommended dose is 20 mg BONSPRI administered by subcutaneous injection with:
If an injection of BONSPRI 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.
No studies have been performed in MS patients over 55 years.
Based on the limited data available, no dose adjustment is considered necessary in patients over 55 years old (see section 5.2). Patients enrolled in the ongoing clinical trials continue to be dosed with 20 mg ofatumumab monthly after they reach the age of 55.
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 5.2).
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 5.2).
The safety and efficacy in paediatric MS patients below the age of 18 years have not yet been established. No data are available.
BONSPRI 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 BONSPRI should be performed under the guidance of a healthcare professional (see section 4.4).
Comprehensive instructions for administration are provided in the PATIENT INFORMATION LEAFLET "Instructions for use of BONSPRI pre-filled syringe."
No cases of overdose have been reported in RMS clinical studies.
Doses up to 700 mg have been administered intravenously in clinical studies with MS patients without dose-limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted as necessary.
2 years.
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the pre-filled syringe in the outer carton in order to protect from light.
BONSPRI is supplied in a single-use glass syringe, equipped with a stainless steel needle, a plunger stopper and a rigid needle shield, containing 0,4 ml solution. The syringe is assembled with a plunger rod and a needle safety device.
BONSPRI is available in unit packs containing 1 pre-filled syringe and in multipacks containing 3 (3 packs of 1) pre-filled syringes.
Not all pack sizes may be marketed.
Before injection, the pre-filled syringe should be taken out of the refrigerator for about 15 to 30 minutes to allow it to reach room temperature. The pre-filled syringe should be kept in the original carton until ready to use, and the needle cap should not be removed until just before the injection is performed. Prior to use, the solution should be inspected visually by looking through the viewing window. The solution should be clear to slightly cloudy. The pre-filled syringe should not be used if the liquid contains visible particles or is cloudy.
Comprehensive instructions for administration are given in the PATIENT INFORMATION LEAFLET “Instructions for use of BONSPRI pre-filled syringe”.
Pre-filled syringes are for single use only. Dispose used pre-filled syringes in a sharps disposal container (closable, puncture resistant container). For the safety and health of you and others, pre-filled syringes must never be re-used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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