Product information

Pre-treatment assessments¹

Assessment prior to first dose of KESIMPTA^® 

• Pre-screening

  • Hepatitis B virus (HBV)

    Prior to initiating KESIMPTA^®, perform Hepatitis B virus (HBV) screening. KESIMPTA^® is contraindicated in patients with active HBV confirmed by positive results for HBsAg and anti-HBV tests.


  • Quantitative serum immunoglobulins
    Prior to initiating KESIMPTA^®, perform testing for quantitative serum immunoglobulins. For patients with low serum immunoglobulins, consult immunology experts before initiating treatment with KESIMPTA^®. 

• Vaccinations

  Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, administer all necessary immunizations according to immunization guidelines at least 4 weeks prior to initiation of KESIMPTA^® for live or live-attenuated vaccines, and whenever possible, at least 2 weeks prior to initiation of KESIMPTA^® for inactivated vaccines. 

Assessment before every injection

• Infection assessment

  In case of active infection, delaying injection of KESIMPTA® should be considered until the infection resolves. 

• Pre-medication

  The decision to initiate or continue premedication should be made on an individual patient basis.  

Initiating KESIMPTA^®1 
 

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The initial dosing period consists of three weekly 20 mg doses by subcutaneous injection at Weeks 0, 1, and 2: 

Adapted from the KESIMPTA^® Product Monograph. 

Convenient, once-monthly maintenance dosing¹

Following the initial dosing period, the recommended maintenance dose is 20 mg, administered by subcutaneous injection once monthly. Starting at Week 4, you inject once monthly on the same date. 

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Adapted from the KESIMPTA^® Product Monograph.

Please refer to the KESIMPTA^® Product Monograph for complete dosing and administration information. 
 

KESIMPTA^® is intended for patient self-administration by subcutaneous injection.

The first injection should be performed under the guidance of a healthcare professional. 

Missed dose

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 reset to administer the next sequential dose at the recommended once a month intervals. 
 

Overdosage 

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. 

The flexibility of self-administered injections²
 

KESIMPTA^® is self-administered subcutaneously by the patient with the SensoReady^® Pen 

Administration should be performed by an individual who has been trained to administer the product. 

The first injection should be performed under the guidance of a healthcare professional.  

KESIMPTA^® is intended for patient self-administration by subcutaneous injection. 

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MS=multiple sclerosis; RRMS=relapsing remitting multiple sclerosis.