What is required for a patient with multiple sclerosis to initiate treatment with Kesimpta (ofatumumab)?

Pre-Treatment Requirements for Kesimpta (Ofatumumab) Initiation

Before starting Kesimpta, patients must undergo screening for active infections (particularly hepatitis B), complete necessary vaccinations, and have the first injection administered under healthcare professional supervision. 1

Mandatory Pre-Treatment Screening

Infection Screening

• Screen for active infections before initiating therapy, as Kesimpta is a B-cell depleting therapy that increases infection risk 1
• Hepatitis B screening is essential - check hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) status, as reactivation can occur with B-cell depleting therapies 2
• Delay treatment if active infection is present until the infection is fully resolved and any antibiotic course is completed 2

Vaccination Requirements

• Complete all necessary vaccinations at least 4-6 weeks before starting Kesimpta, particularly live or live-attenuated vaccines 1
• Live vaccines are contraindicated during treatment and after discontinuation until B-cell repletion occurs 1
• Inactivated vaccines may be administered but may have reduced efficacy due to B-cell depletion 1

Baseline Laboratory Testing

• Obtain baseline quantitative serum immunoglobulin levels (IgG and IgM) before treatment initiation 1
• Complete blood count with differential to establish baseline lymphocyte counts 2
• Liver function tests to establish baseline hepatic function 2

Special Population Considerations

Ophthalmologic Evaluation

• Perform ophthalmologic examination before starting treatment in patients with diabetes mellitus or history of uveitis/macular edema 2
• This screening helps identify pre-existing risk factors for macular edema, which occurs in ≤0.6% of patients on long-term treatment 2

Pregnancy and Contraception

• Confirm pregnancy status in females of reproductive potential before initiating therapy 1
• Counsel patients to use effective contraception during treatment and for at least 6 months after the last dose, as Kesimpta can cause fetal harm including B-cell lymphopenia and reduced antibody response in offspring 1

First Injection Requirements

Supervised Administration

• The first injection must be performed under the guidance of an appropriately trained healthcare professional 1
• This supervision allows for immediate management of potential injection-related reactions or hypersensitivity reactions, which occur most commonly within 24 hours of the first injection 1
• Systemic injection reactions were reported in 21% of patients, predominantly mild to moderate in severity (99.8%), with symptoms including fever, headache, myalgia, chills, and fatigue 1

Dosing Schedule Initiation

• Initial loading doses are administered at Weeks 0,1, and 2 (20 mg subcutaneously each) to achieve rapid B-cell depletion 3
• Maintenance dosing begins at Week 4, then monthly thereafter (20 mg subcutaneously) 3
• This stepwise approach minimizes systemic injection-related reactions compared to single high-dose administration 3

Contraindications to Starting Treatment

Absolute Contraindications

• Active hepatitis B infection - must be treated before initiating Kesimpta 2, 1
• History of life-threatening hypersensitivity reaction to ofatumumab or any component 1
• Active, untreated infections or sepsis - treatment must be delayed until resolution 2

Relative Contraindications Requiring Caution

• Severe immunoglobulin deficiency or history of recurrent infections - requires careful risk-benefit assessment 1
• Recent treatment with other B-cell depleting therapies - consider timing of B-cell repletion before switching 2, 4

Patient Education Requirements

• Instruct patients to seek immediate medical attention if symptoms of systemic injection-related reactions or hypersensitivity reactions occur, including anaphylaxis, angioedema, bronchospasm, throat irritation, dyspnea, or hypotension 1
• Educate patients about infection risk and the need to report fever, persistent cough, or other signs of infection promptly 1
• Train patients on proper self-injection technique after the supervised first dose, as subsequent injections can be self-administered at home 5, 3

Common Pitfalls to Avoid

• Do not assume premedication with corticosteroids, antihistamines, or acetaminophen is necessary - only limited benefit was observed in clinical studies, and these are not routinely recommended 1
• Do not start Kesimpta within 6 months of receiving anti-CD20 medications without confirming B-cell repletion, as carryover effects can complicate immune reconstitution 2, 4
• Do not overlook the need for contraception counseling - the 6-month post-treatment window is critical due to potential fetal harm 1