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KESIMPTA is a brand name for Ofatumumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: KESIMPTA® (ofatumumab injection) is indicated for: • the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical and imaging features (see 14 CLINICAL TRIALS). Kesimpta treatment should be initiated and supervised by health professionals experienced in the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Kesimpta is intended for patient self-administration by subcutaneous injection. Administration should be performed by an individual who has been trained to administer the product. The first injection of Kesimpta should be performed under the guidance of an experienced health professional (see 7 WARNINGS AND PRECAUTIONS).
KESIMPTA® (ofatumumab) Page 5 of 49 Assessment Prior to First Dose of Kesimpta Hepatitis B Virus Screening 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.
For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment (see 7 WARNINGS AND PRECAUTIONS).
Serum Immunoglobulins Prior to initiating Kesimpta, perform testing for quantitative serum immunoglobulins (see 7 WARNINGS AND PRECAUTIONS). 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 (see 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
Assessment before every injection Infection Assessment In case of active infection, delaying injection of Kesimpta should be considered until the infection resolves (see 7 WARNINGS AND PRECAUTIONS). Premedication The decision to initiate or continue premedication should be made on an individual patient basis (see 7 WARNINGS AND PRECAUTIONS).
2 Recommended Dose and Dosage Adjustment The recommended dosage of Kesimpta is: • initial dosing of 20 mg by subcutaneous injection at weeks 0, 1 and 2, followed by • subsequent monthly dosing of 20 mg by subcutaneous injection, starting at week 4.
Special populations The pharmacokinetics of ofatumumab have not been studied in patients with renal or hepatic impairment, pediatric and geriatric patients (see 10 CLINICAL PHARMACOLOGY, Special population). 4 Administration The usual sites for subcutaneous injections are the abdomen, the thigh and the upper outer arm.
1 Adverse Reaction Overview Approximately 1500 (n=1420 at the date of submission) patients with RMS received ofatumumab in clinical studies. In the two Phase 3 pivotal studies, 1882 patients with RMS were randomized, 946 of whom were treated with ofatumumab for a median duration of 85 KESIMPTA® (ofatumumab) Page 11 of 49 weeks; 33% (n=312) of patients receiving ofatumumab were treated for more than 96 weeks (see 14 CLINICAL TRIALS).
2%) were similar in the ofatumumab and teriflunomide groups. The most common adverse reactions occurring in >10% of patients treated with Kesimpta, and more frequently than in patients treated with teriflunomide, were upper respiratory tract infections, injection-related reactions (systemic), headache, and injection-site reactions (local).
3%), defined in trial protocols as IgM at 10% below the lower limit of normal (LLN). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 5) 1) Pooled data from treatment epochs of G2301 and G2302 (safety set) 2) Teriflunomide group received matching placebo injections Description of selected adverse drug reactions Upper Respiratory Tract Infections A higher proportion of ofatumumab-treated patients experienced upper respiratory tract infections compared to teriflunomide-treated patients.
8% of teriflunomide-treated patients. The infections were predominantly mild to moderate and mostly consisted of nasopharyngitis, upper respiratory tract infection and influenza. *Grouping of preferred terms (PTs) was considered for adverse drug reactions frequency determination and includes the following: nasopharyngitis, upper respiratory tract infection, influenza, sinusitis, pharyngitis, rhinitis, viral upper respiratory infection, tonsillitis, acute sinusitis, pharyngotonsillitis, laryngitis, pharyngitis streptococcal, viral rhinitis, sinusitis bacterial, tonsillitis bacterial, viral pharyngitis, viral tonsillitis, chronic sinusitis, nasal herpes, tracheitis.
0 WARNINGS AND PRECAUTIONS, Injections-related reactions 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 5 OVERDOSAGE..............................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 10 8 ADVERSE REACTIONS ................................................................................................
13 9 DRUG INTERACTIONS ................................................................................................ 14 10 CLINICAL PHARMACOLOGY .......................................................................................
15 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 16 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 17 PART II: SCIENTIFIC INFORMATION .......................................................................................
Kesimpta is contraindicated in patients: • Who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• With active HBV infection (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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KESIMPTA® (ofatumumab) Page 6 of 49 Prior to administration, allow Kesimpta to reach room temperature for about 15 to 30 minutes. Visually inspect for particulate matter prior to administration. Do not use if the solution contains visible particles or is cloudy.
Do not freeze. Do not shake. Comprehensive instructions for the administration of Kesimpta are provided in the Patient Medication Information. 5 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.
9% of patients treated with ofatumumab, respectively. 4% with second, <3% from third injection). 8%) mild to moderate in severity. 2%) ofatumumab-treated MS patients reported serious injection-related reactions. KESIMPTA® (ofatumumab) Page 13 of 49 There were no life-threatening injection-related reactions.
The most frequently reported symptoms (≥2%) included fever, headache, myalgia, chills, and fatigue. Local reactions at the administration site were very common. Injection-site reactions were all mild to moderate in severity and non-serious in nature.
The most frequently reported symptoms (≥2%) included erythema, pain, itching, and swelling (see 7 WARNINGS AND PRECAUTIONS). 3 Less Common Clinical Trial Adverse Reactions In RMS clinical trials, there are no adverse reactions that occurred at an incidence rate of <1%.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Immunoglobulins In Study G2301 and Study G2302, a decrease in mean level of immunoglobulin M (IgM) was observed in Kesimpta-treated patients, but was not associated with risk of infections.
34 g/L. 2% after 96 weeks. 4%) in the teriflunomide group and were mostly grade 1 or 2 and transient in nature. Causality to Kesimpta has not been established. 5 Post-Market Adverse Reactions The following adverse drug reactions have been derived from postmarketing experience […]
18 13 PHARMACEUTICAL INFORMATION ............................................................................ 18 14 CLINICAL TRIALS ........................................................................................................
22 15 MICROBIOLOGY ........................................................................................................ 23 16 NON-CLINICAL TOXICOLOGY .....................................................................................
23 PATIENT MEDICATION INFORMATION .................................................................................. 25 PATIENT MEDICATION INFORMATION ..................................................................................
38 KESIMPTA® (ofatumumab) Page 4 of 49 PART I: […]