2.1 Assessments 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 Hepatitis B surface antigen [HBsAg] and anti-HBV tests. For patients who are negative for HBsAg and positive for Hepatitis B core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult liver disease experts before starting and during treatment with KESIMPTA [see Warnings and Precautions (5.1)].

Serum Immunoglobulins

Prior to initiating KESIMPTA, perform testing for quantitative serum immunoglobulins [see Warnings and Precautions (5.3)]. 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 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 Warnings and Precautions (5.1)].

2.2 Recommended Dosage

The recommended dosage of KESIMPTA is:

• initial dosing of 20 mg by subcutaneous injection at Weeks 0, 1, and 2, followed by
• subsequent dosing of 20 mg by subcutaneous injection once monthly 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.

2.3 Administration Instructions

Administer by subcutaneous injection only.

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

Administer KESIMPTA in the abdomen, thigh, or outer upper arm subcutaneously. Do not give injection into moles, scars, stretch marks, or areas where the skin is tender, bruised, red, scaly, or hard.

The first injection of KESIMPTA should be performed under the guidance of a healthcare professional [see Warnings and Precautions (5.2)].

KESIMPTA Sensoready® pens and syringes are for one-time use only and should be discarded after use. See Instructions for Use for complete administration instructions.

2.4 Preparation of KESIMPTA

The KESIMPTA “Instructions for Use” for each presentation contains more detailed instructions on the preparation of KESIMPTA.

Before administration, remove KESIMPTA Sensoready Pen or KESIMPTA prefilled syringe from the refrigerator and allow KESIMPTA to reach room temperature for about 15 to 30 minutes. DO NOT remove the needle cover while allowing the prefilled syringe to reach room temperature.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the liquid contains visible particles or is cloudy.