KESIMPTA Sensoready pens and prefilled syringes must be refrigerated at 2ºC to 8ºC (36ºF to 46ºF). Keep the product in the original carton to protect from light until the time of use. Do not freeze. To avoid foaming, do not shake.
Advise the patient to read FDA-approved patient labeling (Medication Guide and Instructions for Use).
Advise patients to contact their healthcare provider for any signs of infection during treatment or after the last dose. Signs include fever, chills, constant cough, or dysuria [see Warnings and Precautions (5.1)].
Advise patients that KESIMPTA may cause reactivation of hepatitis B infection and that monitoring will be required if they are at risk [see Warnings and Precautions (5.1)].
Advise patients that PML has happened with an intravenous form of ofatumumab administered at a higher intravenous dosage in patients with CLL, as well as with drugs that are similar to KESIMPTA, and may happen with KESIMPTA. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their healthcare provider if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes [see Warnings and Precautions (5.1)].
Advise patients to complete any required live or live-attenuated vaccinations at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of KESIMPTA for inactivated vaccines.
Administration of live-attenuated or live vaccines is not recommended during KESIMPTA treatment and until B-cell recovery [see Warnings and Precautions (5.1)].
Inform patients about the signs and symptoms of injection-related reactions, and that these reactions generally occur within 24 hours and predominantly following the first injection. Advise patients to contact their healthcare provider if they experience signs or symptoms of injection-related reactions [see Warnings and Precautions (5.2)].
Advise females of childbearing potential to use effective contraception while receiving KESIMPTA and for 6 months after the last treatment of KESIMPTA [see Warnings and Precautions (5.4) and Use in Specific Populations (8.3)].
Instruction on Injection Technique
Patients or caregivers should be instructed by a healthcare professional on how to administer KESIMPTA [see Instructions for Use].
Instruct patients or caregivers in the technique of proper syringe and needle disposal, and advise them not to reuse these items. Instruct patients to inject the full amount of KESIMPTA according to the directions provided in the Instructions for Use. Dispose of pens and syringes in a puncture-resistant container.
Novartis Pharmaceuticals Corporation
East Hanover, NJ 07936 U.S. License No.: 1244
KESIMPTA and SENSOREADY is a [registered] trademark of Novartis AG.
|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Approved: August 2020|
|KESIMPTA® (KEY-simp-ta)(ofatumumab)injection, for subcutaneous use|
|What is the most important information I should know about KESIMPTA?KESIMPTA can cause serious side effects, including: Infections. Serious infections can happen during treatment with KESIMPTA. If you have an active infection, your healthcare provider should delay your treatment with KESIMPTA until your infection is gone. KESIMPTA taken before or after other medicines that weaken the immune system may increase your risk of getting infections.Tell your healthcare provider right away if you have any infections or get any symptoms, including painful and frequent urination, nasal congestion, runny nose, sore throat, fever, chills, cough, or body aches.
|What is KESIMPTA? KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including:
| Do not use KESIMPTA if you: |
|Before using KESIMPTA, tell your healthcare provider about all of your medical conditions, including if you: |
| How should I use KESIMPTA?See the detailed Instructions for Use that comes with KESIMPTA for information about how to prepare and inject a dose of KESIMPTA and how to properly throw away (dispose of) used KESIMPTA Sensoready pens or prefilled syringes. |
|What are the possible side effects of KESIMPTA? KESIMPTA may cause serious side effects, including: See “What is the most important information I should know about KESIMPTA?” |
| How should I store KESIMPTA? |
|General information about the safe and effective use of KESIMPTA. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use KESIMPTA for a condition for which it was not prescribed. Do not give KESIMPTA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about KESIMPTA that is written for health professionals.|
|What are the ingredients in KESIMPTA? Active ingredient: ofatumumabInactive ingredients: Sensoready pen and prefilled syringe: arginine, disodium edetate, polysorbate 80, sodium acetate trihydrate, sodium chloride, and Water for Injection. Hydrochloric acid may be added.Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936For more information, go to www.novartis.us or call 1-888-669-6682.|
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