KESIMPTA (Page 5 of 8)

16.2 Storage and Handling

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.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read FDA-approved patient labeling (Medication Guide and Instructions for Use).

Infections

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)].

Vaccinations

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)].

Injection-Related Reactions

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)].

Contraception

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.

Manufactured by:
Novartis Pharmaceuticals Corporation
East Hanover, NJ 07936 U.S. License No.: 1244

KESIMPTA and SENSOREADY is a [registered] trademark of Novartis AG.

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This Medication Guide has been approved by the U.S. Food and Drug Administration. Approved: August 2020
MEDICATION GUIDE
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.
  • Hepatitis B virus (HBV) reactivation. Before starting treatment with KESIMPTA, your healthcare provider will do blood tests to check for HBV. If you have ever had HBV infection, the HBV may become active again during or after treatment with KESIMPTA. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. You should not receive KESIMPTA if you have active hepatitis B liver disease. Your healthcare provider will monitor you for HBV infection during and after you stop using KESIMPTA.
Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes during treatment with KESIMPTA.
  • Progressive Multifocal Leukoencephalopathy (PML). PML may happen with KESIMPTA. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, changes in thinking and memory which may lead to confusion and personality changes.
  • Weakened immune system. KESIMPTA taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
What is KESIMPTA? KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including:
  • clinically isolated syndrome
  • relapsing-remitting disease
  • active secondary progressive disease
It is not known if KESIMPTA is safe or effective in children.
Do not use KESIMPTA if you:
  • have active hepatitis B virus infection.
Before using KESIMPTA, tell your healthcare provider about all of your medical conditions, including if you:
  • have or think you have an infection including HBV or PML. See “What is the most important information I should know about KESIMPTA?”
  • have ever taken, currently take, or plan to take medicines that affect your immune system. These medicines could increase your risk of getting an infection.
  • have had a recent vaccination or are scheduled to receive any vaccinations.
    • You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with KESIMPTA. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with KESIMPTA and until your healthcare provider tells you that your immune system is no longer weakened.
    • Whenever possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with KESIMPTA.
    • Talk to your healthcare provider about vaccinations for your baby if you used KESIMPTA during your pregnancy.
  • are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if KESIMPTA will harm your unborn baby. Females who can become pregnant should use birth control (contraception) during treatment with KESIMPTA and for 6 months after your last treatment. Talk with your healthcare provider about what birth control method is right for you during this time.
  • are breastfeeding or plan to breastfeed. It is not known if KESIMPTA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take KESIMPTA.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
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.
  • Use KESIMPTA exactly as your healthcare provider tells you to use it.
  • KESIMPTA is given as an injection under your skin (subcutaneous injection), in your thigh or stomach-area (abdomen) by you or a caregiver. A caregiver may also give you an injection of KESIMPTA in your upper outer arm.
  • Your healthcare provider will show you how to prepare and inject KESIMPTA the right way before you use it for the first time.
  • Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with moles, scars or stretch marks.
  • The initial dosing is 20 mg of KESIMPTA given by subcutaneous injection at Weeks 0, 1, and 2. There is no injection at Week 3. Starting at Week 4 and then every month, the recommended dose is 20 mg of KESIMPTA administered by subcutaneous injection.
  • If you miss an injection of KESIMPTA at Week 0, 1, or 2, talk to your healthcare provider. If you miss a monthly injection, give it as soon as possible without waiting until the next scheduled dose. After that, give your KESIMPTA injections a month apart.
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?”
  • Injection-related reactions. Injection-related reactions is a common side effect of KESIMPTA. Injecting KESIMPTA can cause injection-related reactions that can happen within 24 hours (1 day) following the first injections and with later injections. Talk with your healthcare provider if you have any of these signs and symptoms:
    • at or near the injection site: redness of the skin, swelling, itching and pain or
    • that may happen when certain substances are released in your body: fever, headache, pain in the muscles, chills, and tiredness.
  • Low immunoglobulins. KESIMPTA may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.
The most common side effects of KESIMPTA include:
  • upper respiratory tract infection, with symptoms, such as sore throat and runny nose, and headache. See “What is the most important information I should know about KESIMPTA?”
  • headache
These are not all the possible side effects of KESIMPTA. Call your doctor for medical advice about side effects.You may report side effects to FDA at 1-800-FDA-1088.
How should I store KESIMPTA?
  • Store KESIMPTA in a refrigerator between 36°F to 46°F (2°C to 8°C).
  • Keep KESIMPTA in the original carton until ready for use to protect from light.
  • Do not freeze KESIMPTA.
  • Do not shake KESIMPTA.
Keep KESIMPTA and all medicines out of the reach of children.
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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