16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
KESIMPTA (ofatumumab) injection is a preservative-free, clear to slightly opalescent and colorless to slightly brownish-yellow solution for subcutaneous administration, which is supplied as follows:
KESIMPTA Sensoready Pen:
Carton of one 20 mg/0.4 mL single-dose prefilled Sensoready Pen NDC 0078-1007-68
KESIMPTA Prefilled Syringe:
Carton of one 20 mg/0.4 mL single-dose prefilled syringe NDC 0078-1007-69
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).
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 |
| 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.
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.
- 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.
- 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:
It is not known if KESIMPTA is safe or effective in children.
- clinically isolated syndrome
- relapsing-remitting disease
- active secondary progressive disease
| 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: |
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.
- 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.
| 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?” |
The most common side effects of KESIMPTA include:
- 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.
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.
- 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?”
| How should I store KESIMPTA? |
Keep KESIMPTA and all medicines out of the reach of children.
- 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.
|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.
|This Instructions for Use has been approved by the U.S. Food and Drug Administration.||Issued: August 2020|
|INSTRUCTIONS FOR USE
KESIMPTA® [KEY-simp-ta ](ofatumumab)injection, for subcutaneous useSensoready® Pen|
This Instructions for Use contains information on how to inject KESIMPTA Sensoready Pen. Be sure that you read, understand, and follow this Instructions for Use before injecting KESIMPTA. Your healthcare provider should show you how to prepare and inject KESIMPTA the right way using the Sensoready Pen before you use it for the first time. Talk to your healthcare provider if you have any questions before you use KESIMPTA for the first time.Important Information You Need to Know Before Injecting KESIMPTA Sensoready Pen. |
Throw away (dispose of) the used KESIMPTA Sensoready Pen right away after use. Do not re-use a KESIMPTA Sensoready Pen. See “How should I dispose of used KESIMPTA Sensoready Pens?” at the end of this Instructions for Use.
- Do not use the KESIMPTA Sensoready Pen if either the seal on the outer carton or the seal on the KESIMPTA Sensoready Pen is broken. Keep the KESIMPTA Sensoready Pen in the sealed outer carton until you are ready to use it.
- Do not shake the KESIMPTA Sensoready Pen.
- If you drop your KESIMPTA Sensoready Pen, do not use it if it looks damaged, or if you dropped it with the cap removed.
|How should I store KESIMPTA Sensoready Pen? |
Keep KESIMPTA Sensoready Pen and all medicines out of the reach of children.KESIMPTA Sensoready Pen parts (see Figure A):Figure A Do not remove the cap until you are ready to inject.
- Store your carton of KESIMPTA Sensoready Pen in a refrigerator, between 36°F to 46°F (2°C to 8°C).
- Keep KESIMPTA Sensoready Pen in the original carton until ready to use to protect from light.
- Do not freeze KESIMPTA Sensoready Pen.
|What you need for your injection: Included in the carton:
A new KESIMPTA Sensoready Pen (see Figure B).
||Figure B |
|Not included in the carton (see Figure C):
See “How should I dispose of used KESIMPTA Sensoready Pens?” at the end of this Instructions for Use.
- 1 alcohol wipe
- 1 cotton ball or gauze
- Sharps disposal container
|Figure C |
|Before your injection Take the KESIMPTA Sensoready Pen out of the refrigerator 15 to 30 minutes before injecting to allow it to reach room temperature.Step 1. Important safety checks before you inject (see Figure D):|
Do not use if the liquid contains visible particles or is cloudy.You may see a small air bubble, which is normal.
- Look through the viewing window. The liquid should be clear to slightly cloudy.
Contact your pharmacist or healthcare provider if your pen fails any of these checks.
- Look at the expiration date (EXP) on your KESIMPTA Sensoready Pen. Do not use your pen if the expiration date has passed.
|Figure D |
|Step 2. Choose your injection site: |
- The recommended site is the front of the thighs. You may also use the lower stomach area (lower abdomen), but not the area 2 inches around the navel (belly button) (see Figure E).
- Do not inject into areas where the skin is tender, bruised, red, scaly or hard. Avoid areas with moles, scars or stretch marks.
- If a caregiver or healthcare provider is giving you your injection, they may also inject into your outer upper arm (see Figure F).
|Figure E Figure F (Caregiver and healthcare provider only) |
|Step 3. Clean your injection site: |
- Wash your hands with soap and water.
- Using a circular motion, clean the injection site with the alcohol wipe. Leave it to dry before injecting (see Figure G).
- Do not touch the cleaned area again before injecting.
|Figure G |
|Your injection Step 4. Remove the cap: |
You may see a few drops of medicine come out of the needle. This is normal.
- Only remove the cap when you are ready to use the KESIMPTA Sensoready Pen.
- Twist off the cap in the direction of the arrow (see Figure H).
- Throw away the cap. Do not try to re-attach the cap.
- Use the KESIMPTA Sensoready Pen within 5 minutes of removing the cap.
|Figure H |
|Step 5. Hold your KESIMPTA Sensoready Pen: |
- Hold the KESIMPTA Sensoready Pen at 90 degrees to the cleaned injection site (see Figure I).
|Figure I |
|Important: During the injection you will hear 2 loud clicks: |
You must keep holding the KESIMPTA Sensoready Pen firmly against the skin until the green indicator fills the window and stops moving.
- The 1st click indicates that the injection has started
- A 2nd click will indicate that the injection is almost complete
|Step 6. Start your injection: |
- Press the KESIMPTA Sensoready Pen firmly against the skin to start the injection (see Figure J).
- The 1st click indicates the injection has started.
- Keep holding the KESIMPTA Sensoready Pen firmly against your skin.
- The green indicator shows the progress of the injection.
|Figure J |
|Step 7. Complete your injection: |
- Listen for the 2nd click. This indicates that the injection is almost complete.
- Check to see if the green indicator fills the window and has stopped moving (see Figure K).
- The KESIMPTA Sensoready Pen can now be removed (see Figure L).
|Figure K |
|After your injection |
- In case the green indicator does not fill the window, it means the medicine has not been delivered. Contact your healthcare provider if the green indicator is not visible.
- There may be a small amount of blood at the injection site. You can press a cotton ball or gauze over the injection site and hold it for 10 seconds. Do not rub the injection site. You may cover the injection site with a small adhesive bandage, if needed.
|Figure L |
|How should I dispose of used KESIMPTA Sensoready® Pens?Step 8. Put your used KESIMPTA Sensoready Pen in a FDA-cleared sharps disposal container right away after use (see Figure M). Do not throw away (dispose of) your used KESIMPTA Sensoready Pen in your household trash.If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles, syringes and pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal.Keep the sharps container out of the reach of children. Manufactured by:Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936U.S. License No.: 1244
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
|Figure M |
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