KESIMPTA- ofatumumab injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OFATUMUMAB (UNII: M95KG522R0) (OFATUMUMAB - UNII:M95KG522R0)

Available from:

Novartis Pharmaceuticals Corporation

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. KESIMPTA is contraindicated in patients with: - Active HBV infection [see Warnings and Precautions (5.1)] . Risk Summary There are no adequate data on the developmental risk associated with the use of KESIMPTA in pregnant women. Ofatumumab may cross the placenta and cause fetal B-cell depletion based on findings from animal studies (see Data ). Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. B-cell levels in infants following maternal exposure to KESIMPTA have not been studied in clinical trials. The potential duration of B-cell depletion in infants exposed to ofatumumab in utero , and the impact of B-cell depletion on the safety and effectiveness of vaccines, are unknown. Avoid administering live vaccines to neonates and infants exposed to KESIMPTA in utero until B-cell recovery occurs [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)] . Following administration of ofatumumab to pregnant monkeys, increased mortality, depletion of B-cell populations, and impaired immune function were observed in the offspring, in the absence of maternal toxicity, at plasma levels substantially higher than that in humans (see Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Intravenous administration of ofatumumab (weekly doses of 0, 20, or 100 mg/kg) to pregnant monkeys during the period of organogenesis (gestations days 20 to 50) resulted in no adverse effects on embryofetal development; however, B-cell depletion was observed in fetuses at both doses when assessed on gestation day 100. Plasma exposure (Cave ) at the no-effect dose (100 mg/kg) for adverse effects on embryofetal development was greater than 5000 times that in humans at the recommended human maintenance dose of 20 mg. A no-effect dose for effects on B-cells was not identified; plasma exposure (Cave ) at the low-effect dose (20 mg/kg) was approximately 780 times that in humans at the recommended human maintenance dose (RHMD) of 20 mg/month. Intravenous administration of ofatumumab (5 weekly doses of 0, 10, and 100 mg/kg, followed by biweekly doses of 0, 3, and 20 mg/kg) to pregnant monkeys throughout pregnancy resulted in no adverse effects on the development of the offspring. However, postnatal death, B-cell depletion, and impaired immune function were observed in the offspring at the high dose. The deaths at the high dose were considered secondary to B-cell depletion. Plasma exposure (Cave ) in dams at the no-effect dose (100/20 mg/kg) for adverse developmental effects was approximately 500 times that in humans at RHMD. A no-effect level for mortality and immune effects in offspring was not established because of the limited number of evaluable offspring at the low dose. Risk Summary There are no data on the presence of ofatumumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Human IgG is excreted in human milk, and the potential for absorption of ofatumumab to lead to B-cell depletion in the infant is unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for KESIMPTA and any potential adverse effects on the breastfed infant from KESIMPTA or from the underlying maternal condition. Contraception Females of childbearing potential should use effective contraception while receiving KESIMPTA and for 6 months after the last treatment of KESIMPTA [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)] . Safety and effectiveness in pediatric patients have not been established. Clinical studies of KESIMPTA did not include sufficient numbers of geriatric patients to determine whether they respond differently from younger subjects. - 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. - 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. - If needed, KESIMPTA Sensoready Pen may be stored for up to 7 days at room temperature, up to 86°F (30°C). - Write the date taken out of the refrigerator in the space provided on the carton. - If stored below 86°F (30°C), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days. If this KESIMPTA is not used within those 7 days, then discard the medicine. - Do not freeze KESIMPTA Sensoready Pen. - 1 alcohol wipe - 1 cotton ball or gauze - Sharps disposal container - Look through the viewing window. The liquid should be clear to slightly cloudy. - Look at the expiration date (EXP) on your KESIMPTA Sensoready Pen. Do not use your pen if the expiration date has passed. - 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 ). - 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. - 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. - Hold the KESIMPTA Sensoready Pen at 90 degrees to the cleaned injection site (see Figure I ). - The 1st click indicates that the injection has started - A 2nd click will indicate that the injection is almost complete - 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. - 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 ). - 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. - 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. T2022-54 - Do not use the KESIMPTA prefilled syringe if either the seal on the outer carton or the seal of the blister is broken. Keep the KESIMPTA prefilled syringe in the sealed carton until you are ready to use it. - Do not shake the KESIMPTA prefilled syringe. - The KESIMPTA prefilled syringe has a needle guard that will be activated to cover the needle after the injection is finished. The needle guard will help to prevent needle stick injuries to anyone who handles the KESIMPTA prefilled syringe after injection. - Do not remove the needle cap until just before you give the injection. - Avoid touching the syringe guard wings before use. Touching them may cause the needle guard to be activated too early. - Throw away (dispose of) the used KESIMPTA prefilled syringe right away after use. Do not re-use a KESIMPTA prefilled syringe. See "How should I dispose of used KESIMPTA prefilled syringes?” at the end of these Instructions for Use. - Store your carton of the KESIMPTA prefilled syringe in a refrigerator, between 36°F to 46°F (2°C to 8°C). - Keep the KESIMPTA prefilled syringe in the original carton until ready to use to protect from light. - If needed, KESIMPTA prefilled syringe may be stored for up to 7 days at room temperature, up to 86°F (30°C). - Write the date taken out of the refrigerator in the space provided on the carton. - If stored below 86°F (30°C), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days. If this KESIMPTA is not used within those 7 days, then discard the medicine. - Do not freeze the KESIMPTA prefilled syringe. - 1 alcohol wipe - 1 cotton ball or gauze - Sharps disposal container - Areas of your body that you may use as injection sites include: the front of your thighs (see Figure D ) the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see Figure D ) your outer upper arms, if a healthcare provider or caregiver is giving you the injection (see Figure E ). - the front of your thighs (see Figure D ) - the lower stomach-area (abdomen), but not the area 2 inches around your navel (belly button) (see Figure D ) - your outer upper arms, if a healthcare provider or caregiver is giving you the injection (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. - 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. T2022-55

Product summary:

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 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. If necessary, KESIMPTA may be stored for up to 7 days at room temperature, not to exceed 30°C (86°F). Write the date removed from the refrigerator in the space provided on the carton labeling. If stored below 30°C (86°F), unused KESIMPTA may be returned to the refrigerator and must be used within the next 7 days or discarded after 7 days.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Novartis Pharmaceuticals Corporation
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration.
Revised: 1/2024
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, which can be life-threatening or cause
death, 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

Summary of Product characteristics

KESIMPTA- OFATUMUMAB INJECTION, SOLUTION
NOVARTIS PHARMACEUTICALS CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KESIMPTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KESIMPTA.
KESIMPTA (OFATUMUMAB) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2009
RECENT MAJOR CHANGES
Warnings and Precautions, Infections (5.1)
1/2024
INDICATIONS AND USAGE
KESIMPTA is a CD20-directed cytolytic antibody indicated for the
treatment of relapsing forms of multiple
sclerosis (MS), to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary
progressive disease, in adults. (1)
DOSAGE AND ADMINISTRATION
Hepatitis B virus (HBV) and quantitative serum immunoglobulins
screening are required before the first
dose. (2.1)
Administer KESIMPTA by subcutaneous injection only. (2.2, 2.3)
Initial Dosing: 20 mg administered at Weeks 0, 1, and 2. (2.2)
Subsequent Dosing: 20 mg administered monthly starting at Week 4.
(2.2)
DOSAGE FORMS AND STRENGTHS
Injection: 20 mg/0.4 mL solution in a single-dose prefilled Sensoready
Pen (3)
Injection: 20 mg/0.4 mL solution in a single-dose prefilled syringe
(3)
CONTRAINDICATIONS
Active HBV infection. (4)
WARNINGS AND PRECAUTIONS
Infections: Serious, including life-threatening and fatal infections,
have occurred in patients treated with
anti-CD20 therapies. Delay KESIMPTA administration in patients with an
active infection until the
infection is resolved. Vaccination with live-attenuated or live
vaccines is not recommended during
treatment with KESIMPTA and after discontinuation, until B-cell
repletion. (5.1)
Injection-Related Reactions: Management for injection-related
reactions depends on the type and
severity of the reaction. (5.2)
Reduction in Immunoglobulins: Monitor the level of immunoglobulins at
the beginning, during, and after
discontinuation of treatment with KESIMPTA until B-cell repletion.
Consider discontinuing KESIMPTA if a
patient develops a serious opportunistic in