United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - ofatumumab (unii: m95kg522r0) (ofatumumab - unii:m95kg522r0) - ofatumumab 20 mg in 1 ml - chronic lymphocytic leukemia (cll) arzerra (ofatumumab) is indicated: - in combination with chlorambucil, for the treatment of previously untreated patients with cll for whom fludarabine-based therapy is considered inappropriate [see clinical studies (14.1)] - in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed cll [see clinical studies (14.2)] - for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive cll [see clinical studies (14.3)] - for the treatment of patients with cll refractory to fludarabine and alemtuzumab [see clinical studies (14.4)] none. risk summary arzerra may cause fetal b-cell depletion based on findings from animal studies and the drug’s mechanism of action [see clinical pharmacology (12.1)] . there are no data on arzerra use in pregnant women to inform a drug-associated risk. however, there are clinical considerations [see clinical considerations] . no terato

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ofatumumab, quantity: 50 mg/ml - injection, solution - excipient ingredients: arginine; sodium acetate trihydrate; sodium chloride; polysorbate 80; disodium edetate; hydrochloric acid; water for injections - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) to delay the progression of physical disability and reduce the frequency of relapse (refer to section 5.1).

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ofatumumab, quantity: 50 mg/ml - injection, solution - excipient ingredients: arginine; sodium acetate trihydrate; sodium chloride; polysorbate 80; disodium edetate; hydrochloric acid; water for injections - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) to delay the progression of physical disability and reduce the frequency of relapse (refer to section 5.1).

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ofatumumab, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; arginine; sodium acetate; disodium edetate; polysorbate 80 - 1. previously untreated cll : arzerra is indicated, in combination with chlorambucil or bendamustine, for the treatment of patients with chronic lymphocytic leukaemia (cll) who have not received prior therapy and are inappropriate for fludarabine-based therapy.,2. refractory cll: arzerra, as a single agent, is indicated for the treatment of patients chronic lymphocytic leukaemia (cll) refractory to fludarabine and alemtuzumab.

Australia - English - Department of Health (Therapeutic Goods Administration)

novartis pharmaceuticals australia pty ltd - ofatumumab, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: water for injections; hydrochloric acid; sodium chloride; arginine; sodium acetate; disodium edetate; polysorbate 80 - 1. previously untreated cll: arzerra is indicated, in combination with chlorambucil or bendamustine, for the treatment of patients with chronic lymphocytic leukaemia (cll) who have not received prior therapy and are inappropriate for fludarabine-based therapy.,2. refractory cll: arzerra, as a single agent, is indicated for the treatment of patients chronic lymphocytic leukaemia (cll) refractory to fludarabine and alemtuzumab.

United States - English - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - ofatumumab (unii: m95kg522r0) (ofatumumab - unii:m95kg522r0) - 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

European Union - English - EMA (European Medicines Agency)

novartis ireland ltd - ofatumumab - multiple sclerosis, relapsing-remitting - immunosuppressant - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features (see section 5.1).

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novartis corporation (malaysia) sdn. bhd. - ofatumumab -

Israel - English - Ministry of Health

novartis israel ltd - ofatumumab - solution for injection - ofatumumab 50 mg/ml - ofatumumab - kesimpta is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (rms) with active disease defined by clinical or imaging features

European Union - English - EMA (European Medicines Agency)

novartis europharm ltd - ofatumumab - leukemia, lymphocytic, chronic, b-cell - monoclonal antibodies - previously untreated chronic lymphocytic leukaemia (cll): arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of patients with cll who have not received prior therapy and who are not eligible for fludarabine-based therapy. relapsed cll: arzerra is indicated in combination with fludarabine and cyclophosphamide for the treatment of adult patients with relapsed cll. refractory cll: arzerra is indicated for the treatment of cll in patients who are refractory to fludarabine and alemtuzumab.,