OCREVUS- ocrelizumab injection

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

OCRELIZUMAB (UNII: A10SJL62JY) (OCRELIZUMAB - UNII:A10SJL62JY)

Dostopno od:

Genentech, Inc.

INN (mednarodno ime):

ocrelizumab

Sestava:

ocrelizumab 300 mg in 10 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

OCREVUS 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 - Primary progressive MS, in adults OCREVUS is contraindicated in patients with: - Active HBV infection [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)] - A history of life-threatening infusion reaction to OCREVUS [see Warnings and Precautions (5.1)] Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy and fetal/neonatal/infant outcomes in women exposed to OCREVUS during pregnancy. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-833-872-4370 or visiting www.ocrevuspregnancyregistry.com. Risk Summary OCREVUS is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins are known to cross the placental barrier. There are no adequate data on the developmental risk associated with use of OCREVUS in pregnant women. However, 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 OCREVUS have not been studied in clinical trials. The potential duration of B-cell depletion in such infants, and the impact of B-cell depletion on vaccine safety and effectiveness, is unknown [see Warnings and Precautions (5.2)] . Following administration of ocrelizumab to pregnant monkeys at doses similar to or greater than those used clinically, increased perinatal mortality, depletion of B-cell populations, renal, bone marrow, and testicular toxicity were observed in the offspring in the absence of maternal toxicity [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 Following intravenous administration of OCREVUS to monkeys during organogenesis (loading doses of 15 or 75 mg/kg on gestation days 20, 21, and 22, followed by weekly doses of 20 or 100 mg/kg), depletion of B-lymphocytes in lymphoid tissue (spleen and lymph nodes) was observed in fetuses at both doses. Intravenous administration of OCREVUS (three daily loading doses of 15 or 75 mg/kg, followed by weekly doses of 20 or 100 mg/kg) to pregnant monkeys throughout the period of organogenesis and continuing through the neonatal period resulted in perinatal deaths (some associated with bacterial infections), renal toxicity (glomerulopathy and inflammation), lymphoid follicle formation in the bone marrow, and severe decreases in circulating B-lymphocytes in neonates. The cause of the neonatal deaths is uncertain; however, both affected neonates were found to have bacterial infections. Reduced testicular weight was observed in neonates at the high dose. A no-effect dose for adverse developmental effects was not identified; the doses tested in monkey are 2 and 10 times the recommended human dose of 600 mg, on a mg/kg basis. Risk Summary There are no data on the presence of ocrelizumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Ocrelizumab was excreted in the milk of ocrelizumab-treated monkeys. Human IgG is excreted in human milk, and the potential for absorption of ocrelizumab 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 OCREVUS and any potential adverse effects on the breastfed infant from OCREVUS or from the underlying maternal condition. Contraception Women of childbearing potential should use effective contraception while receiving OCREVUS and for 6 months after the last infusion of OCREVUS [see Clinical Pharmacology (12.3)] . Safety and effectiveness of OCREVUS in pediatric patients have not been established. Clinical studies of OCREVUS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Povzetek izdelek:

OCREVUS (ocrelizumab) injection is a preservative-free, sterile, clear or slightly opalescent, and colorless to pale brown solution supplied as a carton containing one 300 mg/10 mL (30 mg/mL) single-dose vial (NDC 50242-150-01). Store OCREVUS vials at 2°C to 8°C (36°F to 46°F) in the outer carton to protect from light. Do not freeze or shake.

Status dovoljenje:

Biologic Licensing Application

Navodilo za uporabo

Genentech, Inc.
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This Medication Guide has been approved by the U.S. Food and Drug
Administration
Revised: 1/2024
MEDICATION GUIDE
OCREVUS® (oak-rev-us)
(ocrelizumab)
injection,
for intravenous use
What is the most important information I should know about OCREVUS?
OCREVUS can cause serious side effects, including:
•
Infusion reactions: Infusion reactions are a common side effect of
OCREVUS, which can be
serious and may require you to be hospitalized. You will be monitored
during your infusion and
for at least 1 hour after each infusion of OCREVUS for signs and
symptoms of an infusion
reaction. Tell your healthcare provider or nurse if you get any of
these symptoms:
•
itchy skin
•
rash
•
hives
•
tiredness
•
coughing or
wheezing
•
trouble breathing
•
throat irritation
or pain
•
feeling faint
•
fever
•
redness on your
face (flushing)
•
nausea
•
headache
•
swelling of the
throat
•
dizziness
•
shortness of
breath
•
fatigue
•
fast heart beat
These infusion reactions can happen for up to 24 hours after your
infusion. It is important that you call
your healthcare provider right away if you get any of the signs or
symptoms listed above after each
infusion.
If you get infusion reactions, your healthcare provider may need to
stop or slow down the rate of your
infusion.
•
Infection:
•
Infections are a common side effect. OCREVUS increases your risk of
getting upper
respiratory tract infections, lower respiratory tract infections, skin
infections, and herpes
infections. Serious infections can happen with OCREVUS, which can be
life-threatening
or cause death. Tell your healthcare provider if you have an infection
or have any of the
following signs of infection including fever, chills, a cough that
does not go away, or
painful urination. Signs of herpes infection include:
•
cold sores
•
shingles
•
genital sores
•
skin rash
•
pain
•
itching
Signs of a more serious herpes infection include:
•
changes in vision
•
severe or persistent
•
confusion
•
eye redness

Lastnosti izdelka

OCREVUS- OCRELIZUMAB INJECTION
GENENTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OCREVUS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OCREVUS.
OCREVUS (OCRELIZUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2017
RECENT MAJOR CHANGES
Warnings and Precautions (5.2)
1/2024
INDICATIONS AND USAGE
OCREVUS 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)
Primary progressive MS, in adults (1)
DOSAGE AND ADMINISTRATION
Hepatitis B virus and quantitative serum immunoglobulin screening are
required before the first dose
(2.1)
Pre-medicate with methylprednisolone (or an equivalent corticosteroid)
and an antihistamine (e.g.,
diphenhydramine) prior to each infusion (2.2)
Administer OCREVUS by intravenous infusion
Start dose: 300 mg intravenous infusion, followed two weeks later by a
second 300 mg intravenous
infusion (2.3)
Subsequent doses: 600 mg intravenous infusion every 6 months (2.3)
Must be diluted prior to administration (2.3, 2.6)
Monitor patients closely during and for at least one hour after
infusion (2.3, 2.5)
DOSAGE FORMS AND STRENGTHS
Injection: 300 mg/10 mL (30 mg/mL) in a single-dose vial (3)
CONTRAINDICATIONS
Active hepatitis B virus infection (4)
History of life-threatening infusion reaction to OCREVUS (4)
WARNINGS AND PRECAUTIONS
Infusion Reactions: Management recommendations for infusion reactions
depend on the type and
severity of the reaction. Permanently discontinue OCREVUS if a
life-threatening or disabling infusion
reaction occurs (2.3, 5.1)
Infections: Serious, including life-threatening and fatal infections,
have occurred. Delay OCREVUS
administration in patients with an active infection until the
infection is resolved. Vaccination with live-
attenuated or live vaccines is not recommended during treatment w