BENLYSTA- belimumab injection, powder, lyophilized, for solution BENLYSTA- belimumab solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

BELIMUMAB (UNII: 73B0K5S26A) (BELIMUMAB - UNII:73B0K5S26A)

Pieejams no:

GlaxoSmithKline LLC

SNN (starptautisko nepatentēto nosaukumu):

BELIMUMAB

Kompozīcija:

BELIMUMAB 400 mg in 5 mL

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

BENLYSTA (belimumab) is indicated for the treatment of: Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus. Use of BENLYSTA is not recommended in this situation. BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab. Pregnancy Exposure Registry There is a pregnancy exposure registry that evaluates pregnancy outcomes in women with lupus exposed to BENLYSTA during pregnancy. Healthcare professionals are encouraged to refer patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/. Risk Summary Available data on use of BENLYSTA in pregnant women, from observational studies, published case reports, and postmarketing surveillance, are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with SLE (see Clinical Considerations) . Monoclonal antibodies, such as belimumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant (see Clinical Considerations) . In an animal combined embryo-fetal and pre- and post-natal development study with monkeys that received belimumab by intravenous administration, there was no evidence of fetal harm with exposures approximately 9 times (based on intravenous administration) and 20 times (based on subcutaneous administration) the exposure at the maximum recommended human dose (MRHD). Belimumab-related findings in monkey fetuses and/or infants included reductions of B-cell counts, reductions in the density of lymphoid tissue B-lymphocytes in the spleen and lymph nodes, and altered IgG and IgM titers. The no-adverse-effect-level (NOAEL) was not identified for these findings; however, they were reversible within 3 to 12 months after the drug was discontinued (see Data) . Based on animal data and the mechanism of action of belimumab, the immune system in infants of treated mothers may be adversely affected. It is unknown, based on available data, whether immune effects, if identified, are reversible [see Clinical Pharmacology (12.1)]. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Pregnant women with SLE are at increased risk of adverse pregnancy outcomes, including worsening of the underlying disease, premature birth, miscarriage, and intrauterine growth restriction. Maternal lupus nephritis increases the risk of hypertension and preeclampsia/eclampsia. Passage of maternal autoantibodies across the placenta may result in adverse neonatal outcomes, including neonatal lupus and congenital heart block. Fetal/Neonatal Adverse Reactions: Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to BENLYSTA in utero. Monitor an infant of a treated mother for B-cell reduction and other immune dysfunction [see Warnings and Precautions (5.5)]. Data Animal Data: In a combined embryo-fetal and pre- and post-natal development study, pregnant cynomolgus monkeys received belimumab at intravenous doses of 0, 5, or 150 mg/kg every 2 weeks from confirmation of pregnancy at Gestation Days (GD) 20 to 22, throughout the period of organogenesis (up to approximately GD 50), and continuing to either the day of scheduled cesarean section (GD 150 [late third trimester]) or the day of parturition. There was no evidence of maternal toxicity, effects on embryofetal and infant survival, or structural abnormalities at exposure approximately 9 times the MRHD of 10 mg/kg intravenously or 20 times the MRHD of 200 mg subcutaneously (on an AUC basis with maternal animal intravenous doses up to 150 mg/kg). Belimumab-related findings in mothers included reductions of immature and mature B-cell counts and in fetuses and/or infants included reductions of immature and mature B-cell counts, reductions in the density of lymphoid tissue B-lymphocytes in the spleen and lymph nodes, reduced spleen weights, increased IgG titers, and reduced IgM titers. B-cell counts in infant monkeys exposed to belimumab in utero recovered by 3 months of age and in mothers after 1 year. IgG and IgM levels in infant monkeys recovered by 6 months of age and the reductions in B-lymphocytes in the lymph nodes and spleen were reversed by 1 year of age. Belimumab crossed the placenta, as it was detected in fetal cord blood and amniotic fluid on GD 150. Risk Summary No information is available on the presence of belimumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Belimumab was detected in the milk of cynomolgus monkeys; however, due to species-specific differences in lactation physiology, animal data may not predict drug levels in human milk. Maternal IgG is known to be present in human milk. If belimumab is transferred into human milk, the effects of local exposure in the gastrointestinal tract and potential limited systemic exposure in the infant to belimumab are unknown. The lack of clinical data during lactation precludes clear determination of the risk of BENLYSTA to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BENLYSTA, and any potential adverse effects on the breastfed child from BENLYSTA or from the underlying maternal condition. Contraception Following an assessment of benefit versus risk, if prevention of pregnancy is warranted, females of reproductive potential should use effective contraception during treatment and for at least 4 months after the final treatment. Safety and effectiveness of BENLYSTA have been established for the treatment of SLE and lupus nephritis in pediatric patients 5 to 17 years old. Use of BENLYSTA in pediatric patients with SLE is supported by evidence from pharmacokinetic (PK) and efficacy results from a pediatric study (Trial 6), as well as PK exposure and extrapolation of the established efficacy of BENYLSTA plus standard therapy from the Phase 3 intravenous studies in adults with SLE. A randomized, double‑blind, placebo‑controlled, PK, efficacy, and safety study (Trial 6) to evaluate intravenously administered BENLYSTA 10 mg/kg plus standard therapy compared with placebo plus standard therapy over 52 weeks was conducted in 93 pediatric patients with SLE. The proportion of pediatric patients achieving an SRI-4 response was higher in patients receiving BENLYSTA plus standard therapy compared with placebo plus standard therapy. Pediatric patients receiving BENLYSTA plus standard therapy also had a lower risk of experiencing a severe flare compared with placebo plus standard therapy [see Clinical Studies (14.3)] . Pharmacokinetics were evaluated in a total of 53 pediatric patients with SLE and were consistent with the adult population with SLE [see Clinical Pharmacology (12.3)] . Use of BENLYSTA in pediatric patients with active lupus nephritis is based on the extrapolation of efficacy from the intravenous study in adults (n = 224) with active lupus nephritis, and supported by pharmacokinetic data from intravenous studies in adults (n = 224) with active lupus nephritis and from pediatric patients (n = 53) with SLE. Estimated belimumab exposures for pediatric patients were comparable to adults with active lupus nephritis [see Clinical Pharmacology (12.3)] . The safety and effectiveness of intravenous administration of BENLYSTA have not been established in pediatric patients younger than 5 years of age. The safety and effectiveness of subcutaneous administration of BENLYSTA have not been established in pediatric patients younger than 18 years of age. Clinical studies of BENLYSTA did not include sufficient numbers of subjects aged 65 or older to determine whether they respond differently from younger subjects. Use with caution in geriatric patients. The safety and efficacy of BENLYSTA were evaluated in studies that included patients with SLE who had mild (creatinine clearance [CrCl] ≥60 and <90 mL/min), moderate (CrCl ≥30 and <60 mL/min), or severe (CrCl ≥15 and <30 mL/min) renal impairment. No dosage adjustment is recommended in patients with renal impairment. No formal trials were conducted to examine the effects of hepatic impairment on the pharmacokinetics of belimumab. No dosage adjustment is recommended in patients with hepatic impairment. In Trial 2 and Trial 3 (intravenous dosing), SLE Responder Index-4 (SRI-4) response rates were lower for Black patients receiving BENLYSTA plus standard therapy relative to Black patients receiving placebo plus standard therapy [see Clinical Studies (14.1)] . In Trial 4 (intravenous dosing), a 2:1 randomized, placebo-controlled trial in Black patients, SLE Responder Index (SRI-S2K) response rates were higher for Black patients receiving BENLYSTA plus standard therapy (49%) relative to Black patients receiving placebo plus standard therapy (42%). However, the treatment difference was not statistically significant [see Clinical Studies (14.1)] . In Trial 7 (subcutaneous dosing), SRI-4 response was 45% (26/58) in Black patients receiving BENLYSTA plus standard therapy compared with 39% (13/33) in Black patients receiving placebo plus standard therapy [see Clinical Studies (14.4)] . The safety profile of BENLYSTA in Black patients was consistent with the known safety profile of BENLYSTA administered in the overall population [see Adverse Reactions (6.1)] . Instructions for Use BENLYSTA (ben-LIST-ah) (belimumab) injection, for subcutaneous use Prefilled Syringe Read this Instructions for Use before you start to use BENLYSTA and each time you refill your prescription. There may be new information. You should also receive training from your healthcare provider on how to use the prefilled syringe the right way. If you do not follow these instructions the prefilled syringe may not work properly. BENLYSTA is for use under the skin only (subcutaneous). Important Storage Information Important Warnings BENLYSTA Prefilled Syringe Parts Before use After Use – Needle is covered by Needle Guard Supplies needed for the injection BENLYSTA Prefilled Syringe Alcohol Swab (not included) Gauze Pad or Cotton Ball (not included) Sharps Container (not included) 1 Gather and check supplies Gather supplies Check expiration date 2 Prepare and inspect the BENLYSTA Prefilled Syringe Allow to come to room temperature Inspect BENLYSTA solution 3 Choose and clean the injection site Choose the injection site Clean the injection site 4 Prepare for the injection Remove the Needle Cap 5 Inject BENLYSTA Insert the Needle Complete the injection 6 Dispose of used prefilled syringe and inspect Dispose of the used prefilled syringe Throw away (dispose of) the used syringe and Needle Cap in a Sharps Container. See Figure J. Inspect the injection site Additional information For more information about BENLYSTA, go to www.BENLYSTA.com or call 1-877-423-6597. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Trademarks are owned by or licensed to the GSK group of companies. Manufactured by GlaxoSmithKline LLC Philadelphia, PA 19104, U.S. License No. 1727, and Distributed by GlaxoSmithKline Durham, NC 27701 ©2022 GSK group of companies or its licensor. BNL:5IFU-S Revised July 2022 Instructions for Use BENLYSTA (ben-LIST-ah) (belimumab) injection, for subcutaneous use Prefilled Autoinjector Read this Instructions for Use before you start to use BENLYSTA and each time you refill your prescription. There may be new information. You should also receive training from your healthcare provider on how to use the autoinjector the right way. If you do not follow these instructions the autoinjector may not work properly. BENLYSTA is for use under the skin only (subcutaneous). Important Storage Information Important Warnings BENLYSTA Autoinjector Parts Supplies needed for the injection BENLYSTA Autoinjector Alcohol Swab (not included) Gauze Pad or Cotton Ball (not included) Sharps Container (not included) 1 Gather and check supplies Gather supplies Check expiration date 2 Prepare and inspect the BENLYSTA Autoinjector Allow to come to room temperature Inspect BENLYSTA solution 3 Choose and clean the injection site Choose the injection site Clean the injection site 4 Prepare for the injection Remove the Ring Cap Position the autoinjector 5 Inject BENLYSTA Start the injection Complete the injection 6 Dispose of used autoinjector and inspect Dispose of the used autoinjector Throw away (dispose of) the used autoinjector and Ring Cap in a Sharps Container. See Figure K. Inspect the injection site Additional information For more information about BENLYSTA, go to www.BENLYSTA.com or call 1-877-423-6597. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Trademarks are owned by or licensed to the GSK group of companies. Manufactured by GlaxoSmithKline LLC Philadelphia, PA 19104, U.S. License No. 1727, and Distributed by GlaxoSmithKline Durham, NC 27701 ©2022 GSK group of companies or its licensor. BNL:5IFU-A Revised July 2022

Produktu pārskats:

BENLYSTA (belimumab) for injection is a sterile, preservative-free, lyophilized powder for reconstitution and dilution prior to intravenous infusion provided in single‑dose glass vials with a rubber stopper (not made with natural rubber latex) and a flip‑off seal. Each 5‑mL vial contains 120 mg of belimumab. Each 20‑mL vial contains 400 mg of belimumab. BENLYSTA vials are supplied as follows: 120 mg belimumab in a 5-mL single-dose vial (NDC 49401-101-01) 400 mg belimumab in a 20-mL single-dose vial (NDC 49401-102-01) Refrigerate vials at 36°F to 46°F (2°C to 8°C). Store vials in the original carton until use to protect from light. Do not freeze. Avoid exposure to heat. BENLYSTA (belimumab) injection is a clear to opalescent, and colorless to pale yellow solution for subcutaneous use. Each single-dose prefilled autoinjector or single-dose prefilled syringe is designed to deliver 200 mg of belimumab in 1 mL of solution and is supplied as follows: 200 mg/mL single-dose prefilled autoinjector with 27-gauge, half-inch needle attached (NDC 49401-088-01) in a carton of 4 (NDC 49401-088-35). 200 mg/mL single-dose prefilled glass syringe with 27-gauge, half-inch needle attached (NDC 49401-088-42) in a carton of 4 (NDC 49401-088-47). Prior to Dispensing Refrigerate prefilled autoinjectors and prefilled syringes at 36°F to 46°F (2°C to 8°C). Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Avoid exposure to heat. Following Dispensing Refrigerate prefilled autoinjectors and prefilled syringes at 36°F to 46°F (2°C to 8°C). Keep the product in the original carton to protect from light until the time of use. Do not freeze. Do not shake. Avoid exposure to heat. BENLYSTA may be stored outside of the refrigerator up to 86°F (30°C) for up to 12 hours if protected from sunlight. Do not use and do not place back in refrigerator if left out for more than 12 hours.

Autorizācija statuss:

Biologic Licensing Application

Lietošanas instrukcija

BENLYSTA- BELIMUMAB SOLUTION
GlaxoSmithKline LLC
----------
MEDICATION GUIDE
BENLYSTA (ben-LIST-ah)
(belimumab)
for injection, for intravenous use
BENLYSTA (ben-LIST-ah)
(belimumab)
injection, for subcutaneous use
What is the most important information I should know about BENLYSTA?
Immunosuppressive agents, including BENLYSTA can cause serious side
effects. Some of these side
effects may cause death. The following are serious adverse reactions
that have occurred in patients
receiving BENLYSTA:
1.
Infections. Infections could be serious, leading to hospitalization or
death. Tell your healthcare
provider right away if you have any of the following symptoms of an
infection:
•
fever
•
chills
•
pain or burning with urination
•
urinating often
•
coughing up mucus
•
warm, red, or painful skin or sores on your
body
2.
Allergic (hypersensitivity) reactions. Serious allergic reactions can
happen on the day of, or in the
days after, receiving BENLYSTA and may cause death. Your healthcare
provider will watch you
closely while you are receiving BENLYSTA given in a vein (intravenous
infusion) and after your
infusion for signs of a reaction. Allergic reactions can sometimes be
delayed. Tell your healthcare
provider right away if you have any of the following symptoms of an
allergic reaction following
use of BENLYSTA:
•
itching
•
swelling of the face, lips, mouth, tongue, or
throat
•
trouble breathing
•
anxiousness
•
low blood pressure
•
dizziness or fainting
•
headache
•
nausea
•
skin rash
3.
Mental health problems and suicide. Symptoms of mental health problems
can occur. Tell your
healthcare provider right away if you have any of the following
symptoms:
•
thoughts of suicide or dying
•
attempt to commit suicide
•
trouble sleeping (insomnia)
•
new or worse anxiety
•
new or worse depression
•
acting on dangerous impulses
•
other unusual changes in your behavior or
mood
•
thoughts of hurting yourself or others
What is BENLYSTA?
•
BENLYSTA is a prescription medicine used to treat pe

Produkta apraksts

BENLYSTA- BELIMUMAB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
BENLYSTA- BELIMUMAB SOLUTION
GLAXOSMITHKLINE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BENLYSTA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BENLYSTA.
BENLYSTA (BELIMUMAB) FOR INJECTION, FOR INTRAVENOUS USE
BENLYSTA (BELIMUMAB) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2011
RECENT MAJOR CHANGES
Warnings and Precautions, Serious Infections (5.1)
2/2024
Warnings and Precautions, Concomitant Use with Other Biologic
Therapies
(5.6)
2/2023
INDICATIONS AND USAGE
BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor
indicated for the treatment of:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
•
CONTRAINDICATIONS
Previous anaphylaxis to belimumab. (4)
WARNINGS AND PRECAUTIONS
•
•
patients aged 5 years and older with active systemic lupus
erythematosus (SLE) who are receiving
standard therapy; (1)
patients aged 5 years and older with active lupus nephritis who are
receiving standard therapy. (1)
Limitations of Use: The efficacy of BENLYSTA has not been evaluated in
patients with severe active
central nervous system lupus. Use of BENLYSTA is not recommended in
this situation. (1)
Intravenous Dosage for Adult and Pediatric Patients with SLE or Lupus
Nephritis:
−10 mg/kg at 2‑week intervals for the first 3 doses and at
4‑week intervals thereafter. Reconstitute,
dilute, and administer as an intravenous infusion over a period of 1
hour. (2.2)
−Consider prophylactic premedication for infusion reactions and
hypersensitivity reactions. (2.2)
Subcutaneous Dosage for Adults with SLE:
−200 mg once weekly. (2.3)
Subcutaneous Dosage for Adults with Lupus Nephritis:
−400 mg (two 200-mg injections) once weekly for 4 doses, then 200 mg
once weekly thereafter. (2.3)
See Full Prescribing Information for complete preparation and
administration information. (2.2, 2.3)
Intravenous Infusion:
−For Injection: 120