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EBGLYSS is a brand name for Lebrikizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ebglyss (lebrikizumab injection) is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Ebglyss can be used with or without topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI). TCI may be used but should be reserved for problem areas only, such as the face, neck, intertriginous, and genital areas.
2 Recommended Dose and Dosage Adjustment The recommended dose of Ebglyss is an initial dose of 500 mg (two 250 mg injections) injected subcutaneously at Week 0 and Week 2, followed by 250 mg (one injection) every two weeks until Week 16.
3 Pharmacokinetics). Continued therapy beyond 16 weeks should be carefully considered in a patient who does not show treatment benefit within this time period. 3 Pharmacokinetics). 3 Pharmacokinetics). 3 Pharmacokinetics). 1 INDICATIONS, Pediatrics).
Adolescents (12 to < 18 years who weigh ≥ 40 kg):
No dose adjustment is required for adolescent patients > 12 years of age and who weigh ≥ 40 kg. 4 Administration Ebglyss is for subcutaneous administration. Ebglyss is intended for use under the guidance of a healthcare professional.
Provide proper training to patients and/or caregivers on the subcutaneous injection technique of Ebglyss according to the Instructions for Use, included with the packaged product. Adult patients may self-inject, or caregivers may give Ebglyss after training in subcutaneous injection technique.
For adolescent patients, caregivers may give injections after training in subcutaneous injection technique. Sites for injection include the abdomen, thigh, and back of the upper arm. Administration of Ebglyss in the back of the upper arm must be performed by a caregiver or healthcare professional.
Rotation of injection sites is recommended. Do not inject into areas where the skin is tender, bruised, red, hard, or in an area of skin that is affected by atopic dermatitis or skin lesions. Before injection, remove Ebglyss prefilled pen or Ebglyss prefilled syringe from the refrigerator and leave at room temperature for 45 minutes without removing the needle cap.
Do not warm by using a heat source such as hot water or microwave. Inspect Ebglyss visually for particulate matter and discoloration prior to administration. Do not use if the liquid contains visible particles, is discolored or cloudy.
). Vaccination Prior to initiating therapy with Ebglyss, consider completion of all age-appropriate immunizations according to current immunization guidelines. Treatment with a live (attenuated) vaccine should be completed before starting the treatment.
Avoid concurrent use of live vaccines in patients treated with Ebglyss. No data are available on the response to live vaccines in patients treated with Ebglyss. 4 Drug- Drug Interactions). 1 Pregnant Women There are no available data on Ebglyss use in pregnant women.
Human immunoglobulin G (IgG) is known to cross the placental barrier; therefore, Ebglyss may be transmitted from the mother to the developing fetus. Developmental toxicity studies in pregnant monkeys at doses up to 18 times (adolescents) and 22 times (adults) the human exposure at the recommended human dose revealed no evidence of harm to the developing fetus.
Lebrikizumab was detected in fetal serum at concentrations that were approximately 30% of maternal serum concentrations at all tested dose levels (see 16 NON-CLINICAL TOXICOLOGY). As a precautionary measure, it is preferable to avoid the use of Ebglyss during pregnancy.
Women of reproductive potential should be advised to use effective contraception. 2 Breast-feeding There are no data on the presence of Ebglyss in human milk, the effects on the breastfed infant, or the effects on milk production. In a pre- and post-natal developmental toxicity study in pregnant cynomolgus monkeys, lebrikizumab was detected in serum of all offspring at higher concentrations than maternal serum levels until the end of the observation period on post-natal day 180 (see 16 NON-CLINICAL TOXICOLOGY).
A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue from lebrikizumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
, Vaccination 2026-01 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ........................................................................... 2 TABLE OF CONTENTS.................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................... 4 1 INDICATIONS ..................................................................................................... 1 Pediatrics ..................................................................................................
2 Geriatrics .................................................................................................. 4 2 CONTRAINDICATIONS ...................................................................................... 4 4 DOSAGE AND ADMINISTRATION ....................................................................
1 Dosing Considerations .............................................................................. 2 Recommended Dose and Dosage Adjustment ......................................... 4 Administration ...........................................................................................
5 Missed Dose ............................................................................................. 5 5 OVERDOSAGE ................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............
6 7 WARNINGS AND PRECAUTIONS ..................................................................... 1 Special Populations .................................................................................. 1 Pregnant Women ...................................................................................
2 Breast-feeding ........................................................................................ 3 Pediatrics ............................................................................................... 4 Geriatrics ................................................................................................
Ebglyss is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Ebglyss is preservative-free. 5 Missed Dose If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing on the regularly scheduled dosing interval, starting on the new dosing day. PrEBGLYSSTM (lebrikizumab) Page 6 of 39 Unclassified / Non classifié
1 INDICATIONS, Pediatrics). 2 INDICATIONS, Geriatrics). 6%). 3% of Ebglyss-treated patients reported at least one serious adverse event (SAE). 4% in the placebo group during the initial treatment period of up to 16 weeks. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Adults and Adolescents The safety of Ebglyss was evaluated across 4 randomized, double-blind, placebo-controlled, multicenter trials in subjects with moderate-to-severe atopic dermatitis including 3 phase 3 trials (ADvocate 1, ADvocate 2, and ADhere), and one phase 2 dose ranging trial (KGAF).
In these 4 trials, all subjects (pooled across treatment groups) had a mean age of 37 years; 50% of subjects were men; 62% were White, 13% were Black, and 20% were Asian. In the phase 3 studies, 30% of the subjects had asthma, 50% had allergic rhinitis, 31% had food allergy, and 14% had allergic conjunctivitis at baseline.
ADvocate 1, ADvocate 2, and KGAF compared the safety of Ebglyss monotherapy to placebo. ADhere compared the safety of Ebglyss + TCS to placebo + TCS through 16 weeks. 783 subjects within these studies were treated with Ebglyss in the 16-week placebo-controlled period.
A total of 891 subjects within the atopic dermatitis development program were treated with Ebglyss for at least 1 year. The long-term safety of Ebglyss was assessed in the two monotherapy studies up to Week 52. The long-term safety of Ebglyss in combination with TCS was evaluated for ADhere patients who enrolled in a long-term extension study up to 56 weeks of treatment.
7% of patients treated with lebrikizumab 250 mg Q4W reported a TEAE from Week 16 to Week 52. PrEBGLYSSTM (lebrikizumab) Page 9 of 39 Unclassified / Non classifié Table 2 summarizes the adverse reactions that were reported more frequently in the Ebglyss groups than in the placebo group during the 16-week placebo-controlled period of the clinical trials.
5%) […]
8 8 ADVERSE REACTIONS ..................................................................................... 1 Adverse Reaction Overview...................................................................... 2 Clinical Trial Adverse Reactions ...............................................................
1 Clinical Trial Adverse Reactions – Pediatrics ....................................... 3 Less Common Clinical Trial Adverse Reactions ..................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .....................................................................................
10 9 DRUG INTERACTIONS .................................................................................... 2 Drug Interactions Overview..................................................................... 4 Drug-Drug Interactions............................................................................
5 Drug-Food Interactions ........................................................................... 6 Drug-Herb Interactions............................................................................ 7 Drug-Laboratory Test Interactions ..........................................................
11 10 CLINICAL PHARMACOLOGY.......................................................................... 1 Mechanism of Action .............................................................................. 2 Pharmacodynamics ................................................................................
3 Pharmacokinetics ................................................................................... 12 11 STORAGE, STABILITY AND DISPOSAL ........................................................ 14 12 SPECIAL HANDLING INSTRUCTIONS ...........................................................
14 PART II: SCIENTIFIC INFORMATION ........................................................................ 15 13 PHARMACEUTICAL INFORMATION .............................................................. 15 14 CLINICAL TRIALS ............................................................................................
15 15 MICROBIOLOGY .............................................................................................. 19 16 NON-CLINICAL TOXICOLOGY ........................................................................ 19 PATIENT MEDICATION INFORMATION ....................................................................
21 INSTRUCTIONS FOR USE ......................................................................................... 25 INSTRUCTIONS FOR USE ......................................................................................... 33 PrEBGLYSSTM (lebrikizumab) Page 4 of 39 Unclassified / Non classifié PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Ebglyss (lebrikizumab injection) is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older with a body weight of at least 40 kg, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Ebglyss can be used with or without topical corticosteroids. 2 Recommended Dose and […]