lebrikizumab

REMS

Moderate to severe atopic dermatitis in patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable (can be used with or without topical corticosteroids; topical calcineurin inhibitor use should be reserved for sensitive areas only, including face, neck, and intertriginous and genital areas).

Action ⬆ ⬇

Monoclonal antibody that inhibits interleukin-13, which inhibits cytokine-induced inflammatory responses.

Therapeutic effects:

Decreased severity of atopic dermatitis.

Pharmacokinetics ⬆ ⬇

Absorption: 86% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Degraded into small peptides and amino acids via catabolic pathways.

Half-Life: 24.5 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	7–8 days	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

Pre-existing helminth infections;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Children <12 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

EENT: conjunctivitis, keratitis

Hemat: eosinophilia

Local: injection site reactions

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA)

Interactions ⬆ ⬇

Drug-drug:

May ↑ risk of infection associated with live vaccines; avoid use of live vaccines during treatment.

Route/Dosage ⬆ ⬇

SC (Adults and Children ≥12 yr and ≥40 kg): 500 mg (given as two 250-mg injections) initially; then 500 mg (given as two 250-mg injections) in 2 wk; then 250 mg every 2 wk. In patients who achieve clear or almost clear skin after 16 wk of therapy, may ↓ dose to 250 mg every 4 wk.

Availability ⬆ ⬇

Solution for injection (prefilled pens and syringes): 250 mg/2 mL

Assessment ⬆ ⬇

Monitor for hypersensitivity reaction, including angioedema and urticaria. If serious reaction occurs, discontinue lebrikizumab and treat as clinically indicated.
Monitor for signs of helminth infections. If infection occurs and is unresponsive to treatment, hold lebrikizumab until infection resolves.

Lab Test Considerations:

May cause transient eosinophilia.

Implementation ⬆ ⬇

Update all age-appropriate vaccines according to current guidelines prior to initiating therapy.
May use with topical corticosteroids or calcineurin inhibitors for sensitive skin areas only.
SC: Leave prefilled syringe at room temperature for 45 min; prefilled pen does not need to warm to room temperature. Protect from light. Solution is clear to opalescent, colorless to slightly yellow to brown. Do not use if discolored, cloudy, or contains particulates. Administer SUBQ into abdomen, thigh, and back of upper arm. Alternate injection sites and do not inject within 2 inches of navel or into areas where skin is tender, bruised, red, indurated, not intact, or affected by atopic dermatitis.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
- Instruct patient or caregiver on the appropriate steps for storage, administration technique and disposal of equipment, if self-administration is appropriate. If dose missed, administer as soon as possible; then resume at next scheduled time.
Advise patient to avoid use of live vaccines immediately prior to or during therapy.
Advise patient to notify health care professional if signs of helminth infection (abdominal pain, diarrhea, blood in stool, weakness, weight loss) occur.
Advise patient to notify health care professional if new or worsening conjunctivitis or keratitis (eye swelling, redness, tearing, discharge, or pain; blurry vision; light sensitivity) occurs.
Advise patient to notify health care professional if injection site reactions (pain, redness, dermatitis, pruritus, swelling, rash) occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding and encourage reporting of pregnancy to Eli Lilly and Company: 1-800-545-5979.

Evaluation/Desired Outcomes ⬆ ⬇

Decreased severity of atopic dermatitis.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

71124- SAMSUNG BIOLOGICS Co., Ltd.
- 71124-0028-
  - 71124-0028-0- 5 kg in 1 BOTTLE, PLASTIC (71124-0028-0)

71124- SAMSUNG BIOLOGICS Co., Ltd.
- 71124-0028-
  - 71124-0028-1- 5 kg in 1 BOTTLE, PLASTIC (71124-0028-1)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇