emicizumab

Absorption: 80–93% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: 27 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None known.

Use Cautiously in:

Severe renal impairment;
Severe hepatic impairment;
OB: Use during pregnancy only if potential maternal benefit outweighs potential fetal risk;
Lactation: Safety not established in breastfeeding;
Rep: Women of reproductive potential.

Adv. Reactions/Side Effects ⬆ ⬇

GI: diarrhea

Hemat: THROMBOEMBOLISM, THROMBOTIC MICROANGIOPATHY

Local: injection site reactions

MS: arthralgia

Neuro: headache

Misc: antibody development, fever

Interactions ⬆ ⬇

Drug-drug:

↑risk of thrombotic microangiopathy and thromboembolism when used with activated prothrombin complex concentrate for up to 6 mo after last dose of emicizumab.

Route/Dosage ⬆ ⬇

SC (Adults and Children ): 3 mg/kg once weekly for 4 wk, followed by maintenance dose of 1.5 mg/kg once weekly or 3 mg/kg every 2 wk or 6 mg/kg every 4 wk.

Availability ⬆ ⬇

Solution for injection: 30 mg/mL; 60 mg/0.4 mL; 105 mg/0.7 mL; 150 mg/mL

Assessment ⬆ ⬇

Monitor for signs and symptoms of thrombotic angiopathy (thrombocytopenia, microangiopathic hemolytic anemia, acute kidney injury). If signs or symptoms occur, discontinue therapy immediately; may resolve within 1 wk.
Monitor for signs and symptoms of thromboembolism (swelling, erythema or pain in extremities, dizziness, headache, dyspnea, numbness in face, chest pain or tightness, eye pain or swelling, tachycardia, vision changes, hemoptysis) during therapy. If signs or symptoms occur, discontinue therapy immediately; may resolve within 1 mo.
Monitor for signs of loss of efficacy (↑ breakthrough bleeding). If neutralizing anti-emicizumab antibodies suspected, assess cause and consider changing therapy.

Lab Test Considerations:

Monitor plasma factor VIII inhibition activity to determine dosing for factor replacement or anticoagulation. Do not use activated clotting time, activated partial thromboplastin time (aPTT), or all assays based on aPTT, such as one-stage factor VIII activity, to monitor activity due to the effects of emicizumab. Assess patient for signs of bleeding.

Implementation ⬆ ⬇

May continue factor VIII products for prophylaxis during 1st wk of therapy. Discontinue prophylactic use of bypassing agents the day before starting therapy.
SC: Do not combine vials of different concentrations in a single injection. Solution is colorless to slight yellow; do not administer if discolored or contains particulates. Refrigerate and protect from light; do not freeze or shake. May store at room temperature for ≤7 days. Administer ≤1-mL dose with a 1-mL syringe and doses >1 mL with a 2-mL or 3-mL syringe of transparent polypropylene or polycarbonate with Luer-Lock tip, graduation 0.01 mL, sterile, for injection only, single-use, latex-free, and nonpyrogenic. Use an 18 gauge, 1–1½ inch, single bevel or semiblunted tip needle for transfer and a 25–27 gauge, ⅜–½ inch needle for injection. Administer into upper outer arm, thigh, or any quadrant of abdomen; rotate sites with each dose. Avoid moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Instruct patient and caregiver in the correct technique for preparation, injection, and how to dispose of materials. Take missed doses as soon as possible; do not take two doses on the same day.
Advise patient to notify health care provider immediately if signs and symptoms of thrombotic microangiopathy (confusion, abdomen or back pain, weakness, nausea, vomiting, swelling of extremities, yellowing of skin and eyes, ↓ urination) or thromboembolism occur.
Advise patient to notify health care provider of therapy before blood tests or procedures.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Rep: Advise women of reproductive potential to use contraception during therapy and notify health care provider if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Prevention or reduction in frequency of bleeding.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

50242- Genentech, Inc.
- 50242-920- Hemlibra
  - 50242-920-01- 1 VIAL, SINGLE-USE in 1 CARTON (50242-920-01) / 1 mL in 1 VIAL, SINGLE-USE

50242- Genentech, Inc.
- 50242-921- Hemlibra
  - 50242-921-01- 1 VIAL, SINGLE-USE in 1 CARTON (50242-921-01) / .4 mL in 1 VIAL, SINGLE-USE

50242- Genentech, Inc.
- 50242-922- Hemlibra
  - 50242-922-01- 1 VIAL, SINGLE-USE in 1 CARTON (50242-922-01) / .7 mL in 1 VIAL, SINGLE-USE

50242- Genentech, Inc.
- 50242-923- Hemlibra
  - 50242-923-01- 1 VIAL, SINGLE-USE in 1 CARTON (50242-923-01) / 1 mL in 1 VIAL, SINGLE-USE

50242- Genentech, Inc.
- 50242-927- Hemlibra
  - 50242-927-01- 1 VIAL, SINGLE-USE in 1 CARTON (50242-927-01) / .4 mL in 1 VIAL, SINGLE-USE

50242- Genentech, Inc.
- 50242-930- Hemlibra
  - 50242-930-01- 1 VIAL, SINGLE-USE in 1 CARTON (50242-930-01) / 2 mL in 1 VIAL, SINGLE-USE

71124- SAMSUNG BIOLOGICS Co., Ltd.
- 71124-0009-
  - 71124-0009-0- 1 SOLUTION in 1 VIAL, SINGLE-USE (71124-0009-0)

71124- SAMSUNG BIOLOGICS Co., Ltd.
- 71124-0010-
  - 71124-0010-0- 1 SOLUTION in 1 VIAL, SINGLE-USE (71124-0010-0)

71124- SAMSUNG BIOLOGICS Co., Ltd.
- 71124-0011-
  - 71124-0011-0- 1 SOLUTION in 1 VIAL, SINGLE-USE (71124-0011-0)

71124- SAMSUNG BIOLOGICS Co., Ltd.
- 71124-0012-
  71124-0012-0- 1 SOLUTION in 1 VIAL, SINGLE-USE (71124-0012-0)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇