emicizumab

REMS

Routine prophylaxis to prevent or reduce the frequency of bleeding in patients with hemophilia A (congenital factor VIII deficiency) (with or without factor VIII inhibitors).

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: THROMBOEMBOLIC EVENTS, 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 concurrently with activated prothrombin complex concentrate for up to 6 mo after last dose of emicizumab.

Availability ⬆ ⬇

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

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 or6 mg/kg every 4 wk.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective hemostasis.

Therapeutic effects:

Prevention or reduction in frequency of bleeding.

Classifications ⬆ ⬇

Therapeutic Classification: hemostatic agents

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

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

Patient/Family Teaching ⬆ ⬇

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 2 doses same day. Advise patient and caregiver to read Medication Guide prior to starting and with each refill in case of changes.
Advise patient to notify health care professional immediately if signs and symptoms of thrombotic microangiopathy (confusion, abdomen or back pain, weakness, nausea, vomiting, swelling of arms and legs, feeling sick, yellowing of skin and eyes, decreased urination) or thromboembolism occur.
May interfere with and provide false readings for lab tests measuring blood clotting. Advise patient to notify health care professional of therapy before blood tests or procedures.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise women of reproductive potential to use contraception during therapy and notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation ⬆ ⬇

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

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Indications ⬇