concizumab

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

Atherosclerotic disease, crush injury, cancer, disseminated intravascular coagulation, thrombotic microangiopathy, or septicemia (↑ risk of thromboembolic events);
Rep: Women of reproductive potential;
OB: Use during pregnancy only if potential maternal benefit outweighs potential fetal risk;
Lactation: Safety not established in breastfeeding;
Pedi: Children <12 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

CV: ARTERIAL THROMBOEMBOLISM, DEEP VEIN THROMBOSIS (DVT)

Derm: urticaria

Hemat: ↑fibrin D-dimer, ↑prothrombin fragment 1.2

Local: injection site reactions

Resp: PULMONARY EMBOLISM (PE)

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

Use of bypassing agents, including recombinant factor VIIa or activated prothrombin complex concentrate may ↑ risk of thromboembolic events.

Availability ⬆ ⬇

Solution for injection (prefilled pens): 60 mg/1.5 mL; 150 mg/1.5 mL; 300 mg/3 mL

Route/Dosage ⬆ ⬇

SC (Adults and Children ≥12 yr): Loading dose of 1 mg/kg on Day 1; then 0.2 mg/kg once daily starting on Day 2. Concizumab plasma concentration should be monitored 4 wk after start of treatment; subsequent dosing should be based on plasma concentration as follows: <200 ng/mL: 0.25 mg/kg once daily; 200–4000 ng/mL: 0.2 mg/kg once daily; >4000 ng/mL: 0.15 mg/kg once daily. Additional concizumab plasma concentrations can be monitored once patient has been receiving same maintenance dose for ≥8 wk; maintain level >200 ng/mL.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Monoclonal antibody that acts as an antagonist of endogenous tissue factor pathway inhibitor, which increases production of factor Xa and leads to improved thrombin generation and clot formation.

Therapeutic effects:

Prevention of or reduction in frequency of bleeding episodes.

Classifications ⬆ ⬇

Therapeutic Classification: temporary class

Pharmacologic Classification: monoclonal antibodies, temporary class

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following SUBQ administration unknown.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Metabolized into small peptides via catabolic pathways.

Half-Life: 24 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	8–99 hr	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of concizumab. Instruct patient or caregiver in correct technique for injection, storage, and place to discard syringes and needles. Advise patient against sudden discontinuation of drug due to potential for bleeding. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Tell patient if a dose is missed in first 4 wk of treatment or if ≥7 doses are missed, contact health care provider for instructions. If 2–6 doses are missed after the first 4 wk, give two doses as soon as you remember; then continue your normal daily dose the next day.
Advise patients and family to call 911 and immediately seek treatment for signs and symptoms of hypersensitivity reactions (difficulty breathing; chest tightness; hives; rash; light-headedness; itching; swelling of the face, lips, tongue, or throat).
Advise patient to immediately report and seek treatment for signs and symptoms of venous thromboembolism such as PE (chest pain, trouble breathing, fast heartbeat), DVT (calf pain or tenderness, leg and foot swelling), headache, facial numbness, visual changes, or eye pain.
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: May cause fetal harm. Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Advise women to use effective contraception during treatment and for 7 wk after ending treatment.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

0169- Novo Nordisk
- 0169-2080- Alhemo
  - 0169-2080-15- 1 SYRINGE, PLASTIC in 1 CARTON (0169-2080-15) / 1.5 mL in 1 SYRINGE, PLASTIC

0169- Novo Nordisk
- 0169-2081- Alhemo
  - 0169-2081-03- 1 SYRINGE, PLASTIC in 1 CARTON (0169-2081-03) / 3 mL in 1 SYRINGE, PLASTIC

0169- Novo Nordisk
- 0169-2084- Alhemo
  - 0169-2084-15- 1 SYRINGE, PLASTIC in 1 CARTON (0169-2084-15) / 1.5 mL in 1 SYRINGE, PLASTIC

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Indications ⬇

Contraind./Precautions ⬆ ⬇