concizumab

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

Contraind./Precautions ⬆ ⬇

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.

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.

Availability ⬆ ⬇

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

Assessment ⬆ ⬇

Monitor for signs and symptoms of hypersensitivity reactions (rash, urticaria, pruritus, flushing, dizziness, vomiting, abdominal pain) and angioedema (swelling of throat, lips, tongue, or face; dyspnea; wheezing; hoarseness). Discontinue concizumab immediately and provide supportive care.
Monitor for signs and symptoms of venous thromboembolism such as PE (chest pain, dyspnea, tachycardia), DVT (calf pain or tenderness, lower extremity edema, localized warmth or erythema), or stroke (headache, facial numbness, unilateral weakness, aphasia, eye pain or swelling, vision changes). Discontinue therapy if suspected.

Lab Test Considerations:

Verify negative pregnancy test before starting therapy.
May cause ↑ fibrin D dimer and prothrombin fragment 1+2.

Implementation ⬆ ⬇

Treatment should be initiated in a nonbleeding state.
Always use a new needle for each injection. A concizumab pen must not be shared between patients, even if the needle is changed.
SC: Administer into a pinched fold of skin in the abdomen or thigh, with rotation of injection site every day. Do not administer in areas where the skin is tender, bruised, red, or hard or in areas where there are moles, scars, or stretch marks. Solution is clear to slightly opalescent and colorless to slightly yellow; may contain translucent to white particles. Do not use if the solution is discolored. Store refrigerated; do not freeze. Once opened, discard unused portion after 28 days.
Adjustments for Missed Doses: If patient misses a dose during the initial 4 wk period, inform health care professional and resume once-daily dosing at the initial 0.2 mg/kg dose level. After the initial 4 wk, once maintenance dose has been established, for one missed dose, resume once daily treatment at the maintenance dose level; for 2–6 missed doses, resume treatment with a double dose followed by once daily treatment at the maintenance dose level; for ≥7 missed doses, health care provider should be contacted, and a new loading dose should be considered.

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.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇