caplacizumab

Contraindicated in:

Hypersensitivity.

Use Cautiously in:

Underlying coagulopathy (↑ risk of bleeding);
Severe hepatic impairment;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: urticaria

Hemat: bleeding

MS: back pain, myalgia

Neuro: fatigue, headache, paresthesia

Resp: dyspnea

Misc: fever, hypersensitivity reactions

Interactions ⬆ ⬇

Drug-drug:

↑risk of bleeding with anticoagulants, aspirin, clopidogrel, ticagrelor, prasugrel, fibrinolytics, NSAIDs, SNRIs, or SSRIs; avoid concurrent use with anticoagulant and antiplatelet agents.

Availability ⬆ ⬇

Lyophilized powder for injection: 11 mg/vial

Route/Dosage ⬆ ⬇

IV SC (Adults ): First day of treatment: 11 mg via IV bolus given ≥15 min before plasma exchange, then followed by 11 mg via SUBQ injection after completion of plasma exchange; Subsequent days of treatment during daily plasma exchange: 11 mg via SUBQ injection once daily after completion of plasma exchange; Treatment after plasma exchange period: 11 mg via SUBQ injection once daily for 30 day following last daily plasma exchange. If signs of persistent disease continue, treatment may be extended for up to an additional 28 days. Discontinue drug if patients experiences ≥2 recurrences of acquired TTP while on therapy.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Targets the A1 domain of von Willebrand factor (vWF) and inhibits the interaction between vWF and platelets, which subsequently inhibits platelet adhesion and platelet consumption.

Therapeutic effects:

Increased platelet count and cessation of plasma exchange.

Classifications ⬆ ⬇

Therapeutic Classification: antiplatelet agents

Pharmacologic Classification: anti-von Willebrand Factor, monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability; 90% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Target-bound caplacizumab metabolized by liver; unbound drug is broken down by proteolytic enzymes. Unbound drug excreted in the urine.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	Unknown	6–7 hr	Unknown

Patient/Family Teaching ⬆ ⬇

Instruct patient to take caplacizumab as directed. Administer doses missed during plasma exchange period as soon as possible. Doses missed after plasma exchange period can be administered within 12 hr of scheduled time of administration. Beyond 12 hr, omit missed dose and administer next daily dose according to usual dosing schedule. Advise patient to read Instructions for Use before starting and with each Rx refill in case of changes.
Instruct patient on correct procedure for self-injection and needle disposal.
Advise patient that bruising and bleeding may occur more easily and that nosebleeds and bleeding of gums may occur and may take longer than usual to stop bleeding. Advise patients to notify health care professional immediately if excessive bleeding or bruising occur.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Increased risk of bleeding in mother, fetus, and neonate; monitor closely.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

58468- Genzyme Corporation
- 58468-0225- Cablivi
  - 58468-0225-1- 1 KIT in 1 CARTON (58468-0225-1) * 1 mL in 1 VIAL, GLASS (58468-0227-1) * 1 mL in 1 SYRINGE, GLASS (58468-0229-1)

68225- Patheon Italia S.p.A.
- 68225-256-
  - 68225-256-00- 126 CARTON in 1 CONTAINER (68225-256-00) / 247 VIAL in 1 CARTON / 2 mL in 1 VIAL

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Indications ⬇

Contraind./Precautions ⬆ ⬇