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Cablivi caplacizumab Kit — NDC 58468-0225-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cablivi caplacizumab Kit — NDC 58468-0225-1 (Billing 58468-0225-01)

by Genzyme Corporation · 1 KIT in 1 CARTON * 1 mL in 1 VIAL, GLASS * 1 mL in 1 SYRINGE, GLASS

This is a package of Cablivi caplacizumab Kit from Genzyme Corporation, marketed since Feb 2019 and currently FDA-listed. It is this product's only package size.

NDC 58468-0225-01
🏷️ FDA NDC (as labeled) 58468-0225-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 58468-0225-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
58468 labeler · 0225 product · 1 package
Package marketed since
Feb 6, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5846802251 6
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 58468-0225-1
Product NDC 58468-0225
11-digit billing NDC 58468022501
NCPDP billing unit EA — each (per item)
RxCUI 2110616, 2110618
Application # BLA761112
SPL Set ID 2348f06e-8004-4040-832e-e9e86a39f905
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-02-06
Dosage form KIT
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 85151020806420
GPI class Cablivi
GCN Seq No 079493
GCN 45993
HICL code 045591
Ingredient (HICL) Caplacizumab-Yhdp
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z26
Therapeutic class — specific (HIC3) Agents To Tx Thrombotic Thrombocytopenic Purpura
AHFS code 20:12.10.00
AHFS class Von Willebrand Factor-Related Antithromb
FDB label name CABLIVI 11 MG KIT
FDB brand name Cablivi
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079493
  • GCN: 45993
  • GPI-14 (Medi-Span): 85151020806420
  • HICL (First Databank): 045591
  • AHFS class code: 20:12.10.00
  • RxCUI (RxNorm): 2110616
Why two NDCs? The FDA registers this code as 58468-0225-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 58468-0225-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other antithrombotic agents class.

Drug family (ATC) Other antithrombotic agents
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CABLIVI 11 MG KIT Ingredient Caplacizumab-Yhdp

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $9,127.33 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
58468-0225-01 You're viewing this Main listing 1 KIT in 1 CARTON * 1 mL in 1 VIAL, GLASS * 1 mL in 1 SYRINGE, GLASS 2019-02-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cablivithis 58468-0225-01 Genzyme 1 kit — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2019
First FDA approval
Feb 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2031. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 6, 2019 ⏳ ~4.3 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Cablivicaplacizumab-yhdp
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2019 2021 2023 2025 2027 2029 2031
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateFeb 6, 2031
Common questions
Is there a biosimilar for CABLIVI 11 MG KIT?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGenzyme Corporation
FDA applicationBLA761112 (BLA)
Labeler code58468
First marketedFeb 2019
Product typeHuman Prescription Drug
Portfolio33 products on file

More NDCs from Genzyme Corporation labeler code 58468

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 76 words ▾

1 INDICATIONS AND USAGE CABLIVI is indicated for the treatment of adult and pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. CABLIVI is a von Willebrand factor (vWF)-directed antibody fragment indicated for the treatment of adult and pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION CABLIVI should be administered upon the initiation of plasma exchange therapy. The recommended dose of CABLIVI is as follows: ( 2.1 ) First day of treatment: 11 mg bolus intravenous injection at least 15 minutes prior to plasma exchange followed by an 11 mg subcutaneous injection after completion of plasma exchange on day 1. Subsequent treatment during daily plasma exchange: 11 mg subcutaneous injection once daily following plasma exchange.

Treatment after the plasma exchange period: 11 mg subcutaneous injection once daily for 30 days beyond the last plasma exchange. If after initial treatment course, sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remain present, treatment may be extended for a maximum of 28 days. Discontinue CABLIVI if the patient experiences more than 2 recurrences of aTTP, while on CABLIVI.

The first dose should be administered by a healthcare provider as a bolus intravenous injection. Administer subsequent doses subcutaneously in the abdomen. ( 2.3 )

2.1Recommended Dose and Schedules CABLIVI should be administered upon initiation of plasma exchange therapy. The recommended dose of CABLIVI is as follows: First day of treatment : 11 mg bolus intravenous injection at least 15 minutes prior to plasma exchange followed by an 11 mg subcutaneous injection after completion of plasma exchange on day 1. Subsequent days of treatment during daily plasma exchange : 11 mg subcutaneous injection once daily following plasma exchange.

Treatment after plasma exchange period : 11 mg subcutaneous injection once daily continuing for 30 days following the last daily plasma exchange. If after initial treatment course, sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remain present, treatment may be extended for a maximum of 28 days. Discontinue CABLIVI if the patient experiences more than 2 recurrences of aTTP, while on CABLIVI.

Avoid concomitant use of antiplatelet agents or anticoagulants [see Warnings and Precautions (5.1) ]. Missed Dose Administer the first dose of CABLIVI intravenously before the initial plasma exchange. If the administration of the first intravenous dose of CABLIVI is missed and plasma exchange is already administered, administer the first CABLIVI dose intravenously and administer the next dose subcutaneously on the following day according to the usual dosing schedule.

If a dose of CABLIVI is missed during the plasma exchange period, it should be given as soon as possible. If a dose of CABLIVI is missed after the plasma exchange period, it can be administered within 12 hours of the scheduled time of administration. Beyond 12 hours, the missed dose should be skipped and the next daily dose administered according to the usual dosing schedule.

2.2Discontinuation for Surgery and Other Interventions Withhold CABLIVI treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions [see Warnings and Precautions (5.1) ] .

2.3Reconstitution and Administration Instructions The first dose of CABLIVI should be administered by a healthcare provider as a bolus intravenous injection. Administer subsequent doses subcutaneously in the abdomen. Avoid injections around the navel.

Do not administer consecutive injections in the same abdominal quadrant. Adult patients may self-inject, or adult caregivers may inject CABLIVI subcutaneously after proper instruction on the preparation and administration of CABLIVI, including aseptic technique [see Instructions for Use ] if a healthcare provider determines that it is appropriate. In pediatric patients 12 years of age and older, CABLIVI must be administered by a healthcare provider or an adult caregiver.

If the carton was not stored at room temperature, allow the CABLIVI vial and diluent syringe to reach room temperature [25°C to 30°C (77°F to 86°F)] by holding them in your hands for 10 seconds. Do not use any other way to warm up the vial and syring… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 33 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 11 mg as a white lyophilized powder in a single-dose vial. For injection: 11 mg as a lyophilized powder in a single-dose vial. ( 3 )

⛔ Contraindications 46 words ▾

4 CONTRAINDICATIONS CABLIVI is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of the excipients. Hypersensitivity reactions have included urticaria [see Adverse Reactions (6.1) ] . Previous severe hypersensitivity reaction to caplacizumab-yhdp or any of the excipients. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Hemorrhage: Serious and fatal bleeding can occur. Risk of bleeding is increased in patients with underlying coagulopathies or on concomitant antiplatelet agents or anticoagulants. If clinically significant bleeding occurs, interrupt treatment. Withhold CABLIVI 7 days prior to elective surgery, dental procedures, or other invasive interventions. ( 5.1 )

5.1Hemorrhage CABLIVI increases the risk of bleeding [see Adverse Reactions (6.1) ] . In clinical studies, severe bleeding adverse reactions of epistaxis, gingival bleeding, upper gastrointestinal hemorrhage, and metrorrhagia were each reported in 1% of subjects. Overall, bleeding events occurred in approximately 58% of patients on CABLIVI versus 43% of patients on placebo.

In the postmarketing setting, cases of life-threatening and fatal bleeding were reported in patients receiving CABLIVI. The risk of bleeding is increased in patients with underlying coagulopathies (e.g., hemophilia, other coagulation factor deficiencies). It is also increased with concomitant use of CABLIVI with drugs affecting hemostasis and coagulation [see Drug Interactions (7) and Clinical Pharmacology (12.3) ] .

Avoid concomitant use of CABLIVI with antiplatelet agents, thrombolytic drugs, heparin, or anticoagulants. Interrupt use of CABLIVI if clinically significant bleeding occurs. If needed, von Willebrand factor concentrate may be administered to rapidly correct hemostasis.

If CABLIVI is restarted, monitor closely for signs of bleeding. Withhold CABLIVI for 7 days prior to elective surgery, dental procedures or other invasive interventions. If emergency surgery is needed, the use of von Willebrand factor concentrate may be considered to correct hemostasis.

After the risk of surgical bleeding has resolved, and CABLIVI is resumed, monitor closely for signs of bleeding.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are also discussed in other sections of the labeling: Hemorrhage [see Warnings and Precautions (5.1) ] In adults, the most common adverse reactions (incidence >15%) are epistaxis, headache, and gingival bleeding. In pediatric patients, the most frequently reported adverse reactions are epistaxis and tachycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ablynx US at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. TITAN and HERCULES The safety of CABLIVI was evaluated in two placebo-controlled clinical studies (HERCULES, in which 71 patients received CABLIVI; and TITAN, in which 35 patients received CABLIVI). The data described below and in the Warnings and Precautions reflect exposure to CABLIVI during the blinded periods of both studies, which include 106 patients with aTTP who received at least one dose, age 18 to 79 years, of whom 69% were female and 73% were White.

The median treatment duration with CABLIVI was 35 days (range 1–77 days). The most frequently reported adverse reactions (>15%) were epistaxis, headache and gingival bleeding. Seven patients (7%) in the CABLIVI group experienced an adverse reaction leading to study drug discontinuation.

None of the adverse reactions leading to discontinuation were observed in more than 1% of patients. Among 106 patients treated with CABLIVI during the TITAN and HERCULES studies, serious bleeding adverse reactions reported in ≥2% patients included epistaxis (4%) and subarachnoid hemorrhage (2%). Adverse reactions that occurred in ≥2% of patients treated with CABLIVI and more frequently than in those treated with placebo across the pooled data from the two trials are summarized in Table 1.

Urticaria was seen during plasma exchange. Table 1: Adverse Reactions in ≥2% of Patients Treated with CABLIVI and More Frequent than Placebo During the Blinded Periods of aTTP Studies (HERCULES and TITAN) Adverse Reaction by Body System CABLIVI (N=106) n (%) Placebo (N=110) n (%) Gastrointestinal disorders Gingival bleeding 17 (16) 3 (3) Rectal hemorrhage 4 (4) 0 (0) Abdominal wall hematoma 3 (3) 1 (1) General disorders and administration site conditions Fatigue 16 (15) 10 (9) Pyrexia 14 (13) 12 (11) Injection site hemorrhage 6 (6) 1 (1) Catheter site hemorrhage 6 (6) 5 (5) Injection site pruritus 3 (3) 0 (0) Musculoskeletal and connective tissue disorders Back pain 7 (7) 4 (4) Myalgia 6 (6) 2 (2) Nervous system disorders Headache 22 (21) 15 (14) Paresthesia 13 (12) 11 (10) Renal and urinary disorders Urinary tract infection 6 (6) 4 (4) Hematuria 4 (4) 3 (3) Reproductive system and breast disorders Vaginal hemorrhage 5 (5) 2 (2) Menorrhagia 4 (4) 1 (1) Respiratory, thoracic and mediastinal disorders Epistaxis 31 (29) 6 (6) Dyspnea 10 (9) 5 (5) Skin and subcutaneous tissue disorders Urticaria 15 (14) 7 (6) Pediatric Patients The safety of CABLIVI in patients aged ≤18 years with aTTP was evaluated in an observational, retrospective chart review (OBS17325) [see Clinical Studies (14) ] .

The most commonly reported events were epistaxis in 4 (13.3%) patients and tachycardia in 4 (13.3%) patients. One serious bleeding adverse reaction (hemorrhage urinary tract) was reported. The adverse reaction profile in pediatric patients 12 years and older with aTTP was consistent with that in adults.

6.3Postmarketing Experience The following adverse reactions have been identified during postapproval use of CABLIVI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to caplacizumab-yhdp exp… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 82 words ▾

7 DRUG INTERACTIONS Concomitant use of anticoagulants or antiplatelet agents with CABLIVI may increase the risk of bleeding. Monitor closely for bleeding with concomitant use. ( 7 ) Concomitant Use of Anticoagulants, Thrombolytic Drugs, Heparin or Antiplatelet Agents Concomitant use of CABLIVI with any anticoagulant, thrombolytic drugs, heparin or antiplatelet agent may increase the risk of bleeding.

Avoid concomitant use when possible. Assess and monitor closely for bleeding with concomitant use [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data on CABLIVI use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, there are potential risks of hemorrhage in the mother and fetus associated with use of CABLIVI (see Clinical Considerations ) . In animal reproduction studies, there was no evidence of adverse developmental outcomes with intramuscular administration of caplacizumab-yhdp during organogenesis in guinea pigs at exposures approximately 30 times the AUC in humans at the recommended subcutaneous injection dose of 11 mg (see Data ) .

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Fetal/neonatal adverse reactions CABLIVI may increase the risk of bleeding in the fetus and neonate. Monitor neonates for bleeding [see Warnings and Precautions (5.1) ] . Maternal adverse reactions All patients receiving CABLIVI, including pregnant women, are at risk for bleeding.

Pregnant women receiving CABLIVI should be carefully monitored for evidence of excessive bleeding [see Warnings and Precautions (5.1) ] . Data Animal data Two separate reproduction studies were conducted in pregnant guinea pigs with administration of caplacizumab-yhdp during the organogenesis period. In an embryo-fetal development study, caplacizumab-yhdp was administered intramuscularly at doses up to 20 mg/kg/day from gestational day (GD) 6 to GD 41 in guinea pigs.

No maternal toxicity or adverse developmental outcomes were observed. In a toxicokinetic study assessing the exposure of caplacizumab-yhdp in the dams and fetuses, caplacizumab-yhdp was administered once daily to female guinea pigs at doses up to 40 mg/kg/day (corresponding to a drug exposure of approximately 30 times the AUC in humans at the recommended dose of 11 mg) by intramuscular injection from GD 6 to GD 41 or GD 61. Exposure to caplacizumab-yhdp was observed in the dams and fetuses, with no effects on embryo-fetal development.

8.2Lactation Risk Summary There is no information regarding the presence of caplacizumab-yhdp in human milk, the effects on the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CABLIVI and any potential adverse effects on the breastfed child from CABLIVI, or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of CABLIVI in pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy have been established. Use of CABLIVI for this indication is supported by evidence from an observational, retrospective chart review and pharmacokinetic/pharmacodynamic modeling and simulation data [see Adverse Reactions (6) , Clinical Pharmacology (12.3) and Clinical Studies (14) ] . The safety and effectiveness of CABLIVI in pediatric patients less than 12 years of age have not been established.

8.5Geriatric Use Clinical studies of CABLIVI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

8.6Hepatic Impairment No formal studies with CABLIVI have been conducted in patients with severe acute or chronic hepatic impairment and no data regarding the use of CABLIVI in these populations are available. Due to a potential increased risk of bleeding, use of CABLIVI in patients with severe hepatic impairment requires close monitoring for bleeding [see Warnings and Precautions (5.1) ] .

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no available data on CABLIVI use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, there are potential risks of hemorrhage in the mother and fetus associated with use of CABLIVI (see Clinical Considerations ) . In animal reproduction studies, there was no evidence of adverse developmental outcomes with intramuscular administration of caplacizumab-yhdp during organogenesis in guinea pigs at exposures approximately 30 times the AUC in humans at the recommended subcutaneous injection dose of 11 mg (see Data ) .

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background rate of major birth defects and miscarriage in the indicated population is unknown. In the U.S. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Fetal/neonatal adverse reactions CABLIVI may increase the risk of bleeding in the fetus and neonate. Monitor neonates for bleeding [see Warnings and Precautions (5.1) ] . Maternal adverse reactions All patients receiving CABLIVI, including pregnant women, are at risk for bleeding.

Pregnant women receiving CABLIVI should be carefully monitored for evidence of excessive bleeding [see Warnings and Precautions (5.1) ] . Data Animal data Two separate reproduction studies were conducted in pregnant guinea pigs with administration of caplacizumab-yhdp during the organogenesis period. In an embryo-fetal development study, caplacizumab-yhdp was administered intramuscularly at doses up to 20 mg/kg/day from gestational day (GD) 6 to GD 41 in guinea pigs.

No maternal toxicity or adverse developmental outcomes were observed. In a toxicokinetic study assessing the exposure of caplacizumab-yhdp in the dams and fetuses, caplacizumab-yhdp was administered once daily to female guinea pigs at doses up to 40 mg/kg/day (corresponding to a drug exposure of approximately 30 times the AUC in humans at the recommended dose of 11 mg) by intramuscular injection from GD 6 to GD 41 or GD 61. Exposure to caplacizumab-yhdp was observed in the dams and fetuses, with no effects on embryo-fetal development.

🧒 Pediatric Use 90 words ▾

8.4Pediatric Use The safety and effectiveness of CABLIVI in pediatric patients 12 years of age and older with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy have been established. Use of CABLIVI for this indication is supported by evidence from an observational, retrospective chart review and pharmacokinetic/pharmacodynamic modeling and simulation data [see Adverse Reactions (6) , Clinical Pharmacology (12.3) and Clinical Studies (14) ] . The safety and effectiveness of CABLIVI in pediatric patients less than 12 years of age have not been established.

🧓 Geriatric Use 27 words ▾

8.5Geriatric Use Clinical studies of CABLIVI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🆘 Overdosage 54 words ▾

10 OVERDOSAGE In case of overdose, based on the pharmacological action of CABLIVI, there is the potential for an increased risk of bleeding [see Warnings and Precautions (5.1) ] . Monitor patients for signs and symptoms of bleeding if overdose occurs. Consider the use of von Willebrand factor concentrate to correct hemostasis, if needed.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Caplacizumab-yhdp targets the A1-domain of vWF, and inhibits the interaction between vWF and platelets, thereby reducing both vWF-mediated platelet adhesion and platelet consumption.

12.2Pharmacodynamics Ristocetin cofactor (RICO) activity was used to assess vWF activity. Subcutaneous doses of caplacizumab-yhdp at greater than or equal to the approved recommended dosage to healthy subjects and patients with aTTP decreased RICO activity levels to below 20% approximately 4 hours post-dose. RICO activity returned to baseline values within 7 days of drug discontinuation.

Caplacizumab-yhdp decreased vWF antigen and factor VIII:C levels. These reductions were transient and returned to baseline upon cessation of treatment.

12.3Pharmacokinetics Caplacizumab-yhdp pharmacokinetics depends on the expression of the target vWF and are not dose proportional. Higher levels of vWF antigen increase the fraction of drug-target complex retained in the circulation. Steady-state was reached following the first administration of CABLIVI in healthy subjects, with minimal accumulation.

Following a single subcutaneous dose of 10 mg caplacizumab-yhdp to healthy subjects the mean (CV%) peak concentration (C max ) was 528 (20%) ng/mL and AUC 0–24 was 7951 (16%). Following subcutaneous dosing of 10 mg caplacizumab-yhdp daily for 14 days to healthy subjects, the mean (CV%) C max was 348 (30%) ng/mL and AUC 0–τ was 6808 (26%) hr∙ng/mL. Absorption The bioavailability of subcutaneous caplacizumab-yhdp is approximately 90%.

The maximum concentration was observed 6 to 7 hours after subcutaneous dosing of 10 mg caplacizumab-yhdp once daily in healthy subjects. Distribution Caplacizumab-yhdp central volume of distribution is

6.33L in patients with aTTP. Elimination The half-life of caplacizumab-yhdp is concentration and target-level dependent. Metabolism The available data suggest target-bound caplacizumab-yhdp is metabolized within the liver.

Because caplacizumab-yhdp is a monoclonal antibody fragment, it is expected to be catabolized by various proteolytic enzymes. Excretion The available nonclinical data suggest unbound caplacizumab-yhdp is cleared renally. Antidrug Antibodies No clinically significant differences in the pharmacokinetics of caplacizumab-yhdp were observed in patients with pre-existing or treatment-emergent anti-drug antibodies.

Specific Populations No clinically significant differences in the pharmacokinetics of caplacizumab-yhdp were observed based on age (18 to 79 years), sex (66% females), race (White [83%] and Black [17%]), blood group (O [41%] and other groups [59%]), or renal impairment (mild [CrCl: 60 to 90 mL/min], moderate [CrCl: 30 to 60 mL/min] or severe [CrCl: 15 to 30 mL/min]). The effect of hepatic impairment on the pharmacokinetics of caplacizumab-yhdp is unknown [see Use in Specific Populations (8.6) ] . Pediatric population A pharmacokinetic-pharmacodynamic (PK/PD) population model was developed using clinical data from adult populations following intravenous and subcutaneous administration of caplacizumab-yhdp.

Simulations performed based on this PK/PD model showed that the predicted caplacizumab-yhdp exposure and suppression of von Willebrand factor antigen (vWF:Ag) are similar in pediatric patients ≥12 years of age to those in adults when the adult dose (11 mg/day) is used in children. Drug Interaction Studies No dedicated drug-drug interaction studies with caplacizumab-yhdp have been conducted.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of caplacizumab-yhdp. The prevalence of pre-existing antibodies binding to caplacizumab-yhdp observed during clinical studies and during ev… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 27 words ▾

12.1Mechanism of Action Caplacizumab-yhdp targets the A1-domain of vWF, and inhibits the interaction between vWF and platelets, thereby reducing both vWF-mediated platelet adhesion and platelet consumption.

📦 How Supplied / Storage and Handling 129 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied CABLIVI (caplacizumab-yhdp) for injection is a sterile, white, preservative-free, lyophilized powder in a single-dose vial. Each carton (NDC 58468-0225-1) contains: one 11 mg CABLIVI single-dose vial (NDC 58468-0227-1) one 1 mL Sterile Water for Injection, USP, prefilled glass syringe (diluent for CABLIVI) (NDC 58468-0229-1) one sterile vial adapter one sterile hypodermic needle (30 gauge) two individually packaged alcohol swabs

16.2Storage Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Unopened vials may be stored in the original carton at room temperature up to 30°C (86°F) for a single period of up to 2 months. Do not return CABLIVI to the refrigerator after it has been stored at room temperature.

📦 Storage and Handling 62 words ▾

16.2Storage Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Unopened vials may be stored in the original carton at room temperature up to 30°C (86°F) for a single period of up to 2 months. Do not return CABLIVI to the refrigerator after it has been stored at room temperature.

📋 Description 102 words ▾

11 DESCRIPTION Caplacizumab-yhdp is a von Willebrand factor (vWF)-directed antibody fragment that consists of two identical humanized building blocks, linked by a three-alanine linker. Caplacizumab-yhdp is produced in Escherichia coli by recombinant DNA technology and has an approximate molecular weight of 28 kDa. CABLIVI (caplacizumab-yhdp) for injection is a sterile, white, preservative-free, lyophilized powder.

Each single-dose vial delivers 11 mg caplacizumab-yhdp, anhydrous citric acid (0.18 mg), polysorbate 80 (0.10 mg), sucrose (62 mg), and trisodium citrate dihydrate (4.91 mg). After reconstitution with 1 mL of Sterile Water for Injection, USP, the final concentration is 11 mg/mL, at a pH of approximately 6.5.

💬 Information for Patients 148 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Bleeding [see Warnings and Precautions (5.1) ] Advise patients and/or caregivers that bruising and bleeding may occur more easily, that nose bleeds and bleeding of gums may occur, and that it may take them longer than usual to stop bleeding. Advise patients and/or caregivers to contact their healthcare provider immediately if symptoms of excessive bruising, excessive bleeding, or major bleeding occur.

Signs and symptoms of bleeding include pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness [see Warnings and Precautions (5.1) ] . Advise patients and/or caregivers to inform their healthcare provider before scheduling any elective surgery, dental procedure or other invasive interventions.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Caplacizumab-yhdp pharmacokinetics depends on the expression of the target vWF and are not dose proportional. Higher levels of vWF antigen increase the fraction of drug-target complex retained in the circulation. Steady-state was reached following the first administration of CABLIVI in healthy subjects, with minimal accumulation.

Following a single subcutaneous dose of 10 mg caplacizumab-yhdp to healthy subjects the mean (CV%) peak concentration (C max ) was 528 (20%) ng/mL and AUC 0–24 was 7951 (16%). Following subcutaneous dosing of 10 mg caplacizumab-yhdp daily for 14 days to healthy subjects, the mean (CV%) C max was 348 (30%) ng/mL and AUC 0–τ was 6808 (26%) hr∙ng/mL. Absorption The bioavailability of subcutaneous caplacizumab-yhdp is approximately 90%.

The maximum concentration was observed 6 to 7 hours after subcutaneous dosing of 10 mg caplacizumab-yhdp once daily in healthy subjects. Distribution Caplacizumab-yhdp central volume of distribution is

6.33L in patients with aTTP. Elimination The half-life of caplacizumab-yhdp is concentration and target-level dependent. Metabolism The available data suggest target-bound caplacizumab-yhdp is metabolized within the liver.

Because caplacizumab-yhdp is a monoclonal antibody fragment, it is expected to be catabolized by various proteolytic enzymes. Excretion The available nonclinical data suggest unbound caplacizumab-yhdp is cleared renally. Antidrug Antibodies No clinically significant differences in the pharmacokinetics of caplacizumab-yhdp were observed in patients with pre-existing or treatment-emergent anti-drug antibodies.

Specific Populations No clinically significant differences in the pharmacokinetics of caplacizumab-yhdp were observed based on age (18 to 79 years), sex (66% females), race (White [83%] and Black [17%]), blood group (O [41%] and other groups [59%]), or renal impairment (mild [CrCl: 60 to 90 mL/min], moderate [CrCl: 30 to 60 mL/min] or severe [CrCl: 15 to 30 mL/min]). The effect of hepatic impairment on the pharmacokinetics of caplacizumab-yhdp is unknown [see Use in Specific Populations (8.6) ] . Pediatric population A pharmacokinetic-pharmacodynamic (PK/PD) population model was developed using clinical data from adult populations following intravenous and subcutaneous administration of caplacizumab-yhdp.

Simulations performed based on this PK/PD model showed that the predicted caplacizumab-yhdp exposure and suppression of von Willebrand factor antigen (vWF:Ag) are similar in pediatric patients ≥12 years of age to those in adults when the adult dose (11 mg/day) is used in children. Drug Interaction Studies No dedicated drug-drug interaction studies with caplacizumab-yhdp have been conducted.

🧬 Pharmacodynamics 76 words ▾

12.2Pharmacodynamics Ristocetin cofactor (RICO) activity was used to assess vWF activity. Subcutaneous doses of caplacizumab-yhdp at greater than or equal to the approved recommended dosage to healthy subjects and patients with aTTP decreased RICO activity levels to below 20% approximately 4 hours post-dose. RICO activity returned to baseline values within 7 days of drug discontinuation.

Caplacizumab-yhdp decreased vWF antigen and factor VIII:C levels. These reductions were transient and returned to baseline upon cessation of treatment.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of CABLIVI for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) in combination with plasma exchange and immunosuppressive therapy was established in a pivotal multicenter, randomized, double-blind, placebo-controlled trial (HERCULES) (NCT02553317). HERCULES A total of 145 patients were enrolled in the HERCULES study; the median age was 45 (range: 18 to 79) years, 69% were female, 73% were White. Patients were randomized to either CABLIVI (n=72) or placebo (n=73).

Patients in both groups received plasma exchange and immunosuppressive therapy. Patients were stratified according to the severity of neurological involvement (Glasgow Coma Scale score ≤12 or 13 to 15). Patients with sepsis, infection with E. coli 0157, atypical hemolytic uremic syndrome, disseminated intravascular coagulation or congenital thrombotic thrombocytopenic purpura were not eligible for enrollment.

Patients received a single 11 mg CABLIVI bolus intravenous injection or placebo prior to the first plasma exchange on study, followed by a daily subcutaneous injection of 11 mg CABLIVI or placebo after completion of plasma exchange, for the duration of the daily plasma exchange period and for 30 days thereafter. If after the initial treatment course, sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remained present, treatment was extended for 7-day intervals for a maximum of 28 days.

The median treatment duration with CABLIVI was 35 days. The clinical trial protocol specified the CABLIVI dose as 10 mg, to be delivered by withdrawing all of the reconstituted solution from the vial and administering the full amount. A dose recovery study showed that the mean dose that can be withdrawn from a vial is 11 mg.

Therefore, based on the dose recovery study, the mean dose delivered in the trial was 11 mg. The efficacy of CABLIVI in patients with aTTP was established based on time to platelet count response (platelet count ≥150,000/µL followed by cessation of daily plasma exchange within 5 days). Time to platelet count response was shorter among patients treated with CABLIVI, compared to placebo.

Figure 1: Platelet Response over Time Treatment with CABLIVI resulted in a lower number of patients with TTP-related death, recurrence of TTP, or at least one treatment-emergent major thromboembolic event (a composite endpoint) during the treatment period (see Table 2 ). Table 2: Patients in the HERCULES Study with aTTP-Related Death, a Recurrence of aTTP, or at Least One Treatment-Emergent Major Thromboembolic Event During Study Drug Treatment Period (ITT population) Number of patients with CABLIVI N=72 Placebo N=73 n (%) Based on 71 patients who received at least one dose of study drug. n (%) N = number of patients within the population of interest (by treatment group) n = number of patients with events; TTP = thrombotic thrombocytopenic purpura; ITT = intent to treat.

TTP-related death 0 3 (4.1) Recurrence of TTP (exacerbation) Exacerbation defined as thrombocytopenia after initial recovery of platelet count (platelet count ≥150,000/µL with subsequent stop of daily plasma exchange within 5 days) that required reinitiation of daily plasma exchange during the 30-day post daily plasma exchange period. 3 (4.2) 28 (38.4) At least one treatment-emergent major thromboembolic event 6 (8.5) 6 (8.2) Total p<0.0001 9 (12.7) 36 (49.3) The proportion of patients with a recurrence of TTP in the overall study period (the drug treatment period plus the 28-day follow-up period after discontinuation of drug treatment) was lower in the CABLIVI group (9/72 patients [13%]) compared to the placebo group (28/73 patients [38%] (p<0.001).

In the 6 patients in the CABLIVI group who experienced a recurrence of TTP during the follow-up period (i.e., a relapse defined as recurrent thrombocytopenia after initial recovery of platelet count (platelet count ≥150,000/µL) that required reinitiation of dail… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 41 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to evaluate the potential of caplacizumab-yhdp for carcinogenicity or genotoxicity. Animal reproduction studies assessing the effects of caplacizumab-yhdp on male and female fertility have not been conducted.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 38 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been performed to evaluate the potential of caplacizumab-yhdp for carcinogenicity or genotoxicity. Animal reproduction studies assessing the effects of caplacizumab-yhdp on male and female fertility have not been conducted.

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE CABLIVI ® [cab-LIV-ee] (caplacizumab-yhdp) for injection, for subcutaneous use single-dose vial This Instructions for Use has been approved by the U.S. Food and Drug Administration. This Instructions for Use contains information on how to inject CABLIVI.

Be sure that you read, understand, and follow this Instructions for Use before you inject CABLIVI and each time you get a refill. There may be new information. Your healthcare provider should show you or your caregiver how to prepare and inject CABLIVI properly before your first injection.

In children 12 years of age and older, CABLIVI must be given by a healthcare provider or an adult caregiver. Talk to your healthcare provider or call 1-800-745-4447 if you have any questions. Important Information You Need to Know Before Injecting CABLIVI : Make sure that the name CABLIVI appears on the carton and vial label.

This Instructions for Use is only for administration of CABLIVI under the skin (subcutaneous). Use CABLIVI exactly as prescribed by your healthcare provider. Inject CABLIVI into your stomach (abdomen).

Avoid the 2-inch area around your belly button (navel). Do not inject into any other area of the body. Do not inject into the same site on your stomach (abdomen) on consecutive days.

See " step 10: Prepare your injection site ". For each injection, one CABLIVI carton is needed. Only use the vial one time.

See the section below titled, " Each CABLIVI carton contains: " for what supplies are needed to prepare your prescribed dose. Do not use CABLIVI after the expiration date on the carton. Do not reuse any of the supplies.

After your injection, throw away (dispose of) the used vial with any remaining CABLIVI liquid in it. Throw away (dispose of) the used vial with the adapter attached and the syringe with the needle attached in an FDA-cleared sharps disposal container. See " Step 13: Dispose of the used syringe and vial " at the end of this Instructions for Use for more disposal information.

Storing CABLIVI Store CABLIVI in the refrigerator between 36°F to 46°F (2°C to 8°C). Store CABLIVI in the original carton to protect from light. Do not freeze CABLIVI.

Unopened CABLIVI vials may be stored at room temperature up to 86°F (30°C) in the original carton for a single period of up to two months. Write the date removed from the refrigerator in the space provided on the carton. Do not return CABLIVI to the refrigerator after it has been stored at room temperature.

Use the mixed CABLIVI solution immediately. The mixed CABLIVI solution can be stored for up to 4 hours in the refrigerator at 36°F to 46°F (2°C to 8°C). Keep CABLIVI and all medicines out of the reach of children.

Each CABLIVI carton contains: 1 vial of CABLIVI 1 prefilled syringe containing 1 mL Sterile Water for Injection, USP 1 sterile vial adapter 1 sterile needle 2 alcohol swabs Additional supplies needed that are not included in the CABLIVI carton: FDA-cleared sharps disposal container Cotton balls Preparing to inject a dose of CABLIVI : Wash your hands well with soap and water. Prepare a clean flat surface. Check to make sure the carton contains all of the items needed to prepare a dose.

Check the expiration date (See Figure A ) . Do not use CABLIVI if the date has passed. Do not use CABLIVI if the packaging or any supplies inside of the carton are damaged in any way.

Figure A Step 1: Bring the vial and syringe to room temperature Place all the supplies in the carton and the additional supplies not in the CABLIVI carton on the clean flat surface. If the carton was not stored at room temperature, allow the vial and the syringe to reach room temperature by holding them in your hands for 10 seconds (See Figure B ) . Do not use any other way to warm up the vial and syringe.

Figure B Step 2: Clean the rubber stopper Remove the green plastic flip-off cap from the metal cap of the vial (See Figure C ) . Do not use the vial if the green plastic cap is missing. Figure C Clean the exposed rubber stopp… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 85 words ▾

PRINCIPAL DISPLAY PANEL - Kit Carton NDC 58468-0225-1 Rx only Cablivi ® caplacizumab-yhdp for Injection For Intravenous and Subcutaneous Use Must be reconstituted with diluent provided. Single-dose vial. Discard unused portion.

Each carton contains: - One 11 mg Cablivi single-dose vial - One 1 mL Sterile Water for Injection, USP, prefilled glass syringe (diluent for Cablivi) - One sterile vial adapter - One sterile hypodermic needle (30 gauge) - Two individually packaged alcohol swabs 11 mg per vial sanofi PRINCIPAL DISPLAY PANEL - Kit Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cablivi — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cablivi. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$10.39M
Claims incl. refills
48
Beneficiaries
28
Spend / beneficiary
$371,247.24
Spend / claim
$216,560.89
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Genzyme Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Genzyme Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 58468-0220-01 · Genzyme 58468-0251-05 · Genzyme →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.