Cablivi

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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 )
• 2.1 Recommended 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.
• 2.2 Discontinuation 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) ] .
• 2.3 Reconstitution 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 syringe.
• Reconstitute CABLIVI before administration using the provided syringe containing 1 mL Sterile Water for Injection, USP, to yield an 11 mg/mL single-dose solution.
• Using aseptic technique throughout the preparation of the solution, attach the vial adapter to the vial containing CABLIVI.
• Remove the plastic cap from the syringe and attach it to the vial adapter by twisting it clockwise until it cannot twist any further.
• Slowly push the syringe plunger down until the syringe is empty.
• Do not remove the syringe from the vial adapter.
• Gently swirl the vial until the cake or powder is completely dissolved.
• Do not shake.
• Visually inspect that the reconstituted solution is clear and colorless.
• Withdraw all of the clear, colorless reconstituted solution from the vial into the syringe.
• Label the CABLIVI syringe.
• Administer the full amount of reconstituted solution.
• For the initial intravenous injection, if using an intravenous line, the glass syringe should be connected to a standard Luer lock and flushed with either 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.
• Use the CABLIVI solution immediately.
• If not, use CABLIVI within 4 hours after reconstitution when stored in the refrigerator at 2°C to 8°C (36°F to 46°F).

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

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

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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.
• 6.1 Clinical 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.
• 6.3 Postmarketing 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 exposure.
• General disorders and administration site conditions:
• Injection site reactions including injection site pain, injection site bruising and injection site erythema

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How 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
• 16.2 Storage 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.

Quoted from the official label, section “How Supplied”.

How to store it

• 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.

Quoted from the official label, section “Storage and Handling”.

What is in it

• 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.

Quoted from the official label, section “Description”.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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