Version May 2024
Thrombotic thrombocytopenic purpura, acquired: Administer caplacizumab upon initiation of plasma exchange therapy.
First day of treatment: IV followed by SubQ: 11 mg IV at least 15 minutes prior to plasma exchange, followed by 11 mg SubQ after completion of plasma exchange on day 1.
Subsequent treatment days (during daily plasma exchange): SubQ: 11 mg once daily following plasma exchange.
Treatment after plasma exchange period: SubQ: 11 mg once daily, continuing for 30 days following the last daily plasma exchange; if sign(s) of persistent underlying disease remain present (eg, suppressed ADAMTS13 activity levels) after initial treatment course, treatment may be extended up to a maximum of 28 days.
Discontinuation: Discontinue caplacizumab if >2 recurrences of acquired thrombotic thrombocytopenic purpura (aTTP) occur during treatment. Withhold caplacizumab treatment 7 days prior to elective surgery, dental procedures, and/or other invasive interventions.
Missed dose: If a caplacizumab dose is missed during the plasma exchange period, administer as soon as possible. If a caplacizumab dose is missed after the plasma exchange period, administer within 12 hours of the scheduled administration time; beyond 12 hours, the missed dose should be skipped and the next daily dose administered according to the usual dosing schedule.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling. However, no clinically meaningful effect was noted in caplacizumab pharmacokinetics in patients with CrCl 15 to 90 mL/minute.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Use with caution in patients with severe acute or chronic hepatic impairment; monitor closely for bleeding.
Bleeding: If clinically significant bleeding occurs, interrupt treatment. If rapid correction of hemostasis is required, von Willebrand factor concentrate may be administered. Monitor closely if caplacizumab is reinitiated.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Dermatologic: Urticaria (14%)
Gastrointestinal: Gingival hemorrhage (16%)
Hematologic & oncologic: Iatrogenic bleeding (58%)
Nervous system: Fatigue (15%), headache (21%), paresthesia (12%)
Respiratory: Epistaxis (29%)
Miscellaneous: Fever (13%)
1% to 10%:
Cardiovascular: Subarachnoid hemorrhage (2%)
Dermatologic: Injection site pruritus (3%)
Endocrine & metabolic: Heavy menstrual bleeding (4%), intermenstrual bleeding (1%)
Genitourinary: Hematuria (4%), urinary tract infection (6%), vaginal hemorrhage (5%)
Hematologic & oncologic: Hematoma (abdominal wall: 3%), rectal hemorrhage (4%), upper gastrointestinal hemorrhage (1%)
Immunologic: Antibody development (3%)
Local: Bleeding at injection site (6%), catheter site hemorrhage (6%)
Neuromuscular & skeletal: Back pain (7%), myalgia (6%)
Respiratory: Dyspnea (9%)
Postmarketing:
Hematologic & oncologic: Major hemorrhage (including major hemorrhage, life-threatening)
Local: Erythema at injection site
Previous severe hypersensitivity (eg, urticaria) to caplacizumab or any component of the formulation
Concerns related to adverse effects:
• Bleeding: Caplacizumab increases the risk of bleeding; bleeding events occur commonly. Life-threatening and fatal bleeding has occurred. Severe bleeding events (epistaxis, gingival bleeding, upper gastrointestinal hemorrhage, and metrorrhagia) were reported in a small number of patients in clinical studies. The risk of bleeding is increased in patients with underlying coagulopathies (eg, hemophilia, or other coagulation factor deficiencies) and with concomitant use of caplacizumab with medications affecting hemostasis and coagulation; avoid concomitant use with antiplatelets or anticoagulants. Withhold caplacizumab 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 caplacizumab has been resumed, monitor closely for signs of bleeding.
• Hypersensitivity: Urticaria has been reported.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with severe acute or chronic hepatic impairment (due to the potential increased risk of bleeding); monitor closely.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Injection [preservative free]:
Cablivi: 11 mg [contains polysorbate 80]
No
Kit (Cablivi Injection)
11 mg (per each): $9,890.40
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Kit, Injection:
Cablivi: 11 mg [contains polysorbate 80]
IV: Administer the first (initial) dose as an IV bolus by connecting the glass syringe to a standard luer lock (do not use a needleless connector). Flush with either NS or D5W.
SubQ: Subsequent doses are administered subcutaneously into the abdomen. Avoid injections around the navel. Rotate abdominal quadrants; do not administer consecutive injections into the same quadrant.
The initial IV dose should be administered by a health care provider; subcutaneous doses may be administered by the patient (or caregiver) following appropriate training.
Thrombotic thrombocytopenic purpura, acquired: Treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults, in combination with plasma exchange and immunosuppressive therapy.
Caplacizumab may be confused with bevacizumab, canakinumab, cemiplimab, emicizumab, idarucizumab
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the adverse/toxic effect of Caplacizumab. Specifically, the risk of bleeding may be increased. Management: Avoid coadministration of caplacizumab with antiplatelets if possible. If coadministration is required, monitor closely for signs and symptoms of bleeding. Interrupt use of caplacizumab if clinically significant bleeding occurs. Risk D: Consider therapy modification
Anticoagulants: Caplacizumab may enhance the anticoagulant effect of Anticoagulants. Management: Avoid coadministration of caplacizumab with antiplatelets if possible. If coadministration is required, monitor closely for signs and symptoms of bleeding. Interrupt use of caplacizumab if clinically significant bleeding occurs. Risk D: Consider therapy modification
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Caplacizumab crosses the placenta (Kühne 2021).
Data related to the use of caplacizumab during pregnancy are limited (Kühne 2021; Odetola 2023). There is a risk of bleeding with caplacizumab; monitor both the mother and the newborn if exposure occurs during pregnancy.
Untreated thrombotic thrombocytopenic purpura (TTP) is associated with adverse pregnancy outcomes. Agents other than caplacizumab are currently recommended to treat TTP during pregnancy (BSH [Scully 2023]; ISTH [Zheng 2020]).
It is not known if caplacizumab is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Consider monitoring ADAMTS13 activity levels (Scully 2019). Monitor for signs/symptoms of bleeding, especially in patients at increased risk (severe hepatic impairment or who are on concurrent medications affecting hemostasis and coagulation).
Caplacizumab is a von Willebrand factor (vWF)-directed monoclonal antibody fragment which targets the A1-domain of vWF, inhibiting the interaction between vWF and platelets, reducing both vWF-mediated platelet adhesion and platelet consumption.
Onset: Ristocetin cofactor (RCo) activity levels are decreased to below 20% within 4 hours after a dose.
Duration: RCo activity returns to baseline within 7 days following discontinuation.
Distribution: Vd: 6.33 L
Metabolism: Caplacizumab is likely catabolized by various proteolytic enzymes; target-bound caplacizumab is metabolized hepatically
Bioavailability: SubQ: ~90%
Time to peak: SubQ: 6 to 7 hours
Excretion: Unbound caplacizumab is eliminated renally.
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