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Drug overview for CABLIVI (caplacizumab-yhdp):
Generic name: caplacizumab-yhdp (KAP-la-SIZ-ue-mab)
Drug class: Agents to treat Thrombotic Thrombocytopenic Purpura (TTP)
Therapeutic class: Hematological Agents
Caplacizumab-yhdp is an antithrombotic agent.
No enhanced Uses information available for this drug.
Generic name: caplacizumab-yhdp (KAP-la-SIZ-ue-mab)
Drug class: Agents to treat Thrombotic Thrombocytopenic Purpura (TTP)
Therapeutic class: Hematological Agents
Caplacizumab-yhdp is an antithrombotic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
CABLIVI 11 MG KIT
The following indications for CABLIVI (caplacizumab-yhdp) have been approved by the FDA:
Indications:
Acquired thrombotic thrombocytopenic purpura
Professional Synonyms:
Thrombotic thrombocytopenic purpura, acquired
Indications:
Acquired thrombotic thrombocytopenic purpura
Professional Synonyms:
Thrombotic thrombocytopenic purpura, acquired
The following dosing information is available for CABLIVI (caplacizumab-yhdp):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
*The first dose should be administered by a healthcare provider as a bolus intravenous injection. Administer subsequent doses subcutaneously in the abdomen.
*Caplacizumab-yhdp should be administered upon the initiation of plasma exchange therapy. The recommended dose of caplacizumab-yhdp 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 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 caplacizumab-yhdp if the patient experiences more than 2 recurrences of aTTP while on caplacizumab-yhdp.
*The first dose should be administered by a healthcare provider as a bolus intravenous injection. Administer subsequent doses subcutaneously in the abdomen.
*Caplacizumab-yhdp should be administered upon the initiation of plasma exchange therapy. The recommended dose of caplacizumab-yhdp 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 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 caplacizumab-yhdp if the patient experiences more than 2 recurrences of aTTP while on caplacizumab-yhdp.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CABLIVI 11 MG KIT | Maintenance | Adults inject 11 mg by subcutaneous route once daily in the abdomen for 30 days beyond the last plasma exchange |
| CABLIVI 11 MG VIAL | Maintenance | Adults inject 11 mg by subcutaneous route once daily in the abdomen for 30 days beyond the last plasma exchange |
No generic dosing information available.
The following drug interaction information is available for CABLIVI (caplacizumab-yhdp):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Caplacizumab/Anticoagulants; Antiplatelets SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Bleeding has been reported with the use of caplacizumab.(1) CLINICAL EFFECTS: Concurrent use of caplacizumab with either anticoagulants or antiplatelets may increase the risk of hemorrhage.(1) PREDISPOSING FACTORS: The risk for bleeding episodes may be greater in patients with disease-associated factors (e.g. hemophilia, coagulation factor deficiencies). Drug associated risk factors include concurrent use of multiple drugs which inhibit anticoagulant/antiplatelet metabolism and/or have an inherent risk for bleeding (e.g. NSAIDs). PATIENT MANAGEMENT: Avoid the use of caplacizumab with anticoagulants and antiplatelets. Interrupt caplacizumab therapy if clinically significant bleeding occurs. Patients may require von Willebrand factor concentrate to rapidly correct hemostasis. If caplacizumab is restarted, closely monitor for signs of bleeding.(1) If concurrent therapy is warranted, monitor patients receiving concurrent therapy for signs of blood loss, including decreased hemoglobin, hematocrit, fecal occult blood, and/or decreased blood pressure and promptly evaluate patients with any symptoms. When applicable, perform agent-specific laboratory tests (e.g. INR, aPTT) to monitor efficacy and safety of anticoagulation. Discontinue anticoagulation in patients with active pathologic bleeding. Instruct patients to report any signs and symptoms of bleeding, such as unusual bleeding from the gums or nose; unusual bruising; red or black, tarry stools; red, pink or dark brown urine; acute abdominal or joint pain and/or swelling. The time of highest risk for a coumarin-type drug interaction is when the precipitant drug is initiated or discontinued. Contact the prescriber before initiating, altering the dose or discontinuing either drug. DISCUSSION: Bleeding has been reported with caplacizumab. In clinical studies, severe bleeding adverse reactions of epistaxis, gingival bleeding, upper gastrointestinal hemorrhage, and metrorrhagia were each reported in 1% of patients. Overall, bleeding events occurred in approximately 58% of patients on caplacizumab versus 43% of patients on placebo.(1) In post-marketing reports, cases of life-threatening and fatal bleeding were reported with caplacizumab.(1) |
ACD SOLUTION A, ACD-A, ACETYL SALICYLIC ACID, AGGRASTAT, ANAPROX DS, ANJESO, ARGATROBAN, ARGATROBAN-0.9% NACL, ARIXTRA, ARTHROTEC 50, ARTHROTEC 75, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, ASPIRIN, ASPIRIN-DIPYRIDAMOLE ER, BISMUTH SUBSALICYLATE, BIVALIRUDIN, BRILINTA, BROMFENAC SODIUM, BUPIVACAINE-KETOROLAC-KETAMINE, BUTALBITAL-ASPIRIN-CAFFEINE, CALDOLOR, CAMBIA, CARISOPRODOL-ASPIRIN, CARISOPRODOL-ASPIRIN-CODEINE, CELEBREX, CELECOXIB, CHOLINE MAGNESIUM TRISALICYLAT, CILOSTAZOL, CITRATE PHOSPHATE DEXTROSE, CLOPIDOGREL, COMBOGESIC, COMBOGESIC IV, CONSENSI, COXANTO, DABIGATRAN ETEXILATE, DAYPRO, DICLOFENAC, DICLOFENAC POTASSIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM ER, DICLOFENAC SODIUM MICRONIZED, DICLOFENAC SODIUM-MISOPROSTOL, DIFLUNISAL, DIPYRIDAMOLE, DISALCID, DOLOBID, DURLAZA, EC-NAPROSYN, EFFIENT, ELIQUIS, ELMIRON, ELYXYB, ENOXAPARIN SODIUM, ENOXILUV, EPTIFIBATIDE, ETODOLAC, ETODOLAC ER, FELDENE, FENOPROFEN CALCIUM, FENOPRON, FLURBIPROFEN, FONDAPARINUX SODIUM, FRAGMIN, HEPARIN SODIUM, HEPARIN SODIUM IN 0.45% NACL, HEPARIN SODIUM-0.45% NACL, HEPARIN SODIUM-0.9% NACL, HEPARIN SODIUM-D5W, HYDROCODONE-IBUPROFEN, IBU, IBUPAK, IBUPROFEN, IBUPROFEN LYSINE, IBUPROFEN-FAMOTIDINE, INDOCIN, INDOMETHACIN, INDOMETHACIN ER, INFLAMMACIN, INFLATHERM(DICLOFENAC-MENTHOL), JANTOVEN, KENGREAL, KETOPROFEN, KETOPROFEN MICRONIZED, KETOROLAC TROMETHAMINE, KIPROFEN, LODINE, LOFENA, LOVENOX, LURBIPR, MB CAPS, MECLOFENAMATE SODIUM, MEFENAMIC ACID, MELOXICAM, NABUMETONE, NABUMETONE MICRONIZED, NALFON, NAPRELAN, NAPROSYN, NAPROTIN, NAPROXEN, NAPROXEN SODIUM, NAPROXEN SODIUM CR, NAPROXEN SODIUM ER, NAPROXEN-ESOMEPRAZOLE MAG, NEOPROFEN, NORGESIC, NORGESIC FORTE, ORPHENADRINE-ASPIRIN-CAFFEINE, ORPHENGESIC FORTE, OXAPROZIN, PENTOSAN POLYSULFATE SODIUM, PHENYL SALICYLATE, PHENYLBUTAZONE, PIROXICAM, PLAVIX, PRADAXA, PRASUGREL HCL, R.E.C.K.(ROPIV-EPI-CLON-KETOR), RELAFEN DS, RIVAROXABAN, ROPIVACAINE-CLONIDINE-KETOROLC, ROPIVACAINE-KETOROLAC-KETAMINE, SALSALATE, SAVAYSA, SODIUM SALICYLATE, SPRIX, SULINDAC, SUMATRIPTAN SUCC-NAPROXEN SOD, SYMBRAVO, TICAGRELOR, TIROFIBAN HCL, TOLECTIN 600, TOLMETIN SODIUM, TORONOVA II SUIK, TORONOVA SUIK, TOXICOLOGY SALIVA COLLECTION, TRESNI, TREXIMET, URIMAR-T, URNEVA, VIMOVO, VIVLODEX, WARFARIN SODIUM, XARELTO, YOSPRALA, ZIPSOR, ZONTIVITY, ZORVOLEX, ZYNRELEF |
There are 0 moderate interactions.
The following contraindication information is available for CABLIVI (caplacizumab-yhdp):
Drug contraindication overview.
Previous severe hypersensitivity reaction to caplacizumab-yhdp or any of the excipients.
Previous severe hypersensitivity reaction to caplacizumab-yhdp or any of the excipients.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Increased risk of bleeding |
| Invasive surgical procedure |
There are 0 moderate contraindications.
The following adverse reaction information is available for CABLIVI (caplacizumab-yhdp):
Adverse reaction overview.
Most common adverse reactions (incidence >15%) are epistaxis, headache, and gingival bleeding.
Most common adverse reactions (incidence >15%) are epistaxis, headache, and gingival bleeding.
There are 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Hemorrhage |
Hypersensitivity drug reaction Menorrhagia Rectal bleeding Upper GI bleed |
| Rare/Very Rare |
|---|
|
Hematoma of abdominal wall |
There are 17 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Epistaxis Gingival bleeding Headache disorder |
Abnormal vaginal bleeding Back pain Bruising Dyspnea Fatigue Fever Hematuria Injection site pain Injection site sequelae Myalgia Paresthesia Urinary tract infection Urticaria |
| Rare/Very Rare |
|---|
|
Injection site erythema |
The following precautions are available for CABLIVI (caplacizumab-yhdp):
The safety and effectiveness of caplacizumab-yhdp in pediatric patients have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Risk Summary: There are no available data on caplacizumab-yhdp 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 caplacizumab-yhdp. 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.
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: Caplacizumab-yhdp may increase the risk of bleeding in the fetus and neonate. Monitor neonates for bleeding.
All patients receiving caplacizumab-yhdp, including pregnant women, are at risk for bleeding. Pregnant women receiving caplacizumab-yhdp should be carefully monitored for evidence of excessive bleeding. 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.
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: Caplacizumab-yhdp may increase the risk of bleeding in the fetus and neonate. Monitor neonates for bleeding.
All patients receiving caplacizumab-yhdp, including pregnant women, are at risk for bleeding. Pregnant women receiving caplacizumab-yhdp should be carefully monitored for evidence of excessive bleeding. 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.
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 caplacizumab-yhdp and any potential adverse effects on the breastfed child from caplacizumab-yhdp, or from the underlying maternal condition.
Clinical studies of caplacizumab-yhdp did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
The following prioritized warning is available for CABLIVI (caplacizumab-yhdp):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CABLIVI (caplacizumab-yhdp)'s list of indications:
| Acquired thrombotic thrombocytopenic purpura | |
| M31.19 | Other thrombotic microangiopathy |
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