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.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Caplacizumab/Anticoagulants; Antiplatelets; Thrombolytics

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 anticoagulants, antiplatelets, or thrombolytics 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, antiplatelets, and thrombolytics. 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)

There are no moderate interactions for this drug.

Previous severe hypersensitivity reaction to caplacizumab-yhdp or any of the excipients.

There are no contraindication contraindications for this drug.

• Increased risk of bleeding
• Invasive surgical procedure

There are no moderate contraindications for this drug.

Most common adverse reactions (incidence >15%) are epistaxis, headache, and gingival bleeding.

More Frequent

• Hemorrhage

Less Frequent

• Hypersensitivity drug reaction
• Menorrhagia
• Rectal bleeding
• Upper GI bleed

Rare or Very Rare

• Hematoma of abdominal wall

More Frequent

• Epistaxis
• Gingival bleeding
• Headache disorder
• Tachycardia

Less Frequent

• Abnormal vaginal bleeding
• Back pain
• Bruising
• Dyspnea
• Fatigue
• Fever
• Hematuria
• Injection site pain
• Injection site sequelae
• Myalgia
• Paresthesia
• Urinary tract infection
• Urticaria

Rare or Very Rare

• Injection site erythema

No enhanced messaging available.

The safety and effectiveness of caplacizumab-yhdp in pediatric patients have not been established.

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.

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.

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.