CABLIVI

CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

It is recommended to take CABLIVI every day you receive plasma exchange and for 30 days after your last plasma exchange session. Your doctor may decide you need to take CABLIVI for more than 30 days. This additional period may last up to 28 days.

The latest innovation in TTP treatment is caplacizumab, a humanized single variable domain immunoglobulin that targets the A1 domain of VWF to inhibit its interaction with platelets.

Despite the fact that caplacizumab has demonstrated efficacy in treating TTP and is conditionally recommended by the International Society on Thrombosis and Haemostasis iTTP guidelines,4 cost remains a major barrier to its widespread use. At ∼$7700 for a single dose, an average course of therapy costs ∼$270 000.

Antibiotics, Antineoplastic.Immunosuppressive Agents.Muscle Relaxants, Central.Platelet Aggregation Inhibitors.Mitomycin.Cyclosporine.Clopidogrel.Quinine. Ticlopidine.

What is it? TTP is a rare, life-threatening blood disorder. In TTP, blood clots form in small blood vessels throughout your body. The clots can limit or block the flow of blood to your organs, such as your brain, kidneys, and heart.

Corticosteroids are used in the acute management of acquired TTP, and should be started upfront together with PEX. Steroids are believed to suppress the production of anti-ADAMTS13 autoantibodies.

The mainstay of treatment in TTP is plasma exchange (PEX) with high-dose corticosteroid therapy. [29] Corticosteroids operate by decreasing the activity of the reticuloendothelial system as well as decreasing autoantibody production.

The cost for Cablivi injectable kit yhdp 11 mg is around $8,688 for a supply of 1 kits, depending on the pharmacy you visit. Quoted prices are for cash-paying customers and are not valid with insurance plans. This price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.

CABLIVI (caplacizumab-yhdp) is a prescription medicine used for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Caplacizumab (Cablivi, caplacizumab-yhdp) Antibody fragment that targets the A1-domain of von Willebrand factor (vWF), and inhibits the interaction between vWF and platelets; thereby, reducing both vWF-mediated platelet adhesion and platelet consumption.

Cablivi was developed by Ablynx, a Sanofi company. Sanofi Genzyme, the specialty care global business unit of Sanofi, will work with relevant local authorities to make Cablivi available to patients in need in countries across Europe.

On February 6, 2019, the Food and Drug Administration approved caplacizumab-yhdp (CABLIVI, Ablynx NV) for adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Researchers estimated treatment of a TTP episode would require four individual rituximab 375 mg/m2 doses, at a cost of $7,724 per dose; treatment with caplacizumab was $270,000 per episode.

Caplacizumab (INN; trade name Cablivi) is a bivalent single-domain antibody (VHH) designed for the treatment of thrombotic thrombocytopenic purpura (TTP) and thrombosis. This drug was developed by Ablynx NV.

In addition, the US list price of caplacizumab that we used in our models ($270 000 per TTP episode) underestimated the total cost of the drug when taking into account the cost of each dose of caplacizumab ($8000) and the total number of days of caplacizumab treatment reported in the 2 clinical trials.

The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life- …

Adults—11 milligrams (mg) injected under the skin after completion of plasma exchange on Day 1. Then, 11 mg injected under the skin once a day after each plasma exchange. After plasma exchange period, 11 mg injected under the skin once a day for 30 days after the last daily plasma exchange.

The elimination of caplacizumab is divided between target-driven disposition which is driven by the binding to the von Willebrand factor and non-target disposition driven by the combination of catabolism and renal elimination. The reported half-life is reported to be in the range of 16-27 hours.

The most common side effects include nosebleed, headache and bleeding gums. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of CABLIVI. Call your doctor for medical advice about side effects.

Ticlopidine may also cause a potentially life-threatening decrease in platelets, which may occur as part of a syndrome that includes injury to red blood cells, causing anemia, kidney abnormalities, neurologic changes, and fever. This condition is called thrombotic thrombocytopenic purpura (TTP).

Kidney failure.Low platelet count (thrombocytopenia)Low red blood cell count (caused by the premature breakdown of red blood cells)Nervous system problems.Severe bleeding (hemorrhage)Stroke.

passing blood in your urine.passing blood when you poo or having black poo.severe bruising.prolonged nosebleeds (lasting longer than 10 minutes)vomiting blood or coughing up blood.sudden severe back pain.difficulty breathing or chest pain.

Kidney problems, including kidney failure. If you develop new or worse kidney problems, they may tell you to stop taking BIKTARVY.

Biktarvy can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis), liver problems, new or worsening kidney problems, including kidney failure, and drug interactions.

Erleada (apalutamide) is a prescription oral tablet used to treat certain types of prostate cancer. Erleada can cause side effects that range from mild to serious. Examples include heart-related side effects, fatigue (low energy), and joint pain.

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

Treatment after PEX period: 11 mg subcutaneous injections once daily for 30 days following the last daily PEX. If, after the 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.

CABLIVI is a monoclonal antibody fragment that was developed to inhibit microthrombi formation in aTTP by binding specifically to the A1 domain of vWF. CABLIVI blocks the interaction between vWF and platelets, thereby reducing both vWF-mediated platelet adhesion and platelet consumption.

PARIS – February 6, 2019 – The U.S. Food and Drug Administration (FDA) has approved Cablivi ® (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults.

Daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment.

In patients with an episode of refractory TTP, addition of rituximab to PEX and corticosteroids increases platelet counts in >80% of patients and may decrease the time required to achieve a platelet count response.

In the setting of TTP, rituximab was initially used in relapsed or refractory patients and was found to be effective in attaining remission and reducing relapse rates.

The anti-CD20 monoclonal antibody rituximab has been reported to have activity in TTP that is refractory to plasma exchange. A study by Scully et al found that weekly rituximab given within 3 days of acute admission for TTP was safe and effective, with reduced stay and relapse.

Summary: Caplacizumab is a humanized anti-von Willebrand factor monoclonal antibody fragment that inhibits the interaction between ultralarge von Willebrand factor multimers and platelets.