Caplacizumab

Caplacizumab is a prescription medication used for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

• Caplacizumab is available under the following different brand names: Cablivi, caplacizumab-yhdp

Common side effects of Caplacizumab include:

• nosebleed
• headache
• bleeding gums
• fatigue
• fever
• injection site reactions (bleeding, itching)
• back pain
• muscle pain
• numbness and tingling
• urinary tract infection (UTI)
• blood in the urine
• abnormal vaginal bleeding
• shortness of breath
• hives

Serious side effects of Caplacizumab include:

• hives
• heavy bleeding that won't stop (including bleeding from the rectum, vagina, nose, gums, or the site where the medication was injected)
• vomiting blood
• red or black tarry stools
• blood in the urine
• sudden severe headache, nausea, vomiting
• sudden, sharp abdominal pain, nausea, vomiting
• frequent, painful, or urgent urination

Rare side effects of Caplacizumab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 11 mg/single-dose vial

Thrombotic thrombocytopenic purpura

Adult dosage

• Administer upon initiation of plasma exchange therapy
• First day: 11 mg IV bolus at least 15 minutes before plasma exchange, followed by 11 mg SC after completion of plasma exchange on day 1
• Subsequent days during daily plasma exchange: 11 mg SC once a day following plasma exchange
• After the plasma exchange period: 11 mg SC once a day for 30 days following the last daily plasma exchange
• After initial treatment course: If sign(s) of persistent underlying disease (eg, suppressed ADAMTS13 activity levels remain present), treatment may be extended for a maximum of 28 days.
• Discontinue if 2 and more recurrences of aTTP occur while on caplacizumab

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Caplacizumab has severe interactions with no other drugs.
• Caplacizumab has serious interactions with at least 37 other drugs.
• Caplacizumab has moderate interactions with the following drugs:
  • efgartigimod alfa
  • ublituximab
• Caplacizumab has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Documented hypersensitivity, including urticaria

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Caplacizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Caplacizumab?”

Cautions

• Bleeding
  • Increases bleeding risk; severe bleeding (epistaxis, gingival bleeding, upper GI hemorrhage, metrorrhagia) observed in clinical trials
  • Cases of life-threatening and fatal bleeding were reported
  • Risk for bleeding is increased in patients with underlying coagulopathies (eg, hemophilia, other coagulation factor deficiencies)
  • Avoid coadministration with antiplatelet agents or anticoagulants; interrupt use if clinically significant bleeding occurs; if the drug is restarted after the bleeding resolves, monitor closely for signs of bleeding
• If emergency surgery is needed, von Willebrand factor concentrate may be administered to rapidly correct hemostasis
• Withhold for 7 days before surgery or other invasive interventions

Pregnancy and Lactation

• Data are not available regarding the drug’s use in pregnant women to evaluate the risk for birth defects and miscarriage; however, there are potential risks for hemorrhage in the mother and fetus associated with caplacizumab use
• Lactation
  • No data are available regarding the presence of the drug in human milk, its effects on breastfed infants, or milk production