Caplacizumab

Generic name: caplacizumab
Brand name: Cablivi
Dosage form: injectable kit (11 mg)
Drug class: Platelet aggregation inhibitors

Medically reviewed by A Ras MD.

What is caplacizumab?

Caplacizumab is a prescription medicine that is used to treat acquired thrombotic thrombocytopenic purpura (aTTP).

Description

Caplacizumab-yhdp is a von Willebrand factor (vWF)-directed antibody fragment that consists of two identical humanized building blocks, linked by a three-alanine linker. Caplacizumab-yhdp is produced in Escherichia coli by recombinant DNA technology and has an approximate molecular weight of 28 kDa.

CABLIVI (caplacizumab-yhdp) for injection is a sterile, white, preservative-free, lyophilized powder. Each single-dose vial delivers 11 mg caplacizumab-yhdp, anhydrous citric acid (0.18 mg), polysorbate 80 (0.10 mg), sucrose (62 mg), and trisodium citrate dihydrate (4.91 mg). After reconstitution with 1 mL of Sterile Water for Injection, USP, the final concentration is 11 mg/mL, at a pH of approximately 6.5.

Mechanism of Action

Caplacizumab-yhdp targets the A1-domain of vWF, and inhibits the interaction between vWF and platelets, thereby reducing both vWF-mediated platelet adhesion and platelet consumption.

Before taking caplacizumab, tell your doctor:

If you are allergic to caplacizumab; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take caplacizumab with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take caplacizumab?

Tell all of your health care providers that you take caplacizumab. This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If caplacizumab is stopped, your doctor will tell you when to start taking caplacizumab again after your surgery or procedure.
Have blood work checked as you have been told by the doctor. Talk with the doctor.
You may bruise or bleed more easily. This includes nosebleeds and bleeding of the gums that may take longer than normal to stop. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is caplacizumab best taken?

Use caplacizumab as ordered by your doctor. Read all information given to you. Follow all instructions closely.

It is given as a shot into the fatty part of the skin in the belly area.
It may be given into a vein by a doctor or other healthcare provider.
If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
Wash your hands before and after use.
This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
If stored in a refrigerator, let caplacizumab come to room temperature before mixing. Do not heat caplacizumab.
Do not shake.
Use the mixed drug right away. If needed, you can store the mixed drug in a refrigerator for up to 4 hours.
Move site where you give the shot each time.
Do not give into skin within 2 inches of the belly button.
Do not use if the solution is cloudy, leaking, or has particles.
Do not give if the solution is not clear and colorless.
Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

Take a missed dose as soon as you think about it.
If it is less than 12 hours until the next dose, skip the missed dose and go back to your normal time.
Do not take 2 doses at the same time or extra doses.

What are the side effects of caplacizumab that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
A burning, numbness, or tingling feeling that is not normal.
Shortness of breath.

What are some other side effects of caplacizumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

Headache.
Feeling tired or weak.
Mild fever.
Back pain.
Muscle pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out caplacizumab?

Store in a refrigerator. Do not freeze.
Store in the original container to protect from light.
If needed, caplacizumab can be left out at room temperature for up to 2 months. Throw away drug if left at room temperature for more than 2 months.
Do not put caplacizumab back in the refrigerator after it has been stored at room temperature.
Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – KIT CARTON

NDC 58468-0225-1
Rx only
Cablivi®
caplacizumab-yhdp
for Injection
For Intravenous and Subcutaneous Use
Must be reconstituted with diluent provided.
Single-dose vial. Discard unused portion.
Each carton contains:

SRC: NLM .

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