Pronunciation:

kap-la-SIZ-ue-mab - yhdp

Classifications:

Pharmacologic—

Caplacizumab

Uses of This Medicine:

Caplacizumab-yhdp injection is used in combination with plasma exchange and immunosuppressive therapy (medicines to weaken the immune system) to treat acquired thrombotic thrombocytopenic purpura (aTTP).

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of caplacizumab-yhdp injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of caplacizumab-yhdp injection have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of caplacizumab-yhdp injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Acenocoumarol
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemiparin
• Betrixaban
• Bivalirudin
• Cangrelor
• Certoparin
• Cilostazol
• Clopidogrel
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Desirudin
• Dipyridamole
• Edoxaban
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Fondaparinux
• Heparin
• Iloprost
• Lepirudin
• Nadroparin
• Parnaparin
• Phenindione
• Phenprocoumon
• Prasugrel
• Protein C
• Reviparin
• Rivaroxaban
• Selexipag
• Sulfinpyrazone
• Sulodexide
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Treprostinil
• Vorapaxar
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clotting problems (eg, coagulation factor deficiencies) or
• Hemophilia (bleeding disorder) or
• Liver disease, severe—Use with caution. May increase the risk of bleeding.

Proper Use of This Medicine:

A nurse or other trained health professional will give you the first dose of this medicine at least 15 minutes before starting plasma exchange treatment in a medical facility. It is given through a needle placed into one of your veins.

You may also be taught how to give your medicine at home. It is usually given as a shot under the skin of your stomach. Make sure you understand all instructions before you give yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.

To use the medicine:

• Allow the vial and the syringe to reach room temperature by holding them in your hands for 10 seconds.
• Dissolve the powder in the vial using the liquid in the syringe. Then, attach the vial adapter.
• Remove the plastic cap from the syringe and attach it to the vial adapter by twisting it clockwise until it cannot twist any further.
• Slowly push the syringe plunger down until the syringe is empty. Do not remove the syringe from the vial adapter.
• Gently swirl the vial until the powder is completely dissolved. Do not shake.
• Check the solution in the vial. It should be clear and colorless. All powder must be fully dissolved. Do not use the medicine if it is cloudy, clumpy, or has particles in it.
• Use a new needle and syringe each time you inject your medicine.
• Use each vial only one time. Do not save an open vial.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injectable dosage form (solution):
  • For acquired thrombotic thrombocytopenic purpura:
    • 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.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine after the plasma exchange period and it is within 12 hours from your regular schedule, take the missed dose as soon as possible. If you miss a dose and it is more than 12 hours from your regular schedule, skip the missed dose and take your next dose at your usual time.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may also store this medicine at room temperature in its original carton for up to 2 months. Do not return it back to the refrigerator once stored at room temperature. You may keep the mixed solution in the refrigerator for up to 4 hours.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may increase your risk of serious bleeding problems, which may be life-threatening. Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, or weakness, pain, swelling, or discomfort in a joint, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal.

Be extra careful to avoid injuries. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Gently brush and floss your teeth. Be careful when using sharp objects, including razors and fingernail clippers.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine 7 days before having surgery, dental procedures, or other operations.

Do not use a blood thinner or antiplatelet medicine together with this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bladder pain

bleeding gums

bloody or cloudy urine

chest tightness

difficult, burning, or painful urination

difficulty with breathing

fever

frequent urge to urinate

hives or welts, itching, skin rash

lower back or side pain

nosebleed

redness of the skin

unusual tiredness or weakness

Less common

Bleeding from the anus

bloody stools

confusion

headache, sudden, severe, and continuing

heavy non-menstrual vaginal bleeding

longer or heavier menstrual periods

nausea

stomach pain

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

bleeding at the catheter site

bleeding or itching at the injection site

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

difficulty in moving

headache (mild)

joint pain or swelling

muscle pains, cramps, or stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.