Caplacizumab-yhdp (Intravenous, Subcutaneous)

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

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

It is very important that your doctor checks your progress at regular visits to ensure 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. Contact your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, 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 get 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.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Tell your doctor if you have had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies, including to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients closely.

Pediatric

Studies have not been done on how caplacizumab-yhdp injection affects children. We do not know if it is safe or effective for them.

Geriatric

While studies on how caplacizumab-yhdp injection affects older adults have not been done, there are no expected age-related issues that would limit its use in elderly patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. If you are taking this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been highlighted for their potential significance but may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Blood clotting problems (e.g., coagulation factor deficiencies) or
• Hemophilia (bleeding disorder) or
• Severe liver disease—Use with caution, as it may increase the risk of bleeding.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. Your health care professional may also be able to tell you 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.

Pharmacologic Class: Caplacizumab

Find detailed information on biosimilars for this medication.

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.