Adamts13, recombinant-krhn (Intravenous)

ADAMTS13, recombinant-krhn injection is used to prevent or treat blood clots in patients with congenital thrombotic thrombocytopenic purpura (cTTP). This medicine works by replacing low amounts of the enzyme (ADAMTS13) in the body.

This medicine is to be given only by or under the supervision of your doctor.

It is very important that your doctor check your or your child's 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 cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening an require immediate medical attention. Check with your doctor right away if you or your child have a cough, difficulty swallowing, dizziness, fast heartbeat, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, rash, itching, trouble breathing, or unusual tiredness or weakness after receiving 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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Adzynma® injection in children. Safety and efficacy have been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Adzynma® 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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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:

• Allergy to hamsters—May increase risk of an allergic reaction.

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 or nurse immediately if any of the following side effects occur:

More common

• Body aches or pain
• chills
• cough
• ear congestion
• fever
• headache, severe and throbbing
• loss of voice
• sneezing
• sore throat
• stuffy or runny nose
• trouble breathing
• unusual tiredness or weakness

Incidence not known

• Blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest tightness
• confusion
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• hives, itching, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• restlessness
• unusual drowsiness, dullness, or feeling of sluggishness
• 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

• Diarrhea
• stomach pain

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.

In the U.S.

• Adzynma

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Blood Modifier Agent

Pharmacologic Class: ADAMTS13, Recombinant

A nurse or other trained health professional will give you or your child this medicine. It is given through a needle placed into one of your veins.

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