Pronunciation:

kriz-an-LIZ-ue-mab - tmca

Brand Names:

• Adakveo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Blood Modifier Agent

Pharmacologic—

Crizanlizumab

Uses of This Medicine:

Crizanlizumab-tmca injection is used to prevent vaso-occlusive crisis in patients with sickle cell disease. Vaso-occlusive crisis is a common and painful complication of sickle cell disease that occurs when blood circulation is blocked by sickled red blood cells and may lead to organ damage.

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

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of crizanlizumab-tmca injection in children 16 years of age and older. However, safety and efficacy have not been established in children younger than 16 years of age.

Older adults—

Appropriate studies on the relationship of age to the effects of crizanlizumab-tmca injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

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

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.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 minutes.

You will receive your first infusion, and then a second infusion 2 weeks later. After that, you will receive an infusion every 4 weeks.

Your doctor may want you to take hydroxyurea (Hydrea®) while you are receiving this medicine.

This medicine usually comes with patient information leaflet. Read and follow the instructions carefully and make sure you understand them before receiving this medicine.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

Your doctor will check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine may cause infusion-related reactions, which can be life-threatening and require medical attention. Tell your doctor right away if you or your child have a fever, chills, nausea, vomiting, dizziness, itching skin or rash, sweating, trouble breathing, or unusual tiredness or weakness after receiving this medicine.

Do not change your dose or suddenly stop using this medicine without checking first with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

More common

Back, joint, or body pain

chest pain or discomfort

diarrhea

difficulty with moving

fever

muscle pain or stiffness

nausea and vomiting

sore throat

stomach pain

Less common

Chest tightness

chills

dizziness

flushing

headache

itching skin or rash

sweating

trouble breathing

unusual tiredness or weakness

Incidence not known

Confusion

cough

numbness or tingling in the face, arms, or legs

trouble walking or speaking

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

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.