Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Adakveo

Descriptions


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.

This product is available in the following dosage forms:

  • Solution

Before Using

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 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.

Geriatric

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.

Breastfeeding

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.

Drug Interactions

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

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

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. Tell your doctor right away if you or your child have a fever, chills, nausea, vomiting, dizziness, itching skin or rash, sweating, troubled 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.

Side Effects

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

  1. Fever

Less common

  1. Back pain
  2. chest tightness
  3. chills
  4. dizziness
  5. flushing
  6. headache
  7. itching skin or rash
  8. nausea and vomiting
  9. sweating
  10. trouble breathing
  11. unusual tiredness or weakness

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

  1. Back pain
  2. difficulty with moving
  3. joint pain
  4. muscle pain or stiffness

Incidence not known

  1. 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.