Crizanlizumab

Crizanlizumab is a prescription medication used to treat the symptoms of Sickle Cell Disease 

• Crizanlizumab is available under the following different brand names: Adakveo, crizanlizumab-ymca

Common side effects of Crizanlizumab include:

• nausea,
• fever,
• joint pain, and
• back pain

Serious side effects of Crizanlizumab include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe dizziness,
• nausea,
• tiredness,
• itching,
• chills,
• sweating,
• fever,
• wheezing, and
• shortness of breath

Rare side effects of Crizanlizumab include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 10 mg /mL (10 mL)

Sickle Cell Disease

Adult dosage

• 5 mg /kg Intravenous on Week 0, Week 2, and every 4 weeks thereafter

Pediatric dosage

• Children below 16 years: Safety and efficacy not established
• Children below 16 years
• 5 mg/kg Intravenous on Week 0, Week 2, and every 4 weeks thereafter

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Crizanlizumab has no noted severe interactions with any other drugs.
• Crizanlizumab has no noted serious interactions with any other drugs.
• Crizanlizumab has no noted moderate interactions with any other drugs.
• Crizanlizumab has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Crizanlizumab?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Crizanlizumab?”

Cautions

• Infusion-related reactions
• Infusion-related reactions (defined as occurring within 24 hours of infusion) were observed
• In the post-marketing setting, cases of infusion-related reactions, including severe pain events, were reported, which required hospitalizations; most of these infusion-related reactions were reported during first and second infusions
• The management of pain events has included acetaminophen, NSAIDs, opioids, antihistamines, intravenous fluids, and/or oxygen therapy
• Some patients have also experienced subsequent complications, such as acute chest syndrome and fat embolism, particularly those treated with steroids
• Monitor for and advise patients of signs and symptoms of infusion-related reactions, which may include pain in various locations, headache, fever, chills, nausea, vomiting, diarrhea, fatigue, dizziness, pruritus, urticaria, sweating, shortness of breath, or wheezing
• Discontinue infusion for severe infusion-related reactions and institute appropriate medical care
• Exercise caution with corticosteroids in patients with sickle cell disease unless clinically indicated (.g, treatment of anaphylaxis)
• Drug interaction overview
  • Interference with automated platelet counts (platelet clumping) has been observed following administration when blood samples were collected in tubes containing ethylenediaminetetraacetic acid (EDTA); mitigation strategies are recommended

Pregnancy and Lactation

• Based on data from animal studies, fetal harm may occur when administered to a pregnant woman
• There are insufficient human data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Advise pregnant women of the potential risk to a fetus
• Only use during pregnancy if expected benefit justifies the potential risk to the fetus
• Disease-associated maternal and/or embryofoetal risk
• Women with sickle cell disease have an increased risk of adverse pregnancy outcomes for the mother and the fetus
• Pregnant women are at greater risk for Vaso occlusive crises, preeclampsia, eclampsia, and maternal mortality
• For the fetus, there is an increased risk for intrauterine growth restriction, preterm delivery, low birth weight, and perinatal mortality
• Lactation
  • There are no data on the presence of crizanlizumab-tmca in human or animal milk, the effects on the breastfed child, or the effects on milk production
  • Maternal IgG is known to be present in human milk
  • Effects of local gastrointestinal exposure and