Crizanlizumab

Crizanlizumab-tmca is a humanized IgG2 kappa monoclonal antibody that binds to P-selectin and blocks interactions with its ligands, including P-selectin glycoprotein ligand 1 (PSGL-1). Crizanlizumab can also dissociate preformed P-selectin/PSGL-1 complex.

• ADAKVEO ® is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. ADAKVEO is a selectin blocker indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.

• None. None.contraindicated

Administer 5 mg/kg by intravenous infusion over a period of 30 minutes on Week 0, Week 2, and every 4 weeks thereafter. ( 2.1 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.2 ) 2.1 Recommended Dosage Administer ADAKVEO 5 mg/kg by intravenous infusion over a period of 30 minutes at Week 0, Week 2, and every 4 weeks thereafter. If a dose is missed, administer ADAKVEO as soon as possible. If ADAKVEO is administered within 2 weeks after the missed dose, continue dosing according to the patient's original schedule. If ADAKVEO is administered more than 2 weeks after the missed dose, continue dosing every 4 weeks thereafter. Physicians should reevaluate the treatment at least yearly, to assess individual patient’s response to treatment and consider discontinuing therapy with ADAKVEO if no perceived benefit is achieved. ADAKVEO may be given with or without hydroxyurea. 2.2 Preparation and Administration ADAKVEO should be prepared and administered by a healthcare professional. Preparation Use aseptic technique to prepare the solution for infusion. Calculate the dose (mg) and the total volume (mL) of ADAKVEO solution required, and the number of ADAKVEO vials needed based on the patient’s actual body weight. Prepare 5 mg of ADAKVEO per kg of actual body weight. Calculate the volume of ADAKVEO to be used according to the following equation: Dilution Dilute ADAKVEO in 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a total volume of 100 mL for intravenous infusion as follows: Obtain the number of vials required.

Infusion-Related Reactions: Monitor for and advise patients of signs and symptoms. Discontinue ADAKVEO infusion for severe reactions and manage medically. Temporarily interrupt or slow the rate of infusion for mild or moderate infusion-related reactions and initiate symptomatic treatment. Exercise caution with corticosteroids in patients with sickle cell disease unless clinically indicated (e.g., treatment of anaphylaxis). ( 5.1 ) Interference With Automated Platelet Counts (platelet clumping): Run test as soon as possible or use citrate tubes. ( 5.2 ) 5.1 Infusion-Related Reactions In the SUSTAIN clinical trial, infusion-related reactions (IRRs) (defined as occurring during/within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. In the STAND clinical trial, IRRs were observed in 6 (7%) patients treated with ADAKVEO 5 mg/kg. IRRs presented most frequently as pain, nausea, vomiting, fatigue, dizziness, pruritis, diarrhea, and pyrexia. Some IRRs have required hospitalizations. The majority of these IRRs occurred during the first and second infusions. Monitor for and advise patients to report signs and symptoms of IRRs. Discontinue ADAKVEO infusion for severe IRRs and institute appropriate medical care. Consider permanent discontinuation of ADAKVEO treatment in case of severe IRRs.

The following clinically significant adverse reactions are described elsewhere in the labeling: Infusion-related reactions [see Warnings and Precautions (5.1)] The most common adverse reactions (incidence ≥ 10%) were headache, arthralgia, nausea, back pain, fatigue, abdominal pain, pyrexia, diarrhea, vomiting, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Sickle Cell Disease SUSTAIN Trial The safety of ADAKVEO was evaluated in the SUSTAIN trial [see Clinical Studies (14.1)] . Eligible patients were diagnosed with sickle cell disease (any genotype, including HbSS, HbSC, HbS beta 0 -thalassemia, HbS beta + -thalassemia, and others). Patients received ADAKVEO 5 mg/kg (N = 66) or 2.5 mg/kg (N = 64) or placebo (N = 62) administered by intravenous infusion on Week 0, Week 2, and every 4 weeks thereafter. The safety evaluation below is limited to the patients who received the recommended dose of 5 mg/kg. Among the 66 patients that received the recommended dose (5 mg/kg), 83% were exposed for 6 months or longer and 61% were exposed for approximately one year; forty-two (64%) patients were treated with ADAKVEO in combination with hydroxyurea.

Pregnancy: May cause fetal harm. ( 8.1 ) 8.1 Pregnancy Risk Summary Based on data from animal studies, ADAKVEO has the potential to cause fetal harm when administered to a pregnant woman. In an animal reproduction study, intravenous administration of crizanlizumab-tmca to pregnant cynomolgus monkeys from the onset of organogenesis through delivery resulted in a non-dose related increased fetal loss (abortions/stillbirths) at doses approximately 2.8 times the exposure at the recommended clinical dose at 5 mg/kg/dose once every 4 weeks (see Data) . There are insufficient human data on ADAKVEO 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. ADAKVEO should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is approximately 14% and up to 43%, respectively. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Women with sickle cell disease have an increased risk of adverse pregnancy outcomes for the mother and the fetus.

Metabolism

The pharmacokinetics of crizanlizumab-tmca were evaluated in healthy volunteers and patients with sickle cell disease. The mean crizanlizumab-tmca C max , AUC last , or AUC inf increased disproportionally over the dose range of 0.2 to 8 mg/kg (0.04 to 1.6 times the approved recommended dosage) in healthy volunteers.

• Nov 15, 2019BLABLA761128Novartis Pharms Corp

1. 1Sickle Cell Anaemia With Crisis35626%
2. 2Pain35226%
3. 3Back Pain14911%
4. 4Infusion Related Reaction1319.5%
5. 5Arthralgia956.9%
6. 6Pain In Extremity886.4%
7. 7Chest Pain805.8%
8. 8Drug Ineffective795.7%
9. 9Nausea795.7%
10. 10Pyrexia765.5%
11. 11Headache715.1%
12. 12Fatigue684.9%
13. 13Acute Chest Syndrome523.8%
14. 14Haemoglobin Decreased503.6%
15. 15Diarrhoea433.1%

The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Crizanlizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients
  Active not recruiting · Phase 3 · Interventional · 255 enrolled · Novartis Pharmaceuticals
  NCT03814746updated 2026-06-08
• Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
  Recruiting · Phase 4 · Interventional · 130 enrolled · Novartis Pharmaceuticals
  NCT04657822updated 2026-06-08
• A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)
  Recruiting · Phase 3 · Interventional · 315 enrolled · Novartis Pharmaceuticals
  NCT06439082updated 2026-05-27
• Crizanlizumab Pregnancy Outcomes Intensive Monitoring
  Completed · Observational · 13 enrolled · Novartis Pharmaceuticals
  NCT07554547updated 2026-04-28
• Crizanlizumab for Treatment of Retinal Vasculopathy With Cerebral Leukoencephalopathy (RVCL)
  Completed · Phase 2 · Interventional · 18 enrolled · Washington University School of Medicine
  NCT04611880updated 2026-04-23
• Managed Access Programs for SEG101, Crizanlizumab
  Available · Expanded access · Novartis Pharmaceuticals
  NCT03720626updated 2026-04-14
• A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism
  Completed · Phase 2 · Interventional · 36 enrolled · Novartis Pharmaceuticals
  NCT03938454updated 2026-01-13
• Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients
  Completed · Phase 2 · Interventional · 117 enrolled · Novartis Pharmaceuticals
  NCT03474965updated 2025-10-16
• An Indian Multi-centric Phase IV Study to Assess the Safety of Crizanlizumab in Sickle Cell Disease Patients
  Completed · Phase 4 · Interventional · 140 enrolled · Novartis Pharmaceuticals
  NCT04662931updated 2025-09-26
• Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients
  Terminated · Phase 1 · Phase 2 · Interventional · 45 enrolled · Novartis Pharmaceuticals
  NCT04097821updated 2025-08-07

Frequently asked questions

How does Crizanlizumab work?

Crizanlizumab-tmca is a humanized IgG2 kappa monoclonal antibody that binds to P-selectin and blocks interactions with its ligands, including P-selectin glycoprotein ligand 1 (PSGL-1). Crizanlizumab can also dissociate preformed P-selectin/PSGL-1 complex.

What is Crizanlizumab used for?

According to FDA labeling, Crizanlizumab carries indications including: ADAKVEO ® is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. ADAKVEO is a selectin blocker indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Crizanlizumab?

Crizanlizumab is classified as Other hematological agents, Selectin Blocker, Antibody Interactions, P-Selectin Blockers.

What are the brand names for Crizanlizumab?

Crizanlizumab is marketed under brand names including Adakveo.

What are the contraindications for Crizanlizumab?

Crizanlizumab labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.