Important Safety Information

 

Infusion-Related Reactions

In the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated

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Indication


ADAKVEO® (crizanlizumab-tmca) 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.

Safety

Adverse Reactions

Infusion-Related Reactions

In the SUSTAIN clinical trial, infusion-related reactions (occurring within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. Monitor patients for signs and symptoms. Discontinue ADAKVEO infusion for severe reactions and manage medically.

Majority of adverse reactions with ADAKVEO were mild to moderate (grade 1 or 2)1

Adverse Drug Reactions Reported ≥10% of ADAKVEO® (crizanlizumab-tmca) Patients With a Difference Between Arms of >3% Compared With Placebo in SUSTAIN

 

 

 

ADAKVEO (5 mg/kg)
N=66; n (%)

Placebo
N=62; n (%)

Adverse
Drug Reactions

All Grades

Grades ≥3

All Grades

Grades ≥3

Gastrointestinal disorders

       

Nausea

12 (18)

0

7 (11)

1 (2)

Musculoskeletal disorders and connective tissue disorders

 

 

 

 

Arthralgia
Back pain

12 (18)
10 (15)

1 (2)
0

5 (8)
7 (11)

1 (2)
0

General disorders and administration site conditions

 

 

 

 

Pyrexia

7 (11)

1 (2)

4 (7)

0

  • Serious adverse reactions were reported in 2 patients (3%) treated with ADAKVEO 5 mg/kg; both reactions were pyrexia
  • Two deaths (3%) occurred in the ADAKVEO 5 mg/kg treatment group. None of the deaths were considered to be related to ADAKVEO
  • Clinically relevant adverse reactions (all grades) that were reported in <10% of patients treated with ADAKVEO included: oropharyngeal pain, abdominal pain (abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness), diarrhea, vomiting, pruritus (pruritus and vulvovaginal pruritus), musculoskeletal chest pain, myalgia, infusion-site reaction (infusion-site extravasation, infusion-site pain, and infusion-site swelling), and infusion-related reaction

Other Safety Measures

Rates of infection, blood count results, and blood chemistry findings were similar to those with placebo2

Infection rates
  • Similar infection rates were observed with ADAKVEO and placebo (overall, 51.5% vs 53.2%; serious, 12.1% vs 16.1%)
    • Infections were observed with ADAKVEO and placebo, and included urinary tract infection (13.6% vs 11.3%), upper respiratory tract infection (10.6% vs 9.7%), pneumonia (6.1% vs 4.8%), and influenza (1.5% vs 0%)
Blood count results
  • The incidence of neutropenia was 3.0% for ADAKVEO vs 6.5% for placebo
  • No significant clinical differences between ADAKVEO vs placebo in hemoglobin (LSM: 1.5; 0.8 vs -0.7); reticulocyte count (LSM: -9.79; -7.12 vs 2.68); or haptoglobin (LSM: 0.03; 0.04 vs 0.01)
Blood chemistry findings
  • No significant clinical differences between ADAKVEO vs placebo in LDH (LSM: 8.2; -25.4 vs -33.5) or indirect bilirubin (LSM: -3.0; -2.3 vs 0.7)

LSM, least squares mean; LDH, lactate dehydrogenase.

References: 1. Adakveo [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019. 2. Data on file. Study NCT01895361. Novartis Pharmaceuticals Corp; 2016.

Indication

ADAKVEO® (crizanlizumab-tmca) 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.

Important Safety Information

Infusion-Related Reactions

In the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. Monitor patients for signs and symptoms of infusion-related reactions, which may include fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, or shortness of breath or wheezing. Discontinue ADAKVEO infusion for severe reactions and institute appropriate medical care.

Laboratory Test Interference: Platelet Counts

Interference with automated platelet counts (platelet clumping) has been observed following administration of ADAKVEO, in particular, when blood samples were collected in tubes containing EDTA.

Run blood samples within 4 hours of blood collection or collect blood samples in tubes containing citrate. When needed, estimate platelet count via peripheral blood smear.

Pregnancy

Based on animal data ADAKVEO has the potential to cause fetal harm when administered to a pregnant woman. 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.

Most Common Adverse Reactions

The most frequently reported adverse reactions (≥10%) in patients treated with ADAKVEO were nausea (18%), arthralgia (18%), back pain (15%), and pyrexia (11%).

Other Clinically Important Adverse Reactions

Clinically relevant adverse reactions (all grades) that were reported in <10% of patients treated with ADAKVEO included: oropharyngeal pain, abdominal pain (abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness), diarrhea, vomiting, pruritus (pruritus and vulvovaginal pruritus), musculoskeletal chest pain, myalgia, infusion-site reaction (infusion-site extravasation, infusion-site pain, and infusion-site swelling), and infusion-related reaction.

Please see full Prescribing Information.