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Adakveo

Last reviewed on RxList: 5/11/2020
Adakveo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Adakveo?

Adakveo (crizanlizumab-tmca) is a selectin blocker used to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease.

What Are Side Effects of Adakveo?

Common side effects of Adakveo include:

Dosage for Adakveo

The dose of Adakveo is 5 mg/kg administered by intravenous infusion over a period of 30 minutes on Week 0, Week 2, and every 4 weeks thereafter.

Adakveo In Children

The safety and effectiveness of Adakveo for sickle cell disease have been established in pediatric patients aged 16 years and older. The safety and efficacy of Adakveo in pediatric patients below the age of 16 years have not been established.

What Drugs, Substances, or Supplements Interact with Adakveo?

Adakveo may interact with other medicines.

Tell your doctor all medications and supplements you use.

Adakveo During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Adakveo; it may harm a fetus. Women with sickle cell disease have an increased risk of adverse pregnancy outcomes for the mother and the fetus. It is unknown if Adakveo passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Adakveo (crizanlizumab-tmca) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Adakveo Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur within 24 hours after you receive this medicine. Call your doctor if you feel dizzy, nauseated, tired, itchy, chilled, sweaty, or have a fever, wheezing, or shortness of breath.

Common side effects may include:

  • nausea;
  • fever;
  • joint pain; or
  • back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Adakveo (Crizanlizumab-tmca Injection)

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Adakveo Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Infusion-related reactions [see WARNINGS AND PRECAUTIONS]

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

The safety of ADAKVEO was evaluated in the SUSTAIN trial [see Clinical Studies]. Eligible patients were diagnosed with sickle cell disease (any genotype including HbSS, HbSC, HbS beta0-thalassemia, HbSbeta+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.

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.

The most common adverse reactions (≥ 10%) were nausea, arthralgia, back pain, and pyrexia.

Table 1 summarizes the adverse reactions in the SUSTAIN trial.

Table 1: Adverse Reactions (≥ 10%) in Patients Receiving ADAKVEO With a Difference Between Arms of > 3% Compared to Placebo in SUSTAIN

Adverse Reactions ADAKVEO 5 mg/kg
N = 66 n (%)
Placebo
N = 62 n (%)
All Grades (%) Grade ≥ 3 (%) All Grades (%) Grade ≥ 3 (%)
Gastrointestinal Disorders
Nausea 12 (18) 0 7 (11) 1 (2)
Musculoskeletal and Connective Tissue Disorders
Arthralgia 12 (18) 1 (2) 5 (8) 1 (2)
Back pain 10 (15) 0 7 (11) 0
General Disorders and Administration Site Conditions
Pyrexia 7 (11) 1 (2) 4 (7) 0

Clinically relevant adverse reactions (all Grades) that were reported in less than < 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.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other crizanlizumab products may be misleading.

The immunogenicity of ADAKVEO was evaluated using a validated bridging immunoassay for the detection of binding anti-crizanlizumab-tmca antibodies. In a single arm, open label multiple dose study, 0 of the 45 patients with sickle cell disease treated with ADAKVEO 5 mg/kg tested positive for treatment-induced anti-crizanlizumab-tmca antibodies. In a single-dose study of healthy subjects, 1 of the 61 (1.6%) evaluable subjects tested positive for a treatment-induced anticrizanlizumab-tmca antibodies.

Read the entire FDA prescribing information for Adakveo (Crizanlizumab-tmca Injection)

Related Resources for Adakveo

© Adakveo Patient Information is supplied by Cerner Multum, Inc. and Adakveo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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