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Adcetris

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Adcetris

Adcetris

Adcetris Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Adcetris (brentuximab vedotin) is an antibody conjugated drug (a combination of three components) indicated for treatment of patients with Hodgkin lymphoma (Hodgkin's disease) and for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL). Adcetris is to be used in patients who have received two prior chemotherapy treatments and cannot receive a transplant. Adcetris may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment. The drug is not available as a generic. Common side effect with Adcetris can include neutropenia, peripheral sensory neuropathy, fatigue, upper respiratory tract infection, nausea, diarrhea, anemia, pyrexia, thrombocytopenia, rash, abdominal pain, cough, and vomiting.

Adcetris is available in single -use vials when reconstituted with 10.5 ml of sterile water contain strength of 5 mg per ml brentuximab vedotin. The recommended dose for Adcetris is 1.8 mg/kg administered only as an intravenous infusion over 30 minutes every 3 weeks. Continue treatment until a maximum of 16 cycles, disease progression, or unacceptable toxicity. Serious side effects include neuropathy, pulmonary embolism, pneumothorax, pyelonephritis, septic shock, arrhythmia, Stevens-Johnson syndrome and tumor lysis syndrome. Adcetris can cause fetal harm. Women receiving Adcetris are advised to avoid pregnancy. Women who become pregnant while receiving Adcetris should speak with their doctors immediately. Additionally, patients should be advised to avoid nursing while receiving Adcetris. Safety and effectiveness has not been established in the pediatric population.

Our Adcetris 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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Adcetris FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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.

ADCETRIS was studied as monotherapy in 160 patients in two phase 2 trials. Across both trials, the most common adverse reactions ( ≥ 20%), regardless of causality, were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting. The most common adverse reactions occurring in at least 10% of patients in either trial, regardless of causality, using the NCI Common Toxicity Criteria Version 3.0, are shown in Table 1.

Experience in Hodgkin Lymphoma

ADCETRIS was studied in 102 patients with HL in a single arm clinical trial in which the recommended starting dose and schedule was 1.8 mg/kg intravenously every 3 weeks. Median duration of treatment was 27 weeks (range, 3 to 56 weeks) [see Clinical Studies].

The most common adverse reactions ( ≥ 20%), regardless of causality, were neutropenia, peripheral sensory neuropathy, fatigue, upper respiratory tract infection, nausea, diarrhea, anemia, pyrexia, thrombocytopenia, rash, abdominal pain, cough, and vomiting.

Experience in Systemic Anaplastic Large Cell Lymphoma

ADCETRIS was studied in 58 patients with sALCL in a single arm clinical trial in which the recommended starting dose and schedule was 1.8 mg/kg intravenously every 3 weeks. Median duration of treatment was 24 weeks (range, 3 to 56 weeks) [see Clinical Studies].

The most common adverse reactions ( ≥ 20%), regardless of causality, were neutropenia, anemia, peripheral sensory neuropathy, fatigue, nausea, pyrexia, rash, diarrhea, and pain.

Combined Experience

Table 1: Most Commonly Reported ( ≥ 10%) Adverse Reactions

Adverse Reaction HL
Total N = 102
% of patients
sALCL
Total N = 58
% of patients
Any Grade Grade 3 Grade 4 Any Grade Grade 3 Grade 4
Blood and lymphatic system disorders
  Neutropenia* 54 15 6 55 12 9
  Anemia* 33 8 2 52 2 -
  Thrombocytopenia* 28 7 2 16 5 5
  Lymphadenopathy 11 - - 10 - -
Nervous system disorders
  Peripheral sensory neuropathy 52 8 - 53 10 -
  Peripheral motor neuropathy 16 4 - 7 3 -
  Headache 19 - - 16 2 -
  Dizziness 11 - - 16 - -
General disorders and administration site conditions
  Fatigue 49 3 - 41 2 2
  Pyrexia 29 2 - 38 2 -
  Chills 13 - - 12 - -
  Pain 7 - - 28 - 5
  Edema peripheral 4 - - 16 - -
Infections and infestations
  Upper respiratory tract infection 47 - - 12 - -
Gastrointestinal disorders
  Nausea 42 - - 38 2 -
  Diarrhea 36 1 - 29 3 -
  Abdominal pain 25 2 1 9 2 -
  Vomiting 22 - - 17 3 -
  Constipation 16 - - 19 2 -
Skin and subcutaneous tissue disorders
  Rash 27 - - 31 - -
  Pruritus 17 - - 19 - -
  Alopecia 13 - - 14 - -
  Night sweats 12 - - 9 - -
  Dry skin 4 - - 10 - -
Respiratory, thoracic and mediastinal disorders
  Cough 25 - - 17 - -
  Dyspnea 13 1 - 19 2 -
  Oropharyngeal pain 11 - - 9 - -
Musculoskeletal and connective tissue disorders
  Arthralgia 19 - - 9 - -
  Myalgia 17 - - 16 2 -
  Back pain 14 - - 10 2 -
  Pain in extremity 10 - - 10 2 2
  Muscle spasms 9 - - 10 2 -
Psychiatric disorders
  Insomnia 14 - - 16 - -
  Anxiety 11 2 - 7 - -
Metabolism and nutrition disorders
  Decreased appetite 11 - - 16 2 -
Investigations
  Weight decreased 6 - - 12 3 -
*Derived from laboratory values and adverse reaction data

Infusion reactions

Two cases of anaphylaxis were reported in phase 1 trials. There were no Grade 3 or 4 infusion-related reactions reported in the phase 2 trials, however, Grade 1 or 2 infusion-related reactions were reported for 19 patients (12%). The most common adverse reactions ( ≥ 2%) associated with infusion-related reactions were chills (4%), nausea (3%), dyspnea (3%), pruritus (3%), pyrexia (2%), and cough (2%).

Serious adverse reactions

In the phase 2 trials, serious adverse reactions, regardless of causality, were reported in 31% of patients receiving ADCETRIS. The most common serious adverse reactions experienced by patients with HL include peripheral motor neuropathy (4%), abdominal pain (3%), pulmonary embolism (2%), pneumonitis (2%), pneumothorax (2%), pyelonephritis (2%), and pyrexia (2%). The most common serious adverse reactions experienced by patients with sALCL were septic shock (3%), supraventricular arrhythmia (3%), pain in extremity (3%), and urinary tract infection (3%). Other important serious adverse reactions reported include PML, Stevens-Johnson syndrome and tumor lysis syndrome.

Dose modifications

Adverse reactions that led to dose delays in more than 5% of patients were neutropenia (14%) and peripheral sensory neuropathy (11%) [see Dose Modification].

Discontinuations

Adverse reactions led to treatment discontinuation in 21% of patients. Adverse reactions that led to treatment discontinuation in 2 or more patients with HL or sALCL were peripheral sensory neuropathy (8%) and peripheral motor neuropathy (3%).

Post Marketing Experience

The following adverse reactions have been identified during post-approval use of ADCETRIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cases of PML have been reported [see BOXED WARNING, WARNINGS AND PRECAUTIONS].

Immunogenicity

Patients with HL and sALCL in the phase 2 trials [see Clinical Studies] were tested for antibodies to brentuximab vedotin every 3 weeks using a sensitive electrochemiluminescent immunoassay. Approximately 7% of patients in these trials developed persistently positive antibodies (positive test at more than 2 timepoints) and 30% developed transiently positive antibodies (positive in 1 or 2 post-baseline timepoints). The anti-brentuximab antibodies were directed against the antibody component of brentuximab vedotin in all patients with transiently or persistently positive antibodies. Two of the patients (1%) with persistently positive antibodies experienced adverse reactions consistent with infusion reactions that led to discontinuation of treatment. Overall, a higher incidence of infusion related reactions was observed in patients who developed persistently positive antibodies.

A total of 58 patient samples that were either transiently or persistently positive for anti­brentuximab vedotin antibodies were tested for the presence of neutralizing antibodies. Sixty-two percent of these patients had at least one sample that was positive for the presence of neutralizing antibodies. The effect of anti-brentuximab vedotin antibodies on safety and efficacy is not known.

Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to ADCETRIS with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Adcetris (Brentuximab Vedotin) »

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