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NINLARO SIDE EFFECTS

  • Generic Name: ixazomib capsules
  • Brand Name: Ninlaro
  • Drug Class: Antineoplastics Proteasome Inhibitors
Last updated on MDtodate: 10/9/2022

SIDE EFFECTS

The following adverse reactions are described in detail in other sections of the prescribing information:

  • Thrombocytopenia
  • Gastrointestinal Toxicities
  • Peripheral Neuropathy
  • Peripheral Edema
  • Cutaneous Reactions
  • Thrombotic Microangiopathy
  • Hepatotoxicity

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.

The safety population from the randomized, double-blind, placebo-controlled clinical study included 720 patients with relapsed and/or refractory multiple myeloma, who received NINLARO in combination with lenalidomide and dexamethasone (NINLARO regimen; N=360) or placebo in combination with lenalidomide and dexamethasone (placebo regimen; N=360).

The most frequently reported adverse reactions (≥ 20%) in the NINLARO regimen and greater than the placebo regimen were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. Serious adverse reactions reported in ≥ 2% of patients included thrombocytopenia (2%) and diarrhea (2%). For each adverse reaction, one or more of the three drugs was discontinued in ≤ 1% of patients in the NINLARO regimen.

Table 1 summarizes the adverse reactions occurring in at least 5% of patients with at least a 5% difference between the NINLARO regimen and the placebo regimen.

Table 1: Non-Hematologic Adverse Reactions Occurring in ≥ 5% of Patients with a ≥ 5% Difference Between the NINLARO Regimen and the Placebo Regimen (All Grades, Grade 3 and Grade 4)

System Organ Class / Preferred Term NINLARO + Lenalidomide and Dexamethasone
N=360
Placebo + Lenalidomide and Dexamethasone
N=360
N (%) N (%)
All Grade 3 Grade 4 All Grade 3 Grade 4
Infections and infestations
  Upper respiratory tract infection 69 (19) 1 (< 1) 0 52 (14) 2 (< 1) 0
Nervous system disorders
  Peripheral neuropathies* 100 (28) 7 (2) 0 77 (21) 7 (2) 0
Gastrointestinal disorders
  Diarrhea 151 (42) 22 (6) 0 130 (36) 8 (2) 0
  Constipation 122 (34) 1 (< 1) 0 90 (25) 1 (< 1) 0
  Nausea 92 (26) 6 (2) 0 74 (21) 0 0
  Vomiting 79 (22) 4 (1) 0 38 (11) 2 (< 1) 0
Skin and subcutaneous tissue disorders
  Rash* 68 (19) 9 (3) 0 38 (11) 5 (1) 0
usculoskeletal and connective tissue disorders
  Back pain 74 (21) 2 (< 1) 0 57 (16) 9 (3) 0
General disorders and administration site conditions
  Edema peripheral 91 (25) 8 (2) 0 66 (18) 4 (1) 0
Note: Adverse reactions included as preferred terms are based on MedDRA version 16.0.
*Represents a pooling of preferred terms

 

Table 2 represents pooled information from adverse event and laboratory data.

Table 2: Thrombocytopenia and Neutropenia

NINLARO + Lenalidomide and Dexamethasone
N=360
Placebo + Lenalidomide and Dexamethasone
N=360
N (%) N (%)
Any Grade Grade 3-4 Any Grade Grade 3-4
Thrombocytopenia 281 (78) 93 (26) 196 (54) 39 (11)
Neutropenia 240 (67) 93 (26) 239 (66) 107 (30)

 

Herpes Zoster

Herpes zoster was reported in 4% of patients in the NINLARO regimen and 2% of patients in the placebo regimen. Antiviral prophylaxis was allowed at the healthcare provider’s discretion. Patients treated in the NINLARO regimen who received antiviral prophylaxis had a lower incidence (< 1%) of herpes zoster infection compared to patients who did not receive prophylaxis (6%).

Eye Disorders

Eye disorders were reported with many different preferred terms but in aggregate, the frequency was 26% in patients in the NINLARO regimen and 16% of patients in the placebo regimen. The most common adverse reactions were blurred vision (6% in the NINLARO regimen and 3% in the placebo regimen), dry eye (5% in the NINLARO regimen and 1% in the placebo regimen), and conjunctivitis (6% in the NINLARO regimen and 1% in the placebo regimen). Grade 3 adverse reactions were reported in 2% of patients in the NINLARO regimen and 1% in the placebo regimen.

Adverse Reactions Reported Outside Of The Randomized Controlled Trial

The following serious adverse reactions have each been reported at a frequency of < 1%: acute febrile neutrophilic dermatosis (Sweet’s syndrome), Stevens-Johnson syndrome, transverse myelitis, posterior reversible encephalopathy syndrome, tumor lysis syndrome, and thrombotic thrombocytopenic purpura.

 

SRC: NLM .

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