Ninlaro

Ninlaro Adverse Reactions

ixazomib

Manufacturer:

Takeda

Distributor:

DKSH
Full Prescribing Info
Adverse Reactions
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 6 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. (See Table 6.)

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Table 7 represents pooled information from adverse event and laboratory data. (See Table 7.)

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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 physician'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.
Postmarketing: Clinically significant adverse drug reactions are listed here if they have not been reported previously.
Blood and lymphatic system disorders: thrombotic microangiopathy.
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