nt versus corticosteroids with optional oral cyclophosphamide for patients with relapsed and refractory multiple myeloma, mortality was higher in the patients treated with Kyprolis in comparison to the control arm in the subgroup of 48 patients ≥ 75 years of age. The most common cause of discontinuation due to an adverse reaction was acute renal failure (2%).
Safety of Kyprolis monotherapy dosed at 20/56 mg/m2 by 30-minute infusion was eva luated in a multicenter, open-label study in patients with relapsed and/or refractory multiple myeloma. The study treatment is described in Section 14.3. The patients received a median of 4 (range 1–10) prior regimens.
The common adverse reactions occurring at a rate of 20% or greater with Kyprolis monotherapy are presented in Table 12.
Table 12: Most Common Adverse Reactions (≥ 20%) with Kyprolis Monotherapy
Dyspnea includes preferred terms of dyspnea and dyspnea exertional.
Hypertension includes hypertension, hypertensive crisis, and hypertensive emergency.
Adverse Reactions Occurring at a Frequency of < 20%
Blood and lymphatic system disorders: febrile neutropenia, leukopenia, neutropenia
Cardiac disorders: cardiac arrest, cardiac failure, cardiac failure congestive, myocardial infarction, myocardial ischemia
Eye disorders: cataract, blurred vision
Gastrointestinal disorders: abdominal pain, abdominal pain upper, constipation, dyspepsia, toothache
General disorders and administration site conditions: asthenia, infusion site reaction, multi-organ failure, pain
Hepatobiliary disorders: hepatic failure
Infections and infestations: bronchitis, bronchopneumonia, influenza, pneumonia, nasopharyngitis, respiratory tract infection, sepsis, urinary tract infection
Metabolism and nutrition disorders: hypercalcemia, hyperglycemia, hyperkalemia, hyperuricemia, hypoalbuminemia, hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia, tumor lysis syndrome
Musculoskeletal and connective tissue disorders: arthralgia, musculoskeletal pain, musculoskeletal chest pain, myalgia, pain in extremity
Nervous system disorders: hypoesthesia, paresthesia, peripheral motor neuropathy, peripheral neuropathy, peripheral sensory neuropathy
Psychiatric disorders: anxiety
Renal and urinary disorders: acute renal failure, renal failure, renal impairment
Respiratory, thoracic and mediastinal disorders: dysphonia, epistaxis, oropharyngeal pain, pulmonary edema
Skin and subcutaneous tissue disorders: erythema, hyperhidrosis, pruritus, rash
Vascular disorders: embolic and thrombotic events, venous (including deep vein thrombosis and pulmonary embolism), hypotension
Grade 3 and higher adverse reactions occurring at an incidence of > 1% include febrile neutropenia, cardiac arrest, cardiac failure congestive, pain, sepsis, urinary tract infection, hyperglycemia, hyperkalemia, hyperuricemia, hypoalbuminemia, hypocalcemia, hyponatremia, hypophosphatemia, renal failure, renal failure acute, renal impairment, pulmonary edema, and hypotension.
Laboratory Abnormalities
Table 13 describes Grade 3–4 laboratory abnormalities reported at a rate of > 10% for patients who received Kyprolis monotherapy.
Table 13: Grade 3–4 Laboratory Abnormalities (> 10%) with Kyprolis Monotherapy
6.2 Postmarketing Experience
The following additional adverse |
