ence
MEPRON
(n = 73)
Pentamidine
(n = 71)
Fever 40% 25%
Nausea 22% 37%
Rash 22% 13%
Diarrhea 21% 31%
Insomnia 19% 14%
Headache 18% 28%
Vomiting 14% 17%
Cough 14% 1%
Abdominal pain 10% 11%
Pain 10% 10%
Sweat 10% 3%
Monilia, oral 10% 3%
Asthenia 8% 14%
Dizziness 8% 14%
Anxiety 7% 10%
Anorexia 7% 10%
Sinusitis 7% 6%
Dyspepsia 5% 10%
Rhinitis 5% 7%
Taste perversion 3% 13%
Hypoglycemia 1% 15%
Hypotension 1% 10%
Patients discontinuing therapy due to an adverse experience 7% 41%
Patients reporting at least 1 adverse experience 63% 72%
Laboratory test abnormalities reported in ≥5% of patients in the pentamidine comparative study are presented in Table 11. Laboratory abnormality was reported as the reason for discontinuation of treatment in 2 of 73 patients who received MEPRON. One patient (1%) had elevated creatinine and BUN levels and 1 patient (1%) had elevated amylase levels. Laboratory abnormalities were the sole or contributing factor in 14 patients who prematurely discontinued pentamidine therapy. In the 71 patients who received pentamidine, laboratory parameters most frequently reported as reasons for discontinuation were hypoglycemia (11%), elevated creatinine levels (6%), and leukopenia (4%).
Table 11. Treatment-Emergent Laboratory Test Abnormalities in the Pentamidine Comparative PCP Treatment Study
Laboratory Test Percentage of Patients Developing a Laboratory Test Abnormality
Abnormality MEPRON Pentamidine
Anemia (Hgb<8.0 g/dL) 4% 9%
Neutropenia (ANC<750 cells/mm3) 5% 9%
Hyponatremia (<0.96 x LLN) 10% 10%
Hyperkalemia (>1.18 x ULN) 0% 5%
Alkaline phosphatase (>2.5 x ULN) 5% 2%
Hyperglycemia (>1.8 x ULN) 9% 13%
Elevated AST (>5 x ULN) 0% 5%
Elevated amylase (>1.5 x ULN) 8% 4%
Elevated creatinine (>1.5 x ULN) 0% 7%
ULN = upper limit of normal range.
LLN = lower limit of normal range.
Postmarketing Experience
In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of MEPRON. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to MEPRON.
Blood and Lymphatic System Disorders
Methemoglobinemia, thrombocytopenia.
Immune System Disorders
Hypersensitivity reactions including angioedema, bronchospasm, throat tightness, and urticaria.
Eye Disorders
Vortex keratopathy.
Gastrointestinal Disorders
Pancreatitis.
Hepatobiliary Disorders
Rare cases of hepatitis, and one case of fatal liver failure have been reported with atovaquone usage.
Skin and Subcutaneous Tissue Disorders
Erythema multiforme, Stevens-Johnson syndrome, and skin desquamation have been reported in patients rec
