"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
The most frequently reported unsolicited adverse events (1 to 5%) in clinical trials, regardless of their relation to NebuPent (pentamidine isethionate) therapy were as follows (n=931):
Body as a Whole: Night sweats.
Nervous System: Headache.
Special Senses: Bad taste.
Adverse events of less than 1% incidence were as follows (No causal relationship to treatment has been established for these adverse events):
Gastrointestinal: Abdominal cramps, abdominal pain, constipation, dry mouth, dyspepsia, gastritis, gastric ulcer, gingivitis, hiatal hernia, hypersalivation, oral ulcer/abscess, splenomegaly, and vomiting.
Infection: Bacterial pneumonia, central venous line related sepsis, cryptococcal meningitis, cytomegalovirus (CMV) colitis, CMV retinitis, esophageal Candida, histoplasmosis, Kaposi's sarcoma, non-specific mycoplasma, oral herpes, non- specific otitis, non-specific pharyngitis, pharyngeal herpes, non-specific serious infection, tonsillitis, tuberculosis, and viral encephalitis.
Neurological: Anxiety, confusion, depression, drowsiness, emotional lability, hallucination, hypesthesia, insomnia, memory loss, neuralgia, neuropathy, non- specific neuropathy, nervousness, paranoia, paresthesia, peripheral neuropathy, seizure, tremors, unsteady gait, and vertigo.
Respiratory system: Asthma, bronchitis, bronchospasm, chest congestion, chest tightness, coryza, cyanosis, eosinophilic or interstitial pneumonitis, gagging, hemoptysis, hyperventilation, laryngitis, laryngospasm, non-specific lung disorder, nasal congestion, pleuritis, pneumothorax, rales, rhinitis, shortness of breath, non-specific sputum, and tachypnea.
In a clinical trial where some adverse events were solicited by investigators, the incidences were as follows:
From post-marketing clinical experience with NebuPent (pentamidine isethionate) the following spontaneous adverse events have been reported: anaphylaxis, colitis, diabetes, dyspnea, esophigitis, hematochezia, increased blood urea nitrogen (BUN) and serum creatinine levels, melena, pancreatitis (see WARNINGS), syndrome of inappropriate antidiuretic hormone (SIADH), and torsade de pointes.
Read the Nebupent (pentamidine isethionate) Side Effects Center for a complete guide to possible side effects
While specific studies on drug interactions with NebuPent (pentamidine isethionate) have not been conducted, the majority of patients in clinical trials received concomitant medications, including zidovudine, with no reported interactions. Because the nephrotoxic effects may be additive, the concomitant or sequential use of NebuPent (pentamidine isethionate) and other nephrotoxic drugs such as aminoglycosides, amphotericin B, cisplatin, foscarnet, or vancomycin should be closely monitored and avoided, if possible.
Read the Nebupent Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/4/2011
Additional Nebupent Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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