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Nebupent (Pentamidine Isethionate) - Warnings and Precautions

 
 



WARNINGS

The potential for development of acute PJP still exists in patients receiving NebuPent prophylaxis. Therefore, any patient with symptoms suggestive of the presence of a pulmonary infection, including but not limited to dyspnea, fever or cough, should receive a thorough medical evaluation and appropriate diagnostic tests for possible acute PJP as well as for other opportunistic and nonopportunistic pathogens. The use of NebuPent may alter the clinical and radiographic features of PJP and could result in an atypical presentation, including but not limited to mild disease or focal ­infection.

Prior to initiating NebuPent prophylaxis, symptomatic patients should be evaluated appropriately to exclude the presence of PJP. The recommended dose of NebuPent for the prevention of PJP is insufficient to treat acute PJP.

PRECAUTIONS

IMPORTANT: DO NOT MIX THE NEBUPENT SOLUTION WITH ANY OTHER DRUGS. DO NOT USE THE RESPIRGARD ® II NEBULIZER TO ADMINISTER A BRONCHODILATOR. (See DOSAGE AND ADMINISTRATION ).


Pulmonary

Inhalation of NebuPent may induce bronchospasm or cough. This has been noted particularly in some patients who have a history of smoking or asthma. In clinical trials, cough and bronchospasm were the most frequently reported adverse experiences associated with NebuPent administration (38% and 15%, respectively of patients receiving the 300 mg dose); however less than 1% of the doses were interrupted or terminated due to these effects. For the majority of patients, cough and bronchospasm were controlled by administration of an aerosolized bronchodilator (only 1% of patients withdrew from the study due to treatment-associated cough or bronchospasm). In patients who experience bronchospasm or cough, administration of an inhaled bronchodilator prior to giving each NebuPent dose may minimize recurrence of the symptoms.

General

The extent and consequence of pentamidine accumulation following chronic inhalation therapy are not known. As a result, patients receiving NebuPent should be closely monitored for the development of serious adverse reactions that have occurred in patients receiving parenteral pentamidine, including hypotension, hypogly­cemia, hyperglycemia, hypocalcemia, anemia, thrombocytopenia, leukopenia, hepatic or renal dysfunction, ventricular tachycardia, pancre­atitis, Stevens-Johnson syndrome, hyperkalemia and abnormal ST segment of ECG.

Extrapulmonary infection with P. jiroveci has been reported infrequently. Most, but not all, of the cases have been reported in patients who have a history of PJP. The presence of extrapulmonary pneumocystosis should be considered when evaluating patients with unexplained signs and symptoms.

Cases of acute pancreatitis have been reported in patients receiving aerosolized pentamidine. NebuPent should be discontinued if signs or symptoms of acute pancreatitis develop.

Drug Interactions

While specific studies on drug interactions with NebuPent 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 and other nephrotoxic drugs such as aminoglycosides, amphotericin B, cisplatin, foscarnet, or vancomycin should be closely monitored and avoided, if possible.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Literature reports indicate that pentamidine was not mutagenic in the Ames bacterial (S. typhimurium) test and did not induce an increase in chromosomal aberrations in Chinese Hamster Ovary (CHO) cell or in human lymphocytes in vitro .

No studies have been conducted to determine effects of pentamidine isethionate on carcinogenicity or fertility.

Pregnancy-Pregnancy Category C

There are no adequate and well controlled studies of NebuPent in pregnant women.  A literature report indicated that intravenously administered pentamidine in pregnant rats at 4 mg/kg/day was embryolethal; teratogenicity was not observed in this study.  It is unknown whether pentamidine administered via the aerosolized route crosses the placenta at clinically significant concentrations.  It is not known whether NebuPent can cause fetal harm when administered to a pregnant woman.  NebuPent should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether NebuPent is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from NebuPent, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Because many drugs are excreted in human milk, NebuPent should not be given to a nursing mother unless the potential benefits are judged to outweigh the unknown risks.

Pediatric Use

The safety and effectiveness of NebuPent in pediatric patients (birth to 16 years of age) have not been established.

Page last updated: 2010-12-07

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