Pentamidine isethionate (inhaled)

FDA label, Fresenius Kabi USA, LLC, respiratory (inhalation), effective 2024-10-15. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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Basis

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DOSAGE AND ADMINISTRATION: IMPORTANT: NEBUPENT MUST BE DISSOLVED ONLY IN STERILE WATER FOR INJECTION, USP. DO NOT USE SALINE SOLUTION FOR RECONSTITUTION BECAUSE THE DRUG WILL PRECIPITATE. DO NOT MIX THE NEBUPENT SOLUTION WITH ANY OTHER DRUGS. DO NOT USE THE RESPIRGARD ® II NEBULIZER TO ADMINISTER A BRONCHODILATOR. Reconstitution The contents of one vial (300 mg) must be dissolved in 6 mL Sterile Water for Injection, USP.

Place the entire reconstituted contents of the vial into the Respirgard ® II nebulizer reservoir for administration. Dosage The recommended adult dosage of NebuPent for the prevention of Pneumocystis jiroveci pneumonia is 300 mg once every four weeks administered via the Respirgard ® II nebulizer. The dose should be delivered until the nebulizer chamber is empty (approximately 30 to 45 minutes).

Stability Freshly prepared solutions for aerosol use are ­recommended. After reconstitution with sterile water, the NebuPent solution is stable for 48 hours in the original vial at room temperature if protected from light. Reconstitution The contents of one vial (300 mg) must be dissolved in 6 mL Sterile Water for Injection, USP.

Place the entire reconstituted contents of the vial into the Respirgard ® II nebulizer reservoir for administration. Dosage The recommended adult dosage of NebuPent for the prevention of Pneumocystis jiroveci pneumonia is 300 mg once every four weeks administered via the Respirgard ® II nebulizer. The dose should be delivered until the nebulizer chamber is empty (approximately 30 to 45 minutes).

Stability Freshly prepared solutions for aerosol use are ­recommended. After reconstitution with sterile water, the NebuPent solution is stable for 48 hours in the original vial at room temperature if protected from light.

Drug interactions

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Label text (1 paragraph)

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.

Contraindications

CONTRAINDICATIONS: NebuPent is contraindicated in patients with a ­history of an anaphylactic reaction to inhaled or parenteral pentamidine isethionate.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for pentamidine isethionate (inhaled). Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

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.

Lactation

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.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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Recalls (last 24 months)

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Recruiting clinical trials

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