Version October 2024
Pneumocystis pneumonia, prophylaxis, primary and secondary (alternative agent):
Patients with HIV: Inhalation: 300 mg once every 4 weeks via Respirgard II nebulizer. Continue prophylaxis following initiation of antiretroviral therapy (ART) until CD4 count >200 cells/mm3 for >3 months; some experts discontinue prophylaxis in patients with a CD4 count between 100 to 200 cells/mm3 who are receiving ART and have had an undetectable viral load for ≥3 to 6 months (HHS [OI adult 2020]).
Immunocompromised host, HIV-uninfected (eg, solid organ transplant recipients, cancer related, hematopoietic cell transplant) (off-label use): Inhalation: 300 mg once every 3 or 4 weeks via Respirgard II nebulizer (ASBMT/IDSA [Tomblyn 2009]; AST-IDCOP [Fishman 2019]).
There are no dosage adjustments provided in manufacturer's labeling (has not been studied). Use with caution.
There are no dosage adjustments provided in manufacturer's labeling (has not been studied). Use with caution.
Refer to adult dosing.
(For additional information see "Pentamidine (oral inhalation): Pediatric drug information")
Pneumocystis jirovecii pneumonia; primary or secondary prophylaxis (alternative agent): Limited data available:
Children <5 years:
Hematopoietic stem cell transplantation recipients: Inhalation: 9 mg/kg (maximum dose: 300 mg/dose) once monthly (every 4 weeks) via Respirgard II nebulizer (Tomblyn 2009).
Leukemia patients (Weinthal 1994): Inhalation:
Children <4 years: 150 mg/dose once monthly (every 4 weeks) via Respirgard II nebulizer.
Children 4 to 5 years: 300 mg/dose once monthly (every 4 weeks) via Respirgard II nebulizer.
Children ≥5 years and Adolescents: Inhalation: 300 mg once monthly (every 4 weeks) via Respirgard II nebulizer (HHS [OI adult 2020]; HHS [OI pediatric 2019]; Red Book [AAP 2018]; Quinn 2017; Tomblyn 2009).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>5%:
Central nervous system: Fatigue (66%), dizziness (45%)
Gastrointestinal: Decreased appetite (50%)
Infection: Infection (15%)
Respiratory: Cough (1% to 63%), dyspnea (48%), wheezing (32%), bronchospasm (≤15%)
Miscellaneous: Fever (51%)
1% to 5%:
Cardiovascular: Chest pain
Central nervous system: Headache
Dermatologic: Night sweats
Gastrointestinal: Diarrhea, dysgeusia, nausea, oral candidiasis
Hematologic & oncologic: Anemia
Infection: Herpes virus infection, herpes zoster, influenza
Respiratory: Pharyngitis (≤5%), bronchitis, sinusitis, upper respiratory tract infection
Miscellaneous: Night sweats
<1%, postmarketing, and/or case reports: Abscess (oral), abdominal cramps, abdominal pain, acute pancreatitis, acute rhinitis, ageusia, amnesia, anaphylaxis, anxiety, arthralgia, asthma, bacterial pneumonia, blepharitis, blurred vision, body odor, bronchitis, cerebrovascular accident, chest congestion, chest tightness, colitis, confusion, conjunctivitis, constipation, contact lens intolerance, cyanosis, cytomegalovirus disease (including colitis and retinitis), cytopenia, depression, dermatitis, desquamation, diabetes mellitus, disruption of body temperature regulation, drowsiness, dry hair, dyspepsia, dyspnea, emotional lability, encephalitis (viral), eosinophilia, eosinophilic pneumonitis, erythema, esophageal candidiasis, esophagitis, eye pain, facial edema, flank pain, gag reflex, gastritis, gastric ulcer, gingivitis, gout, hallucination, hematochezia, hemianopia, hemoptysis, hepatic insufficiency, hepatitis, hepatomegaly, herpes virus infection (pharyngeal), hiatal hernia, histoplasmosis, hyperglycemia, hyperkalemia, hypersensitivity reaction, hypertension, hyperventilation, hypocalcemia, hypoesthesia, hypoglycemia, hypotension, hypothermia, hypoxia, increased blood urea nitrogen, increased bronchial secretions, increased serum creatinine, infection (mycoplasma), insomnia, interstitial pneumonitis, Kaposi's sarcoma, laryngitis, laryngospasm, lethargy, lower extremity edema, melena, meningitis (cryptococcal infection), myalgia, nasal congestion, nephritis, nervousness, neuralgia, neuropathy, neutropenia, oral herpes, oral mucosa ulcer, otitis, palpitations, pancreatitis, pancytopenia, paranoia, paresthesia, peripheral neuropathy, pleurisy, pneumothorax, pruritus, pulmonary disease, rales, renal failure, renal insufficiency, renal pain, rhinitis, seizure, sepsis (central venous line-related), serious infection (extrapulmonary pneumocystosis), SIADH, sialorrhea, skin rash, splenomegaly, Stevens-Johnson syndrome, ST segment changes on ECG, syncope, tachycardia, tachypnea, thrombocytopenia, tonsillitis, torsades de pointes, tremor, tuberculosis, unsteady gait, urinary incontinence, urticaria, vasodilation, vasculitis, ventricular tachycardia, vertigo, vomiting, xeroderma, xerostomia
Hypersensitivity to pentamidine isethionate or any component of the formulation
Disease-related concerns:
• Asthma: Use inhalation formulation with caution in patients with asthma. May induce bronchospasm or cough, especially in patients with a smoking or asthma history (an inhaled bronchodilator prior to pentamidine may ameliorate symptoms).
• Pancreatitis: Use with caution in patients with a history of pancreatic disease or elevated amylase/lipase levels; acute pancreatitis (with fatality) has been reported. Discontinue inhalational pentamidine if signs/symptoms of acute pancreatitis occur.
• PCP: Acute PCP may develop despite aerosolized pentamidine prophylaxis. Although rare, extrapulmonary PCP disease may occur and has been associated with aerosolized pentamidine.
Other warnings/precautions:
• Adverse effects: According to the manufacturer, extent and consequence of pentamidine accumulation following chronic inhalation therapy are not known. Patients receiving pentamidine inhalation should be closely monitored for the development of serious adverse reactions that have occurred with parenteral administration of pentamidine, including hypotension, hypoglycemia, hyperglycemia, hypocalcemia, anemia, thrombocytopenia, leukopenia, hepatic or renal dysfunction, ventricular tachycardia (eg, torsade de pointes), pancreatitis, Stevens-Johnson syndrome, hyperkalemia and abnormal ST segment of ECG.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Inhalation, as isethionate:
Nebupent: 300 mg (1 ea)
Generic: 300 mg (1 ea)
Yes
Solution (reconstituted) (Nebupent Inhalation)
300 mg (per each): $200.27
Solution (reconstituted) (Pentamidine Isethionate Inhalation)
300 mg (per each): $112.50 - $180.50
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Inhalation: Deliver via Respirgard II nebulizer until nebulizer is emptied (~30 to 45 minutes). Administer at a flow rate of 5 to 7 L/minute from a 40 to 50 pound-per-square inch (PSI) oxygen or air source. A 40 to 50 PSI air compressor can be used alternatively, with a set flow rate at 5 to 7 L/minute or a set pressure of 22 to 25 PSI. Air compressors <20 PSI should not be used. Use appropriate precautions to minimize exposure to healthcare personnel; refer to individual institutional policy.
Oral inhalation: Deliver via Respirgard II nebulizer with appropriately sized face mask until nebulizer is emptied (up to 30 to 45 minutes). Use appropriate precautions to minimize exposure to health care personnel; refer to individual institutional policy. An inhaled bronchodilator may be administered prior to each dose if the patient experiences bronchospasm or cough with administration; do not use Respirgard to administer albuterol. Do not mix with other nebulizer solutions.
Pneumocystis pneumonia, prophylaxis, primary and secondary: Prevention of Pneumocystis jirovecii pneumonia (PCP) in high-risk patients with HIV, either with a history of PCP or with a CD4+ count ≤200/mm3.
None known.
There are no known significant interactions.
It is not known if clinically significant concentrations reach the fetus when administered via the aerosolized route. Information related to fetal outcomes following maternal use of pentamidine is limited. If administered via the aerosolized route, maternal serum concentrations are lower, minimizing the exposure to the fetus (Gates 1993; Nanda 1992; Sperling 1992). Concern regarding occupational exposure and theoretical risk to pregnant health care workers has been discussed in the literature. Pregnant health care workers should avoid aerosolized exposure if possible (Conover 1988; Ito 1994; Smaldone 1991).
Aerosolized pentamidine may be used as an alternative agent for the prophylaxis of Pneumocystis pneumonia (PCP) in pregnant females with HIV infection who either cannot tolerate the preferred therapy or who wish to avoid it during the first trimester of pregnancy (HHS [OI adult 2020]).
It is not known if pentamidine is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother. Females with HIV infection should completely avoid breastfeeding to decrease the potential transmission of HIV (HHS [perinatal 2019]).
Liver function tests, renal function tests, blood glucose, serum potassium and calcium, CBC and platelets
Interferes with microbial RNA/DNA, phospholipids and protein synthesis, through inhibition of oxidative phosphorylation and/or interference with incorporation of nucleotides and nucleic acids into RNA and DNA
Absorption: Inhalation: Limited systemic absorption with chronic therapy, potential accumulation and systemic effects unknown
Distribution: Binds to tissues and plasma protein; high concentrations are found in the liver, kidney, adrenals, spleen, lungs, and pancreas; poor penetration into CNS; following oral inhalation, high concentrations are found in bronchoalveolar fluid
Half-life elimination: IV: 5 to 8 hours; IM: 7 to 11 hours; may be prolonged with severe renal impairment
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