Products Affected - Description

Reason for the Shortage

• APP had Pentam 300 and NebuPent on shortage due to raw material issues.¹
• APP is the sole supplier of pentamidine isethionate.
  

Available Products

NebuPent lyophilized powder for inhalation, APP
300 mg 15 mL vial (NDC 63323-0877-15)

Pentam 300 lyophilized powder for injection, APP
300 mg 15 mL vial (NDC 63323-0113-10)

Estimated Resupply Dates

APP has Pentam 300 powder for injection and NebuPent powder for inhalation available.¹

Implications for Patient Care

The contents of NebuPent and Pentam 300 are identical, only the labels differ.²  NebuPent is labeled as an inhalation to prevent Pneumocystis carinii pneumonia in high risk patients with HIV.³  Pentam is labeled as an injection for the treatment of Pneumocystis carinii pneumonia.⁴  Pentamidine is not a first line agent for the prevention or treatment of P. jirovecii (formerly known as P. carinii) infections.^5-8

Safety

Pentamidine is often used for patients who cannot tolerate first line therapy, or for those patients with severe adverse effects to first line therapy. Ensure patients continue to receive adequate treatment during this shortage while minimizing severe adverse events.

Alternative Agents & Management

• Reserve any remaining pentamidine supplies for patients who cannot be switched to another therapy. As this shortage is related to raw material issues and there is only a single supplier, this shortage is likely to last multiple months.
• Evaluate all patients currently receiving pentamidine therapy for eligibility to switch to an alternative therapy. Table 1 lists selected alternative regimens to pentamidine for the prevention of P. jiroveci infection while Table 2 offers selected alternative treatment strategies. Consult the most recent available guidelines^7,8 and other references for additional options.
• If available, consider administering Pentam 300 as an inhalation for those patients who cannot be switched from NebuPent therapy. Pentam 300 and NebuPent carry different labels, but are manufactured in identical fashion.²

Related Shortages

• Nitazoxanide Oral Presentations— Resolved
• Paromomycin Capsules— Resolved

1. APP (personal communications). August 9 and 27, July 17, September 17, October 2, and November 9 and 30, 2012; and January 7, 2013.
2. APP Pharmaceuticals. Pentam 300 / NebuPent Manufacturing Process [written communication, received August 31, 2012]. Schaumburg, IL: APP Pharmaceuticals / Fresenius Kabi USA, Vigilance and Medical Affairs; 2012.
3. APP. NebuPent (pentamidine isethionate) inhalation, [product information]. Schaumburg, IL: APP Pharmaceuticals; 2008.
4. APP. PENTAM 300 (pentamidine isethionate) injection, [product information]. Schaumburg, IL: APP Pharmaceuticals; 2008.
5. Moore TA. Agents Active Against Parasites and Pneumocystis. In: Mandell GL, Bennett JE, Dolin R, eds. Mandell, Doublas, and Bennett’s Principles and Practice of Infectious Diseases. 7^th ed. Philadelphia, PA: Elsevier; 2010:631-668.
6. Lexicomp Online. Pneumocystis jirovecii (Infectious Diseases) Lexi-Comp, Inc.; 2012.
7. Mofenson LM, Brady MT, Danner SP, Dominguez KL, Hazra R, Handelsman E, Havens P, Nesheim S, Read JS, Serchuck L, Van Dyke R; Centers for Disease Control and Prevention; National Institutes of Health; HIV Medicine Association of the Infectious Diseases Society of America; Pediatric Infectious Diseases Society; American Academy of Pediatrics. Guidelines for the Prevention and Treatment of Opportunistic Infections among HIV-exposed and HIV-infected children: recommendations from CDC, the National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics. MMWR Recomm Rep. 2009 Sep 4;58(RR-11):1-166.
8. Kaplan JE, Benson C, Holmes KH, Brooks JT, Pau A, Masur H; Centers for Disease Control and Prevention (CDC); National Institutes of Health; HIV Medicine Association of the Infectious Diseases Society of America. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. MMWR Recomm Rep. 2009 Apr 10;58(RR-4):1-207.

Updated

Updated January 9, 2013 by Jane Chandramouli, PharmD, Drug Information Specialist. Created August 31, 2012 by Erin R. Fox, PharmD, Director, Drug Information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.