At a glance
This page provides an informative overview of the ÐÇ¿ÕÓéÀÖ¹ÙÍø Drug Service Formulary.
ÐÇ¿ÕÓéÀÖ¹ÙÍø Drug Service Products
The following information is provided as an informational resource for guidance only. It is not intended as a substitute for professional judgment. These highlights and any hyperlinks may not include all the information needed to use each respective drug or biologic safely and effectively. See full prescribing information (package insert) or IND protocol for each respective drug or biologic, which accompany the product when it is delivered to the treating physician and/or pharmacist.
The Drug Service formulary is subject to change based on current public health needs, updates to treatment guidelines, and/or drug availability. For historical reference, we have included products no longer supplied by the Drug Service.
ACAM2000
Product & Supplier
ACAM2000® (Also known as the "Vaccinia Vaccine"); Manufactured by Sanofi Aventis
Indication & Eligibility
For active immunization against smallpox disease for persons determined to be at high risk for smallpox infection
How Supplied
Lyophilized powder reconstituted with diluent (provided) Contains 100 doses per vial
ACAM2000®, “Vaccinia Vaccine”
Vaccinia vaccine is made of live vaccinia virus derived from plaque purification cloning of Dryvax® (calf lymph vaccine, New York City Board of Health Strain) and grown in African Green Monkey kidney (Vero) cells and tested to be free of adventitious agents. It contains approximately 2.5 – 12.5 x 105 plaque-forming units per dose.
Smallpox was declared globally eradicated in 1980. In 1982, Wyeth Laboratories, the only active manufacturer of licensed vaccinia vaccine in the United States, discontinued production; and, in 1983, distribution to the civilian population was discontinued. Since January 1982, smallpox vaccination has not been required for international travelers, and International Certificates of Vaccination no longer include smallpox vaccination. ACAM2000® is a new-generation smallpox vaccine that was licensed in 2007 for use as a medical countermeasure held by the Strategic National Stockpile.
ÐÇ¿ÕÓéÀÖ¹ÙÍø recommends vaccinia vaccine for laboratory workers who directly handle a) cultures or b) animals contaminated or infected with non-highly attenuated vaccinia virus, recombinant vaccinia viruses derived from non-highly attenuated vaccinia strains, or other orthopoxviruses that infect humans (e.g., monkeypox, cowpox, vaccinia, and variola). Other health-care workers (e.g., physicians and nurses) whose contact with non-highly attenuated vaccinia viruses is limited to contaminated materials (e.g., dressings) and who adhere to appropriate infection control measures are at lower risk for inadvertent infection than laboratory workers. However, because a theoretical risk for infection exists, vaccination can be offered to this group. Read more [PDF – 930KB].
More Information for Clinicians
MMWR Notice to Readers: Newly Licensed Smallpox Vaccine to Replace Old Smallpox Vaccine
ÐÇ¿ÕÓéÀÖ¹ÙÍø's Vaccine-Related Topics: Smallpox Vaccine
How to Request
Smallpox vaccine must be administered by or under the supervision of the physician who registers with ÐÇ¿ÕÓéÀÖ¹ÙÍø.
Ancillary supplies, such as bifurcated needles (for administration) and 1 mL tuberculin syringes with 25 gauge x 5/8" needles (for reconstitution), are supplied with the vaccine.
Contact the ÐÇ¿ÕÓéÀÖ¹ÙÍø Drug Service for more information.
Requests for unapproved uses cannot be granted.
Botulism Antitoxin Heptavalent
Product & Supplier
Botulism Antitoxin Heptavalent (Equine), Types A-G (Also known as "HBAT"; Manufactured by Cangene Corp. – BAT™)
Indication & Eligibility
For the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin
How Supplied
20 mL or 50 mL single-use glass vial
May be received frozen or thawed
Botulism Antitoxin Heptavalent (Equine), Types A-G
Botulism Antitoxin Heptavalent (HBAT) contains equine-derived antibody to the seven known botulinum toxin types (A-G). HBAT is composed of <2% intact immunoglobulin G (IgG) and ≥90% Fab and F(ab')2 immunoglobulin fragments. These fragments are created by the enzymatic cleavage and removal of Fc immunoglobulin components in a process sometimes referred to as despeciation. HBAT is supplied on an emergency basis for the treatment of persons thought to be suffering from botulism and works by neutralizing unbound toxin molecules. In 2010, HBAT became the only botulism antitoxin available in the United States for naturally occurring non-infant botulism.
It is available only from ÐÇ¿ÕÓéÀÖ¹ÙÍø because of its limited use and its relatively short expiration date. The antitoxin is stored at ÐÇ¿ÕÓéÀÖ¹ÙÍø Port Health Stations located in major airports around the nation, ensuring delivery to any location in the United States within hours.
(botulism immune globulin) remains available for infant botulism through the California Infant Botulism Treatment and Prevention Program.
More Information for Clinicians
How to Request
Clinicians who suspect a diagnosis of botulism in a patient should immediately call their state health department's 24-hour telephone number to maintain effective botulism surveillance and to facilitate rapid detection of outbreaks. The state health department will contact ÐÇ¿ÕÓéÀÖ¹ÙÍø to arrange for a clinical consultation by telephone and, if indicated, release of botulism antitoxin. State health departments requesting botulism antitoxin should contact the ÐÇ¿ÕÓéÀÖ¹ÙÍø Emergency Operations Center (EOC) at 770-488-7100. Read more.
For non-emergency questions concerning botulism antitoxin, contact the ÐÇ¿ÕÓéÀÖ¹ÙÍø Drug Service.
Diethylcarbamazine
Product & Supplier
Diethylcarbamazine (Also known as "DEC"; Supplied to ÐÇ¿ÕÓéÀÖ¹ÙÍø by the World Health Organization; Manufactured by E.I.P.I.C.O.)
Indication & Eligibility
For the treatment of certain filarial diseases, including lymphatic filariasis caused by infection with Wuchereria bancrofti, Brugia malayi, or Brugia timori; tropical pulmonary eosinophilia; and loiasis
For prophylactic use in persons determined to be at increased risk for Loa loa infection
Patient must meet the eligibility criteria in the IND protocol
How Supplied
100 mg tablet
Diethylcarbamazine (DEC)
DEC is an antihelminthic agent used for treatment of lymphatic filariasis (caused by infection with Wuchereria bancrofti, Brugia malayi, or Brugia timori), tropical pulmonary eosinophilia, and loiasis; DEC also has prophylactic benefit for Loa loa infection. DEC has been used worldwide for more than 50 years. In the past, Wyeth-Ayerst Laboratories made DEC available as a licensed drug; in the late 1990s, because of unavailability of a bulk chemical supplier, Wyeth-Ayerst discontinued distribution of DEC in the United States.
More Information for Clinicians
Diagnostic assistance for filarial diseases is available through .
How to Request
Contact the ÐÇ¿ÕÓéÀÖ¹ÙÍø Drug Service for more information.
Questions regarding treatment of filarial diseases should be directed to ÐÇ¿ÕÓéÀÖ¹ÙÍø Parasitic Diseases Inquiries (404-718-4745; email [email protected]) M-F 7:30am-4pm EST.
After-hours emergencies: 1-770-488-7100
Diphtheria Antitoxin
Product & Supplier
Diphtheria Antitoxin (Equine) (Also known as "DAT"; Manufactured by Instituto Butantan)
Indication & Eligibility
For prevention or treatment of actual or suspected cases of diphtheria
Patient must meet the eligibility criteria in the IND protocol
How Supplied
1 mL single-use ampule containing 10,000 units
Diphtheria Antitoxin (Equine)
Diphtheria antitoxin (DAT) is used to prevent or treat diphtheria by neutralizing the toxins produced by Corynebacterium diphtheriae. DAT is a sterile, aqueous solution of the refined and concentrated proteins, chiefly globulins, containing antibodies obtained from the serum of horses that have been immunized against diphtheria toxin. DAT is available under an IND protocol sponsored by ÐÇ¿ÕÓéÀÖ¹ÙÍø and is released only for actual or suspected cases of diphtheria. The antitoxin is stored at ÐÇ¿ÕÓéÀÖ¹ÙÍø Port Health Stations located in major airports around the nation, ensuring delivery to any location in the United States within hours.
More Information for Clinicians
ÐÇ¿ÕÓéÀÖ¹ÙÍø's Vaccine-Related Topics: Diphtheria Antitoxin
How to Request
Contact the ÐÇ¿ÕÓéÀÖ¹ÙÍø Drug Service for more information.
Clinicians who suspect a diagnosis of respiratory diphtheria can obtain DAT by contacting the Emergency Operations Center at 770-488-7100. They will be connected with the diphtheria duty officer, who will provide clinical consultation and, if indicated, initiate the release of diphtheria antitoxin.
For non-emergency questions concerning diphtheria antitoxin, contact the ÐÇ¿ÕÓéÀÖ¹ÙÍø Drug Service.
Eflornithine
Product & Supplier
Eflornithine (Also known as "DFMO"; Supplied to ÐÇ¿ÕÓéÀÖ¹ÙÍø by the World Health Organization; Manufactured by Sanofi Aventis – Ornidyl®)
Indication & Eligibility
For the treatment of second-stage African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei gambiense, with involvement of the central nervous system
How Supplied
20 g/100 mL hypertonic solution for IV infusion
Must be diluted with Sterile Water for Injection before use
Eflornithine
Eflornithine is an antitrypanosomal agent that inhibits the enzyme ornithine decarboxylase. Antitrypanosomal treatment is indicated for all persons diagnosed with African trypanosomiasis (sleeping sickness); the choice of therapy depends on the infecting subspecies of the parasite and on the stage of the infection. Eflornithine is considered the drug of choice for the treatment of second-stage Trypanosoma brucei gambiense (West African) infection, with involvement of the central nervous system. It is not effective against T. b. rhodesiense (East African) infection (see melarsoprol). Although the manufacturer, Aventis, maintains its US licensure, eflornithine is not commercially available in the United States.
More Information for Clinicians
Diagnostic assistance for African trypanosomiasis is available through .
How to Request
Contact the ÐÇ¿ÕÓéÀÖ¹ÙÍø Drug Service for more information.
Questions regarding treatment of African trypanosomiasis should be directed to ÐÇ¿ÕÓéÀÖ¹ÙÍø Parasitic Diseases Inquiries (404-718-4745; email [email protected]) M-F 7:30am-4pm EST.
For emergencies outside of regular business hours, call the ÐÇ¿ÕÓéÀÖ¹ÙÍø Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.
Melarsoprol
Product & Supplier
Melarsoprol (Supplied to ÐÇ¿ÕÓéÀÖ¹ÙÍø by the World Health Organization; Manufactured by Sanofi Aventis – Arsobal®)
Indication & Eligibility
For the treatment of second-stage African trypanosomiasis (sleeping sickness), with involvement of the central nervous system
Patient must meet the eligibility criteria in the IND protocol
How Supplied
5 mL glass ampule containing 180 mg/5 mL (36 mg/mL)
Melarsoprol
Melarsoprol is an organoarsenic compound with trypanocidal effects that has been used outside the United States since 1949. Antitrypanosomal treatment is indicated for all persons diagnosed with African trypanosomiasis (sleeping sickness); the choice of therapy depends on the infecting subspecies of the parasite and on the stage of the infection. Melarsoprol is used for the treatment of second-stage infection (involving the central nervous system). It is the only available therapy for second-stage Trypanosoma brucei rhodesiense (East African) infection, whereas eflornithine typically is used for second-stage T. b. gambiense (West African) infection.
More Information for Clinicians
Diagnostic assistance for African trypanosomiasis is available through .
How to Request
Contact the ÐÇ¿ÕÓéÀÖ¹ÙÍø Drug Service for more information.
Questions regarding treatment of African trypanosomiasis should be directed to ÐÇ¿ÕÓéÀÖ¹ÙÍø Parasitic Diseases Inquiries (404-718-4745; email [email protected]) M-F 7:30am-4pm EST.
For emergencies outside of regular business hours, call the ÐÇ¿ÕÓéÀÖ¹ÙÍø Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.
Nitroxoline
Product & Supplier
Nitroxoline (Supplied to ÐÇ¿ÕÓéÀÖ¹ÙÍø by Asieris Pharmaceuticals)
Indication & Eligibility
For the treatment of patients with Free-living Amoebae (FLA) infection. Patient must meet the eligibility criteria in the IND protocol
How Supplied
125 mg tablet
Nitroxoline
Nitroxoline (APL-1202), or 8-hydroxy-5-nitroquinoline, is a hydroxyquinoline derivative used for the treatment of laboratory-confirmed or suspected non-keratitis infections caused by free-living amebae (FLA) including Acanthamoeba spp., Balamuthia mandrillaris, and Naegleria fowleri. Nitroxoline is used in some countries, including Germany, Serbia, Poland and Croatia, as a broad-spectrum antibiotic for acute and/or chronic urinary track infections. Nitroxoline is available as 125mg tablets.
More Information for Clinicians Diagnostic assistance for Free-Living Amebae infection is available through DPDx.
Information about treatment regimens can be found on the following pages:
Clinical Care of Balamuthia Infection | Balamuthia Infection | ÐÇ¿ÕÓéÀÖ¹ÙÍø
Clinical Treatment of Non-keratitis Acanthamoeba Infections | Acanthamoeba Infections | ÐÇ¿ÕÓéÀÖ¹ÙÍø
Clinical Care of Naegleria fowleri Infection | Naegleria fowleri Infection | ÐÇ¿ÕÓéÀÖ¹ÙÍø
How to Request
Contact the ÐÇ¿ÕÓéÀÖ¹ÙÍø Drug Service for more information.
Questions regarding treatment of Free-Living Amebae infection should be directed to ÐÇ¿ÕÓéÀÖ¹ÙÍø Emergency Operations Center: 1-770-488-7100 or email [email protected]
Suramin
Product & Supplier
Suramin (Supplied to ÐÇ¿ÕÓéÀÖ¹ÙÍø by the World Health Organization; Manufactured by Bayer – Germanin)
Indication & Eligibility
For the treatment of first-stage African trypanosomiasis (sleeping sickness) caused by Trypanosoma brucei rhodesiense, without involvement of the central nervous system
Patient must meet the eligibility criteria in the IND protocol
How Supplied
1 gram of suramin for injection in a 10 mL vial (100 mg/mL solution of suramin sodium)
Must be reconstituted with 10 mL Sterile Water for Injection before use
Suramin
Suramin is a negatively charged, high-molecular-weight sulfated naphthylamine. It was introduced in the 1920s for the treatment of African trypanosomiasis (sleeping sickness). Suramin generally is considered the drug of choice for first-stage Trypanosoma brucei rhodesiense (East African) infection, without involvement of the central nervous system. Pentamidine typically is used for first-stage T. b. gambiense (West African) infection.
More Information for Clinicians
Diagnostic assistance for African trypanosomiasis is available through .
How to Request
Contact the ÐÇ¿ÕÓéÀÖ¹ÙÍø Drug Service for more information.
Questions regarding treatment of African trypanosomiasis should be directed to ÐÇ¿ÕÓéÀÖ¹ÙÍø Parasitic Diseases Inquiries (404-718-4745; email [email protected]) M-F 7:30am-4pm EST.
For emergencies outside of regular business hours, call the ÐÇ¿ÕÓéÀÖ¹ÙÍø Emergency Operations Center (770-488-7100) and ask for the person on call for Parasitic Diseases.
Products No Longer Supplied*
Anthrax Vaccine Adsorbed
Anthrax Vaccine Adsorbed (AVA) is indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons 18 through 65 years of age at high risk for exposure or following suspected or confirmed exposure when administered in conjunction with recommended antibacterial drugs. Read more.
Artesunate, Intravenous
In May 2020, FDA-approved artesunate became commercially available. Artesunate is in the class of medications known as artemesinins, which are derivatives from the "qinghaosu" or sweet wormwood plant (Artemisia annua). Intravenous artesunate is the only injectable medication available in the US for severe malaria. Read more.
Benznidazole
In May 2018, FDA-approved benznidazole became commercially available. Benznidazole is a 2-nitroimidazole trypanocidal agent that was introduced in 1971 for the treatment of Trypanosoma cruzi infection—i.e., Chagas disease, also known as American trypanosomiasis. Benznidazole is one of two drugs available for the treatment of Chagas disease (the other is nifurtimox). In the United States, the need to have drugs available for treating Chagas disease has been increasing, largely because of implementation of T. cruzi blood-donor screening in 2007, which has identified chronically infected persons (mainly Latin American immigrants) who might benefit from treatment and has heightened awareness of Chagas disease.
Botulinum Antitoxin Types AB & E
In March 2010, ÐÇ¿ÕÓéÀÖ¹ÙÍø announced the availability of a new heptavalent botulinum antitoxin (HBAT, Cangene Corporation). HBAT replaced the licensed bivalent botulinum antitoxin AB and an investigational monovalent botulinum antitoxin E (BAT-AB and BAT-E, Sanofi Pasteur), becoming the only botulinum antitoxin available in the United States for naturally occurring non-infant botulism. Read more.
Botulinum Toxoid
Pentavalent (ABCDE) botulinum toxoid is a combination of aluminum phosphate-adsorbed toxoid derived from formalin-inactivated types A, B, C, D, and E botulinum toxins, with formaldehyde and thimerosal used as preservatives. Botulinum toxoid was distributed by ÐÇ¿ÕÓéÀÖ¹ÙÍø under an IND protocol for at-risk persons who were actively working or expected to be working with cultures of Clostridium botulinum or the toxins; in 2011, ÐÇ¿ÕÓéÀÖ¹ÙÍø discontinued its program to supply this vaccine. Read more.
Jynneos
In April 2024, FDA-approved JYNNEOS became commercially available. JYNNEOS is a non-replicating vaccine indicated for smallpox and mpox disease prevention in adults aged 18 years and older. JYNNEOS contains a live, attenuated form of the vaccinia virus called Modified Vaccinia Ankara (MVA), which is like variola or Monkeypox viruses but is less harmful. It is non-replicating and capable of generating humoral and cellular immune responses to orthopoxviruses. Read more.
(Sodium Stibogluconate) Pentostam®
In 2020, the worldwide manufacturer of Pentostam®, GSK, notified ÐÇ¿ÕÓéÀÖ¹ÙÍø that due to inability to source the necessary raw materials, they would no longer be able to manufacturer the product and it would be discontinued. Following expiration of the last lot in use, ÐÇ¿ÕÓéÀÖ¹ÙÍø closed the IND treatment protocol due to lack of product availability.
Vaccinia Immune Globulin (VIG)
Vaccinia immune globulin (VIG) is released from the ÐÇ¿ÕÓéÀÖ¹ÙÍø Strategic National Stockpile, if indicated, for the treatment of complications associated with vaccinia vaccination or severe orthopoxvirus infection. Clinicians wishing to obtain VIG should contact the Emergency Operations Center (EOC) at 770-488-7100. They will be connected with ÐÇ¿ÕÓéÀÖ¹ÙÍø medical staff who can assist them in the diagnosis and management of patients with suspected complications of vaccinia vaccination or severe orthopoxvirus infection.
*this list is not all-inclusive
Use of trade names is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.