African trypanosomiasis (sleeping sickness), first-stage disease (without CNS involvement), caused by T. brucei rhodesiense : Note: Suramin is only available through special distribution programs; refer to "Prescribing and Access Restrictions" for additional information.
Children and Adolescents: IV: 2 mg/kg test dose once (maximum dose: 100 mg/dose); if test dose tolerated, then follow with treatment dose of 10 to 15 mg/kg/dose (maximum dose: 1,000 mg/dose) on days 1, 3, 7, 14, and 21 (CDC 2020). Note: Alternate doses and dosing schedules have been described (Faust 2004; WHO 1995), including higher doses of 20 mg/kg/dose (Red Book [AAP 2021]; Voogd 1993).
Children and Adolescents: Avoid use in severe renal impairment (WHO 1995).
Children and Adolescents: Avoid use in severe hepatic impairment (WHO 1995).
(For additional information see "Suramin (United States: Available via CDC drug service investigational drug [IND] protocol only): Drug information")
African trypanosomiasis, first-stage disease, caused by T. brucei rhodesiense : IV: Initial: 4 to 5 mg/kg test dose (day 0), followed by 20 mg/kg (maximum: 1 g/dose) on days 1, 3, 7, 14, and 21 (CDC 2022). Note: Not recommended for trypanosomiasis with CNS involvement (CDC 2021).
Avoid use in severe renal impairment (WHO 1995).
Avoid use in severe hepatic impairment (WHO 1995).
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Postmarketing:
Cardiovascular: Collapse (Voogd 1993, WHO 1995), shock (Voogd 1993)
Dermatologic: Dermatitis (including exfoliative dermatitis) (WHO 1995, Wiedemar 2020), exfoliation of skin (especially superficial peeling of palms and scaling of skin of feet) (Voogd 1993), papular rash (Voogd 1993), pruritus (Voogd 1993), skin rash (CDC 2022), urticaria (Voogd 1993)
Endocrine & metabolic: Albuminuria (WHO 1995), increased thirst (WHO 1995)
Gastrointestinal: Anorexia (WHO 1995), nausea (Babokhov 2013), severe diarrhea (WHO 1995), stomatitis (Voogd 1993, WHO 1995), vomiting (Voogd 1993)
Genitourinary: Prostration (WHO 1995), proteinuria (WHO 1995)
Hematologic & oncologic: Anemia (Wiedemar 2020), bone marrow depression (Wiedemar 2020), disorder of hemostatic components of blood (Voogd 1993), hemolytic anemia (Voogd 1993), immune thrombocytopenia (Vayne 2020)
Hypersensitivity: Hypersensitivity reaction (including anaphylactic shock) (Babokhov 2013, CDC 2022, Wiedemar 2020)
Local: Localized tenderness (palms and soles) (WHO 1995)
Nervous system: Fatigue (WHO 1995), hyperesthesia (cutaneous; including hands and feet) (Voogd 1993), malaise (WHO 1995), peripheral neuropathy (CDC 2022), polyneuropathy (Voogd 1993)
Ophthalmic: Conjunctivitis (Voogd 1993), eyelid edema (Voogd 1993), photophobia (Voogd 1993)
Renal: Nephrotoxicity (CDC 2022), polyuria (WHO 1995)
Miscellaneous: Fever (WHO 1995)
Hypersensitivity to suramin or any component of the formulation
Concerns related to adverse effects:
• Hypersensitivity reaction: Use has been associated with immediate hypersensitivity reactions, including severe reactions leading to shock and loss of consciousness.
• Renal toxicity: Use has been associated with proteinuria and renal toxicity.
Disease-related concerns:
• Hepatic impairment: Avoid use in hepatic impairment.
• Renal impairment: Avoid use in renal impairment.
Suramin is also active against Onchocerca volvulus; patients treated with suramin who have trypanosomiasis and onchocerciasis coinfection may experience severe reactions (due to dying parasites); consider alternate therapy or exclude onchocerciasis coinfection (Kappagoda 2011; Red Book [AAP 2021]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, powder for reconstitution: 1 g [Limited by law to investigational use only]
No
Suramin is not commercially available in the US; it is available for the treatment of patients with African trypanosomiasis through the Centers for Disease Control (CDC) Drug Service to be used under an Investigational New Drug (IND) protocol. To obtain treatment advice and obtain suramin, contact the Division of Parasitic Diseases and Malaria (404-718-4745; [email protected]), the CDC Drug Service (404-639-3670; [email protected]), or for emergencies after business hours, on weekends, and on federal holidays, the CDC Emergency Operations Center (770-488-7100). Additional information from the CDC is available at https://www.cdc.gov/laboratory/drugservice/formulary.html.
Parenteral: IV: Administer by slow IV infusion (Voogd 1993; WHO 1995).
IV: Administer by slow IV infusion over several hours (CDC 2022; Voogd 1993; WHO 1995).
Vials of powder for reconstitution should be protected from light.
Treatment of first-stage African trypanosomiasis (sleeping sickness), without involvement of the central nervous system, due to Trypanosoma brucei rhodesiense. Note: Suramin is only available through the CDC for patients meeting Investigational New Drug eligibility criteria; contact CDC for details.
None known.
There are no known significant interactions.
Monitor for hypersensitivity and hemodynamic stability, especially following test dose (CDC 2020). Also monitor for peripheral neuropathy. Monitor urine output (routinely during therapy); urinalysis, urine protein, CBC, LFTs, and renal function tests (baseline and weekly during therapy) (Sinha 1999; Voogd 1993; WHO 1995).
Absorption: Not absorbed orally.
Distribution: Does not penetrate the CNS.
Protein binding: 99.7% (Babokhov 2013).
Half-life elimination: 44 to 54 days (Babokhov 2013).
Excretion: Detectable unchanged in the urine for 3 months (WHO 1995).
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