Suramin (Systemic)

Primary: AP109
Secondary: AP200

Commonly used brand name(s): 309 F; Antrypol; Bayer 205; Belganyl; Fourneau 309; Germanin; Moranyl; Naganin; Naganol; Naphuride.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

*Not commercially available in the U.S.

Not commercially available in Canada.


Antiprotozoal (systemic){01}{02}{03}{04}{05}{06}{07}{19}

anthelmintic (systemic){01}{08}{09}{11}{12}{13}{19}


Note: Because suramin is not commercially available in the U.S. or Canada, the bracketed information and the use of the superscript 1 in this monograph reflect the lack of labeled (approved) indications for this medication in these countries.


[Trypanosomiasis, African, (treatment)]1—Suramin is used as a primary agent in the treatment of African trypanosomiasis (African sleeping sickness; trypanosome fever) caused by Trypanosoma brucei gambiense or T. b. rhodesiense in patients with early or hemolymphatic disease without central nervous system (CNS) involvement. {01} {02} {03} {04} {05} {06} {07} {19} {27} {36} {45}
—In patients with late stage or chronic trypanosomiasis caused by T. b. gambiense or T. b. rhodesiense involving the CNS, the primary agent is the toxic arsenical compound melarsoprol. Suramin may be administered as a preliminary agent prior to starting melarsoprol therapy in order to reduce the number of trypanosomes in the blood, thereby minimizing the adverse effects of melarsoprol. {02} {36} {42} {49} {57} For patients who cannot tolerate melarsoprol, an alternative treatment is a combination of suramin and tryparsamide. {10} {33} {34} {35} {38} These 2 medications are synergistic in action, and good therapeutic results have been obtained with combined administration. {33} {36} Eflornithine is another agent that has been found to be effective for T. b. gambiense infections. {02} {10} {19} {39} {40} {43} {44} However, eflornithine has variable efficacy against T. b. rhodesiense infections. {10}

[Onchocerciasis (treatment)]1—Suramin is used as a secondary agent in the treatment of onchocerciasis (river blindness) caused by Onchocerca volvulus . {01} {02} {08} {09} {11} {12} {13} {34} {44} {45} {55} {65} This agent is effective in killing the adult worm (macrofilaricidal) {02} {29} {49} {52} {53} {55} and also has partial microfilaricidal action. {33} {36} {53} However, because of its intrinsic toxicity, suramin is now rarely used for this indication. {36} {38} {51} {53} Currently, its use is restricted to radical cure of selected individuals in areas without transmission of onchocerciasis, for expatriates leaving the endemic area, and for severe hyperreactive onchodermatitis in patients whose symptoms are not adequately controlled by repeated treatment with ivermectin. {38} {51} {52} Ivermectin is considered the primary agent in the treatment of onchocerciasis as a microfilaricide; {10} {19} {54} it has been shown to have little or no macrofilaricidal effect. {10} {19} {44} For heavily infected patients, ivermectin may be given prior to suramin therapy to reduce the microfilarial load. {56}

Acceptance not established
Suramin has demonstrated antitumor activity against a variety of neoplasms that are refractory to conventional treatment modalities. {36} {58} {59} {60} {61} {62} {63} These neoplasms include metastatic adrenocortical carcinoma, {62} {63} advanced platinum-resistant ovarian carcinoma, {61} and advanced-stage prostatic carcinoma {58} {59} {60}. The potential usefulness of suramin as an antineoplastic agent may be due to this agent's ability to inhibit lysosomal enzymes and a wide range of growth factors by interfering with binding at their receptors {59} {62} or by altering signal transduction. {59} However, currently there are insufficient data to establish optimal dose, safety, and efficacy of suramin for these indications. {58} {59} {60} {61} {62} {63} {64}.

Suramin alone is not useful in the treatment of late or chronic trypanosomiasis with central nervous system (CNS) involvement {02} {06} {07} because it poorly passes the blood-brain barrier. {36}

In the past, suramin has been used in the treatment of hereditary angioneurotic edema. {03} In this condition there is a lack of complement C1 esterase inhibitors and suramin inhibits complement C1 esterase. {31} However, its therapeutic benefit has been found to be very erratic. {03} Other effective agents, such as aminocaproic acid or tranexamic acid, are preferred for treatment of this condition. {03}

Suramin also was found to be ineffective in the treatment of chronic active hepatitis due to infection with viral hepatitis B. {24}

Although suramin is known to have an effect on deoxyribonucleic acid/ribonucleic acid (DNA/RNA) polymerase and on viral reverse transcriptase of human immunodeficiency virus (HIV) activity (anti-HIV) in vitro , {14} {20} {21} {26} this agent has been used unsuccessfully in the treatment of patients with acquired immunodeficiency syndrome (AIDS) and AIDS-related complex. {21} {22} {23}

1 Not included in Canadian product labeling.


Physicochemical characteristics:

    Polysulfonated naphthylamine {06} {07} derivative of urea {36}
Molecular weight—
    1429.16 {18}

Mechanism of action/Effect:

Trypanosomiasis, African—Trypanocidal; the mechanism is unknown, but the trypanocidal activity may be due to the inhibition of enzymes involved with the oxidation of reduced nicotinamide-adenine dinucleotide (NADH), which functions as a co-enzyme in many cellular reactions, {03} {06} {07} such as respiration and glycolysis, in the trypanosome parasite. {33}

Onchocerciasis—Suramin is macrofilaricidal and partially microfilaricidal. {08} {09} {13}


Poorly absorbed from the gastrointestinal tract; must be given parenterally. {03} {36} {55}


Combines with serum proteins {02} {03} after intravenous administration and a large amount circulates in the blood; some is absorbed by the cells of the reticuloendothelial system, such as the liver, spleen, bone marrow, and connective tissue histiocytes, where it may be detected for more than 12 days after administration {03}; concentration in the kidney is approximately double the concentration in other tissues; accumulation in the adrenal glands is from 3- to 20-fold higher than that in the other organs; {36} it may be present in the bloodstream for as long as 3 {06} {07} to 6 months after the last dose. {03} Suramin is not concentrated in red blood cells or platelets. It has been assumed that suramin poorly passes the blood-brain barrier due to its large molecular size and its strongly anionic nature at physiological pH. {36} Its concentration in the cerebrospinal fluid (CSF) is at most 1% of the corresponding plasma concentration. {03} {16}

Volume of distribution (Vol D) during terminal phase—90±21 L. {17}

Vol D at steady state—38±8 L. {14}

Protein binding:

Very high (approximately 99.7%). {14} {15}


Undergoes little or no metabolism as shown by its long persistence in the blood, {03} {17} apparent lack of metabolites found in plasma chromatograms, and high ratio of renal to total body clearance. {14}


Terminal phase—About 36 to 60 days. {14} {17}

Peak plasma concentration

> 100 mcg per mL; this concentration persists for several weeks. {03} {14}

    Renal—Accounts for the elimination of most of the medication. {02} {14} {55} Suramin is very slowly excreted in the urine {03} {13} {14} {17} due to its combination with blood proteins. {03} {13} About 12% of radiolabeled suramin is recovered in the urine over a 40-day period after administration of the medication to patients with onchocerciasis. {17}
    Fecal—About 4.5% of radiolabeled suramin is recovered in the feces over a 40-day period after administration to patients with onchocerciasis. {17}

Precautions to Consider

Adequate and well-controlled studies in humans have not been done. {01} Suramin is not recommended for use in pregnant women with a chronic nonfatal condition such as onchocerciasis. {02} {03} {49} For a potentially fatal infection such as trypanosomiasis, it has been recommended that suramin be used during pregnancy only when there is no suitable alternative available. {49} The potential benefit of using suramin should justify the potential risk to the fetus. Eflornithine should be considered for use in pregnant women with trypanosomiasis. {39}

Studies in rats have shown that suramin does not cross the placenta into the embryo, but accumulates in the lysosomes of the phagocytic epithelial cells of the umbilical vesicle (which develops from the yolk sac). This interferes with embryonic nutrition resulting in adverse effect on the fetus. {03} {20}

Studies in pregnant rats given doses ranging from 30 mg per kg (mg/kg) of body weight per day (little more than the human therapeutic dose) to 75 mg/kg per day for 12 days have shown that suramin is very toxic, causing the death of 8 to 14% of the mother rats. In rats given higher doses (100 to 170 mg/kg), suramin had abortifacient but not teratogenic effects. {03}

Studies in pregnant mice given a dose of 25 mg/kg per day have not shown suramin to adversely affect the fetus. However, at doses of 40 to 65 mg/kg per day, suramin caused 64% fetal mortality and teratogenic effects were observed in the surviving fetuses. {03}


It is not known whether suramin is distributed into breast milk. However, problems in humans have not been documented.

No information is available on whether the risk of suramin-induced adverse effects is increased in children. However, because of this medication's toxicity, it should be used with caution, after less toxic alternatives have been considered and/or found ineffective. Recommended doses should not be exceeded and the patient should be carefully monitored during therapy. {39} {41} {45} {50}


In one study on the use of suramin in the treatment of onchocerciasis, it was noted that side effects are less well tolerated in this age group, with a longer period of recovery. {12} {40} Because of this medication's toxicity, suramin should be used with caution, after less toxic alternatives have been considered and/or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during therapy. {50}

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).

Risk-benefit should be considered when the following medical problems exist {45}
» Hepatic function impairment{02}{03}    (because some suramin may be absorbed by the liver, hepatic damage may occur through its action on the lysosomal enzymes; elevations of hepatic enzymes, jaundice, and hepatitis have been reported {03} {29} {56})

» Hypersensitivity to suramin{02}{03}
» Renal function impairment{01}{02}{03}    (suramin may be deposited as granules in the renal tubules and renal damage may occur {02} {03} {06} {25} {56})

Suramin should be used with caution in severely debilitated or malnourished patients.{01}{03}{06}{29}{36}
Note: In ocular onchocerciasis, prolonged administration of suramin may result in inflammation and subsequent degenerative changes in the optic disk and retina; the World Health Organization (WHO) prescribing information does not recommend treatment with suramin for totally blind patients with onchocerciasis unless they require relief from the intensely itchy lesions [onchodermatitis] unrelieved by safer alternative; WHO also does not recommend treatment with suramin for light to moderately infected patients whose eyes are not at risk. {48} {65}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

{45}» Complete blood count (CBC)    (suramin may decrease the concentration of erythrocytes, hemoglobin, or platelets on rare occasion {06} {10} {29} {53})

» Creatinine, serum    (should be measured regularly to assess renal function {40})

» Urinalysis    (should be performed before administration of each dose of suramin {47} {49} {56} {65} to detect the presence of albumin; {49} {56} moderate albuminuria indicates the need for a reduction in dose; heavy albuminuria, with the passage of cast cells, calls for immediate discontinuation of treatment {02} {03} {45} {53} {55})

For onchocerciasis
» Ophthalmologic examinations, including examinations for visual acuity, visual fields, and ophthalmoscopy    (ophthalmologic examinations for visual acuity and visual fields may be required prior to, and periodically during, therapy with suramin; slit-lamp examinations may be required before and after treatment, and periodically during treatment, with suramin to detect adverse reactions {02} {06} {12} {45} {55})

Side/Adverse Effects

Note: Adverse effects of suramin may result either from the intrinsic toxicity of this medication or from its filaricidal action. {02} {53} {65} Side effects are usually seen after the third dose, although some side effects may occur weeks after the completion of therapy. Patients should be monitored even after treatment is completed. {53} {65}
Suramin administration has been associated with a rare (1 person in 20,000) but potentially fatal idiosyncratic reaction (See below). This risk is greater in patients with trypanosomiasis who also have concurrent onchocerciasis. {51} {56} {65}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
Arthritis {25}{56}(joint pain)
erythematous maculopapular eruptions (skin rash{01}{28}{29}{37}{46}{56})
nephrotoxicity with albuminuria, transient (cloudy urine){06}{07}{11}{25}{29}{56}
neurological complications such as headache{06}{07}{32}
palmar-plantar hyperesthesias {01}{07}{25}{29}(tenderness of the palms and soles), paresthesias {06}{07}{29}{32}(crawling or tingling sensation of the skin), and peripheral neuropathy {06}{07}{32}(numbness or weakness in arms, hands, legs, or feet)
pruritus {07}{56}(itching)
relative adrenal insufficiency {25}{29}{36}{56}(diarrhea; easy fatigability; faintness, especially after missing meals; increased skin pigmentation; irritability; loss of appetite; nausea; vomiting)
urticaria (stinging sensation on skin; swelling on skin){56}

Incidence less frequent
Lymphadenopathy (painful tender glands in the neck, armpits, or groin{06}{07}{08}{09}{11}{25})
ocular effects such as lacrimation {29}(watery eyes), optic atrophy {06}{07}{08}{09}{11}{25}{29}(changes in or loss of vision), palpebral edema {29}(swelling around eyes), and photophobia {29}(increased sensitivity of eyes to light)
prostration (extreme tiredness or weakness){11}{25}
stomatitis (ulcers or sores in mouth){11}{12}{25}

Incidence rare
Blood dyscrasias such as agranulocytosis (fever and sore throat), anemia (unusual tiredness or weakness){06}{10}{29}, or thrombocytopenia (pinpoint red spots on skin; unusual bleeding or bruising){37}
exfoliative dermatitis (fever with or without chills; red, thickened, or scaly skin; swollen and/or painful glands; unusual bruising){02}{25}{56}
hepatitis (fever with or without chills; skin rash; swelling and/or tenderness in upper abdominal or stomach area; swollen and/or painful glands; unusual bleeding or bruising; unusual tiredness or weakness; yellow eyes or skin){56}
idiosyncratic reaction including collapse (loss of consciousness), nausea
shock (cold and clammy skin; decreased blood pressure; difficulty in breathing; increased heart rate; pale skin), and/or vomiting {01}{06}{07}{11}{25}{29}{30}{32}{56}
jaundice (yellow eyes or skin){56}

Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
Anorexia (loss of appetite){56}
fatigue (weakness){32}
fever {25}{32}
gastrointestinal disturbances (abdominal pain{32}; diarrhea{25}{32} ; nausea{06}{07}{32}; vomiting{06}{11})
malaise{06}{07}{32} (general feeling of discomfort)
metallic taste {06}{07}{32}

Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Suramin (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before receiving this medication
»   Conditions affecting use, especially:
Hypersensitivity to suramin; importance of receiving a test dose for hypersensitivity prior to receiving the full dose

Pregnancy—Not recommended for chronic non-fatal onchocerciasis; recommended during pregnancy for potentially life-threatening trypanosomiasis only if there are no suitable alternatives available; use should justify the potential risk to the fetus

Use in children—Use with caution at recommended doses after less toxic alternatives have been considered and/or found ineffective

Use in the elderly—Use with caution at recommended doses after less toxic alternatives have been considered and/or found ineffective
Other medical problems, especially hepatic function impairment and renal function impairment

Proper use of this medication
» Importance of receiving this medication in the hospital and on a regular schedule

» Proper dosing

Precautions after receiving this medication
Importance of regular visits with the physician after the end of therapy to check progress or adverse effects

Side/adverse effects
Signs of potential side effects, especially arthritis; erythematous maculopapular eruptions; nephrotoxicity; neurological complications such as headache, palmar-plantar hyperesthesias, paresthesias, and peripheral neuropathy; pruritus; relative adrenal insufficiency; urticaria; lymphadenopathy; ocular effects such as lacrimation, optic atrophy, palpebral edema, and photophobia; prostration; stomatitis; blood dyscrasias such as agranulocytosis, anemia, or thrombocytopenia; exfoliative dermatitis; hepatitis; idiosyncratic reaction including collapse, nausea, seizures, shock, and/or vomiting; and jaundice

General Dosing Information
Because suramin is highly toxic, it should be given only under medical supervision. {02} Patients being treated with suramin should receive this medication in the hospital {02} {51} {52} They should be observed for 24 hours after administration of each dose of the medication. {50} A careful assessment of the patient's capacity to withstand the effects of treatment should be done both before and during the administration of suramin. {52}

Suramin should be reconstituted with sterile water for injection and should be administered within 30 minutes {56} as a 10% solution by slow intravenous injection. {02}

Because of the risk of severe reactions, it is advisable to give an initial test dose of 100 to 200 mg (0.1 to 0.2 gram) in 2 mL of sterile water for injection before starting treatment. {02} {06} {10} {49} This test dose should be administered by slow intravenous injection. After injecting the first few microliters, wait at least 1 minute, then inject the next 0.5 mL over 30 seconds and wait one minute. Finally, inject the remainder of the dose over several minutes. Epinephrine (1:1000 solution), parenteral antihistamines, and corticosteroids should be available immediately to deal with any adverse reaction that may arise. {02} A patient who experiences an anaphylactic reaction after the first injection should never receive suramin again. {55}

For treatment of adverse effects
Recommended treatment consists of the following

   • For hypersensitivity reactions—Epinephrine (1:1000 solution), parenteral antihistamines, and corticosteroids. {02}
   • For thrombocytopenia—Intravenous injection of gammaglobulin. {37}
   • Reduction in dosage or discontinuation of treatment. {03}

Parenteral Dosage Forms

Note: Because suramin is not commercially available in the U.S. or Canada, the bracketed uses and the use of superscript 1 in the Dosage Forms section reflect the lack of labeled (approved) indications for this product in these countries.


Usual adult dose
[Trypanosomiasis, African (treatment)]1
Early stage: Intravenous, 100 to 200 mg (0.1 to 0.2 gram) administered slowly as a test dose for hypersensitivity. This is followed after twenty-four hours {46} {50} {64} by a dose of 20 mg per kg of body weight per day to a maximum of 1 gram {42} {56} on days one, three, seven, fourteen, and twenty-one, {10} {32} {34} {56} or weekly, until a total dose of 5 grams is achieved. {56} Patients in poor general condition should receive approximately one-quarter of the normal dose. {01} {46}

Late stage: Intravenous, 100 to 200 mg (0.1 to 0.2 gram) administered slowly as a test dose for hypersensitivity. {45} This is followed after twenty-four hours {46} {48} {50} by a dose of 10 mg per kilogram (kg) of body weight per day every five days for a total of twelve injections. This is given in combination with tryparsamide at a dose of 30 mg per kg of body weight (maximum of 2 grams) per day, also administered intravenously every five days, for a total of twelve injections. One month after completion of therapy, a second course of this combined treatment may be repeated, if necessary. {10} {34}

Note: The following table provides the World Health Organization (WHO) prescribing information for suramin. Doses are for both adults and children (in mg per kg of body weight per day), for cure of early or hemolymphatic stage (A) and for administration before melarsoprol treatment in the late stage (B) of the disease. {02}

  Dose (mg/kg of body weight) per Day

[Onchocerciasis (treatment)]1
Intravenous, 100 to 200 mg (0.1 to 0.2 gram) administered slowly as a test dose for hypersensitivity. Treatment with the full dose may then be started after one week. {48} A total of 66.7 mg per kg of body weight should be administered in six incremental weekly doses apportioned as follows: 3.3 mg/kg week one, 6.7 mg/kg week two, 10 mg/kg week three, 13.3 mg/kg week four, 16.7 mg/kg week five, and 16.7 mg/kg week six. {02}

Usual adult prescribing limits
Up to 1 {42} {56} to 1.5 {01} {28} {39} {41} {47} grams per day.

Usual pediatric dose
[Trypanosomiasis, African (treatment)]1
Early stage: Intravenous, 100 to 200 mg (0.1 to 0.2 gram) administered slowly as a test dose for hypersensitivity. This is followed after twenty-four hours by a dose of 10 to 20 mg per kg of body weight per day on days one, three, seven, fourteen, and twenty-one. {07} {10} {34} {46} {48}

Note: See also table based on the WHO prescribing information in Usual adult dose for the treatment of both early and late stage trypanosomiasis in children.

[Onchocerciasis (treatment)]1
Not usually recommended unless no safer alternative is available. {39} {41} {43} {50}

Usual pediatric prescribing limits
Up to 20 mg per kg of body weight per day. {10} {48}

Strength(s) usually available
Not commercially available.

Note: Although suramin is not commercially available in the U.S., it can be obtained from the Parasitic Disease Drug Service, Centers for Disease Control (CDC), Atlanta, Georgia 30333 (telephone nos.: 404-639-3670; 404-639-2888 on evenings, weekends, or holidays [emergencies only]). {10} {19}

Not commercially available.

Note: Although suramin is not commercially available in Canada, it is made available with authorization from the Bureau of Human Prescription Drugs (BHPD), Health Protection Branch (HPB), Health Canada, Tower B, 3rd Floor, 1600 Scott Street, Ottawa, Ontario K1A 0L2 (telephone no.: 613-941-2108). {40}


1 gram (Rx) [Antrypol] [Bayer 205 (Germany) (South Africa)] [Belganyl] [309 F] [Fourneau 309] [Germanin (Germany) (South Africa)] [Moranyl] [Naganin] [Naganol] [Naphuride{01}{07}{15}{33}{65}]

Packaging and storage:
Store below 25 °C (77 °F), unless otherwise specified by manufacturer. Protect from light. {01}

Preparation of dosage form:
The solution for injection should always be freshly prepared. {01} {33}. Using a sterile technique, slowly inject 10 mL sterile water for injection into the vial containing suramin. The mixture should then be shaken vigorously to dissolve the powder in the solution. {01}

Suramin should be used immediately (preferably within 30 minutes) {56} after reconstitution with sterile water for injection. {33}

Developed: 07/21/1995

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  1. Reviewers consensus on monograph revision of 6/94.
  1. Manufacturer's comment {Bayer (Pty) Ltd—South Africa}, 9/94.
  1. Panel comment, 9/94.
  1. Panel comment, 9/94.
  1. Reynolds JEF, editor. Martindale, the extra pharmacopeia. 29th ed. London: The Pharmaceutical Press, 1989: 515, 527-8.
  1. Panel comment, 9/94.
  1. Panel comments, 9/94.
  1. WHO Expert Committee Report on the Control of Onchocerciasis (TRS 1993): in press.
  1. WHO Expert Committee Report on African Trypanosomiasis (TRS739 1986): 72-3.
  1. Suramin box label (Bayer—Germany), Rec 10/93.
  1. Suramin data sheet from WHO Model Prescribing Information: Drugs used in Parasitic Diseases Rev. 1 (1994): in press.
  1. Strickland GT, editor. Hunter's Tropical Medicine. 7th ed. Philadelphia: W. B. Saunders Co, 1991: 625; 742-3.
  1. Pepin J, Guerin C, Ethier L, et al. Trial of prednisolone for the prevention of melarsoprol-induced encephalopathy in gambiense sleeping sickness. Lancet 1989; 1246-50.
  1. Eisenberger MA, Reyno LM, Jodrell DI, et al. Suramin, an active drug for prostate cancer: interim observations in a phase 1 trial. J Nat Can Inst 1993; 85(8): 611-20.
  1. Myers C, Cooper M, LaRocca R, et al. Suramin: a novel growth factor antagonist with activity in hormone-refractory metastatic prostate cancer. J Clin Oncol 1992; 10(6): 881-9.
  1. Rapoport BL, Falkson G, Raats JI, et al. Suramin in combination with mitomycin C in hormone-resistant prostate cancer. A phase II clinical study. Ann Oncol 1993; 4: 567-73.
  1. Reed E, Cooper MR, LaRocca, RV, et al. Suramin in advanced platinum-resistant ovarian cancer. Eur J Cancer 1992; 28A (4/5): 864-6.
  1. Stein CA, LaRocca RV, Thomas R, et al. Suramin: an anticancer drug with a unique mechanism of action. J Clin Oncol 1989; 7(4): 499-508.
  1. Vierhapper H, Nowotny P, Mostbeck G, et al. Effect of suramin in a patient with adrenocortical carcinoma. Lancet 1989; 1207-8.
  1. Panel comment, 2/95.
  1. Parasitic Disease Advisory Panel Meeting, 11/94.